CD123

VIP236, first-in-class small molecule-drug conjugate (SMDC), preliminary Phase 1 data and update on pipeline progress will be presented by management at a virtual investor event on April 8 at 2:00 PM PT Phase 1 trial ongoing for VIP943, a best-in-class anti-CD123 antibody-drug conjugate (ADC); preliminary data anticipated on or around the 2024 European Hematology Association (EHA)Annual Meeting; in addition, pharmacokinetic data will be shared at the 2024 American Association of Cancer Research (AACR) Annual Meeting Expected cash runway into early Q3 2024 PALO ALTO, Calif., March 29, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. “The last calendar year was pivotal for Vincerx,” said Ahmed Hamdy, M.D., Chief Executive Officer. “Having progressed three clinical programs, including VIP236 and VIP943, both developed with our VersAptxTM platform, and enitociclib, we firmly established ourselves as a clinical-stage cancer therapeutics company with novel product candidates that aim to improve safety and efficacy over traditional chemotherapy.” Raquel Izumi, Ph.D., Chief Operations Officer, added, “VIP236, our first-in-class SMDC, is in a Phase 1 dose-escalation trial for advanced and metastatic solid tumors. To date, we have dosed 20 patients across two dosing schedules and results from the once every 3-week dosing schedule continue to show a strong safety pro dose-dependent clinical activity. We are excited to share more details regarding the preliminary Phase 1 data during the 2024 AACR Annual Meeting.” Dr. Izumi continued, “VIP943, our best-in-class anti-CD123 ADC, is in a Phase 1 dose-escalation trial in hematologic malignancies. Enrollment in the third cohort is underway with a total of 9 patients dosed. Preliminary pharmacokinetic data from the first two cohorts show very little payload in circulation, which aligns with the favorable safety pro in nonhuman primates in our preclinical studies. We look forward to sharing pharmacokinetic data for VIP943 during AACR and more details regarding the preliminary Phase 1 data on or around EHA. Enitociclib, our highly selective CDK9 inhibitor, in a Phase 1 dose-escalation study with the National Institutes of Health (NIH), has signaled encouraging efficacy in Phase 1 combination studies in peripheral T-cell lymphoma (PTCL) and double-hit B-cell lymphoma (DLBCL). Earlier this year, we reported partial responses at doses below expected efficacy levels, highlighting the drugs synergistic potential with other treatments.” Dr. Hamdy concluded, “We entered 2024 with strong momentum and remain focused on aggressively advancing our programs and maximizing the value of our next-generation VersAptx platform.” FOURTH QUARTER AND FULL YEAR 2023 CLINICAL PROGRAM HIGHLIGHTS VersAptx™ Platform VersAptx is Vincerx’s versatile and adaptable, next-generation bioconjugation platform. The modular nature of this platform enables the combination of different targeting, linker, and payload technologies to develop bespoke bioconjugates to address different cancer biologies. Recent preclinical data demonstrated the ability of our legumain linker + KSPi payload with CellTrapper effector chemistry to enhance the potency of TRODELVY® and ENHERTU®, two marketed ADCs, by conjugating TRODELVY's TROP2 and ENHERTU's HER2 antibodies with our effector chemistry. The results of this study demonstrated a significant improvement in the potency of both drugs, with TRODELVY potency amplified by a factor of 20 and ENHERTU potency by a factor of 8. Vincerx published a manuscript in Frontiers in Pharmacology titled, “Neutrophil elastase as a versatile cleavage enzyme for activation of αvβ3 integrin-targeted small molecule drug conjugates with different payload classes in the tumor microenvironment.” Vincerx presented a preclinical poster at the 2023 AACR Annual Meeting demonstrating the promise of VIP924, a first-in-class CXCR5-targeted ADC from the VersAptx platform. VIP236 VIP236 is a αVβ3 SMDC conjugated to an optimized camptothecin (CPT) from the VersAptx platform. VIP236 is a first-in-class product candidate designed to deliver its optimized CPT payload directly to tumor tissues to overcome the chemotherapy-related side effects and transporter liabilities of this well-established class of anticancer drugs. Preclinical studies have shown 11 times more optimized CPT is delivered to the cancerous tissues than found circulating in the blood. Additionally, the active component of VIP236 is designed to bypass cancer resistance mechanisms. The favorable characteristics of VIP236, including improved linker attachment, stable solubility, and tumor-specific payload release, were featured in a peer-reviewed publication titled, “Unleashing the Potential of Camptothecin: Exploring Innovative Strategies for Structural Modification and Therapeutic Advancements,” by Zheng Chen in the March 14, 2024 issue of Journal of Medicinal Chemistry. To date, the VIP236 Phase 1 dose-escalation trial (NTC05371054) has enrolled 20 patients with advanced or metastatic cancer unresponsive to standard therapies. Vincerx will present more details around the preliminary Phase 1 data at the upcoming 2024 AACR Annual Meeting, accompanied by a virtual investor event to review the data and provide a pipeline update on April 8 at 2:00 PM PT. The event can be accessed through the Investors Page on the Vincerx website. VIP943 VIP943 is a novel CD123-targeted antibody-drug conjugate (ADC) from the VersAptx platform. In August 2023, Vincerx received IND clearance for a Phase 1 dose-escalation trial of VIP943 in relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275). In September 2023, Vincerx announced the dosing of its first patient in that study. Enrollment in the third cohort is underway, with a total of 9 patients dosed. Preliminary pharmacokinetic results continue to show very little payload circulating in the blood, validating the favorable safety pro in nonhuman primates in preclinical studies. Vincerx will present more details regarding the preliminary Phase 1 data for VIP943 on or around the 2024 EHA Annual Meeting. Enitociclib Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to the reduction of oncogenes MYC and MCL1. In 2023, Vincerx presented preclinical data supporting the continued advancement of enitociclib at multiple medical congresses. Vincerx also published a manuscript titled, “Enitociclib, a Selective CDK9 Inhibitor, Induces Complete Regression of MYC+ Lymphoma by Downregulation of RNA Polymerase II Mediated Transcription” in Cancer Research Communications, an AACR journal. Enitociclib is currently in a Phase 1 dose-escalation trial (NTC05371054) evaluating the combination of enitociclib, venetoclax, and prednisone in DLBCL and PTCL. This trial is being conducted in collaboration with the NIH. Earlier this year, Vincerx announced that 2 out of 3 patients with PTCL had a partial response (PR). The first patient saw a 91% reduction in their tumor burden, while the second patient saw an 86% reduction in pulmonary lesions and resolution of skin lesions. In addition, 1 out of 2 patients with DH-DLBCL had a PR after one cycle of treatment, seeing an 80% reduction in tumor burden. These responses occurred at doses below expected efficacy levels. VIP924 VIP924 is a first-in-class CXCR5-targeted ADC from the VersAptx platform. Vincerx presented preclinical data at the 2023 AACR Annual Meeting demonstrating significant activity in patient-derived xenograft (PDX) lymphoma mouse models. Vincerx shared preclinical data at the 2023 ASH Annual Meeting showing superior activity and safety compared with commercially available B-cell targeted ADCs. IND application anticipated in late 2025 or early 2026, pending funding. FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS Vincerx had $12.8 million in cash and cash equivalents as of December 31, 2023, as compared to $52.5 million in cash, cash equivalents and marketable securities as of December 31, 2022. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its operating requirements into early third quarter of 2024. Research and development (R&D) expenses for the fourth quarter and full year 2023 were $3.7 million and $29.0 million, respectively, as compared to $11.5 million and $49.8 million, respectively, for each of the same periods in 2022. The year over year decrease of approximately $20.9 million is primarily the result of decreases in third party service and supplier expenses, including manufacturing services associated with our ADC program of approximately $9.7 million and clinical services of approximately $2.6 million, as well as decreases in expenses related to headcount, including declines in stock-based compensation expense of approximately $3.3 million and employee salaries of approximately $3.1 million as a result of our headcount reduction in June 2022. General and administrative (G&A) expenses for the fourth quarter and full year 2023 were $1.8 million and $13.6 million, respectively, as compared to $4.0 million and $18.9 million for the same periods in 2022. The year over year decrease of approximately $5.2 million was primarily driven by decreases in stock-based compensation expense of $2.8 million, professional services of $1.4 million, and a decrease in expenses related to headcount of $0.7 million. For the fourth quarter and full year 2023, Vincerx reported a net loss of $4.9 million, or $0.23 per share, and a net loss of $40.2 million, or $1.89 per share, respectively. For the fourth quarter and full year 2022, Vincerx reported a net loss of $13.8 million, or $0.65 per share, and a net loss of $63.0 million, or $3.00 per share, respectively. About Vincerx Pharma, Inc. Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. Vincerx’s diverse pipeline consists of the next-generation antibody-drug conjugate, VIP943, in Phase 1; small molecule-drug conjugate, VIP236, in Phase 1; preclinical antibody-drug conjugate, VIP924; CDK9 inhibitor, enitociclib, in an NIH-sponsored Phase 1; and VersAptx, its versatile and adaptable, next-generation bioconjugation platform. Vincerx is based in Palo Alto, California, and has a research facility in Monheim, Germany. For more information, please visit and follow Vincerx on LinkedIn. Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, Vincerx’s business model, cash runway, pipeline, strategy, timeline, product candidates and attributes, and preclinical and clinical development, timing, and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside Vincerx’s control. Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to, general economic, financial, legal, political, and business conditions; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx’s in-licensing; failure to realize the benefits of Vincerx’s license agreement with Bayer; risks related to the timing of expected business and product development milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; Vincerx’s capital requirements, availability and uses of capital, and cash runway; and the risks and uncertainties set forth in Form 10-K for the year ended December 31, 2023 and other reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements. Vincerx, the Vincerx logo, CellTrapper, and VersAptx are our trademarks. This press release also contains trademarks and trade names that are the property of their respective owners. Contacts Gabriela Jairala gabriela.jairala@vincerx.com Vincerx Pharma, Inc. Totyana Simien Inizio Evoke Comms totyana.simien@inizioevoke.com Vincerx Pharma, Inc. Condensed Consolidated Balance Sheets (in thousands) Dec 31, 2023 Dec 31, 2022 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 12,782 $ 11,663 Restricted cash 72 70 Short-term marketable securities - 40,796 Prepaid expenses 51 134 Grant receivable 1,044 1,372 Other current assets 784 1,929 Total current assets 14,733 55,964 Right-of-use assets 2,201 3,064 Property, plant and equipment, net 125 177 Other assets 1,158 81 Total assets $ 18,217 $ 59,286 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 2,497 $ 4,065 Accrued expenses 1,755 3,923 Lease liability 1,162 1,024 Common stock warrant liabilities 191 144 Total current liabilities 5,605 9,156 Lease liability, net of current portion 1,340 2,412 Other noncurrent liabilities 50 50 Total liabilities 6,995 11,618 Total stockholders' equity 11,222 47,668 Total liabilities and stockholders' equity $ 18,217 $ 59,286 Vincerx Pharma, Inc. Condensed Consolidated Statements of Operations (unaudited) (in thousands, except per share amounts) For the three months ended For the year ended December 31, December 31, 2023 2022 2023 2022 Operating expenses: General and administrative $ 1,820 $ 4,015 $ 13,636 $ 18,885 Research and development 3,713 11,536 28,973 49,837 Restructuring - - - 2,469 Total operating expenses 5,533 15,551 42,609 71,191 Loss from operations (5,533 ) (15,551 ) (42,609 ) (71,191 ) Other income (expense) Change in fair value of warrant liabilities (59 ) (31 ) (47 ) 6,303 Interest income 198 460 1,251 664 Other income (expense) 444 1,351 1,248 1,240 Total other income (expense) 583 1,780 2,452 8,207 Net loss $ (4,950 ) $ (13,771 ) $ (40,157 ) $ (62,984 ) Net loss per common share, basic and diluted $ (0.23 ) $ (0.65 ) $ (1.89 ) $ (3.00 ) Weighted average common shares outstanding, basic and diluted 21,370 21,138 21,295 21,029

AFM24 combination with atezolizumab (AFM24-102): Follow-up of the Phase 1/2a combination study confirmed four responses in the non-small cell cancer (NSCLC) EGFR-wildtype cohort: one complete response (CR), three partial responses (PR), and seven stable disease patients in the 15 heavily pretreated patients who were evaluated. Mature progression free survival (PFS) data from the 15 EGFR-wildtype NSCLC patients and initial efficacy data from the EGFR-mutant NSCLC cohorts are expected in Q2 2024. Acimtamig (AFM13) combination with AlloNK® (AB-101) natural killer (NK) cells (LuminICE-203): Company on track to report initial efficacy and safety data in Q2 2024. AFM28: Currently enrolling patients in the sixth and final cohort of the Phase 1 dose-escalation study in patients with CD123-positive relapsed/refractory (r/r) AML. Restructuring completed: Company is focused on advancing its three clinical programs. Cash runway into H2 2025: As of December 31, 2023, cash, cash equivalents and investments were €72.0 million. MANNHEIM, Germany, March 28, 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 reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023. “The clinical achievements in 2023 with our three programs, AFM24, acimtamig, and AFM28, provide a strong foundation for us to deliver on meaningful clinical milestones across the portfolio in 2024 and beyond,” said Dr. Andreas Harstrick, Chief Medical Officer and interim Chief Executive Officer at Affimed. “We have seen compelling responses in treatment refractory NSCLC EGFR-wt patients and will report mature PFS data of these patients as well as response data from the NSCLC EGFR-mut cohort in the second quarter. With the LuminICE-203 study of acimtamig with AlloNK successfully launched in 2023, we are progressing toward an initial data update in the second quarter. The long-term follow-up data for study for the AFM13-104, presented at ASH, demonstrating that approximately 30% of patients remain in remission beyond 1 year, have further enhanced our confidence in the therapeutic potential of acimtamig in combination with NK cells. Finally, AFM28 has reached the final dose level in the escalation study providing the basis for continued development. With all three clinical programs moving forward, we are focused on the execution of these programs confident in Affimed’s ability to fulfill our overarching mission of delivering innovative therapies to cancer patients.” Program Updates AFM24 (EGFR/CD16A tumors) As of January 4, clinical response update to the Phase 1/2a AFM24-102 trial in EGFR-wt NSCLC reported 4 confirmed responses, including 1 CR, 3 PRs, and 7 stable diseases in 15 heavily pre-treated patients, resulting in a disease control rate of 73 percent. All patients were pre-treated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1. Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients. In addition, the company continues to enroll in the EGFR-mut NSCLC cohort for a planned number of 25 patients. Mature PFS data from the first 15 patients from the EGFR-wt cohort and response data from the EGFR-mut cohort are expected in Q2 2024. Acimtamig (AFM13; CD30/CD16A tumors) Initial safety and efficacy data from the LuminICE-203 (AFM13-203) study expected in Q2 2024. LuminICE-203 is a Phase 2 clinical study investigating acimtamig in combination with Artiva’s AlloNK cells in patients with r/r classical Hodgkin lymphoma (HL). Safety Review Committee meeting and initiation of enrollment in cohorts 3 and 4 is expected mid-April. Updated Phase 1/2 AFM13-104 study data demonstrated an ORR of 97% and a CR rate of 78% in 32 patients with r/r HL, presented at ASH 2023. As of the cutoff date, the median EFS was 9.8 months with 84% patients alive at 12 months. The median duration of response was 8.8 months. The treatment regimen continues to demonstrate a good safety and tolerability pro no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade. The oral presentation included a total of 42 patients enrolled, with 36 patients treated at the recommended Phase 2 dose (RP2D). All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. AFM28 (CD123/CD16A) Completed enrollment of the fifth cohort, recruiting patients in the sixth and final cohort in the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML. No dose-limiting toxicities were reported. Further clinical development of AFM28 is planned in combination with an allogeneic off-the-shelf NK cell product. Corporate Restructuring: The corporate restructuring announced earlier this year has been fully implemented. The restructuring included a streamlining of operations resulting in a 50% reduction in the Company’s workforce. The Company is focusing resources on advancing its clinical programs, AFM24, acimtamig, and AFM28, through the various stages of development. Upcoming Milestones: Data from the NSCLC expansion cohorts in the Phase 1/2a AFM24+atezolizumab combination study expected in Q2 2024. Initial data readout from the LuminICE-203 (AFM13 combination with AlloNK NK cells) study expected in Q2 2024. Further progress updates from AFM28-101 dose escalation expected in Q2 2024. Full Year 2023 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 December 31, 2023, cash, cash equivalents and investments totaled €72.0 million compared to €190.3 million on December 31, 2022. Based on our current operating plan and assumptions, we anticipate that our liquidity will support operations into H2 2025. Net cash used in operating activities for the year ended December 31, 2023, was €110.3 million compared to €104.9 million for the year ended December 31, 2022. Total revenue for the year ended December 31, 2023, was €8.3 million compared with €41.4 million for the year ended December 31, 2022. Revenue in 2022 and 2023 predominantly relates to the Roivant and Genentech collaborations for which we have now completed the work assigned to us under the respective collaboration agreements. Research and development expenses for the year ended December 31, 2023, were €95.0 million compared to €98.8 million in 2022. General and administrative expenses for the year ended December 31, 2023, were €24.7 million compared to €32.1 million for the year ended December 31, 2022. The decrease was due to a decline in legal, consulting and insurance expenses, as well as share-based payment expenses. Net finance income/costs for the year ended December 31, 2023, were €0.7 million compared to €2.1 million for the year ended December 31, 2022. Net finance income/costs are largely due to foreign exchange gains/losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year. The weighted number of common shares outstanding for the year ended December 31, 2023, was 14.9 million, adjusted to reflect the impact of the reverse stock split executed in the first quarter of 2024. Net loss for the year ended December 31, 2023, was €105.9 million, or €7.09 loss per common share compared with a net loss of €86.0 million, or €6.04 loss per common share, for the year ended December 31, 2022. Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2023, 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 U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro. Conference Call and Webcast Information Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year 2023 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 . To access the call by phone, please use link: , and you will be provided with dial-in details and a pin number. Note: 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 innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, 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: . Forward-Looking Statement 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 acimtamig (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 corporate restructuring, the associated headcount reduction and the impact this may have on Company’s anticipated savings and total costs and expenses, 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 macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, 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 acimtamig in combination with NK cell therapy is based on acimtamig precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s Allo-NK NK cells 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 Fudukidis Director, Investor Relations E-Mail: a.fudukidis@affimed.com Tel.: +1 (917) 436-8102 Affimed N.V. Consolidated statements of comprehensive loss (in € thousand) 2023 2022 2021 Revenue 8,275 41,353 40,366 Other income and expenses – net 4,697 1,417 1,310 Research and development expenses (94,958 ) (98,814 ) (81,488 ) General and administrative expenses (24,675 ) (32,075 ) (24,218 ) Operating loss (106,661 ) (88,119 ) (64,030 ) Finance income / (costs) – net 726 2,117 6,509 Loss before tax (105,935 ) (86,002 ) (57,521 ) Income taxes (3 ) (2 ) (2 ) Loss for the period (105,938 ) (86,004 ) (57,523 ) Other comprehensive loss Items that will not be reclassified to profit or loss Equity investments at fair value OCI – net change in fair value 0 (6,047 ) (7,693 ) Other comprehensive loss 0 (6,047 ) (7,693 ) Total comprehensive loss (105,938 ) (92,051 ) (65,216 ) Basic and diluted loss per share in € per share (undiluted = diluted) (7.09 ) (6.04 ) (4.81 ) Weighted number of common shares outstanding 14,939,916 14,236,229 11,950,238 Affimed N.V. Consolidated statements of financial position (in € thousand) December 31, 2023 December 31, 2022 ASSETS Non-current assets Intangible assets 25 58 Leasehold improvements and equipment 4,905 3,823 Right-of-use assets 8,039 561 12,969 4,442 Current assets Cash and cash equivalents 38,529 190,286 Investments 33,518 0 Other financial assets 851 0 Trade and other receivables 5,327 2,697 Inventories 463 628 Other assets and prepaid expenses 5,500 2,459 84,188 196,070 TOTAL ASSETS 97,157 200,512 EQUITY AND LIABILITIES Equity Issued capital 1,500 1,493 Capital reserves 593,666 582,843 Fair value reserves (1,231) (1,231) Accumulated deficit (536,128) (430,190) Total equity 57,807 152,915 Non current liabilities Borrowings 6,319 11,687 Contract liabilities 464 1,083 Lease liabilities 6,660 176 Total non-current liabilities 13,443 12,946 Current liabilities Trade and other payables 18,916 19,077 Borrowings 5,833 5,930 Lease liabilities 539 396 Contract liabilities 619 9,248 Total current liabilities 25,907 34,651 TOTAL EQUITY AND LIABILITIES 97,157 200,512 Affimed N.V. Consolidated statements of cash flows (in € thousand) 2023 2022 2021 Cash flow from operating activities Loss for the period (105,938) (86,004) (57,523) Adjustments for the period: - Income taxes 3 2 2 - Depreciation and amortization 1,749 2,899 1,334 - Net gain from disposal of subsidiary (4,339) 0 0 - Net loss on disposal of leasehold improvements and equipment 82 0 0 - Share-based payments 10,714 19,110 11,820 - Finance income / (costs) – net (726) (2,117) (6,509) (98,455) (66,110) (50,876) Change in trade and other receivables 1,093 2,113 (2,369) Change in financial assets (851) 0 0 Change in inventories 100 (207) (175) Change in other assets and prepaid expenses (2,737) 1,075 (2,274) Change in trade, other payables, provisions and contract liabilities (9,766) (41,048) (29,990) (110,616) (104,177) (85,684) Interest received 1,743 564 0 Paid interest (1,393) (1,277) (905) Paid income tax (3) (2) (2) Net cash used in operating activities (110,269) (104,892) (86,591) Cash flow from investing activities Purchase of intangible assets 0 (37) (1,654) Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets (3,729) (659) (2,196) Cash received from the sale of financial assets 938 6,301 0 Cash paid for investments in financial assets (34,246) 0 0 Cash received from sale of subsidiary 978 0 0 Net cash (used)/generated in investing activities (36,059) 5,605 (3,850) Cash flow from financing activities Proceeds from issue of common shares, including exercise of share-based payment awards 235 95,907 124,460 Transaction costs related to issue of common shares (35) (6,037) (7,412) Proceeds from borrowings 0 0 17,500 Transaction costs related to borrowings 0 0 (311) Repayment of lease liabilities (491) (733) (564) Repayment of borrowings (5,929) (580) (92) Net cash (used)/generated in financing activities (6,220) 88,557 133,581 Exchange rate related changes of cash and cash equivalents 791 3,386 7,636 Net changes to cash and cash equivalents (152,548) (10,730) 43,140 Cash and cash equivalents at the beginning of the period 190,286 197,630 146,854 Cash and cash equivalents at the end of the period 38,529 190,286 197,630 Affimed N.V. Consolidated statements of changes in equity (in € thousand) Issued Capital Fair Value Accumulated Total capital reserves reserves deficit equity Balance as of January 1, 2021 983 345,164 1,720 (275,874) 71,993 Issue of common shares 240 114,197 114,437 Exercise of share-based payment awards 11 2,906 2,917 Equity-settled share-based payment awards 11,820 11,820 Loss for the period (57,523) (57,523) Other comprehensive loss (7,693) (7,693) Balance as of December 31, 2021 1,234 474,087 (5,973) (333,397) 135,951 Balance as of January 1, 2022 1,234 474,087 (5,973) (333,397) 135,951 Issue of common shares 259 89,545 89,804 Exercise of share-based payment awards 0 101 101 Equity-settled share-based payment awards 19,110 19,110 Transfer of cumulative loss on sale of financial assets 10,789 (10,789) 0 Loss for the period (86,004) (86,004) Other comprehensive loss (6,047) (6,047) Balance as of December 31, 2022 1,493 582,843 (1,231) (430,190) 152,915 Balance as of January 1, 2023 1,493 582,843 (1,231) (430,190) 152,915 Issue of common shares 7 109 116 Equity-settled share-based payment awards 10,714 10,714 Loss for the period (105,938) (105,938) Balance as of December 31, 2023 1,500 593,666 (1,231) (536,128) 57,807

置身当下ADC的竞逐赛，艾伯维终于得到一个极大的利好：FDA将Elahere的加速批准转为完全批准。Elahere的完全获批，无疑开了一个好头，让艾伯维有了更多的底气。01一个抓手卵巢癌被称作“妇癌之王”，是女性生殖系统中最难诊断、最恶性、死亡率最高的疾病。通过标准的减瘤手术联合铂类药物，是卵巢癌基础的治疗方案，虽然大多晚期患者对治疗有响应，但70%的患者仍会复发，五年生存率不足40%，且复发患者较易产生铂类耐药问题。研究发现，FRα在卵巢癌上有非常优异的表达，采用ADC形式靶向FRα的尝试，最终在Elahere上开花结果。2022年11月，Elahere获得FDA批准加速上市，用于FRα阳性、铂耐药上皮卵巢、输卵管或原发性腹膜成人癌症患者的治疗。Elahere的成功与药物设计密不可分。有从业者表示，Elahere选择的毒素为DM4，linker为可裂解连接子。在临床前的动物模型中，无论是表达高低，以DXD为payload的ADC都展现了不错的效果。本次完全批准基于验证性MIRASOL的临床III期试验，该试验支持Elahere作为FRα阳性铂类耐药卵巢癌的潜在新标准。数据显示，Elahere治疗带来了OS获益，并将癌症进展的风险降低了35%。试验结果显示，与IC化疗对照组相比，Elahere的3+级不良事件总体较少，不良事件导致的停药率较低。换言之，Elahere是首个在铂类耐药卵巢癌患者上显示带来OS改善的疗法。这一定程度推动了它的商业化进程。Elahere自加速批准上市后放量迅速，2023年第一季度的销售额为2950万美元，第二季度为7740万美元，第三季度净销售额为1.052亿美元——前9个月累计销售额达到2.12亿美元，极具增长潜力，势必为艾伯维冲击ADC市场提供强力“武器”。根据艾伯维官网，Elahere目前主要的适应症聚焦在卵巢癌领域，有关铂类敏感性卵巢癌的研究正处在临床III期阶段。而ImmunoGen此前的规划显示，Elahere的销售额将通过各种联用尝试，随着覆盖患者的扩大而增加。2023年8月，ImmunoGen宣布就Elahere与武田达成合作。值得注意的是，早在2020年10月，ImmunoGen已这款药物的大中华区权益授权给华东医药，获得4000万美元的首付款以及最高可能达2.65亿美元的里程碑付款。本土同样在布局FRαADC的Biotech，包括百奥泰、普方生物。其中，普方生物开发的Rina-S目前正处于针对多种实体肿瘤的临床I/II期开发阶段。百奥泰旗下BAT8006也尚在早期临床。02一张宏图从并购交易额上看，预计今年年中完成ImmunoGen的案例，算是近年艾伯维少有的大手笔。再往前，则是2019年对艾尔建的630亿美元并购。考虑到眼下“药王”Humira失势的阵痛，重金砸向外部，实属一个不得不做的决定。当然，有限的资金盘子里，势必要做出一番调整。高调宣告抢占ADC领域机会的同时，艾伯维也做了很多减法。到去年下半年，艾伯维接连将ABBV-154、ABBV-011、ABBV-647从管线中划去，加上此前放弃的资产，艾伯维抛弃的ADC多达7款。纵观艾伯维在2023年的动作，不难看出其着重在调整肿瘤领域。2023年财报显示，这家MNC全年净收入543.18亿美元，同比下降6.4%，实现净利48.63亿美元，同比下降58.91%。作为艾伯维聚焦的5大疾病领域之一，肿瘤学领域的贡献不算亮眼，去年业绩下滑10.1%，跌破60亿美元门槛。艾伯维抗肿瘤版图的营收，主要来自Imbruvica和Venclexta，前者由于BTK赛道的激烈竞争和安全性风波，市场份额在大幅流失；后者作为全球上市的唯一一款Bcl-2抑制剂，增长良好，2023年同比增长13.9%，达22.88亿美元。去年5月，艾伯维成功将CD3/CD20双抗Epkinly推向市场，用于治疗接受过二线或多线系统治疗的复发或难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）患者，上市半年卖出3100万美元。不过，在CD20/CD3这个领域，罗氏是艾伯维避不开的直接对手，后者已拥有2款上市的双抗产品。要么首创抢占空白，要么做到最佳引领潮流——朴素的制药道理，在艾伯维身上得到印证。以此而言，追逐ImmunoGen的做法，便多少可以视作艾伯维的创新突破口。除了给艾伯维带来了极具前景的Elahere外，ImmunoGen还有一款处于I期临床的IMGN-151，也是用于治疗卵巢癌的新一代FRαADC，正在多项癌症类型中进行研究；处在II期临床的IMGN-632，则是一款靶向CD123的ADC，已被FDA授予突破性疗法认定，用于治疗复发/难治性母细胞性浆细胞样树突状细胞肿瘤（BPDCN）。这些外部资产，一定程度挽回了艾伯维在ADC领域的门面。毕竟几经调整后，它能拿得出手的创新产品所剩无几。艾伯维内部在研ADC管线中，当属进入全球注册性III期临床的ABBV-399能一骑绝尘。该药是目前全球唯一一款进入III期临床的c-Met靶向ADC，可针对肿瘤细胞表面的c-Met突变进行追踪，并释放一种名为甲基澳瑞他汀（MMAE）的抗有丝分裂药物来杀死癌细胞。2022年1月，ABBV-399被FDA授予突破性疗法资格，用于治疗晚期或转移性铂类治疗后进展的c-Met高表达EGFR野生型非鳞状NSCLC患者。就ABBV-399来说，过去一年也并非乏善可陈。2023年11月，艾伯维宣布了ABBV-399单臂II期LUMINOSITY试验的顶线结果。结果显示，c-Met高表达组的ORR为53.8%，c-Met表达水平中等组的ORR为25.0%。中位缓解持续时间分别为9个月和7.2个月，中位总生存期分别为14.6个月和14.2个月。为了抢占c-Met赛道的机遇，艾伯维还储备了一款下一代在研产品ABBV-400。去年的ASCO年会上，对外展示的早期多瘤种药物爬坡试验结果，显示出该药在转移性结肠癌的整体有效率为22%。目前，该疗法结直肠癌适应症已进入临床II期，肺癌和胃食管腺癌处于临床I期。这家置身转型过程的巨头，已经展示出抗肿瘤故事的冰山一角。但考虑到ADC从者众多，加上早期开发所需要穿越的“死亡之谷”，艾伯维还需砥砺前行。注：以上图片来源同写意来源 | 同写意（药智网获取授权转载）撰稿 | 写意君责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 王存星 19922864877（同微信） 阅读原文，是受欢迎的文章哦