FOR IMMEDIATE
RELEASE
- First patient dosed in company’s first registration-directed
study of AFM13 for patients with relapsed/refractory peripheral T
cell lymphoma (pTCL)
- FDA clearance of investigational new drug application for
first-in-human study of AFM24
- Genentech exercised final option for exclusive target under
strategic oncology collaboration; triggers a payment in an
undisclosed amount to Affimed from Genentech
- Appoints Cassandra Choe-Juliak, MD, MS as Acting Chief Medical
Officer to succeed Leila Alland, MD; Dr. Alland to remain a
consultant for the company
- Pro forma cash position of €106 million, including
approximately €29 million in net proceeds from completed public
offering in November 2019
Heidelberg, Germany, November 19, 2019 - 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 quarter ended
September 30, 2019 and provided an update on clinical and corporate
developments.
“We are excited to commence patient dosing in
our Phase 2 study of AFM13 in support of registration, bringing us
one step closer to delivering a potential new treatment for pTCL
patients, who have very few treatment options,” said Dr. Adi Hoess,
Affimed’s CEO. “In addition, the IND for the first ever clinical
trial bringing together an innate cell engager (AFM13) and adoptive
NK cell transfer has cleared. This study of AFM13 and MD Anderson’s
NK cell product could address a much broader group of patients with
CD30-expressing lymphomas, including Hodgkin lymphoma, cutaneous
T-cell lymphoma and diffuse large B-cell lymphoma.”
Program Updates
AFM13 (CD30/CD16A)
- In November 2019, the first patient was dosed in a Phase 2
registration-directed study of AFM13 as monotherapy in relapsed or
refractory patients with CD30-positive peripheral T cell lymphoma
(pTCL). The results of the study, if positive, could form the basis
for a Biologics License Application submission and support an
accelerated approval given the unmet medical need for safe and
effective new treatments in this hard-to-treat patient population.
The study will also enroll a cohort of patients with transformed
mycosis fungoides, an aggressive subtype of cutaneous T cell
lymphoma.
- The U.S. Food and Drug Administration (FDA) cleared an
investigational new drug application (IND) for an
investigator-sponsored Phase 1 study, in which the University of
Texas MD Anderson Cancer Center (MDACC) plans 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. The combination represents a
novel approach to further improve response rates and durability of
responses in this patient population.
AFM24 (EGFR/CD16A)
·In October
2019, Affimed received clearance of its IND for AFM24 from the FDA,
enabling the company to proceed with its planned Phase 1/2a
clinical study of the tetravalent, bispecific epidermal growth
factor receptor (EGFR)- and CD16A-binding innate cell engager in
patients with advanced cancers known to express EGFR. The clearance
of the IND follows the company’s IND submission in late-September
2019. Affimed expects the study, which is aimed at establishing
safety and identifying initial signals of efficacy of AFM24, to
initiate in the first quarter of 2020.
Pipeline Updates
·Affimed
selected two new CD16A-binding innate cell engager candidates
(AFM28 and AFM32) from our ROCK® platform for undisclosed targets
that the company plans to advance into preclinical studies in 2020
with the aim of supporting future IND submissions. The selection of
the new development candidates follows Affimed’s evaluation of
innate immune cell activity versus a number of potential targets
that are expressed in multiple hematological and solid tumor
malignancies.
Genentech Collaboration
·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. The target selection triggers a payment in an
undisclosed amount to Affimed from Genentech.
Management Changes
·Affimed
announced the appointment of Cassandra Choe-Juliak, MD, MS as
Acting Chief Medical Officer to succeed Dr. Leila Alland, effective
November 30, 2019. Dr. Alland will transition out of her current
role and will serve as a consultant for the company. Dr.
Choe-Juliak has over 13 years of experience in drug development and
medical affairs in immuno-oncology/oncology for both hematological
and solid tumor malignancies. Since joining Affimed in July 2017,
she has served as the clinical leader for the AFM13 development
program.
Dr. Hoess commented, “Cassandra’s deep expertise
in drug development and strong leadership skills have been, and
will continue to be, a tremendous asset to Affimed and our clinical
team as we advance our pipeline of innate cell engagers. I would
also like to thank Leila for her many contributions to Affimed and
wish her success in her future endeavors.”
Financial Highlights
(Figures for the third quarter and nine months
ended September 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial
assets totaled €76.5 million as of September 30, 2019, compared to
€108.8 million as of December 31, 2018. In November 2019, Affimed
completed a public equity offering with net proceeds, after
deducting underwriting discounts and commissions and estimated
offering expenses, of approximately $32 million (€29 million).
Based on its current operating and budget assumptions, the company
anticipates that its cash, cash equivalents and current financial
assets as of September 30, 2019, together with the proceeds from
the stock offering, will enable the Company to fund its planned
clinical development and early development activities at least into
the fourth quarter of 2021.
Net cash used in operating activities was €30.6
million for the nine months ended September 30, 2019, compared to
net cash used in operating activities of €24.9 million for the nine
months ended September 30, 2018. The increase is primarily due to
higher cash expenditure for research and development efforts.
Total revenue was €2.1 million for the three
months ended September 30, 2019 compared to €0.3 million for the
three months ended September 30, 2018. The increase in revenue is
attributable to the recognition of €1.9 million as revenue from the
Genentech collaboration in the third quarter of 2019.
Research and development (R&D) expenses for
the third quarter of 2019 were €11.7 million, compared to R&D
expenses for the third quarter of 2018 of €9.8 million. The
increase was primarily related to higher expenses related to
manufacturing activities for clinical study material for AFM13,
startup activities for the AFM13 registration study in pTCL and
early stage development and discovery activities.
General and administrative expenses for the
third quarter of 2019 were €2.8 million compared to €2.4 million
for the third quarter of 2018.
Net loss was €10.9 million, or €0.17 per common
share, for the third quarter of 2019, compared to a net loss of
€12.0 million, or €0.19 per common share, for the third quarter of
2018.
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, November 19, 2019 at 8:30 a.m. Eastern time to
discuss the company’s financial results and recent corporate
developments. To access the call, please dial +1 (631) 510-7495 for
U.S. callers, or +44 (0) 2071 928000 for international callers, and
reference conference ID 8758067 approximately 15 minutes prior to
the call. An audio webcast of the conference call can be accessed
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 available on Affimed’s website shortly after
the conclusion of the call and will be archived for 30 days
following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical stage
biopharmaceutical 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. 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 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, expectations regarding 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 and the risks, uncertainties and other factors
described under the heading “Risk Factors” in Affimed’s filings
with the Securities and Exchange Commission. 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.Unaudited
consolidated statements of comprehensive income/(loss) (in €
thousands)
|
|
|
For the three monthsended September
30 |
|
For the nine monthsended September
30 |
|
|
|
|
|
|
|
|
|
|
2019 |
|
2018 |
2019 2018 |
|
|
|
|
|
|
|
|
Revenue |
|
2,103 |
|
306 |
17,464 |
988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income –
net |
|
49 |
|
(259) |
332 |
(221) |
|
|
|
|
|
|
|
Research and
development expenses |
|
(11,721) |
|
(9,787) |
(31,253) |
(23,332) |
|
|
|
|
|
|
|
General and
administrative expenses |
|
(2,790) |
|
(2,389) |
(7,566) |
(6,591) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income / (loss) |
|
(12,359) |
|
(12,129) |
(21,023) |
(29,156) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Finance
income / (costs) – net |
|
1,475 |
|
109 |
1,655 |
920 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
before tax |
|
(10.884) |
|
(12,020) |
(19,368) |
(28,236) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
0 |
|
0 |
(4) |
(1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss for
the period |
|
(10,884) |
|
(12,020) |
(19,372) |
(28,237) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income / (loss) Items that will not
be reclassified to profit or lossEquity investments at
fair valueOCI – net change in fair value |
|
(555) |
|
53 |
(531) |
264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income / (loss) |
|
(555) |
|
53 |
(531) |
264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive loss |
|
(11,439) |
|
(11,967) |
(19,903) |
(27,973) |
|
|
|
|
|
|
|
Loss per
share in € per share |
|
(0.17) |
|
(0.19) |
(0.31) |
(0.47) |
|
|
|
|
|
|
|
(undiluted =
diluted) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted number of
common shares outstanding |
|
62,443,550 |
62,400,484 62,437,673 |
59,876,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Affimed N.V.Consolidated
statements of financial position (in € thousands)
|
September 30, 2019 |
|
December 31, 2018 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Intangible assets |
149 |
|
56 |
Leasehold improvements and
equipment |
2,021 |
|
1,414 |
Long term financial
assets |
3,294 |
|
3,825 |
Right-of-use assets |
556 |
|
0 |
|
6,020 |
|
5,295 |
Current
assets |
|
|
|
Cash and cash equivalents |
59,995 |
|
94,829 |
Financial assets |
16,530 |
|
13,974 |
Trade and other
receivables |
1,184 |
|
1,429 |
Inventories |
330 |
|
260 |
Other assets |
1,491 |
|
387 |
|
79,530 |
|
110,879 |
TOTAL
ASSETS |
85,550 |
|
116,174 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
Issued capital |
624 |
|
624 |
Capital reserves |
241,062 |
|
239,055 |
Fair value reserves |
2,063 |
|
2,594 |
Accumulated deficit |
(221,516) |
|
(202,144) |
Total
equity |
22,233 |
|
40,129 |
|
|
|
|
Non-current
liabilities |
|
|
|
Borrowings |
300 |
|
1,690 |
Contract liabilities |
33,672 |
|
37,512 |
Lease liabilities |
192 |
|
0 |
Total non-current
liabilities |
34,164 |
|
39,202 |
|
|
|
|
Current
liabilities |
|
|
|
Trade and other payables |
7,633 |
|
9,425 |
Provisions |
1,131 |
|
0 |
Borrowings |
2,960 |
|
3,083 |
Lease liabilities |
337 |
|
0 |
Contract
liabilities |
17,092 |
|
24,335 |
Total current
liabilities |
29,153 |
|
36,843 |
|
|
|
|
TOTAL EQUITY AND
LIABILITIES |
85,550 |
|
116,174 |
Affimed N.V.Unaudited
consolidated statements of cash flows (in € thousands)
|
|
For the nine months ended September
30 |
|
|
2019 |
|
2018 |
|
Cash flow
from operating activities |
|
|
|
|
Loss for the
period |
(19,372) |
|
(28,237) |
|
Adjustments for
the period: |
|
|
|
|
- Income
taxes |
4 |
|
1 |
|
- Depreciation and
amortization |
648 |
|
303 |
|
- Net gain from
disposal of leasehold improvements and equipment |
(9) |
|
15 |
|
- Share based
payments |
1,981 |
|
1,523 |
|
- Finance income /
costs – net |
(1,655) |
|
(920) |
|
|
(18,403) |
|
(27,315) |
|
Change in trade
and other receivables |
458 |
|
(344) |
|
Change in
inventories |
(70) |
|
(79) |
|
Change in other
assets |
(1,104) |
|
(549) |
|
Change in trade,
other payables, provisions and contract liabilities |
(11,727) |
|
3,473 |
|
Cash used in
operating activities |
(30,846) |
|
(24,814) |
|
Interest
received |
413 |
|
159 |
|
Paid interest |
(180) |
|
(268) |
|
Paid income
tax |
0 |
|
(1) |
|
Net cash
used in operating activities |
(30,613) |
|
(24,924) |
|
|
|
|
|
|
Cash flow
from investing activities |
|
|
|
|
Purchase of
intangible assets |
(143) |
|
(27) |
|
Purchase of
leasehold improvements and equipment |
(926) |
|
(448) |
|
Cash received from
the sale of leasehold improvements and equipment |
0 |
|
1 |
|
Cash paid for
investments in financial assets |
(39,733) |
|
0 |
|
Cash received from
maturity of financial assets |
38,270 |
|
0 |
|
Net cash
used for investing activities |
(2,532) |
|
(474) |
|
|
|
|
|
|
Cash flow
from financing activities |
|
|
|
|
Proceeds from
issue of common shares |
26 |
|
25,110 |
|
Transaction costs
related to issue of common shares |
0 |
|
(1,702) |
|
Proceeds from
borrowings |
562 |
|
0 |
|
Repayment of lease
liabilities |
(299) |
|
0 |
|
Repayment of
borrowings |
(2,339) |
|
(2,250) |
|
Cash flow
from financing activities |
(2,050) |
|
21,158 |
|
Exchange-rate related changes of cash and cash
equivalents |
361 |
|
1,479 |
|
Net
changes to cash and cash equivalents |
(35,195) |
|
(4,240) |
|
Cash and
cash equivalents at the beginning of the period |
94,829 |
|
39,837 |
|
Cash and
cash equivalents at the end of the period |
59,995 |
|
37,076 |
|
Affimed N.V.Unaudited
consolidated statements of changes in equity (in €
thousands)
|
Issued capital |
|
Capital reserves |
|
Fair Value reserves |
|
Accumulated deficit |
|
Total equity |
|
|
|
|
|
|
|
|
|
|
Balance as of January
1, 2018 |
468 |
|
213,778 |
|
7,325 |
|
(182,667) |
|
38,904 |
Issue of common shares |
156 |
|
23,170 |
|
|
|
|
|
23,326 |
Exercise of share based
payment awards |
|
|
68 |
|
|
|
|
|
68 |
Equity-settled share based
payment awards |
|
|
1,523 |
|
|
|
|
|
1,523 |
Loss for the period |
|
|
|
|
|
|
(28,237) |
|
(28,237) |
Other comprehensive
income |
|
|
|
|
264 |
|
|
|
264 |
Balance as of
September 30, 2018 |
624 |
|
238,539 |
|
7,589 |
|
(210,904) |
|
35,848 |
Balance as of
January 1, 2019 |
624 |
|
239,055 |
|
2,594 |
|
(202,144) |
|
40,129 |
Exercise of share based
payment awards |
|
|
26 |
|
|
|
|
|
26 |
Equity-settled share based
payment awards |
|
|
1,981 |
|
|
|
|
|
1,981 |
Loss for the period |
|
|
|
|
|
|
(19,372) |
|
(19,372) |
Other comprehensive
income |
|
|
|
|
(531) |
|
|
|
(531) |
Balance as of
September 30, 2019 |
624 |
|
241,062 |
|
2,063 |
|
(221,516) |
|
22,233 |
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