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 third quarter ended September 30, 2022 and provided
an update on clinical and corporate progress.
“We are excited to have secured a partner that is able to
provide a commercially viable NK cell product that enables us to
start a registration directed, multicenter clinical trial in order
to bring this promising treatment to patients in need as fast as
possible. This collaboration builds on the foundation of the
exceptional data of AFM13 in combination with NK cells that will be
presented at ASH,” said Dr. Adi Hoess, CEO of Affimed. “The
progress we are making across our pipeline has laid the foundation
for the next steps of development. We are looking forward to
sharing key clinical milestones before the end of this year,
including topline data from the REDIRECT study and data from the
combination of AFM13 with NK cells.”
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
- Affimed expects to report topline data from the phase 2
REDIRECT study (AFM13-202) of AFM13 monotherapy in patients with
relapsed / refractory (r/r) CD30-positive peripheral T-cell
lymphoma (PTCL) in mid-December.REDIRECT is a phase 2,
registration-directed study of AFM13 monotherapy that has completed
enrollment of more than 100 r/r PTCL patients. The focus of the
topline data will be the overall response rate and preliminary
assessment of response duration.
- A clinical update from the ongoing phase 1/2 trial with
Affimed’s lead innate cell engager (ICE®) AFM13 precomplexed with
cord blood-derived NK cells followed by three weekly infusions of
AFM13 in patients with CD30-positive r/r Hodgkin and non-Hodgkin
lymphomas will be provided at the upcoming ASH conference in an
oral presentation by Dr. Yago Nieto, M.D., Ph.D., Professor of Stem
Cell Transplantation and Cellular Therapy at The University of
Texas MD Anderson Cancer Center and principal investigator of the
study, on Saturday, December 10, 2022 at 1:15 p.m. CST / 2:15 p.m.
EST.Since the last study update in April 2022 until July 31, 2022
an additional 11 patients were enrolled, resulting in 24 patients
treated at the recommended phase 2 dose (RP2D) with up to 4 cycles;
a total of 30 patients have been enrolled in the study. The
combination treatment continues to show a 100% ORR at the highest
dose level and a further improvement in the CR rate, from the
previously reported 61.5% to 70.8%.The safety profile for AFM13 is
consistent with previously reported data of infusion related
reactions being manageable, with the main treatment-related
side-effect being infusion-related reactions. The side effects
observed in the trial were transient and did not lead to treatment
delays or discontinuations.
- Affimed plans to host an in-person investor meeting and webcast
in conjunction with the American Society of Hematology (ASH) Annual
Meeting and Exposition on Saturday, Dec. 10,
2022.Partnership with ArtivaIn November 2022,
Affimed announced a strategic partnership with Artiva
Biotherapeutics to jointly develop, manufacture and commercialize a
combination therapy of AFM13 and Artiva’s cord blood-derived,
cryopreserved/off-the-shelf, allogeneic NK cell product candidate,
AB-101 in CD30-positive lymphomas.Affimed submitted a pre-IND
meeting request for the AFM13 and AB-101 co-administered
combination therapy to the U.S. Food and Drug Administration (FDA)
requesting feedback on the clinical trial design in
relapsed/refractory (r/r) Hodgkin lymphoma with an exploratory arm
evaluating the combination in r/r CD30-positive peripheral T-cell
lymphoma and potential path to registration. The FDA is expected to
provide feedback by Q1 2023.The companies expect to submit an
Investigational New Drug (IND) application to the FDA in H1
2023.
AFM24 (EGFR/CD16A)
- AFM24-101: Affimed continues to enroll patients in the
expansion phase of the AFM24 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.
- Comprehensive correlative science findings of the AFM24-101
study presented in a poster at the 37th SITC Annual Meeting showed
that starting at low doses of AFM24, NK cell activation was seen in
peripheral blood. CD16A receptor occupancy leveled off at doses of
320mg and above, indicating receptor saturation. Activation of the
adaptive immune system was also seen at higher doses of AFM24. When
tissue biopsies were analyzed, AFM24-treated patients had an
increase in NK cells and cytotoxic T cells in the tumor, suggesting
that treatment with AFM24 activates both the innate and adaptive
immune system in the periphery of the tumor as well as the tumor
microenvironment.
- AFM24-102: Enrollment continues in the phase 1/2a combination
study of AFM24 with the anti-PD-L1 checkpoint inhibitor
atezolizumab (Tecentriq®) in patients with advanced epidermal
growth factor receptor-expressing solid tumors. AFM24-102 includes
patients with non-small cell lung cancer (EGFR wildtype), gastric
and gastroesophageal junction adenocarcinoma and
pancreatic/hepatocellular/biliary tract cancer. Patients being
enrolled in the study are required to have progressed or relapsed
on standard of care therapies. The first cohort (160 mg) was
completed successfully with no reports of dose-limiting toxicities
(DLTs). Enrollment is ongoing in the second dose escalation
cohort treating patients with a weekly AFM24 dose of 480 mg. No
DLTs were observed in the first three patients treated in this
cohort and three additional patients are being enrolled at this
dose level to confirm 480 mg as the RP2D.Data from the first cohort
of the phase 1 dose escalation study presented at SITC showed that
clinical activity was observed in two patients at the 160 mg dose
level. A patient with gastric cancer and skin metastases who had
rapidly progressed following four prior lines of therapy, including
a PD-1 inhibitor, achieved a partial response (PR). The second
patient with pancreatic adenocarcinoma showed stable disease (SD)
beyond four months.
- AFM24-103: In the phase 1/2a combination study of AFM24 with
SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK
cell therapy, enrollment has been completed in the first dose
cohort (160 mg AFM24 weekly), with no DLTs observed. The Company is
currently enrolling patients at the 480 mg dose level.AFM24-103 is
focused on the treatment of patients with non-small cell lung
cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head
and neck, and colorectal cancer.
- Affimed expects to provide data updates from the three ongoing
studies at major scientific conferences in Q2 and Q3 of 2023.
Preclinical Programs
AFM28 (CD123/CD16A)
Affimed’s AFM28 ICE® targets CD16A on NK cells and macrophages,
and CD123 on leukemic blasts and leukemic stem cells that are
prevalent in acute myeloid leukemia (AML).
Pre-clinical data from a collaboration between Affimed and the
Department of Hematology and Oncology, Medical Faculty Mannheim,
Heidelberg University will be presented at the ASH conference.
The study evaluated the efficacy of AFM28 in preclinical AML
models. In a panel of AML cell lines, AFM28 successfully engaged
allogeneic NK cells to destroy CD132-positive tumor cells through
antibody-dependent cytotoxicity (ADCC). ADCC induced by AFM28 was
independent of leukemic cell mutational profiles and was also
effective in targeting cells with low levels of CD123 surface
expression.
Residual leukemic stem cells are a frequent cause for relapse
and associated with poor prognosis. Patient-derived AML cell
cultures incubated with AFM28 and allogeneic NK cells showed
significantly reduced numbers of outgrowing colonies compared to
controls. That indicates that LSCs and progenitor cells were
eliminated. These results were confirmed in an AML mouse model
demonstrating complete inhibition of tumor growth throughout a
42-day treatment period in comparison to untreated control mice who
all developed systemic disease.
The Company anticipates initiating the phase 1 clinical study
for AFM28 in the first half of 2023.
Partnerships and Collaborations
Partnered programs with Genentech and Roivant continue to
progress.
Roivant presented a poster at SITC that AFVT-2101/AFM32
represents a novel approach to treating folate receptor alpha (FRα)
expressing tumors by engaging the innate immune response for safe
and effective tumor cell killing. The company announced that it is
expecting to enter phase 1 clinical trial in 2023.
Affimed is eligible for additional proceeds including
pre-clinical milestones as well as milestones based on early
regulatory achievements.
Third Quarter 2022 Financial Highlights
Affimed's consolidated financial statements are prepared in
accordance with International Financial Reporting Standards (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 September 30, 2022, cash and cash equivalents totaled
€222.9 million compared to €197.6 million on December 31, 2021.
Based on the Company’s current operating plan and assumptions, cash
and cash equivalents are expected to support operations into
mid-2024.
Net cash used in operating activities for the quarter ended
September 30, 2022, was €19.0 million compared to €25.6 million for
the quarter ended September 30, 2021.
Total revenue for the quarter ended September 30, 2022, was
€14.9 million compared with €8.7 million for the quarter ended
September 30, 2021. Revenue predominately relates to the Genentech
and Roivant collaborations.
Research and development expenses for the quarter ended
September 30, 2022, increased by 27% from €20.6 million to €26.1
million compared to the quarter ended September 30, 2021. Research
and development expenses increased primarily due to higher expenses
associated with the development of the AFM13 and AFM24 programs and
included costs to produce clinical trial material, clinical patient
trial costs and manufacturing, 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 19% from €6.8
million in the quarter ended September 30, 2021 to €8.1 million in
the quarter ended September 30, 2022. The increase predominately
relates to an increase in headcount, higher share-based payment
expenses, an increase in insurance premiums and higher consulting
costs.
Net finance income for the quarter ended September 30, 2022
increased by 84% from €1.5 million in the quarter ended September
30, 2021, to €2.7 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 the Euro during the year.
Net loss for the quarter ended September 30, 2022, was €16.5
million, or €0.11 loss per common share compared with a net loss of
€17.1 million, or €0.14 loss per common share, for the quarter
ended September 30, 2021.
The weighted number of common shares outstanding for the quarter
ended September 30, 2022 was 149.3 million.
Additional information regarding these results is included in
the notes to the consolidated financial statements as of September
30, 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
IASB. 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
November 15, 2022, at 8:30 a.m. EST / 14:30 CET to discuss third
quarter 2022 financial results and corporate developments. The
conference call will be available via phone and webcast. The live
audio webcast of the 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/.
To access the call by phone, please use
link https://register.vevent.com/register/BI62ec6e16028b424eba578af8c49e4240,
and you will be provided with dial-in details and a pin number.
Notes: To avoid delays, we
encourage participants to dial into the conference call 15 minutes
ahead of the scheduled start time. 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 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 the Company’s
intentions, beliefs, projections, outlook, analyses and current
expectations concerning, among other things, the potential of
AFM13, AFM24, AFM28 and the Company’s other product candidates, the
value of its ROCK® platform, its ongoing and planned preclinical
development and clinical trials, its collaborations and development
of its products in combination with other therapies, the timing of
and its ability to make regulatory filings and obtain and maintain
regulatory approvals for its product candidates, its intellectual
property position, its collaboration activities, its ability to
develop commercial functions, clinical trial data, its results of
operations, cash needs, financial condition, liquidity, prospects,
future transactions, growth and strategies, the industry in which
it operates, the trends that may affect the industry or the
Company, impacts of the COVID-19 pandemic, the benefits to Affimed
of orphan drug designation, the impact on its business by political
events, war, terrorism, business interruptions and other
geopolitical events and uncertainties, such as the Russia-Ukraine
conflict, the fact that the current clinical data of AFM13 in
combination with NK cell therapy is based on AFM13 precomplexed
with fresh allogeneic cord blood-derived NK cells from The
University of Texas MD Anderson Cancer Center, as opposed to
Artiva’s AB-101 and other uncertainties and 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 the Company
assumes no obligation to update these forward-looking statements,
even if new information becomes available in the future.
Investor Relations Contact Alexander
FudukidisDirector, Investor RelationsE-Mail:
a.fudukidis@affimed.comTel.: +1 (917) 436-8102
|
Unaudited consolidated interim statements of comprehensive
income / (loss) |
(in € thousand) |
|
|
|
|
|
|
|
|
|
|
|
For the three months endedSeptember |
|
For the nine months endedSeptember |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
Revenue |
|
14,888 |
|
8,662 |
|
30,195 |
|
30,028 |
|
|
|
|
|
|
|
|
|
Other income – net |
|
118 |
|
231 |
|
642 |
|
710 |
Research and development expenses |
|
(26,126) |
|
(20,621) |
|
(65,333) |
|
(53,826) |
General and administrative expenses |
|
(8,089) |
|
(6,841) |
|
(23,509) |
|
(16,766) |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(19,209) |
|
(18,569) |
|
(58,005) |
|
(39,854) |
|
|
|
|
|
|
|
|
|
Finance income / (costs) – net |
|
2,719 |
|
1,474 |
|
5,443 |
|
5,421 |
|
|
|
|
|
|
|
|
|
Loss before tax |
|
(16,490) |
|
(17,095) |
|
(52,562) |
|
(34,433) |
|
|
|
|
|
|
|
|
|
Income taxes |
|
0 |
|
0 |
|
(2) |
|
(2) |
|
|
|
|
|
|
|
|
|
Loss for the period |
|
(16,490) |
|
(17,095) |
|
(52,564) |
|
(34,435) |
|
|
|
|
|
|
|
|
|
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) |
|
(3,489) |
|
(6,846) |
|
(8,838) |
|
|
|
|
|
|
|
|
|
Other comprehensive income / (loss) |
|
(73) |
|
(3,489) |
|
(6,846) |
|
(8,838) |
|
|
|
|
|
|
|
|
|
Total comprehensive income / (loss) |
|
(16,563) |
|
(20,584) |
|
(59,410) |
|
(43,273) |
|
|
|
|
|
|
|
|
|
Basic and diluted earnings / (loss) per share in € per
share (undiluted = diluted) |
|
(0.11) |
|
(0.14) |
|
(0.38) |
|
(0.29) |
Weighted number of common shares outstanding |
|
149,339,335 |
|
119,786,695 |
|
140,036,614 |
|
118,545,453 |
Consolidated interim statements of financial
position |
(in € thousand) |
|
|
|
|
|
|
|
September 30, 2022 |
|
December 31, 2021 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Intangible assets |
|
1,555 |
|
1,607 |
Leasehold improvements and equipment |
|
3,584 |
|
3,814 |
Long-term financial assets |
|
0 |
|
12,348 |
Right-of-use assets |
|
710 |
|
972 |
|
|
5,849 |
|
18,741 |
Current assets |
|
|
|
|
Cash and cash equivalents |
|
222,895 |
|
197,630 |
Trade and other receivables |
|
1,691 |
|
4,809 |
Inventories |
|
673 |
|
421 |
Assets held for sale |
|
1,731 |
|
0 |
Other assets and prepaid expenses |
3,560 |
|
3,534 |
|
|
230,550 |
|
206,394 |
|
|
|
|
|
TOTAL ASSETS |
|
236,399 |
|
225,135 |
|
|
|
|
|
EQUITY AND LIABILITIES |
|
|
|
|
Equity |
|
|
|
|
Issued capital |
|
1,493 |
|
1,234 |
Capital reserves |
|
578,390 |
|
474,087 |
Fair value reserves |
|
(5,954) |
|
(5,973) |
Accumulated deficit |
|
(392,826) |
|
(333,397) |
Total equity |
|
181,103 |
|
135,951 |
|
|
|
|
|
Non current liabilities |
|
|
|
|
Borrowings |
13,027 |
|
17,060 |
Contract liabilities |
|
1,238 |
|
7,209 |
Lease liabilities |
|
203 |
|
368 |
Total non-current liabilities |
|
14,468 |
|
24,637 |
|
|
|
|
|
Current liabilities |
|
|
|
|
Trade and other payables |
|
15,078 |
|
18,860 |
Borrowings |
4,957 |
|
580 |
Lease liabilities |
|
541 |
|
683 |
Contract liabilities |
20,252 |
|
44,424 |
Total current liabilities |
|
40,828 |
|
64,547 |
|
|
|
|
|
TOTAL EQUITY AND LIABILITIES |
|
236,399 |
|
225,135 |
Unaudited consolidated interim statements of cash
flows |
(in € thousand) |
|
|
|
For the nine months endedSeptember 30, |
|
|
2022 |
|
2021 |
Cash flow from operating activities |
|
|
|
|
Income / (loss) for the period |
|
(52,564) |
|
(34,435) |
Adjustments for the period: |
|
|
|
|
- Income taxes |
|
2 |
|
2 |
- Depreciation and amortization |
|
1,066 |
|
935 |
- Net gain / loss from disposal of leasehold improvements and
equipment |
|
0 |
|
(2) |
- Share-based payments |
|
14,779 |
|
8,117 |
- Finance income / costs – net |
|
(5,443) |
|
(5,421) |
|
|
(42,160) |
|
(30,804) |
Change in trade and other receivables |
|
3,118 |
|
(1,320) |
Change in inventories |
|
(252) |
|
(446) |
Change in other assets and prepaid expenses |
|
(26) |
|
1,064 |
Change in trade, other payables, provisions and contract
liabilities |
|
(33,888) |
|
(26,802) |
|
|
(73,208) |
|
(58,308) |
Interest received |
|
228 |
|
0 |
Paid interest |
|
(950) |
|
(647) |
Paid income tax |
|
(2) |
|
(2) |
Net cash used in operating activities |
|
(73,932) |
|
(58,957) |
|
|
|
|
|
Cash flow from investing activities |
|
|
|
|
Purchase of intangible assets |
|
(30) |
|
(5) |
Purchase of leasehold improvements and equipment |
|
(263) |
|
(1,527) |
Cash received from the sale of financial assets |
|
3,772 |
|
0 |
Net cash used for investing activities |
|
3,479 |
|
(1,532) |
|
|
|
|
|
Cash flow from financing activities |
|
|
|
|
Proceeds from issue of common shares, including exercise of
share-based payment awards |
|
95,907 |
|
103,379 |
Transaction costs related to issue of common shares |
|
(6,159) |
|
(6,548) |
Proceeds from borrowings |
|
0 |
|
10,000 |
Transaction costs related to borrowings |
|
0 |
|
(236) |
Repayment of lease liabilities |
|
(538) |
|
(372) |
Repayment of borrowings |
|
(70) |
|
(69) |
Cash flow from financing activities |
|
89,140 |
|
106,154 |
|
|
|
|
|
Exchange-rate related changes of cash and cash
equivalents |
|
6,578 |
|
6,223 |
Net changes to cash and cash equivalents |
|
18,687 |
|
45,665 |
Cash and cash equivalents at the beginning of the
period |
|
197,630 |
|
146,854 |
Cash and cash equivalents at the end of the
period |
|
222,895 |
|
198,742 |
Unaudited consolidated interim 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 |
|
205 |
|
94,138 |
|
|
|
|
|
94,343 |
Exercise of share-based payment awards |
|
10 |
|
2,667 |
|
|
|
|
|
2,677 |
Equity-settled share-based payment awards |
|
|
|
8,117 |
|
|
|
|
|
8,117 |
Loss for the period |
|
|
|
|
|
|
|
(34,435) |
|
(34,435) |
Other comprehensive loss |
|
|
|
|
|
(8,838) |
|
|
|
(8,838) |
|
|
|
|
|
|
|
|
|
|
|
Balance as of September 30, 2021 |
|
1,198 |
|
450,086 |
|
(7,118) |
|
(310,309) |
|
133,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of January 1, 2022 |
|
1,234 |
|
474,087 |
|
(5,973) |
|
(333,397) |
|
135,951 |
|
|
|
|
|
|
|
|
|
|
|
Issue of common shares |
|
259 |
|
89,423 |
|
|
|
|
|
89,682 |
Exercise of share-based payment awards |
|
|
|
101 |
|
|
|
|
|
101 |
Equity-settled share-based payment awards |
|
|
|
14,779 |
|
|
|
|
|
14,779 |
Transfer of cumulative loss on sale of financial assets |
|
|
|
|
|
6,865 |
|
(6,865) |
|
0 |
Loss for the period |
|
|
|
|
|
|
|
(52,564) |
|
(52,564) |
Other comprehensive loss |
|
|
|
|
|
(6,846) |
|
|
|
(6,846) |
|
|
|
|
|
|
|
|
|
|
|
Balance as of September 30, 2022 |
|
1,493 |
|
578,390 |
|
(5,954) |
|
(392,826) |
|
181,103 |
|
|
|
|
|
|
|
|
|
|
|
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