UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of April, 2020
Commission File Number: 001-36619
Affimed N.V.
Im Neuenheimer Feld 582,
69120 Heidelberg,
Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or
Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
EXHIBIT INDEX
|
Exhibit |
|
Description of Exhibit |
|
99* |
|
|
* |
Exhibit 99 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act. |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in Heidelberg, Germany.
April 28, 2020.
AFFIMED N.V.
By: /s/ Adi Hoess
Name: Adi Hoess
Title: Chief Executive Officer
By: /s/ Wolfgang Fischer
Name: Wolfgang Fischer
Title: Chief Operating Officer
3
Exhibit 99.1
Affimed Reports 2019 Financial Results and Recent Operational Progress
|
|
· |
|
AFM24: First patient dosed in first-in-human clinical study for advanced EGFR-expressing solid tumors, including colon, lung and other cancers |
|
|
· |
|
AFM13: Initiated registration-directed study in relapsed/refractory peripheral T cell lymphoma; received FDA orphan drug designation for the treatment of T cell lymphoma |
|
|
· |
|
CMO and CSO appointments strengthen executive management team and position company to continue its leadership in innate immunity |
|
|
· |
|
Genentech collaboration: Affimed received milestone payment triggered by Genentech’s selection of final target; ongoing collaboration on track with multiple programs progressing |
|
|
· |
|
Raised €29.5 million in net proceeds from a public equity offering in November 2019 |
Heidelberg, Germany, April 28, 2020 - 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 year ended December 31, 2019 and provided an update on clinical and corporate progress.
“Our clinical trials currently remain active, and we are working closely with our participating physicians and clinical sites to minimize the impact on further progress as they focus on addressing the evolving COVID-19 global health crisis,” said Dr. Adi Hoess, Affimed’s CEO. “During these unprecedented and challenging times, our top priority continues to be supporting our employees, patients and our healthcare partners, while ensuring the continuity of our operations.”
Development Program Updates
Affimed remains committed to continuing its development programs but acknowledges the impact from the evolving COVID-19 pandemic on clinical studies, including potential delays in patient enrollment. The company plans to update expected timing of milestones for its clinical studies after there is more clarity on the duration and magnitude of the impact from the COVID-19 pandemic.
1
AFM13 (CD30/CD16A)
|
|
· |
|
Patient enrollment is ongoing in the Phase 2 registration-directed study of AFM13 as a monotherapy in relapsed or refractory patients with CD30-positive peripheral T cell lymphoma (pTCL). Affimed has successfully activated 42 clinical study sites across nine countries. To ensure patient safety and to avoid imposing additional burdens on healthcare systems already strained by the COVID-19 pandemic, the company has taken the decision to temporarily pause enrollment in the exploratory cohort of patients with CD30-positive relapsed or refractory transformed mycosis fungoides. |
|
|
· |
|
In March 2020, enrollment of all 15 patients was completed in an investigator-sponsored Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. Previously reported data from the study confirmed single-agent activity of AFM13, with an objective response rate (ORR) of 50% (5 of 10 patients). |
|
|
· |
|
Affimed is in close collaboration with the University of Texas MD Anderson Cancer Center (MDACC) to initiate an investigator-sponsored Phase 1 study to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) to patients with relapsed/refractory CD30-positive lymphoid malignancies. |
AFM24 (EGFR/CD16A)
|
|
· |
|
The first patient was successfully dosed in a first-in-human Phase 1/2a clinical trial of AFM24. The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in patients with advanced solid malignancies known to be EGFR-positive and whose disease has progressed after treatment with previous anticancer therapies. |
Preclinical Pipeline Update
|
|
· |
|
Affimed continues to progress AFM28 and AFM32 as preclinical research currently remains unimpacted by the COVID-19 pandemic. |
Genentech Collaboration Update
|
|
· |
|
In November 2019, Genentech exercised its final option for an exclusive target under the ongoing, multi-program strategic oncology collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK® platform to treat multiple cancers. Affimed received a payment from Genentech in an undisclosed amount based on this achievement. Affimed and Genentech |
2
|
continue to progress multiple programs under the ongoing strategic, multi-target collaboration. |
Management Appointments
|
|
· |
|
Dr. Andreas Harstrick joined Affimed as Chief Medical Officer (CMO) in March 2020 and Dr. Arndt Schottelius joined the company as Chief Scientific Officer (CSO) in April 2020. Dr. Harstrick brings a track record of running successful clinical trials that have led to regulatory approvals, deep oncology expertise, and a proven ability to lead large clinical organizations. Dr. Schottelius brings extensive innate immunity expertise, R&D leadership and a successful record of advancing and translating discovery research into preclinical and clinical development. |
COVID-19 Impact Mitigation
COVID-19 has significantly impacted the global healthcare system, including the conduct of clinical trials as medical institutions prioritize the treatment of those afflicted with COVID-19. Affimed has taken several important actions to balance the commitment to treat cancer patients and to mitigate potential health and safety risks posed by the COVID-19 pandemic, while maintaining continuity of its operations and preserving financial flexibility for the future.
Full Year 2019 Financial Highlights
Cash, cash equivalents and current financial assets totaled €104.1 million as of December 31, 2019 compared to €108.8 million as of December 31, 2018. During the fourth quarter of 2019, the company raised €29.5 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, from a completed public offering. Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets as of December 31, 2019 will support operations at least into the first half of 2022.
Net cash used in operating activities was €29.1 million for the twelve months ended December 31, 2019, compared to net cash from operating activities of €49.4 million for the twelve months ended December 31, 2018. The net cash from operating activities in 2018 includes an initial upfront payment and committed funding of €83.2 million ($96.0 million) from the strategic collaboration Affimed entered into with Genentech Inc. in August 2018.
Total revenue was €21.4 million for the year ended December 31, 2019 compared to €23.7 million for the year ended December 31, 2018. Revenue in both years is attributable primarily to the recognition of revenue from the Genentech collaboration in the respective years.
3
Research and development (R&D) expenses were €43.8 million for the year ended December 31, 2019, compared to €35.1 million for the year ended December 31, 2018. The increase was primarily related to higher expenses for startup activities for the AFM13 registration-directed study in pTCL, manufacturing activities for AFM13 clinical study material, and early stage development and discovery activities.
General and administrative (G&A) expenses were €10.3 million for the year ended December 31, 2019, compared to €9.6 million for the year ended December 31, 2018. In 2019, G&A expenses were primarily related to personnel expenses and legal, consulting and audit costs.
Net loss was €32.4 million, or €0.50 per common share, for the year ended December 31, 2019, compared to a net loss of €19.5 million, or €0.32 per common share, for the year ended December 31, 2018.
Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2019 and “Item 5. Operating and Financial Review and Prospects,” which will be included in Affimed’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).
Note on International Financial Reporting Standards (IFRS)
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.
Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Tuesday, April 28, 2020 at 8:30 a.m. Eastern time to discuss the company’s 2019 financial results and recent corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (877) 870-9135 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 7978047 approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts_cp/, and a replay of the webcast will be accessible at the same link for 30 days following the call.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows
4
innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. 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, the potential of AFM24, 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, 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, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. 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.
Affimed Investor and Media Contact:
Gregory Gin, Head of Investor Relations
E-Mail: IR@affimed.com
5
Affimed N.V.
Consolidated statements of comprehensive income/(loss) (in € thousands)
|
|
|
2019 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income – net |
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
|
|
|
|
|
|
General and administrative expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance income / (costs) – net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income / (loss) |
|
|
|
|
|
|
|
|
Items that will not be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Equity investments at fair value |
|
|
|
|
|
|
|
|
OCI – net change in fair value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income / (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share in € per share |
|
|
|
|
|
|
|
|
(undiluted = diluted) |
|
|
|
|
|
|
|
|
Weighted number of common shares outstanding |
|
|
|
|
|
|
|
6
Affimed N.V.
Consolidated statements of financial position (in € thousands)
|
|
|
December 31, 2019 |
|
December 31, 2018 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Non-current assets |
|
|
|
|
|
Intangible assets |
|
|
|
|
|
Leasehold improvements and equipment |
|
|
|
|
|
Long term financial assets |
|
|
|
|
|
Right-of-use assets |
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
Financial assets |
|
|
|
|
|
Trade and other receivables |
|
|
|
|
|
Inventories |
|
|
|
|
|
Other assets |
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
|
|
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
|
Equity |
|
|
|
|
|
Issued capital |
|
|
|
|
|
Capital reserves |
|
|
|
|
|
Fair value reserves |
|
|
|
|
|
Accumulated deficit |
|
|
|
|
|
Total equity |
|
|
|
|
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Borrowings |
|
|
|
|
|
Contract liabilities |
|
|
|
|
|
Lease liabilities |
|
|
|
|
|
Total non-current liabilities |
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Trade and other payables |
|
|
|
|
|
Provisions |
|
|
|
|
|
Borrowings |
|
|
|
|
|
Lease liabilities |
|
|
|
|
|
Contract liabilities |
|
|
|
|
|
Total current liabilities |
|
|
|
|
|
|
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES |
|
|
|
|
7
Affimed N.V.
Consolidated statements of cash flows (in € thousands)
|
|
|
2019 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
Cash flow from operating activities |
|
|
|
|
|
|
|
Loss for the period |
|
|
|
|
|
|
|
Adjustments for the period: |
|
|
|
|
|
|
|
- Income taxes |
|
|
|
|
|
|
|
- Depreciation and amortisation |
|
|
|
|
|
|
|
- Net gain from disposal of leasehold improvements and equipment |
|
|
|
|
|
|
|
- Share based payments |
|
|
|
|
|
|
|
- Finance income / costs – net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in trade and other receivables |
|
|
|
|
|
|
|
Change in inventories |
|
|
|
|
|
|
|
Change in other assets |
|
|
|
|
|
|
|
Change in trade, other payables, provisions and contract liabilities |
|
|
|
|
|
|
|
Cash used in operating activities |
|
|
|
|
|
|
|
Interest received |
|
|
|
|
|
|
|
Paid interest |
|
|
|
|
|
|
|
Paid income tax |
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from investing activities |
|
|
|
|
|
|
|
Purchase of intangible assets |
|
|
|
|
|
|
|
Purchase of leasehold improvements and equipment |
|
|
|
|
|
|
|
Cash received from the sale of leasehold improvements and equipment |
|
|
|
|
|
|
|
Cash paid for investments in convertible note and warrants |
|
|
|
|
|
|
|
Cash paid for investments in financial assets |
|
|
|
|
|
|
|
Cash received from maturity of financial assets |
|
|
|
|
|
|
|
Cash paid for investments in long term financial assets |
|
|
|
|
|
|
|
Net cash used for investing activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from financing activities |
|
|
|
|
|
|
|
Proceeds from issue of common shares |
|
|
|
|
|
|
|
Transaction costs related to issue of common shares |
|
|
|
|
|
|
|
Proceeds from borrowings |
|
|
|
|
|
|
|
Transaction costs related to borrowings |
|
|
|
|
|
|
|
Repayment of lease liabilities |
|
|
|
|
|
|
|
Repayment of borrowings |
|
|
|
|
|
|
|
Cash flow from financing activities |
|
|
|
|
|
|
|
Exchange-rate related changes of cash and cash equivalents |
|
|
|
|
|
|
|
Net changes to cash and cash equivalents |
|
|
|
|
|
|
|
Cash and cash equivalents at the beginning of the period |
|
|
|
|
|
|
|
Cash and cash equivalents at the end of the period |
|
|
|
|
|
|
8
Affimed N.V.
Consolidated statements of changes in equity (in € thousands)
|
|
|
Issued
|
|
Capital
|
|
Fair value
|
|
Accumulated
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
|
|
|
|
|
|
|
|
|
Equity-settled share based payment awards |
|
|
|
|
|
|
|
|
|
|
|
Issue of warrant note (loan Silicon Valley Bank) |
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revaluation shares Amphivena (first time adoption IFRS 9) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
|
|
|
|
|
|
|
|
|
Exercise of share based payment awards |
|
|
|
|
|
|
|
|
|
|
|
Equity-settled share based payment awards |
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
|
|
|
|
|
|
|
|
|
|
Exercise of share based payment awards |
|
|
|
|
|
|
|
|
|
|
|
Equity-settled share based payment awards |
|
|
|
|
|
|
|
|
|
|
|
Loss for the period |
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2019 |
|
|
|
|
|
|
|
|
|
|
9