- AFM24: Affimed successfully completed the first dose cohort of
its first-in-human phase 1/2A Study; Cohort 2 is open for patient
recruitment
- Data on Affimed’s AFM24 (EGFR/CD16A) and Genentech’s RO7297089
(BCMA/CD16A) was presented at AACR Virtual Meeting II, showing
potent killing of tumor cell lines and a good safety profile in the
relevant pre-clinical models
- AFM13: Continued progress on the REDIRECT monotherapy study in
pTCL as well as on the AFM13 combination with cbNk investigator
sponsored study at MD Anderson Cancer Center in CD30-positive T
cell lymphoma
- Management: Appointed Angus Smith as Chief Financial Officer,
following the appointments of Dr. Andreas Harstrick as Chief
Medical Officer and Dr. Arndt Schottelius as Chief Scientific
Officer earlier in the year, completing the management team
- Conference call and webcast scheduled for June 23, 2020 at 8:30
am EDT (2:30 pm CET)
Heidelberg, Germany, June 23, 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 first quarter 2020
and provided an update on clinical and corporate progress.
“We continue to move our clinical programs forward in close
collaboration with our investigators and partners,” said Dr. Adi
Hoess, CEO of Affimed. “We have strengthened the management team
with the recent hiring of Angus Smith as CFO, which nicely
complements the additions of Dr. Andreas Harstrick as CMO and Dr.
Arndt Schottelius as CSO earlier in the year. With good
progress in our clinical programs, the pre-clinical pipeline and
the completion of the management team, we are well positioned to
increase our leadership position as innovators of innate immune
system-based therapeutics.”
Development Program Updates
AFM13 (CD30/CD16A)
- Affimed has successfully activated 46 clinical study sites in
nine 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 investigator-sponsored Phase 1 study with the University of
Texas, MD Anderson Cancer Center to investigate 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.
AFM24 (EGFR/CD16A)
- After the successful completion of dose cohort 1, in the
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, the study was cleared to
begin patient recruitment in dose cohort 2. The company reported
that no dose limiting toxicity was observed in dose cohort 1.
- Affimed researchers presented preclinical data on the
pharmacology and safety of AFM24 at the AACR Virtual Annual Meeting
II.
Genentech Collaboration Update
- In May 2020, Affimed confirmed that its novel BCMA targeted
innate cell engager for the treatment of multiple myeloma has been
partnered with Genentech, a member of the Roche Group.
- Researchers from Genentech and Affimed co-authored a poster on
the preclinical pharmacology and safety data of RO7297089 and
presented data at the AACR Virtual Annual Meeting II.
- On clinicaltrials.gov, Genentech has posted a first-in-human
Phase I, open-label, multicenter, global, dose-escalation study
designed to evaluate the safety, tolerability, and pharmacokinetics
of RO7297089.
Preclinical Pipeline Update
- Affimed continues to progress AFM28 and AFM32 towards late
stage preclinical development.
Management Appointments
- Angus Smith was appointed to the position of Chief Financial
Officer in June and will join the company in mid-July. Mr. Smith
brings broad biopharmaceutical experience to the company including
financial strategy and planning, capital markets, business
development and operations.
- The company announced the additions of Dr. Andreas Harstrick as
Chief Medical Officer and Dr. Arndt Schottelius as Chief Scientific
Officer earlier in the year. Dr. Harstrick, brings broad
development expertise in solid tumor indications, including
EGFR-expressing cancers. Dr. Schottelius brings extensive innate
immunity expertise and a successful record of advancing discovery
research into preclinical and clinical development.
First Quarter 2020 Financial Highlights
(Figures for the first quarter ended March 31, 2020 and 2019 are
unaudited.)
As of March 31, 2020, cash, cash equivalents and current
financial assets totaled €88.2 million compared to €104.1 million
on December 31, 2019. In addition, the company raised €18.8 million
(based on an exchange rate of $/€ of 1.1210 on June 19, 2020) net
proceeds under its at-the-market (“ATM”) program. The pro forma
cash position of the company as of March 31, 2020, including the
net proceeds from the ATM, would be €107.0 million. Based on its
current operating plan and assumptions, Affimed anticipates that
its cash, cash equivalents and current financial assets will
support operations well into the first half of 2022.
Net cash used in operating activities for the quarter ended
March 31, 2020, was €16.5 million, compared to €13.4 million for
the quarter ended March 31, 2019. The increase is primarily due to
higher expenditure related to research and development efforts.
Total revenue for the quarter ended March 31, 2020, was €5.1
million compared to €11.4 million for the same period of 2019.
Revenue in both quarters is primarily attributable to the
recognition of revenue from the Genentech collaboration in the
respective years.
R&D expenses for the quarter ended March 31, 2020, were
€11.4 million compared to research and development expenses of €8.0
million for the same period of 2019. The increase was primarily
related to higher expenses 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 for the quarter
ended March 31, 2020, were €3.5 million compared to €2.4 million
for the quarter ended March 31, 2019. The increase was primarily
related to higher personnel expenses, a result of the strengthening
of the talent pool, higher SOX compliance costs, legal, consulting
and audit costs.
Net loss was €8.3 million, or €0.11 per common share, for the
quarter ended March 31, 2020, compared to a net income of €1.9
million, or €0.03 per common share, for the quarter ended March 31,
2019.
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,
June 23, 2020 at 8:30 a.m. EDT to discuss first 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 8594214
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 Contact:
Alex FudukidisHead of Investor RelationsE-Mail:
IR@affimed.comTel.: (917) 436-8102
Affimed N.V.
Unaudited consolidated statements of
comprehensive income / (loss) (in € thousand)
|
For the three
months ended March 31 |
|
|
|
|
2020 |
|
2019 |
Revenue |
|
|
5,135 |
|
11,353 |
Other income – net |
|
|
(57) |
|
86 |
Research and development
expenses |
|
|
(11,449) |
|
(7,987) |
General and administrative
expenses |
|
|
(3,525) |
|
(2,434) |
Operating income /
(loss) |
|
|
(9,896) |
|
1,018 |
Finance income /
(costs) – net |
|
|
1,607 |
|
834 |
Income / (loss) before
tax |
|
|
(8,289) |
|
1,852 |
|
|
|
|
|
|
Income / (loss) for
the period |
|
|
(8,289) |
|
1,852 |
|
|
|
|
|
|
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 |
|
|
81 |
|
73 |
|
|
|
|
|
|
Other comprehensive
income / (loss) |
|
|
81 |
|
73 |
|
|
|
|
|
|
Total comprehensive
income / (loss) |
|
|
(8,208) |
|
1,925 |
|
|
|
|
|
|
Earnings / (loss) per
share in € per share(undiluted =
diluted) |
|
|
(0.11) |
|
0.03 |
Weighted number of
common shares outstanding |
|
|
76,249,901 |
|
62,430,106 |
Affimed N.V.
Consolidated statements of financial
position (in € thousand)
|
March 31, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
121 |
|
137 |
Leasehold improvements and
equipment |
2,193 |
|
2,291 |
Long term financial
assets |
3,274 |
|
3,193 |
Right-of-use assets |
679 |
|
824 |
|
6,267 |
|
6,445 |
Current
assets |
|
|
|
Cash and cash equivalents |
82,765 |
|
95,234 |
Financial assets |
5,476 |
|
8,902 |
Trade and other
receivables |
2,171 |
|
1,482 |
Inventories |
337 |
|
296 |
|
90,749 |
|
105,914 |
|
|
|
|
TOTAL
ASSETS |
97,016 |
|
112,359 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
762 |
|
762 |
Capital reserves |
271,178 |
|
270,451 |
Fair value reserves |
2,043 |
|
1,962 |
Accumulated deficit |
(242,797) |
|
(234,508) |
Total
equity |
31,186 |
|
38,667 |
|
|
|
|
Non-current
liabilities |
|
|
|
Borrowings |
254 |
|
278 |
Contract liabilities |
30,430 |
|
37,961 |
Lease liabilities |
155 |
|
272 |
Total non-current
liabilities |
30,839 |
|
38,511 |
|
|
|
|
Current
liabilities |
|
|
|
Trade and other payables |
8,434 |
|
10,674 |
Provisions |
497 |
|
517 |
Borrowings |
1,401 |
|
2,105 |
Lease liabilities |
522 |
|
532 |
Contract
liabilities |
24,137 |
|
21,353 |
Total current
liabilities |
34,991 |
|
35,181 |
TOTAL EQUITY AND
LIABILITIES |
97,016 |
|
112,359 |
Affimed N.V.
Unaudited consolidated statements of cash
flows (in € thousand)
|
For the three months ended March 31 |
|
|
2020 |
|
2019 |
Cash flow
from operating activities |
|
|
|
|
Income / (loss)
for the period |
|
(8,289) |
|
1,852 |
Adjustments for
the period: |
|
|
|
|
- Depreciation and
amortization |
|
280 |
|
210 |
- Net gain from
disposal of leasehold improvements and equipment |
|
0 |
|
(9) |
- Share based
payments |
|
727 |
|
601 |
- Finance income /
costs – net |
|
(1,607) |
|
(834) |
|
|
(8,889) |
|
1,820 |
Change in trade
and other receivables |
|
(750) |
|
(6,688) |
Change in
inventories |
|
(41) |
|
(65) |
Change in other
assets |
|
0 |
|
(183) |
Change in trade,
other payables, provisions and contract liabilities |
|
(6,999) |
|
(8,252) |
Cash used in
operating activities |
|
(16,679) |
|
(13,368) |
Interest
received |
|
160 |
|
62 |
Paid interest |
|
(28) |
|
(77) |
Net cash
used in operating activities |
|
(16,547) |
|
(13,383) |
|
|
|
|
|
Cash flow
from investing activities |
|
|
|
|
Purchase of
intangible assets |
|
(2) |
|
(64) |
Purchase of
leasehold improvements and equipment |
|
(20) |
|
(66) |
Cash paid for
investments in financial assets |
|
0 |
|
(21,061) |
Cash received from
maturity of financial assets |
|
3,736 |
|
3,513 |
Net cash
used for investing activities |
|
3,714 |
|
(17,678) |
|
|
|
|
|
Cash flow from financing
activities |
|
|
|
|
Repayment of lease
liabilities |
|
(128) |
|
(82) |
Repayment of
borrowings |
|
(773) |
|
(833) |
Cash flow
from financing activities |
|
(901) |
|
(915) |
|
|
|
|
|
Exchange-rate
related changes of cash and cash equivalents |
|
1,265 |
|
236 |
Net
changes to cash and cash equivalents |
|
(13,734) |
|
(31,976) |
Cash and
cash equivalents at the beginning of the period |
|
95,234 |
|
94,829 |
Cash and
cash equivalents at the end of the period |
|
82,765 |
|
63,089 |
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 |
Equity-settled
share based payment awards |
|
|
|
601 |
|
|
|
|
|
601 |
Income for the
period |
|
|
|
|
|
|
|
1,852 |
|
1,852 |
Other
comprehensive income |
|
|
|
|
|
73 |
|
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
Balance as
of March 31, 2019 |
|
624 |
|
239,656 |
|
2,667 |
|
(200,292) |
|
42,655 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Mar 2024 to Apr 2024
Affimed NV (NASDAQ:AFMD)
Historical Stock Chart
From Apr 2023 to Apr 2024