On April 15, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the year ended December 31, 2020 and provided an update on clinical and corporate progress (Press release, Affimed, APR 15, 2021, View Source [SID1234578090]).
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"2020 was an important year for Affimed. We continued to build on the strong foundation of our scientific discoveries and made significant progress across all our programs. We broadened our clinical pipeline, added new collaborations, built a strong balance sheet, appointed key senior management executives and ensured that our programs stayed on track through the global pandemic," said Dr. Adi Hoess, CEO of Affimed. "We entered 2021 with strong momentum, and the recently announced positive outcome of our interim futility analysis for our registration directed study of AFM13 as monotherapy in PTCL patients, and initial data from the trial investigating AFM13 pre-complexed natural killer cells in Hodgkin lymphoma patients provide further validation for our three-pronged development strategy. As we look ahead into 2021, we anticipate numerous additional updates as we advance our programs."
Clinical Stage Program Updates
Three-pronged Development Strategy
Based on preclinical and clinical data, Affimed is pursuing development of its innate cell engagers (ICE) as monotherapy, and in combination with adoptive NK cell transfer and PD-1/PD-L1 checkpoint inhibitors.
AFM13 (CD30/CD16A)
In March 2021, Affimed reported positive results from the preplanned interim futility analysis for AFM13-202, its phase 2 registration-directed study of AFM13 (CD16A/CD30) as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL). The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study. The response rate in Cohort B was sufficiently comparable to allow merging of both cohorts into a single cohort for all patients with CD30 >1%, per the study protocol. Evidence of anti-tumor response was observed in both cohorts with complete and partial responses. The trial will continue by combining the high- and low-CD30 expressing cohorts into one.
In April 2021, Affimed reported positive initial clinical data from the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center evaluating increasing doses of cord-blood derived NK cells pre-complexed with AFM13 (CD16A/CD30) followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30 positive lymphomas. As of March 31, 2021, all four response evaluable patients, including three patients in cohort 1 (1×106 AFM13-cbNK/kg) and one patient in cohort 2 (1×107 AFM13-cbNK/kg), have achieved an objective response, including two complete responses, according to investigator assessments by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). All four patients had relapsed / refractory Hodgkin lymphoma and were heavily pretreated, with between four and 14 previous lines of therapy which in all cases included brentuximab vedotin (Adcetris) and anti-PD1 antibodies.
AFM24 (EGFR/CD16A)
AFM24-101, the phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE for patients with EGFR-expressing solid tumors, completed dose cohort 4 (160 mg) and patients are currently being enrolled and treated in dose cohort 5 (320 mg). Affimed expects to provide an update on the dose escalation and initiate the dose expansion cohorts during 2021.
An investigational new drug (IND) application was cleared by the U.S. Food and Drug Administration to investigate the combination of AFM24 with NKGen Biotech’s (formerly known as NKMax America) autologous NK cell therapy, SNK01, in a first-in-human proof of concept (POC) trial in patients with EGFR-expressing tumors. Affimed expects to initiate the study in the second half of 2021.
Affimed entered into a clinical collaboration with Roche for a phase 1/2a study evaluating AFM24 in combination with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in EGFR-expressing solid tumors. The phase 1 portion of the study will establish a dosing regimen and assess safety for the combination; in the subsequent phase 2a portion of the study, the clinical activity of the combination will be evaluated in specific tumor types. Affimed expects to initiate the study in the second half of 2021.
Preclinical data was presented at AACR (Free AACR Whitepaper) 2021 showing the potential of AFM24 as monotherapy and in combination with NK cells. As monotherapy, AFM24 induces tumor cell killing independent of KRAS mutations; and, in combination with adoptive NK cells, it leads to AFM24 dose-dependent tumor regression.
Preclinical and Partnered Programs
AFM28 progressed further in IND-enabling studies and Affimed expects an IND application will be filed in the first half of 2022.
In November 2020, Affimed entered into a licensing and strategic collaboration agreement with Roivant Sciences and granted Roivant a license to AFM32 with options for additional ICE molecules against targets not included in Affimed’s current pipeline. AFM32 will be investigated in solid tumors.
In August 2020, Affimed announced that Genentech’s RO7297089, a CD16A/BCMA targeting ICE, is actively recruiting patients into a first-in-human phase 1 trial resulting in the achievement of a milestone payment under the terms of the collaboration.
Affimed entered a collaboration with Artiva Biotherapeutics to assess feasibility and activity of pre-manufactured, co-vialed, cryopreserved, off-the-shelf NK cell combination therapeutics. The R&D collaboration is assessing the feasibility and preclinical activity of combinations of Artiva’s allogeneic NK cell product AB-101 and Affimed’s ICE molecules, building on earlier preclinical studies demonstrating synergistic cytotoxic activity.
Other Corporate Updates
In January 2021, Affimed completed a $115 million underwritten public offering to accelerate and expand the development and manufacturing of its clinical and preclinical ICE molecules.
In January 2021, Affimed entered into a financing agreement with Silicon Valley Bank for up to €25 million in term loans, with €10 million available at closing.
Full Year 2020 Financial Highlights
As of December 31, 2020, cash, cash equivalents and current financial assets totaled €146.9 million compared to €104.1 million on December 31, 2019. The pro forma cash position as of December 31, 2020, including net proceeds from the January 2021 underwritten public offering and the first tranche of the Silicon Valley Bank loan, would be approximately €244.5 million.
Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.
Net cash used in operating activities for the year ended December 31, 2020 amounted to €19.4 million compared to €29.1 million for the year ended December 31, 2019. The amount received in 2020 includes an initial upfront payment and committed funding of €33.3 million (US$ 40 million) from the Roivant collaboration.
Total revenue for the year ended December 31, 2020 was €28.4 million compared with €21.4 million for the year ended December 31, 2019. Revenue for 2020 and 2019 predominantly relate to the Genentech collaboration. Collaboration revenue for the year ended December 31, 2020 amounted to €27.8 million, with €26.2 million from the Genentech collaboration and €1.4 million from the Roivant collaboration. Collaboration revenue of €19.7 million for the year ended December 31, 2019 was from the Genentech collaboration.
Research and development expenses for 2020 increased 14.2% from €43.8 million in the year ended December 31, 2019 to €50.0 million in the year ended December 31, 2020, due to higher expenses for AFM24 and our other projects and infrastructure investments.
General and administrative expenses increased 33.6% from €10.3 million in the year ended December 31, 2019 to €13.7 million in the year ended December 31, 2020. In 2020, general and administrative expenses were largely comprised of personnel expenses of €6.3 million and legal, consulting and audit costs of €5.6 million.
Finance costs for the year ended December 31, 2020 were €6.6 million, compared to finance income of €15 thousand for the year ended December 31, 2019. Finance costs for the year ended December 31, 2020 were largely comprised of foreign exchange losses related to assets denominated in U.S. dollars as a result of the weakening of the U.S. dollar compared to the Euro during the year.
Net loss for the year ended December 31, 2020 was €41.4 million, or €0.50 per common share compared with a net loss of €32.4 million, or €0.50 per common share, for the year ended December 31, 2019. The weighted number of common shares outstanding for the year ended December 31, 2020 was 83.5 million.
Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2020 and "Item 5. Operating and Financial Review and Prospects," which will be included in Affimed’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed will host a conference call and webcast today, April 15, 2021 at 8:30 a.m. EDT to discuss fourth quarter 2020 financial results and recent corporate developments. The conference call will be available via phone and webcast.
To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 4271307 approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be accessible at the same link for 30 days following the call.