Press Release - June 1, 2022
Heidelberg, Germany, June 1, 2022 – 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 first quarter ended March 31, 2022 and provided an update on clinical and corporate progress.
“We are excited about the progress we are making advancing our Innate Cell Engagers (ICE®) including completing enrollment of REDIRECT, our first registration directed study, and establishing a compelling proof of concept for AFM13 combined with NK cells as evidenced by the remarkable clinical data presented at AACR. These results continue to validate our three-pronged development approach and the potential of our ICE® molecules to offer novel treatments for heavily pretreated, relapsed/refractory patients with limited options,” said Dr. Adi Hoess, CEO of Affimed. “Our strong financial position allows us to maintain our focus on execution so that we can bring these important therapies to patients who need them as soon as possible.”
Affimed completed enrollment of its REDIRECT study (AFM13-202). The Company expects to report top-line data in the fourth quarter of 2022. REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
At an AACR 2022 Clinical Trials Plenary Session, Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, presented follow-up data to the investigator sponsored trial (IST) (AFM13-104) investigating the combination of AFM13 pre-complexed with cord blood-derived natural killer cells followed by AFM13 monotherapy in relapsed/refractory CD30+ lymphomas. The treatment resulted in a 100% ORR with 8/13 (62%) patients achieving a complete response after two cycles of treatment at the RP2D.
Durability data presented at AACR for patients treated at the RP2D was also promising. As of the cutoff date, of the eight patients who achieved a CR, seven remained in CR at median follow-up of 6.5 months, including two patients who remained in response after 10 months and two who received a consolidation autologous stem cell transplant (SCT). The safety profile was well managed, with the main treatment related side-effect being infusion related reactions. The investigators did not observe any cases of cytokine release syndrome (CRS), neurotoxicity or graft versus host disease often associated with T-cell therapies. In general, side effects observed in the trial were transient and did not lead to treatment delays or discontinuation. The recently approved amendment to the AFM13-104 trial protocol allows for an increase in the number of CD30-positive lymphoma patients treated at the RP2D to 40 – including Hodgkin and non-Hodgkin’s lymphoma patients. Furthermore, under the amended protocol, patients can receive more than two cycles of treatment.
The Company and MD Anderson expect to report updates on the study at a medical conference in the second half of the 2022.
In the monotherapy phase 1/2a clinical trial (AFM24-101), enrollment in cohort seven of the dose escalation study, which treated patients at the 720mg dose, was completed without dose limiting toxicities. Based on the pharmacokinetic and pharmacodynamic data, and in agreement with the Safety Review Committee (SRC), no further dose escalation is planned. The data confirm the selection of 480mg as the RP2D. The Company is continuing enrollment in the expansion phase of the monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EFGR mutant), and colorectal cancer.
Enrollment continues in the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) (AFM24-102) to treat patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer.
Enrollment continues in the phase 1/2a combination study of AFM24 with the SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech) cells (AFM24-103) to treat patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer.
In these studies, the Company is evaluating the safety and efficacy of AFM24 in nine indication-specific cohorts, with a particular focus on NSCLC, which is represented in all three studies, and CRC, represented in two of the three studies. Affimed expects to report initial data from the studies in the second half of 2022.
AFM28 is a bispecific, tetravalent ICE® that targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML).
The Company expects to submit an IND in June and is planning to start clinical investigation of AFM28 in the second half of 2022.
Partnerships and Collaborations
The Company continues to advance its work with existing partners including MD Anderson, Artiva, and NKGen Biotech to ensure access to an off-the-shelf, cryopreserved NK cell for further development with its ICE® molecules and expects to provide updates on its NK cell development strategy in the second half of 2022.
Affimed’s consolidated financial statements are prepared in accordance with 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 March 31, 2022, cash and cash equivalents totaled €169.9 million compared to €197.6 million on December 31, 2021. The pro forma cash position as of March 31, 2022, including net proceeds – before offering expenses – from the April 2022 underwritten public offering would be approximately €257.5 million.
Based on the Company’s current operating plan and assumptions, cash and cash equivalents, including proceeds from the April 2022 public offering, are expected to support operations into mid-2024.
Net cash used in operating activities for the quarter ended March 31, 2022, was €28.4 million compared to €16.0 million for the quarter ended March 31, 2021. Included in the cash burn for the quarter was a milestone payment to MD Anderson for the initiation of the Phase 2 portion of the AFM13-104 trial, which was expensed in Q4 2021 and paid in Q1 2022.
Total revenue for the quarter ended March 31, 2022, was €8.0 million compared with €11.7 million for the quarter ended March 31, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for the quarter ended March 31, 2022, increased by 61% from €11.4 million to €18.4 million compared to the quarter ended March 31, 2021. Research and development expenses increased primarily due to increased expenses associated with the development of the AFM24 and AFM28 programs and included costs to produce clinical trial material, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.
General and administrative expenses increased 57% from €4.5 million in the quarter ended March 31, 2021, to €7.0 million in the quarter ended March 31, 2022. The increase predominately relates to higher share-based payment expenses and an increase in insurance premiums.
Net finance income for the quarter ended March 31, 2022, decreased by 91% from €5.5 million in the quarter ended March 31, 2021, to €0.5 million. Net finance income is largely the result of foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.
Net loss for the quarter ended March 31, 2022, was €16.7 million, or €0.14 loss per common share compared with a net income of €1.4 million, or €0.01 earnings per common share, for the quarter ended March 31, 2021.
The weighted number of common shares outstanding for the quarter ended March 31, 2022, was 123.4 million. Additional information regarding these results is included in the notes to the consolidated financial statements as of March 31, 2022, which will be included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).
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.
Affimed will host a conference call and webcast June 1, 2022, at 8:30 a.m. EDT / 14:30 CET to discuss first quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast.
To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 4440407 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 https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
A replay of the webcast will be accessible at the same link for 30 days following the call.
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 proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, 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: www.affimed.com.
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 our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and our other product candidates, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict and the risks, uncertainties and other 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 we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Director, Head of Investor Relations
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