- Continued progress in the AFM13 pTCL REDIRECT monotherapy
study
- AFM24 is recruiting patients in cohort 2 of a Phase 1/2a
clinical trial
- Genentech’s RO7297089 is actively recruiting patients into a
first-in-human Phase I trial resulting in the achievement of a
milestone payment under the terms of the collaboration
- Data on AFM24 and RO7297089 (formerly AFM26) were presented at
the virtual AACR II conference in June
- Angus Smith joins the company as Chief Financial Officer
- Dr. Annalisa Jenkins and Harry Welten added to the Supervisory
Board
- €92.6 million of cash, cash equivalents and current financial
assets as of June 30, 2020, providing anticipated cash runway into
the first half of 2022
- Conference call and webcast scheduled for August 11, 2020 at
8:30 am EDT (14:30 CET)
Heidelberg, Germany, August 11, 2020 – 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 second quarter
2020 and provided an update on clinical and corporate progress.
“Affimed’s first half performance demonstrates the strength of
the new management team and our ability to stay focused on
executing our business strategy despite the continuing challenge of
the COVID-19 environment. Always with the patient in mind, we are
committed to advancing our pipeline as well as continuing to deepen
our research to unlock the full potential of the innate immune
system to fight cancer,” said Dr. Adi Hoess, CEO of Affimed. “We
have multiple Innate Cell Engager (ICE®) programs in clinical
development, both partnered and wholly-owned, which are the basis
for providing a cadence of a continuous data output in 2020 and
2021.”
Development Program UpdatesAFM13
(CD30/CD16A)
- Affimed has now successfully activated 54 clinical study sites
in 10 countries in the on-going Phase 2 registration-directed study
of AFM13 as monotherapy in relapsed or refractory patients with
CD30-positive peripheral T-cell lymphoma (pTCL). The study
follows a two-stage Simon design with a preplanned interim analysis
after 40 patients. At the current recruitment rate the company
expects the readout of the interim analysis to happen in
mid-2021.
- The investigator-sponsored Phase 1 study with the University of
Texas, MD Anderson Cancer Center (MDACC), which investigates the
combination of AFM13 with allogeneic NK cells in CD30+ Lymphomas,
has completed the required validation work in order to administer a
stable complex of AFM13 pre-mixed with cord blood-derived
allogeneic NK cells. MDACC has recently posted this study as
enrolling on its website and it is expected to recruit patients as
soon as the COVID-19 conditions in Texas permit.
AFM24 (EGFR/CD16A)
- AFM24-101, a first-in-human Phase 1/2a clinical trial of AFM24,
the EGFR/CD16A targeted innate cell engager for relapsed/
refractory patients with advanced EGFR-expressing solid tumors
continues to recruit according to plan in cohort 2.
- AFM24-101 is an open-label, non-randomized, multi-center,
multiple ascending dose escalation/expansion study to evaluate
AFM24 as monotherapy in adult patients with advanced solid
malignancies known to be EGFR-positive.
- No dose limiting toxicity was observed in dose cohort 1.
- A preclinical poster presentation was shown at the virtual AACR
II conference in June on AFM24, demonstrating that it is
differentiated from all other EGFR targeting entities: (i) it
appears safe - no skin toxicity or other dose limiting toxicities
(DLTs) in cynomolgus monkeys, (ii) it addresses a broad patient
population – AFM24 targets EGFR independent of its mutational
status, and (iii) in contrast to monoclonal antibodies, AFM24
strongly activates NK cells and
macrophages.
Genentech Collaboration Update
- The Genentech-partnered, novel BCMA-targeted innate cell
engager for the treatment of multiple myeloma has now entered a
first-in-human Phase I, open-label, multicenter, global
dose-escalation study designed to evaluate the safety,
tolerability, and pharmacokinetics of RO7297089. The milestone was
achieved in the third quarter and triggers a payment in an
undisclosed amount to Affimed, which is expected to be recognized
in the Company’s third quarter 2020 financial statements.
- At the June virtual AACR II conference, a preclinical poster
presentation on RO7297089 showed potent cell killing in tumor cell
lines employing NK cells as effector cells with minimal increase in
cytokines. A 4-week safety study in cynomolgus monkeys showed
a favorable safety profile with no cytokine release or adverse
findings at the 15 and 50 mg/kg tested dose levels. Furthermore,
time- and dose-dependent reductions in serum IgG levels and plasma
cell markers were observed suggesting selective killing of BCMA
positive cells by engaging CD16a positive immune cells.
Preclinical Pipeline Update
- Progress continues on AFM28 and AFM32 towards late stage
preclinical development.
Management Appointments
- Angus Smith joined the company as Chief Financial Officer on
July 13. Mr. Smith brings broad biopharmaceutical experience to the
company including financial strategy and planning, capital markets,
business development and operations. Mr. Smith’s appointment
completes the planned additions to the management team which now
includes Dr. Andreas Harstrick, Chief Medical Officer and Dr. Arndt
Schottelius, Chief Scientific Officer.
Additions to the Supervisory Board
- Dr. Annalisa Jenkins and Harry Welten were appointed to the
Supervisory Board during the recent Annual General Meeting of
Shareholders. Dr. Jenkins brings a wealth of expertise in advancing
clinical programs through development and regulatory approval. Mr.
Welten is an accomplished financial executive who is well suited to
help drive value-creating strategies for the company. These
additions to the Supervisory Board are expected to further
strengthen the company’s industry know-how, experience and
diversity.
Second Quarter 2020 Financial Highlights
(Figures for the second quarter ended June 30, 2020 and 2019 are
unaudited.)
As of June 30, 2020, cash, cash equivalents and current
financial assets totaled €92.6 million compared to €104.1 million
on December 31, 2019. During the quarter, the company received net
proceeds of approximately €20.8 million under its at-the-market
(“ATM”) program.
Based on its current operating plan and assumptions, Affimed
anticipates that its cash, cash equivalents and current financial
assets will support operations into the first half of 2022.
Net cash used in operating activities for the quarter ended June
30, 2020 was €15.0 million compared to €5.6 million in the second
quarter of 2019. The second quarter 2019 net cash used in operating
activities included a milestone payment to the company from the
Genentech collaboration.
Total revenue for the second quarter of 2020 was €2.9 million
compared with €4.0 million in the second quarter of 2019. Revenue
in 2020 and 2019 predominantly relate to the Genentech
collaboration (2020: €2.7 million, 2019: €3.7 million). Revenue
from the Genentech collaboration in the second quarter 2020 was
comprised of revenue recognized for collaborative research services
performed during the quarter.
R&D expenses for the second quarter of 2020 were €11.7
million compared to €11.5 million in the second quarter of 2019.
Expenses in 2020 relate predominantly to our AFM13 and AFM24
clinical programs as well as to our early stage development and
discovery activities.
G&A expenses for the second quarter of 2020 were €2.6
million compared to €2.3 million in the second quarter of 2019. The
increase is primarily related to higher Sarbanes-Oxley compliance
costs, as well as an increase in legal, consulting and audit
costs.
Net loss for the second quarter of 2020 was €12.2 million or
€0.16 per common share. For the second quarter of 2019, the
company’s net loss was €10.3 million or €0.17 per common share.
Weighted number of common shares outstanding for the quarter
ended June 30, 2020 were 79.2 million.
Affimed encourages shareholders to also review its 6-K filing
for the quarter ended June 30, 2020, as filed with
the United States Securities and Exchange Commission.
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, Tuesday,
August 11, 2020 at 8:30 a.m. EDT to discuss second quarter 2020
financial results and recent corporate developments. The conference
call will be available via phone and webcast.
To access the call, please dial +1 (646) 741-3167 for U.S.
callers, or +44 (0) 2071 928338 for international callers, and
reference passcode 8855368 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. 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.
Investor & Media Contact:
Alex FudukidisHead of Investor RelationsE-Mail:
a.fudukidis@affimed.comTel.: (917) 436-8102
Affimed N.V.Unaudited consolidated
statements of comprehensive income / (loss) (in €
thousand)
|
For the three months |
For the six months |
ended June 30 |
ended June 30 |
|
|
|
2020 |
|
2019 |
2020 |
2019 |
|
|
|
|
|
|
|
Revenue |
|
2,934 |
|
4,008 |
8,069 |
15,361 |
|
|
|
|
|
|
|
Other income – net |
|
85 |
|
197 |
28 |
283 |
Research and development
expenses |
|
(11,697) |
|
(11,545) |
(23,146) |
(19,532) |
General and administrative
expenses |
|
(2,606) |
|
(2,342) |
(6,131) |
(4,776) |
|
|
|
|
|
|
|
Operating income /
(loss) |
|
(11,284) |
|
(9,682) |
(21,180) |
(8,664) |
|
|
|
|
|
|
|
Finance income /
(costs) – net |
|
(954) |
|
(654) |
653 |
180 |
|
|
|
|
|
|
|
Income / (loss) before
tax |
|
(12,238) |
|
(10,336) |
(20,527) |
(8,484) |
|
|
|
|
|
|
|
Income taxes |
|
0 |
|
(4) |
0 |
(4) |
|
|
|
|
|
|
|
Income / (loss) for
the period |
|
(12,238) |
|
(10,340) |
(20,527) |
(8,488) |
|
|
|
|
|
|
|
Other comprehensive
income / (loss) Items that will not be
reclassified to profit or lossEquity investments at fair
valueOCI – net change in fair value |
|
(71) |
|
(49) |
10 |
24 |
|
|
|
|
|
|
|
Other comprehensive
income / (loss) |
|
(71) |
|
(49) |
10 |
24 |
|
|
|
|
|
|
|
Total comprehensive
income / (loss) |
|
(12,309) |
|
(10,389) |
(20,517) |
(8,464) |
|
|
|
|
|
|
|
Earnings / (loss) per
share in € per share |
|
(0.16) |
|
(0.17) |
(0.26) |
(0.14) |
(undiluted =
diluted) |
|
|
|
|
|
|
Weighted number of
common shares outstanding |
|
79,189,686 |
|
62,439,363 |
77,719,793 |
62,434,734 |
Affimed
N.V.Consolidated statements of financial position
(in € thousand)
|
June 30, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
103 |
|
137 |
Leasehold improvements and
equipment |
2,237 |
|
2,291 |
Long term financial
assets |
3,203 |
|
3,193 |
Right-of-use assets |
536 |
|
824 |
|
6,079 |
|
6,445 |
Current
assets |
|
|
|
Cash and cash equivalents |
84,584 |
|
95,234 |
Financial assets |
8,037 |
|
8,902 |
Trade and other
receivables |
2,027 |
|
1,482 |
Inventories |
421 |
|
296 |
|
95,069 |
|
105,914 |
|
|
|
|
TOTAL
ASSETS |
101,148 |
|
112,359 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
845 |
|
762 |
Capital reserves |
292,720 |
|
270,451 |
Fair value reserves |
1,972 |
|
1,962 |
Accumulated deficit |
(255,035) |
|
(234,508) |
Total
equity |
40,502 |
|
38,667 |
|
|
|
|
Non-current
liabilities |
|
|
|
Borrowings |
231 |
|
278 |
Contract liabilities |
27,829 |
|
37,961 |
Lease liabilities |
95 |
|
272 |
Total
non-current liabilities |
28,155 |
|
38,511 |
|
|
|
|
Current
liabilities |
|
|
|
Trade and other payables |
6,606 |
|
10,674 |
Provisions |
484 |
|
517 |
Borrowings |
1,039 |
|
2,105 |
Lease liabilities |
451 |
|
532 |
Contract
liabilities |
23,911 |
|
21,353 |
Total current
liabilities |
32,491 |
|
35,181 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
101,148 |
|
112,359 |
Affimed N.V.Unaudited consolidated
statements of cash flows (in € thousand)
|
|
For the six months ended June 30, |
|
2020 |
|
2019 |
Cash flow
from operating activities |
|
|
|
Income / (loss)
for the period |
(20,527) |
|
(8,488) |
Adjustments for
the period: |
|
|
|
- Income
taxes |
0 |
|
4 |
- Depreciation and
amortisation |
551 |
|
423 |
- Net gain from
disposal of leasehold improvements and equipment |
0 |
|
(9) |
- Share based
payments |
1,410 |
|
1,167 |
- Finance income /
costs – net |
(653) |
|
(180) |
|
(19,219) |
|
(7,083) |
Change in trade
and other receivables |
(649) |
|
228 |
Change in
inventories |
(125) |
|
(70) |
Change in other
assets |
0 |
|
(2,586) |
Change in trade,
other payables, provisions and contract liabilities |
(11,757) |
|
(9,484) |
Cash used in
operating activities |
(31,750) |
|
(18,995) |
Interest
received |
276 |
|
188 |
Paid interest |
(64) |
|
(134) |
Net cash
used in operating activities |
(31,538) |
|
(18,941) |
|
|
|
|
Cash flow
from investing activities |
|
|
|
Purchase of
intangible assets |
(2) |
|
(142) |
Purchase of
leasehold improvements and equipment |
(174) |
|
(755) |
Cash paid for
investments in financial assets |
(8,101) |
|
(35,262) |
Cash received from
maturity of financial assets |
9,088 |
|
25,748 |
Net cash
used for investing activities |
811 |
|
(10,411) |
|
|
|
|
Cash flow
from financing activities |
|
|
|
Proceeds from
issue of common shares |
21,785 |
|
13 |
Transaction costs
related to issue of common shares |
(754) |
|
0 |
Proceeds from
borrowings |
0 |
|
562 |
Repayment of lease
liabilities |
(257) |
|
(206) |
Repayment of
borrowings |
(1,128) |
|
(1,649) |
Cash flow
from financing activities |
19,646 |
|
(1,280) |
|
|
|
|
Exchange-rate related changes of cash and cash
equivalents |
431 |
|
(210) |
Net
changes to cash and cash equivalents |
(11,081) |
|
(30,632) |
Cash and
cash equivalents at the beginning of the period |
95,234 |
|
94,829 |
Cash and
cash equivalents at the end of the period |
84,584 |
|
63,987 |
Affimed N.V.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, 2019 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
Exercise of share based payment awards |
|
|
13 |
|
|
|
|
|
13 |
Equity-settled share based
payment awards |
|
|
1,167 |
|
|
|
|
|
1,167 |
Loss for the period |
|
|
|
|
|
|
(8,488) |
|
(8,488) |
Other comprehensive
income |
|
|
|
|
24 |
|
|
|
24 |
Balance as of
June 30, 2019 |
624 |
|
240,235 |
|
2,618 |
|
(210,632) |
|
32,845 |
|
|
|
|
|
|
|
|
|
|
Balance as of
January 1, 2020 |
762 |
|
270,451 |
|
1,962 |
|
(234,508) |
|
38,667 |
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
83 |
|
20,859 |
|
|
|
|
|
20,942 |
Equity-settled share based
payment awards |
|
|
1,410 |
|
|
|
|
|
1,410 |
Loss for the period |
|
|
|
|
|
|
(20,527) |
|
(20,527) |
Other comprehensive
income |
|
|
|
|
10 |
|
|
|
10 |
Balance as of
June 30, 2020 |
845 |
|
292,720 |
|
1,972 |
|
(255,035) |
|
40,502 |
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