Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a
clinical-stage immuno-oncology company committed to giving patients
back their innate ability to fight cancer, today reported financial
results for the first quarter ended March 31, 2022 and provided an
update on clinical and corporate progress.
“We are excited about the progress we are making advancing our
Innate Cell Engagers (ICE®) including completing enrollment of
REDIRECT, our first registration directed study, and establishing a
compelling proof of concept for AFM13 combined with NK cells as
evidenced by the remarkable clinical data presented at AACR. These
results continue to validate our three-pronged development approach
and the potential of our ICE® molecules to offer novel treatments
for heavily pretreated, relapsed/refractory patients with limited
options,” said Dr. Adi Hoess, CEO of Affimed. “Our strong financial
position allows us to maintain our focus on execution so that we
can bring these important therapies to patients who need them as
soon as possible.”
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
- Affimed completed enrollment of its
REDIRECT study (AFM13-202). The Company expects to report top-line
data in the fourth quarter of 2022. REDIRECT is a phase 2,
registration-directed study of AFM13 monotherapy in patients with
relapsed or refractory CD30-positive peripheral T-cell lymphoma
(PTCL).
- At an AACR 2022 Clinical Trials
Plenary Session, Dr. Yago Nieto, M.D., Ph.D., Professor of Stem
Cell Transplantation and Cellular Therapy at MD Anderson, presented
follow-up data to the investigator sponsored trial (IST)
(AFM13-104) investigating the combination of AFM13 pre-complexed
with cord blood-derived natural killer cells followed by AFM13
monotherapy in relapsed/refractory CD30+ lymphomas. The treatment
resulted in a 100% ORR with 8/13 (62%) patients achieving a
complete response after two cycles of treatment at the RP2D.
Durability data presented at AACR for patients treated at the
RP2D was also promising. As of the cutoff date, of the eight
patients who achieved a CR, seven remained in CR at median
follow-up of 6.5 months, including two patients who remained in
response after 10 months and two who received a consolidation
autologous stem cell transplant (SCT).
The safety profile was well managed, with the main treatment
related side-effect being infusion related reactions. The
investigators did not observe any cases of cytokine release
syndrome (CRS), neurotoxicity or graft versus host disease often
associated with T-cell therapies. In general, side effects observed
in the trial were transient and did not lead to treatment delays or
discontinuation.
The recently approved amendment to the AFM13-104 trial protocol
allows for an increase in the number of CD30-positive lymphoma
patients treated at the RP2D to 40 - including Hodgkin and
non-Hodgkin’s lymphoma patients. Furthermore, under the amended
protocol, patients can receive more than two cycles of
treatment.
The Company and MD Anderson expect to report updates on the
study at a medical conference in the second half of the 2022.
AFM24 (EGFR/CD16A)
- In the monotherapy phase 1/2a
clinical trial (AFM24-101), enrollment in cohort seven of the dose
escalation study, which treated patients at the 720mg dose, was
completed without dose limiting toxicities. Based on the
pharmacokinetic and pharmacodynamic data, and in agreement with the
Safety Review Committee (SRC), no further dose escalation is
planned. The data confirm the selection of 480mg as the RP2D.The
Company is continuing enrollment in the expansion phase of the
monotherapy study at the RP2D. The expansion cohorts include
patients with renal cell carcinoma (clear cell), non-small cell
lung cancer (EFGR mutant), and colorectal cancer.
- Enrollment continues in the phase
1/2a combination study of AFM24 with the anti-PD-L1 checkpoint
inhibitor atezolizumab (Tecentriq®) (AFM24-102) to treat patients
with non-small cell lung cancer (EGFR wildtype), gastric and
gastroesophageal junction adenocarcinoma and
pancreatic/hepatocellular/biliary tract cancer.
- Enrollment continues in the phase
1/2a combination study of AFM24 with the SNK01 (ex vivo expanded
and activated autologous NK cell therapy from NKGen Biotech) cells
(AFM24-103) to treat patients with non-small cell lung cancer
(NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and
neck, and colorectal cancer.
- In these studies, the Company is
evaluating the safety and efficacy of AFM24 in nine
indication-specific cohorts, with a particular focus on NSCLC,
which is represented in all three studies, and CRC, represented in
two of the three studies. Affimed expects to report initial data
from the studies in the second half of 2022.
- Presented a poster at AACR 2022
including data from dose escalation phase of AFM24-101,
highlighting data that informed the selection of 480mg as the RP2D.
Presented a poster at NK2022 conference featuring an analysis of
the longitudinal effects of AFM24 in patients treated in AFM24-101,
confirming the mechanism of action of AFM24 on the innate immune
system.
Preclinical Programs
AFM28 (CD123/CD16A)
- AFM28 is a bispecific, tetravalent
ICE® that targets CD16A on NK cells and macrophages, and CD123 on
leukemic blasts and leukemic stem cells that are prevalent in acute
myeloid leukemia (AML).
- The Company expects to submit an IND
in June and is planning to start clinical investigation of AFM28 in
the second half of 2022.
- At the NK2022 conference, the
Company presented preclinical data demonstrating that AFM28
exhibits greater cell surface retention on NK cells than
conventional monoclonal antibodies. Furthermore, AFM28 induced
lysis of CD123-positive tumor cells when pre-complexed or when
co-administered with cryopreserved NK cells, suggesting that AFM28
in combination with NK cells maintains anti-tumor activity, an
exciting finding in that it presents the promise for an
off-the-shelf therapy targeting leukemic blasts and LSCs in
patients with AML.
Preclinical Pipeline
- Affimed is continuing the generation
of several novel ICE® molecules derived from its proprietary ROCK®
platform.
Partnerships and Collaborations
- The Company continues to advance its
work with existing partners including MD Anderson, Artiva, and
NKGen Biotech to ensure access to an off-the-shelf, cryopreserved
NK cell for further development with its ICE® molecules and expects
to provide updates on its NK cell development strategy in the
second half of 2022.
- Partnered programs with both
Genentech and Roivant continue to progress according to plan, and
Affimed is eligible for additional proceeds from meeting
pre-clinical and early regulatory achievement milestones.
First Quarter 2022 Financial Highlights
Affimed’s consolidated financial statements are prepared in
accordance with IFRS as issued by the International Accounting
Standard Board (IASB). The consolidated financial statements are
presented in euros, the Company’s functional and presentation
currency.
As of March 31, 2022, cash and cash equivalents totaled €169.9
million compared to €197.6 million on December 31, 2021. The pro
forma cash position as of March 31, 2022, including net proceeds -
before offering expenses - from the April 2022 underwritten public
offering would be approximately €257.5 million.
Based on the Company’s current operating plan and assumptions,
cash and cash equivalents, including proceeds from the April 2022
public offering, are expected to support operations into
mid-2024.
Net cash used in operating activities for the quarter ended
March 31, 2022, was €28.4 million compared to €16.0 million for the
quarter ended March 31, 2021. Included in the cash burn for the
quarter was a milestone payment to MD Anderson for the initiation
of the Phase 2 portion of the AFM13-104 trial, which was expensed
in Q4 2021 and paid in Q1 2022.
Total revenue for the quarter ended March 31, 2022, was €8.0
million compared with €11.7 million for the quarter ended March 31,
2021. Revenue predominately relates to the Genentech and Roivant
collaborations.
Research and development expenses for the quarter ended March
31, 2022, increased by 61% from €11.4 million to €18.4 million
compared to the quarter ended March 31, 2021. Research and
development expenses increased primarily due to increased expenses
associated with the development of the AFM24 and AFM28 programs and
included costs to produce clinical trial material, an increase in
costs associated with other early-stage programs and
infrastructure, and an increase in share-based payment
expenses.
General and administrative expenses increased 57% from €4.5
million in the quarter ended March 31, 2021, to €7.0 million in the
quarter ended March 31, 2022. The increase predominately relates to
higher share-based payment expenses and an increase in insurance
premiums.
Net finance income for the quarter ended March 31, 2022,
decreased by 91% from €5.5 million in the quarter ended March 31,
2021, to €0.5 million. Net finance income is largely the result of
foreign exchange gains related to assets denominated in U.S.
dollars as a result of currency fluctuations between the U.S.
dollar and Euro during the year.
Net loss for the quarter ended March 31, 2022, was €16.7
million, or €0.14 loss per common share compared with a net income
of €1.4 million, or €0.01 earnings per common share, for the
quarter ended March 31, 2021.
The weighted number of common shares outstanding for the quarter
ended March 31, 2022, was 123.4 million.
Additional information regarding these results is included in
the notes to the consolidated financial statements as of March 31,
2022, which will be included in 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 June 1, 2022, at
8:30 a.m. EDT / 14:30 CET to discuss first quarter 2022 financial
results and 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 4440407 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-and-corporate-presentation/.
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, AFM28 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, the impact on our business by political events, war,
terrorism, business interruptions and other geopolitical events and
uncertainties, such as the Russia-Ukraine conflict 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 Contact Alexander 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 |
|
|
2022 |
|
2021 |
Revenue |
|
8,006 |
|
|
11,659 |
|
|
|
|
|
|
Other income – net |
|
284 |
|
|
147 |
|
Research and development
expenses |
|
(18,379 |
) |
|
(11,405 |
) |
General and administrative
expenses |
|
(7,045 |
) |
|
(4,486 |
) |
|
|
|
|
|
Operating income /
(loss) |
|
(17,134 |
) |
|
(4,085 |
) |
Finance income /
(costs) – net |
|
471 |
|
|
5,499 |
|
|
|
|
|
|
Income / (loss) before
tax |
|
(16,663 |
) |
|
1,414 |
|
|
|
|
|
|
Income taxes |
|
(2 |
) |
|
(2 |
) |
|
|
|
|
|
Income / (loss) for
the period |
|
(16,665 |
) |
|
1,412 |
|
|
|
|
|
|
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 |
|
(6,174 |
) |
|
(1,253 |
) |
|
|
|
|
|
Other comprehensive
income / (loss) |
|
(6,174 |
) |
|
(1,253 |
) |
|
|
|
|
|
Total comprehensive
income / (loss) |
|
(22,839 |
) |
|
159 |
|
|
|
|
|
|
Basic and diluted
earnings / (loss) per share in € per share |
|
(0.14 |
) |
|
0.01 |
|
(undiluted =
diluted) |
|
|
|
|
Weighted number of
common shares outstanding |
|
123,444,217 |
|
|
116,204,455 |
|
|
|
|
|
|
Affimed
N.V. |
|
|
|
|
Consolidated
statements of financial position |
|
|
|
|
(in €
thousand) |
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Intangible assets |
|
1,580 |
|
|
1,607 |
|
Leasehold improvements and
equipment |
|
3,754 |
|
|
3,814 |
|
Long-term financial
assets |
|
6,174 |
|
|
12,348 |
|
Right-of-use assets |
|
813 |
|
|
972 |
|
|
|
12,321 |
|
|
18,741 |
|
|
|
|
|
|
Current
assets |
|
|
|
|
Cash and cash equivalents |
|
169,850 |
|
|
197,630 |
|
Trade and other
receivables |
|
4,547 |
|
|
4,809 |
|
Inventories |
|
485 |
|
|
421 |
|
Other assets and prepaid
expenses |
|
6,048 |
|
|
3,534 |
|
|
|
180,930 |
|
|
206,394 |
|
|
|
|
|
|
TOTAL
ASSETS |
|
193,251 |
|
|
225,135 |
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
Equity |
|
|
|
|
Issued capital |
|
1,234 |
|
|
1,234 |
|
Capital reserves |
|
478,395 |
|
|
474,087 |
|
Fair value reserves |
|
(12,147 |
) |
|
(5,973 |
) |
Accumulated deficit |
|
(350,062 |
) |
|
(333,397 |
) |
Total
equity |
|
117,420 |
|
|
135,951 |
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Borrowings |
|
15,713 |
|
|
17,060 |
|
Contract liabilities |
|
2,035 |
|
|
7,209 |
|
Lease liabilities |
|
288 |
|
|
368 |
|
Total non-current
liabilities |
|
18,036 |
|
|
24,637 |
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
Trade and other payables |
|
13,537 |
|
|
18,860 |
|
Borrowings |
|
2,039 |
|
|
580 |
|
Lease liabilities |
|
592 |
|
|
683 |
|
Contract liabilities |
|
41,627 |
|
|
44,424 |
|
Total current
liabilities |
|
57,795 |
|
|
64,547 |
|
|
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
|
193,251 |
|
|
225,135 |
|
|
|
|
|
|
Affimed
N.V. |
|
|
|
|
Unaudited
consolidated statements of cash flows (in € thousand) |
|
|
|
|
(in €
thousand) |
|
|
|
|
|
|
For the three months ended |
|
|
March 31 |
|
|
2022 |
|
2021 |
Cash flow
from operating activities |
|
|
|
|
Income / (loss) for the period |
|
(16,665 |
) |
|
1,412 |
|
Adjustments for
the period: |
|
|
|
|
- Income
taxes |
|
2 |
|
|
2 |
|
- Depreciation and
amortization |
|
352 |
|
|
331 |
|
- Share-based
payments |
|
4,247 |
|
|
1,109 |
|
- Finance income /
costs – net |
|
(471 |
) |
|
(5,499 |
) |
|
|
(12,535 |
) |
|
(2,645 |
) |
Change in trade
and other receivables |
|
262 |
|
|
(1,735 |
) |
Change in
inventories |
|
(64 |
) |
|
(189 |
) |
Change in other
assets and prepaid expenses |
|
(2,435 |
) |
|
411 |
|
Change in trade,
other payables, provisions and contract liabilities |
|
(13,336 |
) |
|
(11,822 |
) |
|
|
(28,108 |
) |
|
(15,980 |
) |
Interest
received |
|
27 |
|
|
0 |
|
Paid interest |
|
(337 |
) |
|
(50 |
) |
Paid income
tax |
|
(2 |
) |
|
(2 |
) |
Net cash
used in operating activities |
|
(28,420 |
) |
|
(16,032 |
) |
|
|
|
|
|
Cash flow
from investing activities |
|
|
|
|
Purchase of
intangible assets |
|
0 |
|
|
(4 |
) |
Purchase of
leasehold improvements and equipment |
|
(106 |
) |
|
(962 |
) |
Net cash
used for investing activities |
|
(106 |
) |
|
(966 |
) |
|
|
|
|
|
Cash flow
from financing activities |
|
|
|
|
Proceeds from
issue of common shares, including exercise of share-based payment
awards |
61 |
|
|
101,860 |
|
Transaction costs
related to issue of common shares |
|
(35 |
) |
|
(6,350 |
) |
Proceeds from
borrowings |
|
0 |
|
|
10,000 |
|
Transaction costs
related to borrowings |
|
0 |
|
|
(201 |
) |
Repayment of lease
liabilities |
|
(172 |
) |
|
(92 |
) |
Repayment of
borrowings |
|
(23 |
) |
|
(23 |
) |
Cash flow
from financing activities |
|
(169 |
) |
|
105,194 |
|
|
|
|
|
|
Exchange
rate related changes of cash and cash equivalents |
|
915 |
|
|
5,622 |
|
Net
changes to cash and cash equivalents |
|
(28,695 |
) |
|
88,196 |
|
|
|
|
|
|
Cash and
cash equivalents at the beginning of the period |
|
197,630 |
|
|
146,854 |
|
Cash and
cash equivalents at the end of the period |
|
169,850 |
|
|
240,672 |
|
|
|
|
|
|
|
Affimed
N.V. |
|
|
|
|
|
|
|
|
|
|
Unaudited
consolidated statements of changes in equity |
|
|
|
|
|
|
|
|
(in €
thousand) |
|
|
|
|
|
|
|
|
|
|
|
|
Issuedcapital |
|
Capitalreserves |
|
Fair valuereserves |
|
Accumulateddeficit |
|
Totalequity |
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2021 |
|
983 |
|
345,164 |
|
1,720 |
|
|
(275,874 |
) |
|
71,993 |
|
|
|
|
|
|
|
|
|
|
|
|
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 loss |
|
|
|
|
|
(1,253 |
) |
|
|
|
(1,253 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance as of March
31, 2021 |
|
1,190 |
|
441,644 |
|
467 |
|
|
(274,462 |
) |
|
168,839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2022 |
|
1,234 |
|
474,087 |
|
(5,973 |
) |
|
(333,397 |
) |
|
135,951 |
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of share-based
payment awards |
|
|
|
61 |
|
|
|
|
|
61 |
|
Equity-settled share-based
payment awards |
|
|
|
4,247 |
|
|
|
|
|
4,247 |
|
Loss for the period |
|
|
|
|
|
|
|
(16,665 |
) |
|
(16,665 |
) |
Other comprehensive loss |
|
|
|
|
|
(6,174 |
) |
|
|
|
(6,174 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance as of March
31, 2022 |
|
1,234 |
|
478,395 |
|
(12,147 |
) |
|
(350,062 |
) |
|
117,420 |
|
Affimed NV (NASDAQ:AFMD)
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