Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology
company committed to giving patients back their innate ability to
fight cancer, today reported financial results for the quarter
ended March 31, 2021, and provided an update on clinical and
corporate progress.
“As we continue to build momentum with our clinical programs, we
see growing interest in the important work that we are doing in the
emerging field of innate immuno-oncology. We published clinical
data for AFM13 that is supporting our three-pronged development
strategy of our ICE® as monotherapy, in combination with NK cells
and in combination with a checkpoint inhibitor,” said Dr. Adi
Hoess, CEO of Affimed. “Over the next several months, we have a
number of value-creating events on AFM13, AFM24, where we expect to
initiate several clinical studies, and AFM28, and are allocating
capital across our portfolio to develop multiple opportunities for
shareholder value creation.”
Clinical Stage Program UpdatesAFM13
(CD30/CD16A)
- Affimed is continuing to recruit patients in the REDIRECT study
(AFM13-202) after reporting positive results from the preplanned
interim futility analysis in March 2021; the trial combined the
high- and low-CD30 expressing cohorts into one. Affimed expects to
complete enrollment in the study in the first half of 2022.
REDIRECT is a phase 2, registration-directed study of AFM13 as
monotherapy in patients with relapsed or refractory CD30-positive
peripheral T-cell lymphoma (PTCL).
- Affimed reported all three dose escalation cohorts in the
investigator sponsored trial (IST) at The University of Texas MD
Anderson Cancer Center of AFM13 precomplexed with natural killer
(NK) cells (AFM13-104) are now fully enrolled. The study is
evaluating increasing doses of cord-blood derived NK cells
pre-complexed with AFM13 followed by three weekly infusions of
AFM13 monotherapy in patients with recurrent or refractory
CD30-positive lymphomas.
- Preclinical data published in
Clinical Cancer Research support the therapeutic potential of
AFM13, demonstrating that AFM13 in combination with NK cells
improved tumor recognition and enhanced tumor cell killing in vitro
and in vivo compared to NK cells alone. This data supported the
Investigational New Drug (IND) application for the ongoing phase 1
clinical study of AFM13 pre-complexed with NK cells.
AFM24 (EGFR/CD16A)
- AFM24-101, the phase 1/2a clinical trial of AFM24, the
EGFR/CD16A targeted ICE® for patients with EGFR-expressing solid
tumors, completed dose cohort 5 (320 mg) and patients are currently
being enrolled and treated in dose cohort 6 (480 mg). Affimed
expects to determine the recommended phase 2 dose and initiate dose
expansion cohorts in the second half of 2021.
- The phase 1/2a combination study of AFM24 with NKGen Biotech’s
autologous NK cell therapy, SNK01, a first-in-human proof of
concept trial with EGFR-expressing solid tumors is on track to
start in the second half of 2021.
- The phase 1/2a combination study of AFM24 with the PD-L1
checkpoint inhibitor atezolizumab (Tecentriq®) with EGFR-expressing
solid tumors is on track to start in the second half of 2021.
Preclinical and Partnered Programs
- Affimed expects to disclose the target of its preclinical asset
AFM28 and publish initial preclinical data in the second half of
2021. The company remains on track to file an IND application for
AFM28 in the first half of 2022.
- Genentech has completed the dose
escalation portion of the phase 1 study of RO7297089
(anti-BCMA/CD16A). No dose limiting toxicities were observed during
the study. However, due to broader portfolio considerations,
Genentech decided to stop the phase 1 study of RO7297089. The
decision does not impact the development of other targets pursuant
to the collaboration agreement with Genentech.
First Quarter 2021 Financial Highlights
(Figures for the quarter ended March 31, 2021, and 2020 are
unaudited.)
As of March 31, 2021, cash and cash equivalents totaled €240.7
million compared to €146.9 million on December 31, 2020. Based on
its current operating plan and assumptions, Affimed anticipates
that its cash and cash equivalents will support operations into the
second half of 2023.
Net cash used in operating activities for the quarter ended
March 31, 2021, was €16.0 million compared to €16.5 million for the
quarter ended March 31, 2020.
Total revenue for the quarter ended March 31, 2021, was €11.7
million compared with €5.1 million for the quarter ended March 31,
2020. Revenue predominately relates to the Genentech and Roivant
collaborations.
Research and development expenses for the quarter ended March
31, 2021, remained flat at €11.4 million compared to the quarter
ended March 31, 2020.
General and administrative expenses increased 27.3% from €3.5
million in the quarter ended March 31, 2020, to €4.5 million in the
quarter ended March 31, 2021. The increase relates largely to
higher personnel expenses, higher premiums for our Directors and
Officers liability insurance and higher legal and consulting
expenses.
Net finance income for the quarter ended March 31, 2021,
increased by 242% from €1.6 million in the quarter ended March 31,
2020, to €5.5 million. This increase is largely due to foreign
exchange gains related to assets denominated in U.S. dollars as a
result of the strengthening of the U.S. dollar against the Euro
during the quarter.
Net income for the quarter ended March 31, 2021, was €1.4
million, or €0.01 per common share compared with a net loss of €8.3
million, or loss €0.11 per common share, for the quarter ended
March 31, 2020.
The weighted number of common shares outstanding for the quarter
ended March 31, 2021, was 116.2 million.
Additional information regarding these results will be included
in the notes to the consolidated financial statements as of March
31, 2021 of Affimed’s filings with the U.S. Securities and Exchange
Commission (SEC).
Note on International Financial Reporting Standards
(IFRS)Affimed prepares and reports 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, July 1,
2021, at 8:30 a.m. EDT to discuss first quarter 2021 financial
results and recent corporate developments. The conference call will
be available via phone and webcast.
To access the call, please dial +1 (409) 220-9054 for U.S.
callers, or +44 (0) 8000 323836 for international callers, and
reference passcode 4485380 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/. 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 by actualizing the untapped potential of the innate
immune system. The company’s proprietary ROCK® platform enables a
tumor-targeted approach to recognize and kill a range of
hematologic and solid tumors, enabling a broad pipeline of
wholly-owned and partnered single agent and combination therapy
programs. The ROCK® platform predictably generates customized
innate cell engager (ICE®) molecules, which use patients’ immune
cells to destroy tumor cells. This innovative approach enabled
Affimed to become the first company with a clinical-stage ICE®.
Headquartered in Heidelberg, Germany, with offices in New York, NY,
Affimed is led by an experienced team of biotechnology and
pharmaceutical leaders united by a bold vision to stop cancer from
ever derailing patients’ lives. For more about the company’s
people, pipeline and partners, please visit: www.affimed.com.
Forward-Looking StatementsThis 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 AFM13, AFM24, and our other product candidates,
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. Investor
Relations ContactAlexander FudukidisDirector, Head of
Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917)
436-8102
AFFIMED N.V. |
Unaudited consolidated statements of comprehensive income /
(loss) |
(in € thousand) |
|
|
|
|
|
|
For the three-months
ended March
31, |
|
|
|
2021 |
|
|
2020 |
|
Revenue |
|
11,659 |
|
|
5,135 |
|
|
|
|
|
|
|
|
Other income – net |
|
147 |
|
|
(57 |
) |
Research and development
expenses |
|
(11,405 |
) |
|
(11,449 |
) |
General and administrative
expenses |
|
(4,486 |
) |
|
(3,525 |
) |
|
|
|
|
|
|
|
Operating
loss |
|
(4,085 |
) |
|
(9,896 |
) |
|
|
|
|
|
|
|
Finance
income / (costs)
– net |
|
5,499 |
|
|
1,607 |
|
|
|
|
|
|
|
|
Income
/ (loss) before
tax |
|
1,414 |
|
|
(8,289 |
) |
Income taxes |
|
(2 |
) |
|
0 |
|
|
|
|
|
|
|
|
Income
/ (loss) for
the period |
|
1,412 |
|
|
(8,289 |
) |
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 |
|
(1,253 |
) |
|
81 |
|
Other
comprehensive income
/ (loss) |
|
(1,253 |
) |
|
81 |
|
Total
comprehensive income
/ (loss) |
|
159 |
|
|
(8,208 |
) |
|
|
|
|
|
Earnings
/ (loss) per
share in €
per share |
|
0.01 |
|
|
(0.11 |
) |
(undiluted
= diluted) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
number of common
shares outstanding |
|
116,204,455 |
|
|
76,249,901 |
|
Unaudited
consolidated statements
of financial
position(in €
thousand) |
|
|
March 31,
2021(unaudited) |
|
December 31,
2020 |
ASSETS |
|
|
Non-current
assets |
|
|
Intangible assets |
1,688 |
|
|
1,718 |
|
Leasehold improvements and
equipment |
3,030 |
|
|
2,226 |
|
Long term financial assets |
18,789 |
|
|
20,042 |
|
Right-of-use assets |
1,151 |
|
|
940 |
|
|
24,658 |
|
|
24,926 |
|
Current
assets |
|
|
Cash and cash equivalents |
240,672 |
|
|
146,854 |
|
Trade and other receivables |
4,173 |
|
|
2,439 |
|
Inventories |
435 |
|
|
246 |
|
Other assets |
648 |
|
|
1,260 |
|
|
245,928 |
|
150,799 |
|
TOTAL
ASSETS |
270,586 |
|
|
175,725 |
|
|
|
|
|
EQUITY
AND LIABILITIES |
|
|
|
Equity |
|
|
|
|
|
|
|
Issued capital |
1,190 |
|
|
983 |
|
Capital reserves |
441,644 |
|
|
345,164 |
|
Fair value reserves |
467 |
|
|
1,720 |
|
Accumulated deficit |
(274,462 |
) |
|
(275,874 |
) |
Total
equity |
168,839 |
|
|
71,993 |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
|
|
Borrowings |
9,979 |
|
|
231 |
|
Contract liabilities |
28,550 |
|
|
35,992 |
|
Lease liabilities |
686 |
|
|
482 |
|
Total
non-current liabilities |
39,215 |
|
|
36,705 |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Trade and other payables |
10,974 |
|
|
11,394 |
|
Borrowings |
92 |
|
|
92 |
|
Lease liabilities |
546 |
|
|
492 |
|
Contract liabilities |
50,920 |
|
|
55,049 |
|
Total
current liabilities |
62,532 |
|
|
67,027 |
|
|
|
|
|
|
|
TOTAL
EQUITY AND
LIABILITIES |
270,586 |
|
|
175,725 |
|
Unaudited consolidated statements
of cash
flows |
|
|
|
|
|
|
(in €
thousand) |
|
|
|
|
|
|
|
|
For the three
months ended
March 31, |
|
Cash
flow from
operating activities |
|
2021 |
|
|
2020 |
|
Income / (loss) for the
period |
|
1,412 |
|
|
(8,289 |
) |
Adjustments for the
period: |
|
|
|
|
- Income taxes |
|
2 |
|
|
0 |
|
- Depreciation and
amortization |
|
331 |
|
|
280 |
|
- Share based payments |
|
1,109 |
|
|
727 |
|
- Finance income / costs -
net |
|
(5,499 |
) |
|
(1,607 |
) |
|
|
(2,645 |
) |
|
(8,889 |
) |
|
|
|
|
|
|
|
Change in trade and other
receivables |
|
(1,735 |
) |
|
(750 |
) |
Change in inventories |
|
(189 |
) |
|
(41 |
) |
Change in other assets |
|
411 |
|
|
0 |
|
Change in trade, other
payables, provisions and contract liabilities |
|
(11,822 |
) |
|
(6,999 |
) |
Cash used in operating
activities |
|
(15,980 |
) |
|
(16,679 |
) |
Interest received |
|
0 |
|
|
160 |
|
Paid interest |
|
(50 |
) |
|
(28 |
) |
Paid income tax |
|
(2 |
) |
|
0 |
|
Net
cash used in
operating activities |
|
(16,032 |
) |
|
(16,547 |
) |
|
|
|
|
|
Cash
flow from
investing activities |
|
|
|
|
Purchase of intangible
assets |
|
(4 |
) |
|
(2 |
) |
Purchase of leasehold
improvements and equipment |
|
(962 |
) |
|
(20 |
) |
Cash received from maturity of
financial assets |
|
0 |
|
|
3,736 |
|
Net
cash used for
investing activities |
|
(966 |
) |
|
3,714 |
|
|
|
|
|
|
Cash
flow from
financing activities |
|
|
|
|
Proceeds from issue of common
shares |
|
101,860 |
|
|
0 |
|
Transaction costs related to
issue of common shares |
|
(6,350 |
) |
|
0 |
|
Proceeds from borrowings |
|
10,000 |
|
|
0 |
|
Transaction costs related to
borrowings |
|
(201 |
) |
|
0 |
|
Repayment of lease
liabilities |
|
(92 |
) |
|
(128 |
) |
Repayment of borrowings |
|
(23 |
) |
|
(773 |
) |
Cash
flow from
financing activities |
|
105,194 |
|
|
(901 |
) |
Exchange-rate
related changes
of cash and
cash equivalents |
|
5,622 |
|
|
1,265 |
|
Net
changes to cash
and cash
equivalents |
|
88,196 |
|
|
(13,734 |
) |
Cash
and cash
equivalents at
the beginning of
the period |
|
146,854 |
|
|
95,234 |
|
Cash
and cash
equivalents at
the end of
the period |
|
240,672 |
|
|
82,765 |
|
Unaudited
consolidated statements of changes in equity |
(in € thousand) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issued capital |
|
|
Capital reserves |
|
|
Fair value reserves |
|
|
Accumulated deficit |
|
Total equity |
Balance as of January
1, 2020 |
|
762 |
|
|
270,451 |
|
|
1,962 |
|
|
|
(234,508 |
) |
|
38,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity-settled share based
payment awards |
|
|
|
|
727 |
|
|
|
|
|
|
|
727 |
|
Loss for the period |
|
|
|
|
|
|
|
|
|
|
(8,289 |
) |
|
(8,289 |
) |
Other comprehensive
income |
|
|
|
|
|
|
|
81 |
|
|
|
|
|
81 |
|
Balance as of
March 31, 2020 |
|
762 |
|
|
271,178 |
|
|
2,043 |
|
|
|
(242,797 |
) |
|
31,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2021 |
|
983 |
|
|
345,164 |
|
|
1,720 |
|
|
|
(275,874 |
) |
|
71,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
204 |
|
|
94,215 |
|
|
|
|
|
|
|
94,419 |
|
Exercise of share based
payment awards |
|
3 |
|
|
1,156 |
|
|
|
|
|
|
|
1,159 |
|
Equity-settled share based
payment awards |
|
|
|
|
1,109 |
|
|
|
|
|
|
|
1,109 |
|
Income for the period |
|
|
|
|
|
|
|
|
|
|
1,412 |
|
|
1,412 |
|
Other comprehensive
income |
|
|
|
|
|
|
|
(1,253 |
) |
|
|
|
|
(1,253 |
) |
Balance as of
March 31, 2021 |
|
1,190 |
|
|
441,644 |
|
|
467 |
|
|
|
(274,462 |
) |
|
168,839 |
|
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Sep 2023 to Sep 2024