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 second quarter ended June 30, 2022 and provided
updates on preclinical, clinical and corporate progress.
“During the second quarter, we completed a public offering that
enables Affimed to invest in its lead programs through key
inflection points,” said Dr. Adi Hoess, CEO of Affimed. “The second
half of 2022 is shaping up to be very exciting with data updates
from AFM13 monotherapy and combination studies and our AFM24
program at scientific conferences.”
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
- The Company completed enrollment of
its REDIRECT study (AFM13-202). REDIRECT is a phase 2,
registration-directed study of AFM13 monotherapy in patients with
relapsed/refractory CD30-positive peripheral T-cell lymphoma
(PTCL).Top-line data are expected to be reported in the fourth
quarter of 2022. The focus of the initial data release will be on
the overall response rate assessed by a blinded independent review
committee and the preliminary assessment of response duration.
- Enrollment continues in the phase
1/2 study in collaboration with The University of Texas MD Anderson
Cancer Center (MD Anderson) evaluating cord-blood derived NK cells
pre-complexed with AFM13 followed by single agent AFM13 in patients
with relapsed/refractory CD30+ lymphomas.Data presented at the 2022
Annual Meeting of the American Association for Cancer Research
(AACR 2022) in the Clinical Trials Plenary Session by Dr. Yago
Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and
Cellular Therapy at MD Anderson, reported that after a second cycle
of treatment at the recommended phase 2 dose (RP2D), the complete
response rate increased from 38% (5/13) as reported in December
2021 to 62% (8/13). The overall objective response rate (ORR)
remained at 100% and the treatment was safe and well tolerated by
patients, enabling MD Anderson to continue treatment with up to
four cycles as per the approved amended protocol. The main
treatment- related side effect being infusion-related reactions.
Investigators did not observe any cases of cytokine release
syndrome (CRS), neurotoxicity or graft versus host disease often
associated with T-cell therapies. In general, side effects observed
in the trial were transient and did not lead to treatment delays or
discontinuation.Durability of response data presented at AACR 2022
for patients treated at the RP2D was also promising. Of the eight
patients who achieved a complete response (CR), seven remained in
CR at median follow-up of 6.5 months, including two patients who
remained in response after 10 months and two who received a
consolidation autologous stem cell transplant (SCT).The approved
amendment to the AFM13-104 trial protocol allows for an increase in
the number of CD30-positive lymphoma patients treated at the RP2D
to 40 – including Hodgkin and non-Hodgkin’s lymphoma patients.
Furthermore, under the amended protocol, patients can receive up to
four cycles of treatment.Enrollment continues to progress and as of
July 31, 2022 30 patients have now been treated, including 24 at
the RP2D. 11 additional patients have been treated at the RP2D
since the AACR 2022 data cutoff date.The Company and MD Anderson
expect to report updates on the study at a scientific conference in
the fourth quarter of 2022.The Company continues to make progress
with third parties to ensure access to an off-the-shelf,
cryopreserved NK cell product and expects to announce the
development path for AFM13 with a specific NK cell in the second
half of 2022.Affimed is preparing for a meeting with the FDA later
this year to discuss next development steps for this program and
expects to provide an update once it receives feedback.
AFM24 (EGFR/CD16A)
- The Company is continuing enrollment
in the expansion phase of the monotherapy study at the RP2D (480
mg). The expansion cohorts include patients with renal cell
carcinoma (clear cell), non-small cell lung cancer (EGFR mutant),
and colorectal cancer (KRAS wild-type, MSS).
- Enrollment also continues in two
combination studies: a phase 1/2a combination study of AFM24 with
the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®)
(AFM24-102) and a phase 1/2a combination of AFM24 with SNK01, NKGen
Biotech’s ex vivo expanded and activated autologous NK cell therapy
(AFM24-103).AFM24-102 is now enrolling patients at the 480 mg dose
level of AFM24. The first cohort (160 mg) was completed
successfully with no reports of dose limiting toxicities. AFM24-102
includes the treatment of patients with non-small cell lung cancer
(EGFR wild-type), gastric and gastroesophageal junction
adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer.
AFM24-103 is focused on the treatment of patients with non-small
cell lung cancer (NSCLC, EGFR wild-type), squamous cell carcinoma
of the head and neck, and colorectal cancer (KRAS wild-type/mutant,
MSS).Updates from the monotherapy study, including clinical data
from the dose escalation phase will be shown at ESMO 2022. An
additional update including correlative science data is expected to
be presented at a scientific conference later this year. Affimed
also expects to provide updates from the combination studies in the
second half of 2022, including data from the dose escalation phase
of AFM24-102 at a scientific conference in the fourth quarter of
2022.
Preclinical Programs
AFM28 (CD123/CD16A)
- As planned, the Company submitted an investigational new drug
(IND) application to the FDA in June. Following feedback from the
FDA related to the design of the dose escalation study, Affimed has
made a strategic decision to voluntarily withdraw the IND. The
Company plans to focus early clinical development of AFM28 in
jurisdictions outside of the U.S.
- The Company now anticipates initiating the phase 1 clinical
study in the first half of 2023.AFM28 is Affimed’s wholly-owned,
bispecific, tetravalent innate cell engager (ICE®) that targets
CD16A on NK cells and macrophages, and CD123 on leukemic blasts and
leukemic stem cells that are prevalent in acute myeloid leukemia
(AML).
Preclinical Pipeline
Affimed is continuing to innovate and generate several novel
ICE® molecules derived from its proprietary ROCK® platform.
Partnerships and Collaborations
Partnered programs with both Genentech and Roivant continue to
progress according to plan. Affimed is eligible for additional
proceeds from meeting pre-clinical and early regulatory achievement
milestones.
Scientific Advisory Board
During the quarter, the Company established an independent
advisory panel made up of distinguished opinion leaders with
scientific and clinical expertise in innate immunity and oncology.
The Scientific Advisory Board (SAB) will provide guidance on the
development strategy across preclinical and clinical development
candidates as well as opportunities to apply our platform to cancer
indications of high unmet need. All SAB members are leaders in a
broad range of areas relevant to Affimed's approach to developing
cancer therapies including immuno-oncology, the biology of NK
cells, lymphomas, leukemias, and solid tumors.Second
Quarter 2022 Financial Highlights
Affimed's consolidated financial statements are prepared in
accordance with 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 June 30, 2022 cash and cash equivalents totaled
€237.2 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 June
30, 2022 was €26.5 million compared to €17.3 million for the
quarter ended June 30, 2021.
Total revenue for the quarter ended June 30, 2022 was €7.3
million compared with €9.7 million for the quarter ended June 30,
2021. Revenue predominately relates to the Genentech and Roivant
collaborations.
Research and development expenses decreased by 4% from €21.8
million in the quarter ended June 30, 2021 to €20.8 million for the
quarter ended June 30, 2022. The decrease was primarily due to
lower expenses associated with the development of the AFM13 and
AFM24 programs, a result of a decrease in procurement of clinical
trial material.
General and administrative expenses increased 54% from €5.4
million in the quarter ended June 30, 2021 to €8.4 million in the
quarter ended June 30, 2022. The increase predominately relates to
higher personnel, higher share-based payment expenses and increased
insurance premiums.
Net finance income/(costs) increased from costs of €1.6 million
for the quarter ended June 30, 2021 to income of €2.3 million for
the quarter ended June 30, 2022. Net finance income/(cost) is
largely made up of foreign exchange gains and losses 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 June 30, 2022 was €19.4 million,
or €0.13 loss per common share compared with a net loss of €18.8
million, or €0.16 loss per common share for the quarter ended June
30, 2021.
The weighted number of common shares outstanding for the quarter
ended June 30, 2022 was 147.3 million.
Additional information regarding these results is included in
the notes to the consolidated financial statements as of June 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
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 on August 11,
2022 at 8:30 a.m. EDT / 14:30 CEST to discuss second quarter 2022
financial results and corporate developments. The conference call
will be available via phone and webcast.
To access the call, please dial +1 (866) 374-5140 for U.S.
callers, or +1 (404) 400-0571 for international callers, and use
PIN: 54780189# 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-and-corporate-presentation/.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 our intentions,
beliefs, projections, outlook, analyses and current expectations
concerning, among other things, the potential of AFM13, AFM24,
AFM28 and our other product candidates, 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, the impact on our business by political events, war,
terrorism, business interruptions and other geopolitical events and
uncertainties, such as the Russia-Ukraine conflict 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 Relations Contact Alexander
FudukidisDirector, Investor RelationsE-Mail:
a.fudukidis@affimed.comTel.: +1 (917) 436-8102
AFFIMED N.V.
CONDENSED INTERIM CONSOLIDATED FINANCIAL
STATEMENTS
| Unaudited
consolidated interim statements of comprehensive income /
(loss) |
| (in €
thousand) |
|
|
For the three months ended June
30 |
For the six months ended June
30 |
| |
2022 |
2021 |
2022 |
2021 |
|
|
|
Revenue |
7,301 |
|
9,707 |
|
15,307 |
|
21,366 |
|
|
|
|
|
|
|
| Other income –
net |
240 |
|
332 |
|
524 |
|
479 |
|
| Research and
development expenses |
(20,829 |
) |
(21,800 |
) |
(39,208 |
) |
(33,205 |
) |
| General and
administrative expenses |
(8,374 |
) |
(5,439 |
) |
(15,419 |
) |
(9,925 |
) |
|
|
|
|
|
|
| Operating
loss |
(21,662 |
) |
(17,200 |
) |
(38,796 |
) |
(21,285 |
) |
|
|
|
|
|
|
| Finance
income / (costs) – net |
2,253 |
|
(1,552 |
) |
2,724 |
|
3,947 |
|
|
|
|
|
|
|
| Loss
before tax |
(19,409 |
) |
(18,752 |
) |
(36,072 |
) |
(17,338 |
) |
|
|
|
|
|
|
| Income taxes |
0 |
|
0 |
|
(2 |
) |
(2 |
) |
|
|
|
|
|
|
| Loss for
the period |
(19,409 |
) |
(18,752 |
) |
(36,074 |
) |
(17,340 |
) |
|
|
|
|
|
|
| Other
comprehensive income / (loss) Items that will not
be reclassified to profit or lossEquity investments at
fair value OCI – net change in fair value |
(599 |
) |
(4,097 |
) |
(6,773 |
) |
(5,349 |
) |
|
|
|
|
|
|
| Other
comprehensive income / (loss) |
(599 |
) |
(4,097 |
) |
(6,773 |
) |
(5,349 |
) |
|
|
|
|
|
|
| Total
comprehensive income / (loss) |
(20,008 |
) |
(22,849 |
) |
(42,847 |
) |
(22,689 |
) |
|
Basic and diluted earnings / (loss) per share in € per
share (undiluted = diluted) |
(0.13 |
) |
(0.16 |
) |
(0.27 |
) |
(0.15 |
) |
| Weighted number of
common shares outstanding |
147,326,291 |
|
119,645,207 |
|
135,385,254 |
|
117,924,831 |
|
|
Consolidated interim statements of financial
position |
|
|
|
| (in €
thousand) |
|
|
|
| |
June 30, 2022 |
|
December 31, 2021 |
|
|
(unaudited) |
|
|
| ASSETS |
|
|
|
| Non-current
assets |
|
|
|
|
Intangible assets |
1,553 |
|
|
1,607 |
|
| Leasehold improvements and
equipment |
3,684 |
|
|
3,814 |
|
| Long-term financial
assets |
0 |
|
|
12,348 |
|
| Right-of-use assets |
877 |
|
|
972 |
|
|
|
6,114 |
|
|
18,741 |
|
| Current
assets |
|
|
|
| Cash and cash equivalents |
237,232 |
|
|
197,630 |
|
| Trade and other
receivables |
5,524 |
|
|
4,809 |
|
| Inventories |
571 |
|
|
421 |
|
| Assets held for sale |
4,057 |
|
|
0 |
|
| Other assets and prepaid
expenses |
7,407 |
|
|
3,534 |
|
|
|
254,791 |
|
|
206,394 |
|
|
|
|
|
|
| TOTAL
ASSETS |
260,905 |
|
|
225,135 |
|
|
|
|
|
|
| EQUITY AND
LIABILITIES |
|
|
|
| Equity |
|
|
|
| Issued capital |
1,493 |
|
|
1,234 |
|
| Capital reserves |
573,544 |
|
|
474,087 |
|
| Fair value reserves |
(9,927 |
) |
|
(5,973 |
) |
| Accumulated deficit |
(372,290 |
) |
|
(333,397 |
) |
| Total
equity |
192,820 |
|
|
135,951 |
|
|
|
|
|
|
| Non current
liabilities |
|
|
|
| Borrowings |
14,368 |
|
|
17,060 |
|
| Contract liabilities |
1,392 |
|
|
7,209 |
|
| Lease liabilities |
317 |
|
|
368 |
|
| Total non-current
liabilities |
16,077 |
|
|
24,637 |
|
|
|
|
|
|
| Current
liabilities |
|
|
|
| Trade and other payables |
12,760 |
|
|
18,860 |
|
| Borrowings |
3,498 |
|
|
580 |
|
| Lease liabilities |
613 |
|
|
683 |
|
| Contract liabilities |
35,137 |
|
|
44,424 |
|
| Total current
liabilities |
52,008 |
|
|
64,547 |
|
|
|
|
|
|
| TOTAL EQUITY AND
LIABILITIES |
260,905 |
|
|
225,135 |
|
| Unaudited
consolidated interim statements of cash flows |
|
|
|
|
| (in €
thousand) |
For the six months ended June 30 |
|
|
|
2022 |
|
|
2021 |
|
| Cash flow
from operating activities |
|
|
|
| Income / (loss)
for the period |
(36,074 |
) |
|
(17,340 |
) |
| Adjustments for
the period: |
|
|
|
| - Income
taxes |
2 |
|
|
2 |
|
| - Depreciation and
amortization |
703 |
|
|
624 |
|
| - Share-based
payments |
9,872 |
|
|
4,695 |
|
| - Finance income /
costs – net |
(2,724 |
) |
|
(3,947 |
) |
| |
(28,221 |
) |
|
(15,966 |
) |
| Change in trade
and other receivables |
(715 |
) |
|
(1,324 |
) |
| Change in
inventories |
(150 |
) |
|
(366 |
) |
| Change in other
assets and prepaid expenses |
(3,873 |
) |
|
924 |
|
| Change in trade,
other payables, provisions and contract liabilities |
(21,372 |
) |
|
(16,262 |
) |
| |
(54,331 |
) |
|
(32,994 |
) |
| Interest
received |
82 |
|
|
0 |
|
| Paid interest |
(653 |
) |
|
(377 |
) |
| Paid income
tax |
(2 |
) |
|
(2 |
) |
| Net cash
used in operating activities |
(54,904 |
) |
|
(33,373 |
) |
|
|
|
|
|
| Cash flow
from investing activities |
|
|
|
| Purchase of
intangible assets |
0 |
|
|
(5 |
) |
| Purchase of
leasehold improvements and equipment |
(194 |
) |
|
(1,502 |
) |
| Cash received from
the sale of financial assets |
1,518 |
|
|
0 |
|
| Net cash
used for investing activities |
1,324 |
|
|
(1,507 |
) |
|
|
|
|
|
| Cash flow
from financing activities |
|
|
|
| Proceeds from
issue of common shares, including exercise of share-based payment
awards |
95,907 |
|
|
103,242 |
|
| Transaction costs
related to issue of common shares |
(5,894 |
) |
|
(6,447 |
) |
| Proceeds from
borrowings |
0 |
|
|
10,000 |
|
| Transaction costs
related to borrowings |
0 |
|
|
(236 |
) |
| Repayment of lease
liabilities |
(352 |
) |
|
(228 |
) |
| Repayment of
borrowings |
(47 |
) |
|
(46 |
) |
| Cash flow
from financing activities |
89,614 |
|
|
106,285 |
|
| |
|
|
|
|
Exchange-rate related changes of cash and cash
equivalents |
3,568 |
|
|
4,417 |
|
| Net
changes to cash and cash equivalents |
36,034 |
|
|
71,405 |
|
| Cash and
cash equivalents at the beginning of the period |
197,630 |
|
|
146,854 |
|
| Cash and
cash equivalents at the end of the period |
237,232 |
|
|
222,676 |
|
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 |
|
94,135 |
|
|
|
|
|
94,340 |
|
| Exercise of share-based
payment awards |
9 |
|
2,531 |
|
|
|
|
|
2,540 |
|
| Equity-settled share-based
payment awards |
|
|
4,695 |
|
|
|
|
|
4,695 |
|
| Loss for the period |
|
|
|
|
|
|
(17,340 |
) |
|
(17,340 |
) |
|
Other comprehensive loss |
|
|
|
|
(5,349 |
) |
|
|
|
(5,349 |
) |
| Balance as of June 30,
2021 |
1,197 |
|
446,525 |
|
(3,629 |
) |
|
(293,214 |
) |
|
150,879 |
|
| |
|
|
|
|
|
|
|
|
|
| Balance as of January
1, 2022 |
1,234 |
|
474,087 |
|
(5,973 |
) |
|
(333,397 |
) |
|
135,951 |
|
| |
|
|
|
|
|
|
|
|
|
| Issue of common shares |
259 |
|
89,484 |
|
|
|
|
|
89,743 |
|
| Exercise of share-based payment
awards |
|
|
101 |
|
|
|
|
|
101 |
|
| Equity-settled share-based
payment awards |
|
|
9,872 |
|
|
|
|
|
9,872 |
|
| Transfer of cumulative loss on
sale of financial assets |
|
|
|
|
2,819 |
|
|
(2,819 |
) |
|
0 |
|
| Loss for the period |
|
|
|
|
|
|
(36,074 |
) |
|
(36,074 |
) |
| Other comprehensive loss |
|
|
|
|
(6,773 |
) |
|
|
|
(6,773 |
) |
| |
|
|
|
|
|
|
|
|
|
| Balance as of June 30,
2022 |
1,493 |
|
573,544 |
|
(9,927 |
) |
|
(372,290 |
) |
|
192,820 |
|
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