Mannheim, Germany, March 28, 2024 – 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 ...

Affimed N.V. (NASDAQ:AFMD) Q4 2023 Earnings Conference Call March 28, 2024 8:30 AM ET Company Participants Alexander Fudukidis – Head-Investor Relations Andreas Harstrick – Chief Medical Officer and Interim Acting Chief Executive Officer Michael Wolf – Vice President-Finance Conference Call Participants Srikripa Devarakonda – Truist Daina Graybosch – Leerink Partners Operator Good day, everyone, and welcome to Affimed's Fourth Quarter and Full Year 2023 Earnings and Corporate Update Call. At this time all p ...

Restructuring and Workforce Management - The company approved a restructuring initiative on January 8, 2024, aimed at reducing workforce by up to 50% to focus on clinical programs [30]. - A one-time expenditure for termination payments is expected in the first half of 2024, with anticipated cost savings in the second half [31]. - Future growth may impose significant responsibilities on management, including recruitment and retention of qualified personnel [32]. Clinical Development and Regulatory Risks - The company has limited experience in conducting and managing clinical studies necessary for regulatory approval, which may impact future product commercialization [34]. - The company submitted an IND application for a clinical study evaluating the combination of acimtamig and AlloNK® [34]. - Infusion related reactions (IRRs) were observed in 90% of patients in a phase 1b study evaluating acimtamig with pembrolizumab, with 13% experiencing grade 3 or greater IRRs [46]. - The company faces risks related to regulatory approvals, which can be lengthy and uncertain, potentially delaying revenue generation [38]. - Delays in clinical studies or marketing approvals could increase product development costs and impact commercialization timelines [49]. - Any significant delay in completing clinical studies would adversely affect the company's ability to obtain regulatory approval and generate product revenue [50]. - The company currently has no products approved for sale and cannot guarantee future marketable products [53]. - The product candidate acimtamig has orphan drug designation for the treatment of HL and T-cell lymphoma from the FDA and EMA, indicating a limited potential patient population [59]. - The FDA cleared the IND application for the clinical study evaluating the combination of acimtamig and AlloNK® in patients with R/R classical HL and CD30+ PTCL, with enrollment initiated in October 2023 [56]. - The company faces significant risks in clinical studies, including potential negative or inconclusive results that may not satisfy regulatory requirements [52]. - Delays in patient enrollment for clinical studies could materially adversely affect research and development efforts [59]. - The company competes with other sponsors for patient enrollment in clinical studies, which may hinder timely completion [60]. - Regulatory approval for product candidates is uncertain, especially for those utilizing novel technologies [64]. - Continuous regulatory review will apply to any product candidates that obtain marketing authorization, potentially leading to additional expenses [65]. - The company has not yet established experience in obtaining regulatory approval in international markets, which could limit market potential [69]. Financial Performance and Capital Requirements - The company has incurred significant losses since inception and anticipates continued losses for the foreseeable future, with no products approved for commercial sale [112]. - The company expects its existing liquidity to fund operating expenses and capital expenditures into the second half of 2025 [119]. - The company may need to raise additional capital to continue product development, which could be uncertain [33]. - Future funding requirements will depend on factors such as establishing sales and marketing capabilities and obtaining market acceptance of product candidates [120]. - The company may need to raise additional capital through equity offerings or debt financings, which could dilute shareholders' ownership [124]. - The company has not generated any revenue or profit from product sales to date and may never achieve profitability [112]. - As of December 31, 2023, the company's accumulated deficit was €536.1 million, primarily due to research and development expenses [112]. - As of December 31, 2023, the company had €72.0 million in cash and cash equivalents, with an anticipated cash runway into the second half of 2025 [127]. Intellectual Property and Patent Risks - The patent portfolio for acimtamig includes three families, with key patents expiring in 2026 in Europe and 2029 in the US, while others extend to 2040 and beyond [153]. - The AFM24 patent family includes a non-provisional application filed in 2019, with issued patents not expiring before 2039 [154]. - The AFM28 patent portfolio includes a non-provisional application filed in 2022, with patents not expiring before 2042 [155]. - The company faces risks related to patent enforcement and potential litigation, which could divert management resources and impact financial performance [160]. - The ability to operate without infringing third-party patents is crucial for the company's commercial success [158]. - The company may need to defend against patent infringement claims, which could result in significant costs and operational delays [162]. - The patent protection for some product candidates is dependent on third parties, which could jeopardize the company's rights and exclusivity [163]. - The company relies on third-party intellectual property rights for proprietary technologies critical to its business [164]. Market and Competitive Landscape - The company may face significant competition from established pharmaceutical companies with greater resources and experience in drug development and marketing [92]. - The company’s product candidates may not achieve necessary pricing for sustained profitability due to changing reimbursement regulations [90]. - The market acceptance of product candidates will be influenced by factors such as clinical safety, efficacy, and reimbursement availability [84]. - The company is focused on developing therapies for conditions with limited treatment options, which may lead to challenges in determining the cause of patient deaths during clinical studies [78]. - The company is dependent on external manufacturers for scaling up production processes, which may face regulatory approval challenges and affect product supply [86]. Management and Operational Challenges - Recent resignations of key executives, including the Chief Executive Officer and Chief Financial Officer, may disrupt business operations and strategic implementation [200]. - The company must effectively manage transitions among senior management to avoid adverse impacts on business performance [201]. - The company may need to implement additional internal systems and infrastructure, including financial and reporting systems [127]. - The company relies on third-party manufacturers for clinical testing and commercialization, which increases the risk of insufficient product quantities or delays in development [147]. - Compliance with FDA and EMA requirements is critical, and failure of third-party manufacturers to meet specifications could lead to product recalls or approval delays [148]. Compliance and Regulatory Environment - The company is subject to stringent data privacy regulations, including the GDPR, with potential fines of up to €20 million or 4% of total worldwide annual revenue for non-compliance [194]. - Environmental, health, and safety regulations may lead to substantial compliance costs and liabilities, affecting financial condition and operational capabilities [189]. - The company received a letter from Nasdaq in April 2023 indicating that the bid price for its common shares had closed below the minimum $1.00 per share requirement for continued listing for 30 consecutive business days [207]. - The company applied for a transfer of its common shares from the Nasdaq Global Select Market to the Nasdaq Capital Market, which was approved on October 4, 2023, providing an additional 180 calendar days to regain compliance [207]. - A 1-for-10 reverse stock split was effectuated on March 8, 2024, to meet the minimum $1.00 per share requirement for Nasdaq listing [208]. Shareholder and Equity Considerations - The company has a shelf registration statement allowing it to offer and sell common shares and other securities, which may dilute existing shareholders [212]. - The authorized share capital currently amounts to €3,119,500, comprised of 31,195,000 common shares, each with a nominal value of €0.1 [218]. - Future sales of a substantial number of common shares could adversely affect the share price and dilute existing shareholders [210]. - Certain provisions in the company's Articles of Association may deter acquisition bids and complicate changes in management [220].

MANNHEIM, Germany, March 21, 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, announced today that it will release full year 2023 results and corporate update on March 28, 2024. The Company will host a conference call at 8:30 a.m. EDT / 13:30 CET. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in t ...

Affimed N.V. (AFMD) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Individu ...

Affimed (NASDAQ:AFMD) stock is on the move Friday as investors prepare for the clinical-stage biopharmaceutical company’s shares to undergo a reverse split later today.AFMD stock will go through a one-for-10 reverse stock split after markets close today. That will result in the company’s shares starting to trade on a split-adjusted basis when markets open on Monday.Shareholders approved of this reverse stock split during the company’s on June 21, 2023. It’s also worth mentioning that this split won’t allow ...

I’m about to drop a truth bomb about speculative stocks under $1.Back when I was a freshman in college, the on-campus security officer had this to say: “Tijuana? You don’t wanna.” Subsequently, the crowd erupted in laughter but the officer got his point across. Yes, Tijuana is an exciting and vibrant city, no doubt about it. However, people – especially young underage college students – can get carried away.That’s the reality behind speculative stocks under $1. It’s like Tijuana, where the same restrictions ...

MANNHEIM, Germany, March 06, 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, announced that the Company, with prior approval of the Company's supervisory board and management board, intends to effect a 1-for-10 reverse stock split of its outstanding common shares, par value €0.01 ("Common Shares") per share. The reverse stock split is expected to be effected afte ...

Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohortFollow-up shows three of the initially reported responses have now been confirmed (1 CR, 2 PR) and one still awaiting a confirmatory scanStudy to be expanded to a total of 40 EGFRwt NSCLC patientsEnrollment in the EGFR-mutant (mut) NSCLC cohort is ongoingData from both the EGFRwt and EGFRmut cohorts expected in H1 2024 MANNHEIM, Germa ...

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 ...