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 ...

Financial Data and Key Metrics Changes - As of June 30, 2023, cash and cash equivalents totaled EUR120.1 million, down from EUR190.3 million as of December 31, 2022 [31] - Net cash used in operating activities for Q2 2023 was EUR33.3 million, compared to EUR26.5 million in Q2 2022 [32] - Total revenue for Q2 2023 was EUR1.4 million, a significant decrease from EUR7.3 million in Q2 2022 [33] - Net loss for Q2 2023 was EUR29.4 million or EUR0.20 per common share, compared to a net loss of EUR19.4 million or EUR0.13 per common share in Q2 2022 [35] Business Line Data and Key Metrics Changes - R&D expenses increased by 21.3% from EUR20.8 million in Q2 2022 to EUR25.3 million in Q2 2023, primarily due to higher costs associated with the development of AFM13 and AFM24 [33] - G&A expenses decreased by 25.1% from EUR8.4 million in Q2 2022 to EUR6.3 million in Q2 2023, attributed to a decline in legal, consulting, and insurance expenses [34] Market Data and Key Metrics Changes - The company is focusing on the development of AFM13 in combination with AB101 for Hodgkin lymphoma, with initial data expected in the first half of 2024 [12][15] - AFM24 showed promising activity in heavily pretreated patients with EGFR mutant non-small cell lung cancer, with two partial responses and five stable diseases observed [10][22] Company Strategy and Development Direction - The company is pursuing innovative treatments for cancer, focusing on innate cell engager molecules and their combinations with allogeneic NK cells and checkpoint inhibitors [8] - The strategic focus includes advancing clinical trials for AFM13, AFM24, and AFM28, with several upcoming inflection points anticipated over the next 12 months [12][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the financial stability to execute the business plan into 2025, allowing for continued innovation in cancer treatment [12] - The company is preparing for a Type C meeting with the FDA to discuss the requirements for accelerated approval based on the LuminICE-203 study [41][76] Other Important Information - The company has completed its contractual obligations under collaborations with Genentech and Roivant, which may lead to reduced revenue in the short term [63] - The company is evaluating options to advance AFM24 with an allogeneic off-the-shelf NK cell product [26] Q&A Session Summary Question: What data from the AFM13-203 study could be shown to the FDA by the Type C meeting? - Management indicated that the Type C meeting will focus on the contribution of single agents and not on initial data from the 203 study [41][42] Question: What components is the FDA inquiring about regarding the contribution? - The FDA is asking for the contribution of single agents, including AFM13, AB101, and IL-2 [49][50] Question: Will the confirmatory study be discussed in the Type C meeting? - The confirmatory study will not be discussed in the Type C meeting; the focus will be on the contribution of single agents [88] Question: What is the likelihood that the FDA might say to wait for early preliminary data before discussing? - The risk of the FDA requesting to wait for early data is considered small, as the meeting is specifically to address the contribution of single agents [72] Question: What should be anticipated for the data release in the first half of 2024? - The initial update will focus on safety and response rates, with expectations to enroll 24 patients across the cohorts [61]

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 ...

[Consolidated Financial Statements](index=1&type=section&id=Consolidated%20Financial%20Statements) This section presents the unaudited consolidated financial statements, including comprehensive loss, financial position, cash flows, and changes in equity, for the interim period [Unaudited Consolidated Statements of Comprehensive Loss](index=1&type=section&id=Unaudited%20consolidated%20statements%20of%20comprehensive%20loss) Affimed N.V. reported a significant increase in comprehensive loss for the three months ended March 31, 2023, primarily driven by higher research and development expenses and a decrease in revenue compared to the prior year Unaudited Consolidated Statements of Comprehensive Loss (€ thousand) | Metric | Three months ended March 31, 2023 (€ thousand) | Three months ended March 31, 2022 (€ thousand) | | :-------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Revenue | 4,510 | 8,006 | | Operating loss | (31,461) | (17,134) | | Loss for the period | (31,983) | (16,665) | | Total comprehensive loss | (31,983) | (22,839) | | Basic and diluted loss per share | (0.21) | (0.14) | - Revenue decreased by **43.67%** from **€8,006 thousand** in Q1 2022 to **€4,510 thousand** in Q1 2023[2](index=2&type=chunk) - Operating loss widened by **83.62%** from **€17,134 thousand** in Q1 2022 to **€31,461 thousand** in Q1 2023, largely due to a **60.67%** increase in Research and development expenses[2](index=2&type=chunk) [Consolidated Statements of Financial Position](index=2&type=section&id=Consolidated%20statements%20of%20financial%20position) The company's financial position shows a decrease in total assets and total equity from December 31, 2022, to March 31, 2023, primarily due to a reduction in cash and cash equivalents and an accumulated deficit Consolidated Statements of Financial Position (€ thousand) | Metric | March 31, 2023 (€ thousand) | December 31, 2022 (€ thousand) | | :-------------------------- | :-------------------------- | :----------------------------- | | Total Assets | 167,958 | 200,512 | | Total Equity | 125,090 | 152,915 | | Total Non-current Liabilities | 11,430 | 12,946 | | Total Current Liabilities | 31,438 | 34,651 | | Cash and cash equivalents | 155,848 | 190,286 | - Total assets decreased by **16.24%** from **€200,512 thousand** at December 31, 2022, to **€167,958 thousand** at March 31, 2023[5](index=5&type=chunk) - Total equity decreased by **18.19%** from **€152,915 thousand** to **€125,090 thousand** over the same period, mainly due to an increase in accumulated deficit[5](index=5&type=chunk) [Unaudited Consolidated Statements of Cash Flows](index=3&type=section&id=Unaudited%20consolidated%20statements%20of%20cash%20flows) The company experienced significant net cash outflows from operating activities, leading to a substantial decrease in cash and cash equivalents during the three months ended March 31, 2023 Unaudited Consolidated Statements of Cash Flows (€ thousand) | Cash Flow Activity | Three months ended March 31, 2023 (€ thousand) | Three months ended March 31, 2022 (€ thousand) | | :-------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Net cash used in operating activities | (33,244) | (28,420) | | Net cash used for investing activities | (8) | (106) | | Net cash used for financing activities | (634) | (169) | | Net changes to cash and cash equivalents | (33,886) | (28,695) | | Cash and cash equivalents at the beginning of the period | 190,286 | 197,630 | - Net cash used in operating activities increased by **17.09%** to **€33,244 thousand** in Q1 2023 from **€28,420 thousand** in Q1 2022[7](index=7&type=chunk) - Cash and cash equivalents decreased by **€33,886 thousand** during Q1 2023, starting at **€190,286 thousand** and ending lower than the previous year's starting balance[7](index=7&type=chunk) [Unaudited Consolidated Statements of Changes in Equity](index=4&type=section&id=Unaudited%20consolidated%20statements%20of%20changes%20in%20equity%20for%20the%20year) The company's total equity decreased significantly during the first three months of 2023, primarily due to the loss for the period, despite an increase in capital reserves from equity-settled share-based payment awards Unaudited Consolidated Statements of Changes in Equity (€ thousand) | Metric | Balance as of January 1, 2023 (€ thousand) | Balance as of March 31, 2023 (€ thousand) | | :-------------------------- | :----------------------------------------- | :---------------------------------------- | | Issued capital | 1,493 | 1,493 | | Capital reserves | 582,843 | 587,001 | | Fair Value reserves | (1,231) | (1,231) | | Accumulated deficit | (430,190) | (462,173) | | Total equity | 152,915 | 125,090 | - Total equity decreased by **€27,825 thousand** from **€152,915 thousand** at January 1, 2023, to **€125,090 thousand** at March 31, 2023[9](index=9&type=chunk) - The accumulated deficit increased by **€31,983 thousand** during Q1 2023, reflecting the loss for the period[9](index=9&type=chunk) [Notes to the Condensed Consolidated Interim Financial Statements](index=5&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Interim%20Financial%20Statements) This section provides detailed explanatory notes to the condensed consolidated interim financial statements, covering accounting policies, revenue, financial assets, equity, and subsequent events [1. Reporting Entity](index=5&type=section&id=1.%20Reporting%20entity) Affimed N.V. is a Dutch clinical-stage biopharmaceutical company focused on developing highly targeted cancer immunotherapies, operating through its subsidiaries in Germany, Czech Republic, and the USA - Affimed N.V. is a clinical-stage biopharmaceutical company specializing in cancer immunotherapies[11](index=11&type=chunk) - The Group includes Affimed N.V. and its wholly-owned subsidiaries: Affimed GmbH (Germany), AbCheck s.r.o. (Czech Republic), and Affimed Inc. (USA)[10](index=10&type=chunk) [2. Basis of Preparation and Changes to Group's Accounting Policies](index=5&type=section&id=2.%20Basis%20of%20preparation%20and%20changes%20to%20Group's%20accounting%20policies) The interim financial statements are prepared in accordance with IAS 34, with accounting policies consistent with the prior annual statements. Critical judgments and estimates remain unchanged, and new accounting standards are not expected to have a significant impact - Interim financial statements are prepared in accordance with **IAS 34 Interim Financial Reporting**[12](index=12&type=chunk) - The accounting policies applied are consistent with those in the consolidated financial statements as of and for the year ended December 31, 2022[17](index=17&type=chunk) - New standards and amendments to standards, effective January 1, 2024, are not expected to have a significant effect on the interim financial statements[19](index=19&type=chunk) [Loss per Share](index=5&type=section&id=Loss%20per%20share) The calculation of diluted loss per share excludes anti-dilutive options and warrants due to the net loss reported - Diluted weighted average number of ordinary shares calculation excluded **25,718,919 options and warrants** due to their anti-dilutive effect from the net loss[13](index=13&type=chunk) [Fair Value Measurement](index=6&type=section&id=Fair%20Value%20Measurement) Fair value measurements are categorized into a three-level hierarchy based on input observability, with most current assets and liabilities approximating fair value - Fair value measurements are classified into **Level 1, 2, or 3 hierarchy** based on input observability[20](index=20&type=chunk) - The carrying amount of trade and other receivables, other assets, prepaid expenses, cash and cash equivalents, trade and other payables, and loans reasonably approximates their fair value[21](index=21&type=chunk) [3. Revenue](index=7&type=section&id=3.%20Revenue) Affimed's revenue significantly decreased in Q1 2023 compared to Q1 2022, primarily due to reduced revenue from the Genentech collaboration as work on product candidates was completed. The Roivant collaboration contributed a stable amount of revenue Collaboration Revenue (€ million) | Collaboration | Q1 2023 Revenue (€ million) | Q1 2022 Revenue (€ million) | | :------------ | :-------------------------- | :-------------------------- | | Genentech | 0.2 | 3.9 | | Roivant | 4.3 | 3.9 | - Revenue from the Genentech collaboration decreased significantly from **€3.9 million** in Q1 2022 to **€0.2 million** in Q1 2023, as work on product candidates was completed by the end of 2022[25](index=25&type=chunk) - Remaining performance obligations as of March 31, 2023, are approximately **€6.0 million**, with **€5.1 million** expected to be recognized as revenue over the next 12 months[29](index=29&type=chunk) [Disaggregation of Revenue](index=8&type=section&id=Disaggregation%20of%20revenue) Revenue disaggregation shows all Q1 2023 revenue originated from the USA, with collaboration revenue forming the majority Disaggregation of Revenue (€ thousand) | Category | Three months ended March 31, 2023 (€ thousand) | Three months ended March 31, 2022 (€ thousand) | | :------------------- | :--------------------------------------------- | :--------------------------------------------- | | **Geographic Information:** | | | | Germany | 0 | 137 | | USA | 4,510 | 7,869 | | **Major Service Lines:** | | | | Collaboration revenue | 4,456 | 7,869 | | Service revenue | 54 | 137 | | **Timing on Revenue Recognition:** | | | | Over time | 4,510 | 8,006 | - All revenue in Q1 2023 was generated from the **USA**, compared to **€137 thousand** from Germany in Q1 2022[30](index=30&type=chunk) - Collaboration revenue constituted the vast majority of total revenue in both periods, with **€4,456 thousand** in Q1 2023[30](index=30&type=chunk) [4. Finance Income and Finance Costs](index=8&type=section&id=4.%20Finance%20income%20and%20finance%20costs) The company recorded net finance costs of €519 thousand in Q1 2023, a significant shift from net finance income of €471 thousand in Q1 2022, primarily due to negative foreign exchange differences Finance Income and Finance Costs (€ thousand) | Category | Three months ended March 31, 2023 (€ thousand) | Three months ended March 31, 2022 (€ thousand) | | :----------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Interest SVB Loan Agreement | (477) | (378) | | Foreign exchange differences | (552) | 915 | | Other finance income/costs—net | 510 | (66) | | Total | (519) | 471 | - Foreign exchange differences shifted from an income of **€915 thousand** in Q1 2022 to a cost of **€552 thousand** in Q1 2023[31](index=31&type=chunk) [5. Long-term Financial Assets](index=8&type=section&id=5.%20Long-term%20financial%20assets) The fair value of preferred shares held in Amphivena remains nil as of March 31, 2023, following an impairment recognized in 2021 due to the company's decision to wind down - Preferred shares in Amphivena are recognized at a fair value of **nil**, consistent with December 31, 2022[32](index=32&type=chunk) - The impairment was recognized in 2021 following Amphivena's decision to wind down[32](index=32&type=chunk) [6. Trade and Other Receivables](index=8&type=section&id=6.%20Trade%20and%20other%20receivables) Trade receivables increased to €12 thousand as of March 31, 2023, from nil at December 31, 2022, while other receivables, mainly VAT, decreased Trade and Other Receivables (€ thousand) | Receivable Type | March 31, 2023 (€ thousand) | December 31, 2022 (€ thousand) | | :---------------- | :-------------------------- | :----------------------------- | | Trade receivables | 12 | 0 | | Other receivables | 700 | 1,500 | - Other receivables, primarily value-added tax receivables, decreased from **€1.5 million** at December 31, 2022, to **€0.7 million** at March 31, 2023[33](index=33&type=chunk) [7. Other Assets and Prepaid Expenses](index=9&type=section&id=7.%20Other%20assets%20and%20prepaid%20expenses) Other assets and prepaid expenses significantly increased to €5.2 million as of March 31, 2023, mainly due to a new directors and officers' liability insurance premium Other Assets and Prepaid Expenses (€ million) | Item | March 31, 2023 (€ million) | December 31, 2022 (€ million) | | :--------------------------------------- | :------------------------- | :---------------------------- | | Total Other assets and prepaid expenses | 5.2 | 2.5 | | D&O liability insurance premium | 1.7 | 0 | - A new directors and officers' liability insurance premium of **€1.7 million** was recorded in Q1 2023[34](index=34&type=chunk) [8. Equity](index=9&type=section&id=8.%20Equity) The company's issued share capital remained stable, with no changes in the number of common shares outstanding during Q1 2023. A public offering in April 2022 previously generated significant net proceeds - As of March 31, 2023, the share capital was **€1,493 thousand**, comprising **149,339,335 common shares**[35](index=35&type=chunk) - A public offering in April 2022 generated net proceeds of **€89.8 million ($97.1 million)** from the issuance of **25,875,000 common shares**[35](index=35&type=chunk) [9. Share-based Payments](index=9&type=section&id=9.%20Share-based%20payments) Affimed granted a significant number of share-based awards in Q1 2023, increasing outstanding options, while share-based payment expenses remained stable. The fair value of these awards is determined using Black-Scholes-Merton and Monte Carlo models - **7,668,750 awards** were granted in Q1 2023 with a fair value of **€5.8 million ($6.2 million)**[37](index=37&type=chunk) - Outstanding ESOP 2014 options increased to **22,787,669** as of March 31, 2023, from **15,269,734** at December 31, 2022[38](index=38&type=chunk) Share-based Compensation Expense (€ thousand) | Expense Category | Three months ended March 31, 2023 (€ thousand) | Three months ended March 31, 2022 (€ thousand) | | :---------------------------- | :--------------------------------------------- | :--------------------------------------------- | | Research and development expenses | 2,313 | 2,305 | | General and administrative expenses | 1,845 | 1,942 | | Total compensation expense | 4,158 | 4,247 | [Fair Value Measurement](index=10&type=section&id=Fair%20value%20measurement) Fair value of share-based awards is determined using Black-Scholes-Merton and Monte Carlo models, considering inputs like share price and volatility Fair Value Measurement Inputs (Service Conditions) | Input (Service Conditions) | March 31, 2023 | March 31, 2022 | | :------------------------- | :------------- | :------------- | | Fair value at grant date | $0.81 | $3.32 | | Share price at grant date | $1.07 | $4.47 | | Expected volatility | 90% | 90% | | Risk-free interest rate | 3.95% | 2.18% | - Fair value of options with service conditions is determined using the **Black-Scholes-Merton model**[42](index=42&type=chunk) - Fair value of options with market conditions (granted in Q1 2022) was determined using a **Monte Carlo simulation**[43](index=43&type=chunk) [10. Borrowings](index=11&type=section&id=10.%20Borrowings) Affimed has term loans from Silicon Valley Bank and a smaller loan from UniCredit Leasing CZ. The SVB loan bears interest at ECB Base Rate plus 5.5% and is secured by company assets - The Silicon Valley Bank loan agreement provides up to **€25 million** in term loans, with **€17.5 million** drawn by December 2021[46](index=46&type=chunk) - The SVB loan bears interest at the greater of the European Central Bank Base Rate and 0%, plus **5.5%**, and matures in November 2025[46](index=46&type=chunk) - An amount of **€113 thousand** was outstanding for the UniCredit Leasing CZ loan as of March 31, 2023, with **€97 thousand** classified as current liabilities[48](index=48&type=chunk) [11. Related Parties](index=11&type=section&id=11.%20Related%20parties) Compensation for supervisory and management board members, including share-based payment expenses, increased in Q1 2023 compared to Q1 2022 Related Party Compensation (€ thousand) | Category | Three months ended March 31, 2023 (€ thousand) | Three months ended March 31, 2022 (€ thousand) | | :------------------------ | :--------------------------------------------- | :--------------------------------------------- | | Supervisory Board compensation | 125 | 109 | | Management Board compensation | 944 | 893 | | Share-based payment expenses (Supervisory Directors) | 112 | 279 | | Share-based payment expenses (Managing Directors) | 1,637 | 1,507 | - Management Board compensation increased by **5.71%** in Q1 2023 compared to Q1 2022[49](index=49&type=chunk) [12. Subsequent Events](index=12&type=section&id=12.%20Subsequent%20events) In April 2023, Affimed underwent a reorganization to focus on its three clinical-stage development programs, resulting in a 25% reduction in headcount. The financial impact is being evaluated, with expected cost savings offsetting one-time termination payments - Affimed conducted a reorganization in April 2023 to focus on its three clinical-stage development programs[52](index=52&type=chunk) - The reorganization led to an approximate **25% reduction** in full-time equivalent headcount[52](index=52&type=chunk) - One-time cash expenditure for termination payments is expected to be offset by cost savings during 2023[52](index=52&type=chunk)

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 ...