MANNHEIM, Germany, Jan. 03, 2024 (GLOBE NEWSWIRE) -- 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 announced that it has reached a definitive agreement to sell its wholly-owned subsidiary, AbCheck s.r.o., to Ampersand Biomedicines. Under the terms of the agreement, Ampersand Biomedicines will acquire AbCheck for a purchase price of $6 million, consisting of $5 million in cash to ...

Affimed N.V. (NASDAQ:AFMD) Q3 2023 Results Earnings Conference Call November 14, 2023 8:30 AM ET Company Participants Alexander Fudukidis - Director and Head of Investor Relations Adi Hoess - Chief Executive Officer Andreas Harstrick - Chief Medical Officer Angus Smith - Chief Financial Officer Wolfgang Fischer - Chief Operating Officer Conference Call Participants Srikripa Devarakonda - Truist Securities Li Watsek - Cantor Fitzgerald Daina Graybosch - Leerink Partners Yanan Zhu - Wells Fargo Bradley Canino ...

HARNESSING THE UNTAPPED POTENTIAL OF THE INNATE IMMUNE SYSTEM FOR ONCOLOGY Q3 2023 Financial Results & Operational Progress NASDAQ: AFMD November 14, 2023 Forward-Looking Statements / Cautionary Note 2 This presentation and the accompanying oral commentary contain "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary, including statements regarding our future ...

Affimed N.V. (NASDAQ:AFMD) Q2 2023 Earnings Call Transcript August 10, 2023 8:30 AM ET Company Participants Alex Fudukidis - Director of Investor Relations Adi Hoess - Chief Executive Officer Andreas Harstrick - Chief Medical Officer Angus Smith - Chief Financial Officer Wolfgang Fischer - Chief Operating Officer Arndt Schottelius - Chief Scientific Officer Conference Call Participants Maurice Raycroft - Jefferies Daina Graybosch - Leverink Partners Li Watsek - Cantor Fitzgerald Yale Jen - Laidlaw & Co Yana ...

Affimed N.V. (NASDAQ:AFMD) Q1 2023 Earnings Conference Call May 23, 2023 8:30 AM ET Company Participants Alex Fudukidis - Director of Investor Relations Adi Hoess - Chief Executive Officer Andreas Harstrick - Chief Medical Officer Angus Smith - Chief Financial Officer Wolfgang Fischer - Chief Operating Officer Arndt Schottelius - Chief Scientific Officer Conference Call Participants Maurice Raycroft - Jefferies Li Watsek - Cantor Fitzgerald Srikripa Devarakonda - Truist Securities Bradley Canino - Stifel Ya ...

Exhibit 99.1 Affimed N.V. Unaudited consolidated statements of comprehensive loss (in € thousand) | --- | --- | --- | --- | |-----------------------------------------------------------------------------------------------|-------|-------------------------------------------|-----------------| | | Note | For the three months March \n2023 | ended 31 \n2022 | | Revenue | 3 | 4,510 | 8,006 | | Other income – net | | 410 | 284 | | Research and development expenses | | (29,531) | (18,379) | | General and administra ...

Financial Data and Key Metrics Changes - As of the end of 2022, the company had cash and cash equivalents of €190.3 million, a decrease from €197.6 million at the end of 2021 [31] - Total revenue for 2022 was €41.4 million, compared to €40.4 million in 2021, primarily from collaborations with Genentech and Roivant [31] - Research and development expenses increased by 21% from €81.5 million in 2021 to €98.8 million in 2022, driven by higher costs associated with AFM24 and AFM28 [31] - General and administrative expenses rose by 32% from €24.2 million in 2021 to €32.1 million in 2022, mainly due to higher personnel costs and consulting fees [31] - The net loss for 2022 was €86 million, or €0.60 per share, compared to a loss of €57.5 million, or €0.48 per share, in 2021 [32] Business Line Data and Key Metrics Changes - The AFM13 program showed a high overall response rate of 94% and a complete response rate of 71% in a Phase I/II study with 35 patients [17] - The AFM24 program is expected to report data from three studies in the second or third quarter of 2023, focusing on solid tumors [23] - The AFM28 program is now open for patient enrollment in four European countries, targeting CD123 positive myeloid malignancies [27] Market Data and Key Metrics Changes - The company is focusing on the U.S. and European markets for its clinical trials, particularly in the oncology sector [34] - The collaboration with Artiva for NK cell therapy is expected to enhance the company's market position in treating relapsed/refractory Hodgkin's lymphoma [21] Company Strategy and Development Direction - The primary focus for 2023 is the execution of the AFM13 AB-101 clinical development plan, with plans to submit an IND and initiate a clinical study [11] - The company aims to leverage its unique innate cell engagers to differentiate itself from competitors in the immunotherapy space [8] - The strategy includes advancing combination therapies to improve efficacy and patient outcomes, particularly in underserved cancer populations [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made across all pipeline projects and the potential for significant milestones in 2023 [34] - The company is committed to addressing the needs of patients with limited treatment options, particularly in the oncology field [12] - Management highlighted the importance of collaborations and partnerships in enhancing the company's clinical development capabilities [34] Other Important Information - The company plans to provide updates on clinical trials and data presentations at upcoming scientific conferences [34] - The management team emphasized the importance of patient outcomes in guiding their research and development efforts [12] Q&A Session Summary Question: Timing and patient expectations for AFM24 data - Management confirmed that they are targeting several conferences in Q2 and Q3 for data updates and that patient populations will primarily consist of those with prior treatment failures [36][39] Question: IND filing timeline for AFM13 - Management indicated that they expect to file the IND in the first half of the year and are already preparing sites for patient treatment [43][48] Question: Efficacy expectations for AFM24 monotherapy - Management stated that go/no-go decisions will be based on response rates and duration of responses, with further guidance expected as data matures [52][54] Question: Enrollment progress for AFM28 - Management confirmed that the study is open for enrollment, but no specific data has been released yet [57] Question: Rationale for exploratory cohorts in AFM13 - Management explained that the study includes both Hodgkin lymphoma and peripheral T-cell lymphoma patients to evaluate response rates [70][71]

Exhibit 99.1 PRESS RELEASE Affimed Reports 2022 Financial Results and Operational Progress Heidelberg, Germany, March 23, 2023 – 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 year ended December 31, 2022, and provided an update on clinical and corporate progress. "During 2022, we presented data across our pipeline that show our innate cell enga ...

[PART I](index=7&type=section&id=PART%20I) This section provides an overview of the company's business, financial performance, and governance structure [Key Information](index=7&type=section&id=ITEM%203.%20KEY%20INFORMATION) This section details significant risks in drug development, financial stability, third-party reliance, and intellectual property [Risk Factors](index=7&type=section&id=D.%20Risk%20factors) The company faces substantial risks from uncertain clinical trials, financial losses, third-party reliance, IP challenges, and potential Nasdaq delisting - The company operates as a development-stage entity with a significant history of operating losses, reaching an accumulated deficit of **€430.2 million** as of December 31, 2022[14](index=14&type=chunk)[122](index=122&type=chunk) - There is a significant risk that clinical trials may be delayed or unsuccessful, exemplified by the discontinuation of the AFM11 program due to serious adverse events including a patient death[14](index=14&type=chunk)[31](index=31&type=chunk) - The company depends on the success of its key clinical-stage product candidates, AFM13 and AFM24, which are still in development and may not prove successful or commercially viable[14](index=14&type=chunk) - The company's current liquidity is anticipated to fund operating expenses and capital requirements into 2025, but substantial additional funding will be required to complete development and commercialization[129](index=129&type=chunk)[137](index=137&type=chunk) - The company relies on strategic partnerships with entities like Artiva, Genentech, and MD Anderson Cancer Center, and the failure of these collaborations could slow development progress[17](index=17&type=chunk)[143](index=143&type=chunk) - The company's common shares are at risk of being delisted from Nasdaq if the closing bid price does not recover to the minimum requirement of **$1.00 per share**[212](index=212&type=chunk) [Information on the Company](index=55&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) Affimed is a clinical-stage immuno-oncology company developing innate cell engagers via its ROCK® platform, advancing key candidates [History and Development of the Company](index=55&type=section&id=A.%20History%20and%20development%20of%20the%20company) Founded in 2000, Affimed is a clinical-stage immuno-oncology company developing targeted cancer immunotherapies via its ROCK® platform - Affimed is a clinical-stage immuno-oncology company founded in 2000, focused on developing innate cell engagers (ICE®) using its fit-for-purpose ROCK® platform[249](index=249&type=chunk)[250](index=250&type=chunk) - The company's lead programs are AFM13, AFM24, and AFM28, for which it retains full global commercial rights[252](index=252&type=chunk) - As of the report date, the company has a total headcount of **228** (**219 full-time equivalents**), with main offices in Heidelberg, Germany[254](index=254&type=chunk) [Business Overview](index=57&type=section&id=B.%20Business%20overview) Affimed's strategy involves advancing clinical candidates AFM13, AFM24, and AFM28 to activate the innate immune system against tumors Candidate Pipeline | Candidate | Approach | Indication | Status | | :--- | :--- | :--- | :--- | | **AFM13 (CD30)** | Monotherapy | Peripheral T-cell lymphoma | Topline Data Reported Dec 2022 | | | + Adoptive NK cells | CD30-positive lymphomas | Safety & POC, Data Reported at ASH22 | | **AFM24 (EGFR)** | Monotherapy | Multiple solid tumors | Enrolling Expansion Cohorts | | | + Adoptive NK cells | Multiple solid tumors | Dose Escalation Ongoing | | | + Anti-PD-L1 | Multiple solid tumors | Enrolling Expansion Cohorts | | **AFM28 (CD123)** | Monotherapy | Acute Myeloid Leukemia | Phase 1 study enrolling | | | + Adoptive NK cells | Acute Myeloid Leukemia | Pre-IND | - In a Phase 1/2 study with MD Anderson, AFM13 pre-complexed with cord blood-derived NK cells demonstrated a **97% Objective Response Rate (ORR)** and a **77% Complete Response (CR) rate** in **31 Hodgkin Lymphoma patients** at the recommended Phase 2 dose[307](index=307&type=chunk)[308](index=308&type=chunk) - The company is shifting its focus for AFM13 in PTCL from monotherapy to a combination with Artiva's AB-101 NK cell product, with an IND submission planned for the first half of 2023[304](index=304&type=chunk)[309](index=309&type=chunk) - AFM24 is being investigated in three separate clinical studies: as a monotherapy (AFM24-101), in combination with atezolizumab (AFM24-102), and with SNK01 NK cells (AFM24-103)[261](index=261&type=chunk) - The company's third candidate, AFM28, targets CD123 for Acute Myeloid Leukemia (AML) and initiated a first-in-human Phase 1 study in Q1 2023[262](index=262&type=chunk)[329](index=329&type=chunk) [Organizational Structure](index=93&type=section&id=C.%20Organizational%20structure) Affimed N.V. serves as the parent company, overseeing its three wholly-owned subsidiaries: Affimed GmbH, AbCheck s.r.o., and Affimed, Inc - The registrant, Affimed N.V., has three direct or indirect wholly-owned subsidiaries: Affimed GmbH, AbCheck s.r.o., and Affimed, Inc[464](index=464&type=chunk) [Property, Plant, and Equipment](index=94&type=section&id=D.%20Property,%20plant%20and%20equipment) The company's headquarters are in leased facilities in Heidelberg, Germany, with a planned relocation to Mannheim in mid-2023 under a new ten-year lease - The company is planning to move its headquarters from Heidelberg to a new facility in Mannheim, Germany, around mid-2023 under a new ten-year lease[465](index=465&type=chunk) [Operating and Financial Review and Prospects](index=94&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) This section analyzes the company's financial performance, reporting a **€86.0 million** net loss and **€430.2 million** accumulated deficit in 2022, with **€190.3 million** cash projected into 2025 [Operating Results Overview](index=94&type=section&id=A.%20Operating%20Results%20Overview) Affimed's 2022 net loss increased to **€86.0 million** from **€57.5 million** in 2021, primarily due to increased R&D and G&A expenses Key Financial Metrics | Metric | 2022 (€ thousands) | 2021 (€ thousands) | | :--- | :--- | :--- | | **Total Revenue** | 41,353 | 40,366 | | **Operating loss** | (88,119) | (64,030) | | **Loss for the period** | (86,004) | (57,523) | | **Loss per common share** | (0.60) | (0.48) | Research and Development Expenses by Project | R&D Expenses by Project | 2022 (€ thousands) | 2021 (€ thousands) | Change % | | :--- | :--- | :--- | :--- | | AFM13 | 15,130 | 19,800 | (24)% | | AFM24 | 21,687 | 19,957 | 9% | | AFM28 | 9,290 | 6,451 | 44% | | Other projects and infrastructure | 42,356 | 29,388 | 44% | | Share-based payment expense | 10,351 | 5,892 | 76% | | **Total** | **98,814** | **81,488** | **21%** | - Revenue in 2022 was primarily derived from the Roivant collaboration (**€22.7 million**) and the Genentech collaboration (**€18.5 million**)[475](index=475&type=chunk)[477](index=477&type=chunk)[479](index=479&type=chunk) - General and administrative expenses increased by **32%** to **€32.1 million** in 2022, mainly due to higher personnel costs, including share-based payments, and increased insurance expenses[506](index=506&type=chunk) [Liquidity and Capital Resources](index=101&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) As of December 31, 2022, the company held **€190.3 million** in cash, projected to fund operations into 2025, following an **€89.8 million** public offering - The company ended 2022 with **€190.3 million** in cash and cash equivalents, with a projected cash runway to fund operations into 2025[509](index=509&type=chunk)[520](index=520&type=chunk) - In April 2022, the company raised net proceeds of **€89.8 million** through an underwritten public offering of its common shares[513](index=513&type=chunk)[525](index=525&type=chunk) Cash Flow Summary | Cash Flow Metric | 2022 (€ thousands) | 2021 (€ thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (104,892) | (86,591) | | Net cash generated from/(used for) investing activities | 5,605 | (3,850) | | Net cash generated from financing activities | 88,557 | 133,581 | [Directors, Senior Management and Employees](index=106&type=section&id=ITEM%206.%20DIRECTORS,%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) This section outlines the company's two-tier governance structure, detailing compensation and board practices, with a total headcount of **228** as of March 2023 - The company operates under a two-tier board structure with a separate management board (led by CEO Adi Hoess) and a supervisory board (chaired by Thomas Hecht)[532](index=532&type=chunk)[536](index=536&type=chunk)[544](index=544&type=chunk) Executive Compensation Summary 2022 | (in € thousand) | Adi Hoess (CEO) | Wolfgang Fischer (COO) | Angus Smith (CFO) | Total (All Managing Directors) | | :--- | :--- | :--- | :--- | :--- | | Total cash compensation | 764 | 596 | 629 | 3,662 | | Share-based payment expense | 1,836 | 1,000 | 1,082 | 6,732 | - The company's Equity Incentive Plan 2014 allows for the issuance of new shares, with an automatic increase of **5%** of total outstanding common shares becoming available each year on January 1[551](index=551&type=chunk) - As of March 23, 2023, the company's total headcount was **228** (**219 full-time equivalents**)[582](index=582&type=chunk) [Major Shareholders and Related Party Transactions](index=116&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) This section identifies major shareholders as of March 15, 2023, including key institutional investors holding over **5%** of common shares, and confirms indemnification agreements with directors and officers Major Shareholders as of March 15, 2023 | Shareholder | Shares Beneficially Owned | Percent (%) | | :--- | :--- | :--- | | Entities affiliated with Ridgeback Capital Management | 12,882,610 | 8.6 | | Entities affiliated with Ari Zweiman | 9,106,250 | 6.1 | | Entities affiliated with Blackrock, Inc. | 8,182,926 | 5.5 | | Entities affiliated with Cooperatieve Gilde Healthcare V U.A. | 8,125,000 | 5.4 | | All managing directors and supervisory directors as a group | 6,654,591 | 4.3 | [Financial Information](index=119&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) This section presents the company's IFRS consolidated financial statements, confirming no material legal proceedings and no dividends declared or planned for the past three years or foreseeable future - The company has not been a party to any litigation that has had a material adverse effect on its financial position[597](index=597&type=chunk) - No cash dividends were declared on common shares in 2020, 2021, or 2022, and the company does not anticipate paying any in the foreseeable future[598](index=598&type=chunk) [Additional Information](index=120&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) This section provides supplementary tax information for shareholders in Germany, the Netherlands, and the United States, noting German tax residency and discussing potential PFIC status for U.S. Holders - Although incorporated in the Netherlands, the company is considered exclusively tax resident in Germany under the German-Dutch tax treaty due to its place of effective management being in Germany[239](index=239&type=chunk)[611](index=611&type=chunk) - For U.S. Holders, the company notes that it does not believe it was a Passive Foreign Investment Company (PFIC) for the 2022 taxable year, but its status in future years is uncertain and depends on factors like market capitalization and asset composition[237](index=237&type=chunk)[700](index=700&type=chunk) [PART II](index=141&type=section&id=PART%20II) This section details the company's internal controls, procedures, and corporate governance practices, including compliance with Nasdaq listing standards as a foreign private issuer [Controls and Procedures](index=141&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2022, affirmed by an unqualified auditor opinion - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[725](index=725&type=chunk) - Based on an evaluation using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2022[726](index=726&type=chunk) - The independent registered public accounting firm, KPMG AG, issued an unqualified opinion on the effectiveness of the company's internal control over financial reporting as of December 31, 2022[727](index=727&type=chunk)[763](index=763&type=chunk) [Corporate Governance](index=143&type=section&id=ITEM%2016G.%20Corporate%20governance) As a foreign private issuer on Nasdaq, Affimed adheres to Dutch corporate governance practices, differing from Nasdaq standards in quorum, proxy solicitation, and committee independence - The company, as a foreign private issuer, follows certain Dutch corporate governance practices in lieu of specific Nasdaq listing standards[740](index=740&type=chunk) - Deviations from Nasdaq standards include the lack of a generally applicable quorum requirement for shareholder meetings, different proxy solicitation practices, and opting out of rules requiring compensation and nominating committees to consist entirely of independent directors[741](index=741&type=chunk)[742](index=742&type=chunk)[743](index=743&type=chunk)[744](index=744&type=chunk) [PART III](index=144&type=section&id=PART%20III) This section contains the company's full audited consolidated financial statements for the three years ended December 31, 2022, prepared under IFRS, including the independent auditor's report [Financial Statements](index=144&type=section&id=ITEM%2018.%20Financial%20statements) This section presents the full audited consolidated financial statements for Affimed N.V. and its subsidiaries for the three years ended December 31, 2022, prepared under IFRS - The independent auditor, KPMG AG, identified revenue recognition from collaboration agreements as a critical audit matter due to the challenging and subjective judgment required to evaluate the anticipated total costs of research programs, which are used to measure the stage of completion[768](index=768&type=chunk)[769](index=769&type=chunk) Consolidated Financial Position Summary | (in € thousand) | Dec 31, 2022 | Dec 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 190,286 | 197,630 | | Total Assets | 200,512 | 225,135 | | **Equity and Liabilities** | | | | Total Equity | 152,915 | 135,951 | | Total Liabilities | 47,597 | 89,184 | | Total Equity and Liabilities | 200,512 | 225,135 | - Subsequent to year-end, the company reported that its deposits with Silicon Valley Bank (SVB) were protected following the bank's failure in March 2023, with full access to cash maintained through the newly created bridge bank and the sale of SVB UK to HSBC, with no expected impact on business activities[934](index=934&type=chunk)

Affimed N.V. (NASDAQ:AFMD) Q3 2022 Earnings Conference Call November 15, 2022 8:30 AM ET Company Participants Alex Fudukidis - Director of IR Adi Hoess - CEO Andreas Harstrick - Chief Medical Officer Arndt Schottelius - Chief Scientific Officer Wolfgang Fischer - COO Angus Smith - CFO Conference Call Participants Srikripa Devarakonda - Truist Maurice Raycroft - Jefferies Daina Graybosch - SVB Securities Do Kim - Piper Sandler Li Watsek - Cantor James Shin - Wells Fargo Yale Jen - Laidlaw & Company Zhiqiang ...