- Company to focus on the development of AFM13, AFM24 and preclinical
innate cell engagers, decides to terminate AFM11 T cell engager Phase 1
program -
- Received milestone payment from Genentech, continuing to strengthen
cash position from non-dilutive sources -
- Clinical study updates of AFM13 as monotherapy and in combination with
Keytruda(R) (pembrolizumab) will be highlighted in oral and poster
presentations at the 15(th) International Conference on Malignant
Lymphoma (ICML) -
Heidelberg, Germany, May 22, 2019 - Affimed N.V. (Nasdaq: AFMD), a
clinical stage biopharmaceutical company committed to giving patients
back their innate ability to fight cancer, today announced a plan to
focus its research and development investments on advancing on-going and
previously announced clinical trials for its innate cell engager
candidates, AFM13 and AFM24. As part of the strategic plan, Affimed will
terminate the Phase 1 clinical program of AFM11, a CD19/CD3-targeting
bispecific T cell engager. The Company also provided an update on recent
operational progress and reported financial results for the quarter
ended March 31, 2019.
"We are focused on advancing our CD16A-targeting innate cell engager
product candidates as we progress through 2019, with the goals of
initiating a market registration-directed study of AFM13 and entering
the clinic with AFM24," said Dr. Adi Hoess, Affimed's CEO. "We strongly
believe our innate cell engagers could enhance current immuno-oncology
approaches and address unmet patient needs in treating hematologic and
solid tumor malignancies. We have determined that the optimal use of our
resources at this time is to advance our innate cell engagers, focusing
their development on indications with high unmet need and the potential
for a rapid path to regulatory approval. In addition to advancing our
current clinical product candidates, we are working toward expanding our
early clinical stage pipeline and exploring rational combinations of our
innate cell engagers with other therapeutic modalities such as adoptive
NK cell therapies."
Corporate Updates
-- Affimed received a milestone payment from Genentech, a member of the
Roche Group, triggered by the achievement of a preclinical milestone
under its research collaboration with Genentech to develop and
commercialize novel natural killer (NK) cell engager-based
immunotherapeutics based on Affimed's ROCK(R) platform to treat multiple
cancers.
-- Dr. Martin Treder has informed Affimed that he intends to step down from
his position as Chief Scientific Officer to pursue new opportunities. Dr.
Treder will continue as a consultant to the Company.
Dr. Hoess commented, "Martin oversaw the development of Affimed's
ROCK(R) platform. We thank Martin for his many contributions to Affimed
during his tenure as CSO, and wish him success in his future endeavors."
Pipeline Updates and Upcoming Clinical Plans
CD16A innate cell engager programs
AFM13 (CD30/CD16A)
-- At the American Association for Cancer Research (AACR) Annual Meeting
2019, Affimed together with its collaboration partners from Washington
University School of Medicine, St. Louis, MO, presented data that
describe functional responses of conventional and cytokine-induced
memory-like (CIML) NK cells in the presence or absence of AFM13. In a
poster titled, "The CD30/CD16A bispecific innate immune cell engager
AFM13 elicits heterogeneous single cell NK cell responses and effectively
triggers memory like (ML) NK cells," preclinical data showed that AFM13
significantly enhanced NK cell recognition of CD30-positive tumor cells
and this enhanced tumor recognition correlated with superior NK cell
activation. In the study, the combination of CIML NK cells with AFM13
potentiated cytokine secretion and cytotoxicity towards tumor target
cells, further demonstrating the rationale for combining AFM13 with
adoptive NK cell-based therapies as a promising therapeutic approach for
treating CD30-positive malignancies.
-- Abstracts providing updates on AFM13 clinical studies have been accepted
for oral and poster presentations at the 15th International Conference on
Malignant Lymphoma (ICML), to be held from June 18-22, 2019, in Lugano,
Switzerland. The oral presentation includes updated data from the
combination study of AFM13 with Merck's Keytruda(R) (pembrolizumab) in
patients with relapsed or refractory Hodgkin lymphoma (HL). In addition,
a poster presentation will highlight data from the investigator-sponsored
study of AFM13 as monotherapy in patients with relapsed or refractory
CD30-positive lymphoma with cutaneous manifestations. Details on these
presentations are expected to be available in mid-June through the ICML
meeting website at www.lymphcon.ch.
-- Affimed filed with U.S. Food and Drug Administration (FDA) the full study
protocol for the Company's Phase 2 registration-directed study of AFM13
as monotherapy in relapsed or refractory patients with peripheral T cell
lymphoma (PTCL) and transformed mycosis fungoides, a subset of cutaneous
T cell lymphoma. The study commencement is targeted for the second half
of 2019 pending agreement with the FDA on the final study protocol.
-- An investigator-sponsored study directed towards development of an
off-the-shelf adoptive immunotherapy comprised of AFM13 pre-mixed with
expanded cord blood-derived allogeneic NK cells in patients with
relapsed/refractory CD30-positive malignancies is planned by The
University of Texas MD Anderson Cancer Center (MDACC) with the support of
Affimed.
AFM24 (EGFR/CD16A)
-- At the AACR Annual Meeting 2019, a poster titled, "Preclinical
characterization of the bispecific EGFR/CD16A innate immune cell engager
AFM24 for the treatment of EGFR-expressing solid tumors," highlighted
potentially differentiating features of AFM24 versus standard of care
anti-EGFR therapies, such as the monoclonal antibody cetuximab. AFM24
demonstrated the ability to bridge NK cells and macrophages to EGFR
expressing tumor cell lines, and induced lysis through antibody-dependent
cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis
(ADCP), respectively, which was independent of RAS mutational status.
AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent
anti-tumor efficacy in in vivo tumor models. Importantly, AFM24 showed
reduced inhibition of EGFR phosphorylation relative to the standard of
care, cetuximab. Treatment of cynomolgus monkeys with AFM24 showed a
favorable safety profile, even when treated at high dose levels,
demonstrating AFM24's potential to have significantly lower toxicities in
humans compared to standard of care.
-- Affimed currently anticipates completing investigational new drug
(IND)-enabling studies of AFM24 by mid-year 2019 to support the
initiation of the first-in-human study of AFM24 in the second half of
2019.
Financial Highlights
(Figures for the first quarter of 2019 and for the first quarter 2018
are unaudited.)
Pro-forma cash, cash equivalents and short-term deposits, including the
milestone payment under the Genentech collaboration that the Company
received in April 2019, totaled EUR100.4 million or approximately $113
million, as of March 31, 2019. Cash, cash equivalents and short-term
deposits on December 31, 2018 were EUR108.8 million. Based on its
current operating and budget assumptions, Affimed anticipates that its
cash, cash equivalents and short-term deposits as of March 31, 2019 will
enable the Company to fund its planned clinical development and early
development activities into 2021.
Net cash used in operating activities was EUR13.4 million for the three
months ended March 31, 2019 compared to net cash used in operating
activities of EUR6.9 million for the three months ended March 31, 2018.
Total revenue was EUR11.4 million for the three months ended March 31,
2019 compared to EUR0.5 million for the three months ended March 31,
2018. The increase in revenue is primarily attributable to the
recognition of EUR10.6 million as revenue from the Genentech
collaboration in the first quarter of 2019.
Research and development (R&D) expenses for the first quarter of 2019
were EUR8.0 million compared to EUR6.4 million for the first quarter of
2018. The increase was primarily related to higher expenses related to
clinical study startup activities for the AFM13 registration study in
PTCL, as well as early stage development and discovery activities.
General and administrative (G&A) expenses for the first quarter of 2019
were higher at EUR2.4 million compared to EUR2.0 million for the first
quarter of 2018. This increase was primarily related to higher personnel
expenses.
Net income was EUR1.9 million, or EUR0.03 per common share, for the
first quarter of 2019, compared to a net loss of EUR8.2 million, or
EUR0.15 per common share, for the first quarter of 2018. Net income was
primarily related to significantly increased revenue, partially offset
by higher R&D and G&A expenses.
Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and
financial information in accordance with International Financial
Reporting Standards (IFRS) as issued by the International Accounting
Standards Board (IASB). None of the financial statements were prepared
in accordance with Generally Accepted Accounting Principles (GAAP) 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, Wednesday, May
22, 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 1083705 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/. 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
that engineers targeted immunotherapies, seeking to improve patient
outcomes through the power of innate immunity. Affimed's fit-for-purpose
ROCK(R) platform allows innate immune engagers to be designed for
specific patient populations. The Company is developing single and
combination therapies to treat cancers. 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(R)
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 Contact:
Gregory Gin, Head of Investor Relations
E-Mail: IR@affimed.com
Affimed Media Contact:
Anca Alexandru, Head of Communications, EU IR
E-Mail: media@affimed.com
Affimed N.V.
Unaudited consolidated statements of comprehensive income/(loss) (in EUR
thousand)
For the three months ended
March 31
2019 2018
Revenue 11,353 532
Other income -- net 86 (11)
Research and development expenses (7,987) (6,396)
General and administrative expenses (2,434) (2,038)
--------------------------- ----------
Operating income / (loss) 1,018 (7,913)
Finance income / (costs) -- net 834 (289)
Income / (loss) before tax 1,852 (8,202)
Income taxes 0 (1)
--------------------------- ----------
Income / (loss) for the period 1,852 (8,203)
=========================== ==========
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 73 (195)
--------------------------- ----------
Other comprehensive income / (loss) 73 (195)
Total comprehensive income / (loss) 1,925 (8,398)
=========================== ==========
Earnings / (loss) per share in EUR per share
(undiluted = diluted) 0.03 (0.15)
Weighted number of common shares outstanding 62,430,106 54,838,038
Affimed N.V.
Consolidated statements of financial position (in EUR thousand)
March 31, 2019 December 31, 2018
(unaudited)
ASSETS
Non-current assets
Intangible assets 107 56
Leasehold improvements and equipment 1,374 1,414
Long term financial assets 3,898 3,825
Right-of-use assets 635 0
-------------- -----------------
6,014 5,295
Current assets
Cash and cash equivalents 63,089 94,829
Financial assets 32,043 13,974
Trade and other receivables 8,298 1,429
Inventories 325 260
Other assets 570 387
-------------- -----------------
104,325 110,879
TOTAL ASSETS 110,339 116,174
EQUITY AND LIABILITIES
Equity
Issued capital 624 624
Capital reserves 239,656 239,055
Fair value reserves 2,667 2,594
Accumulated deficit (200,292) (202,144)
-------------- -----------------
Total equity 42,655 40,129
Non-current liabilities
Borrowings 957 1,690
Contract liabilities 33,488 37,512
Lease liabilities 302 0
-------------- -----------------
Total non-current liabilities 34,747 39,202
Current liabilities
Trade and other payables 6,289 9,425
Borrowings 3,083 3,083
Lease liabilities 334 0
Contract liabilities 23,231 24,335
-------------- -----------------
Total current liabilities 32,937 36,843
TOTAL EQUITY AND LIABILITIES 110,339 116,174
Affimed N.V.
Unaudited consolidated statements of cash flows (in EUR thousand)
For the three months ended
March 31
2019 2018
Cash flow from operating activities
Income / (loss) for the period 1,852 (8,203)
Adjustments for the period:
- Income taxes 0 1
- Depreciation and amortisation 210 99
- Net gain from disposal of leasehold improvements
and equipment (9) 0
- Share based payments 601 370
- Finance income / costs -- net (834) 289
-------- -------------
1,820 (7,444)
Change in trade and other receivables (6,688) (711)
Change in inventories (65) (21)
Change in other assets (183) (17)
Change in trade, other payables and contract
liabilities (8,252) 1,345
-------- -------------
Cash used in operating activities (13,368) (6,848)
Interest received 62 26
Paid interest (77) (101)
Net cash used in operating activities (13,383) (6,923)
Cash flow from investing activities
Purchase of intangible assets (64) (9)
Purchase of leasehold improvements and equipment (66) (146)
Cash received from the sale of leasehold improvements
and equipment 0 1
Cash paid for investments in financial assets (21.061) 0
Cash received from maturity of financial assets 3,513 0
-------- -------------
Net cash used for investing activities (17,678) (154)
Cash flow from financing activities
Proceeds from issue of common shares 0 25,042
Transaction costs related to issue of common shares 0 (1,646)
Repayment of lease liabilities (82) 0
Repayment of borrowings (833) (750)
-------- -------------
Cash flow from financing activities (915) 22,646
-------- -------------
Exchange-rate related changes of cash and cash
equivalents 236 (66)
Net changes to cash and cash equivalents (31,976) 15,568
Cash and cash equivalents at the beginning of the
period 94,829 39,837
Cash and cash equivalents at the end of the period 63,089 55,339
-------- --------------
Affimed N.V.
Unaudited consolidated statements of changes in equity (in EUR thousand)
Issued Capital Fair value reserves Accumulated Total
capital reserves deficit equity
Balance as of January 1,
2018 468 213,778 7,325 (182,667) 38,904
======= ======== ===================== =========== ==========
Issue of common shares 156 23,230 23,386
Equity-settled share based
payment awards 370 370
Loss for the period (8,203) (8,203)
Other comprehensive income (195) (195)
Balance as of March 31, 2018 624 237,378 7,130 (190,870) 54,262
======= ======== ===================== =========== ==========
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
======= ======== ===================== =========== ==========
(END) Dow Jones Newswires
May 22, 2019 07:31 ET (11:31 GMT)
© 2019 Dow Jones News
