- 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.
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 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.
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.
About Affimed N.V.
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 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 RelationsE-Mail:
IR@affimed.com
Affimed N.V.Consolidated
statements of comprehensive income/(loss) (in €
thousands)
|
|
|
|
2019 |
2018 |
2017 |
|
|
|
|
|
|
|
Revenue |
|
|
|
21,391 |
23,735 |
2,010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income –
net |
|
|
|
290 |
1,515 |
205 |
|
|
|
|
|
|
|
Research and
development expenses |
|
|
|
(43,791) |
(35,148) |
(21,489) |
|
|
|
|
|
|
|
General and
administrative expenses |
|
|
|
(10,266) |
(9,638) |
(7,986) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
|
|
(32,376) |
(19,536) |
(27,260) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance
income / (costs) – net |
|
|
|
15 |
60 |
(2,983) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before tax |
|
|
|
(32,361) |
(19,476) |
(30,243) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
|
(4) |
(1) |
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for
the period |
|
|
|
(32,365) |
(19,477) |
(30,223) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income / (loss) Items that will not
be reclassified to profit or lossEquity investments at
fair valueOCI – net change in fair value |
|
|
|
(632) |
(4,731) |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income / (loss) |
|
|
|
(632) |
(4,731) |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive loss |
|
|
|
(32,997) |
(24,208) |
(30,223) |
|
|
|
|
|
|
|
Loss per
share in € per share |
|
|
|
(0.50) |
(0.32) |
(0.69) |
|
|
|
|
|
|
|
(undiluted
= diluted) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
number of common shares outstanding |
|
|
64,242,396 60,514,407 |
43,746,073 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Affimed N.V.Consolidated
statements of financial position (in € thousands)
|
December 31, 2019 |
|
December 31, 2018 |
|
|
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
137 |
|
56 |
Leasehold improvements and
equipment |
2,291 |
|
1,414 |
Long term financial
assets |
3,193 |
|
3,825 |
Right-of-use assets |
824 |
|
0 |
|
6,445 |
|
5,295 |
Current
assets |
|
|
|
Cash and cash equivalents |
95,234 |
|
94,829 |
Financial assets |
8,902 |
|
13,974 |
Trade and other
receivables |
1,482 |
|
1,429 |
Inventories |
296 |
|
260 |
Other assets |
0 |
|
387 |
|
105,914 |
|
110,879 |
TOTAL
ASSETS |
112,359 |
|
116,174 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
762 |
|
624 |
Capital reserves |
270,451 |
|
239,055 |
Fair value reserves |
1,962 |
|
2,594 |
Accumulated deficit |
(234,508) |
|
(202,144) |
Total
equity |
38,667 |
|
40,129 |
|
|
|
|
Non-current
liabilities |
|
|
|
Borrowings |
278 |
|
1,690 |
Contract liabilities |
37,961 |
|
37,512 |
Lease liabilities |
272 |
|
0 |
Total non-current
liabilities |
38,511 |
|
39,202 |
|
|
|
|
Current
liabilities |
|
|
|
Trade and other payables |
10,674 |
|
9,425 |
Provisions |
517 |
|
0 |
Borrowings |
2,105 |
|
3,083 |
Lease liabilities |
532 |
|
0 |
Contract
liabilities |
21,353 |
|
24,335 |
Total current
liabilities |
35,181 |
|
36,843 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
112,359 |
|
116,174 |
Affimed N.V.Consolidated
statements of cash flows (in € thousands)
|
2019 |
|
2018 |
|
2017 |
Cash flow from
operating activities |
|
|
|
|
|
Loss for the period |
(32,365) |
|
(19,477) |
|
(30,223) |
Adjustments for the
period: |
|
|
|
|
|
- Income taxes |
4 |
|
1 |
|
(20) |
- Depreciation and
amortisation |
906 |
|
403 |
|
351 |
- Net gain from disposal of
leasehold improvements and equipment |
(5) |
|
25 |
|
(19) |
- Share based
payments |
2,469 |
|
2,035 |
|
1,943 |
- Finance income / costs –
net |
(15) |
|
(60) |
|
2,983 |
|
(29,006) |
|
(17,073) |
|
(24,985) |
Change in trade and other
receivables |
33 |
|
(322) |
|
1,140 |
Change in inventories |
(36) |
|
(19) |
|
(44) |
Change in other
assets |
340 |
|
121 |
|
(399) |
Change in trade, other
payables, provisions and contract liabilities |
(791) |
|
66,856 |
|
(1,018) |
Cash used in operating
activities |
(29,460) |
|
49,563 |
|
(25,306) |
Interest received |
628 |
|
218 |
|
106 |
Paid interest |
(224) |
|
(342) |
|
(349) |
Paid income tax |
0 |
|
(1) |
|
0 |
Net cash used in
operating activities |
(29,056) |
|
49,438 |
|
(25,549) |
|
|
|
|
|
|
Cash flow from
investing activities |
|
|
|
|
|
Purchase of intangible
assets |
(150) |
|
(30) |
|
(43) |
Purchase of leasehold
improvements and equipment |
(1,324) |
|
(691) |
|
(625) |
Cash received from the sale of
leasehold improvements and equipment |
0 |
|
1 |
|
35 |
Cash paid for investments in
convertible note and warrants |
0 |
|
0 |
|
(296) |
Cash paid for investments in
financial assets |
(45,131) |
|
(14,029) |
|
(13,084) |
Cash received from maturity of
financial assets |
50,945 |
|
0 |
|
22,063 |
Cash paid for investments in
long term financial assets |
0 |
|
(861) |
|
0 |
Net cash used for
investing activities |
4,340 |
|
(15,610) |
|
8,050 |
|
|
|
|
|
|
Cash flow from
financing activities |
|
|
|
|
|
Proceeds from issue of common
shares |
31,373 |
|
25,113 |
|
23,123 |
Transaction costs related to
issue of common shares |
(2,215) |
|
(1,701) |
|
(1,648) |
Proceeds from
borrowings |
562 |
|
0 |
|
2,500 |
Transaction costs related to
borrowings |
0 |
|
0 |
|
(11) |
Repayment of lease
liabilities |
(405) |
|
0 |
|
0 |
Repayment of
borrowings |
(3,277) |
|
(2,917) |
|
(167) |
Cash flow from
financing activities |
26,038 |
|
20,495 |
|
23,797 |
Exchange-rate related
changes of cash and cash equivalents |
(917) |
|
669 |
|
(1,867) |
Net changes to cash
and cash equivalents |
1,322 |
|
54,323 |
|
6,297 |
Cash and cash
equivalents at the beginning of the period |
94,829 |
|
39,837 |
|
35,407 |
Cash and cash
equivalents at the end of the period |
95,234 |
|
94,829 |
|
39,837 |
Affimed N.V.Consolidated
statements of changes in equity (in € thousands)
|
Issued capital |
|
Capital reserves |
|
Fair value reserves |
|
Accumulated deficit |
|
Total equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2017 |
333 |
|
190,862 |
|
0 |
|
(152,444) |
|
38,751 |
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
135 |
|
20,922 |
|
|
|
|
|
21,057 |
Equity-settled share based
payment awards |
|
|
1,943 |
|
|
|
|
|
1,943 |
Issue of warrant note (loan
Silicon Valley Bank) |
|
|
51 |
|
|
|
|
|
51 |
Loss for the period |
|
|
|
|
|
|
(30,223) |
|
(30,223) |
|
|
|
|
|
|
|
|
|
|
Balance as of December
31, 2017 |
468 |
|
213,778 |
|
0 |
|
(182,667) |
|
31,579 |
|
|
|
|
|
|
|
|
|
|
Revaluation shares Amphivena
(first time adoption IFRS 9) |
|
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2018 |
468 |
|
213,778 |
|
7,325 |
|
(182,667) |
|
38,904 |
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
156 |
|
23,171 |
|
|
|
|
|
23,327 |
Exercise of share based
payment awards |
|
|
71 |
|
|
|
|
|
71 |
Equity-settled share based
payment awards |
|
|
2,035 |
|
|
|
|
|
2,035 |
Loss for the period |
|
|
|
|
|
|
(19,477) |
|
(19,477) |
Other comprehensive
income |
|
|
|
|
(4,731) |
|
|
|
(4,731) |
|
|
|
|
|
|
|
|
|
|
Balance as of December
31, 2018 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2019 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
138 |
|
28,901 |
|
|
|
|
|
29,039 |
Exercise of share based
payment awards |
|
|
26 |
|
|
|
|
|
26 |
Equity-settled share based
payment awards |
|
|
2,469 |
|
|
|
|
|
2,469 |
Loss for the period |
|
|
|
|
|
|
(32,365) |
|
(32,365) |
Other comprehensive
income |
|
|
|
|
(632) |
|
|
|
(632) |
|
|
|
|
|
|
|
|
|
|
Balance as of December
31, 2019 |
762 |
|
270,451 |
|
1,962 |
|
(234,508) |
|
38,667 |
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