Affimed Reports First Quarter 2024 Financial Results & Business Update
Affimed reported its Q1 2024 financial results, revealing a significant decline in revenue to €0.2 million from €4.5 million in Q1 2023, due to decreased collaboration payments. However, operating expenses also decreased, with R&D expenses down to €15.4 million from €29.5 million and general administrative expenses down to €4.5 million from €6.9 million. Net loss improved to €19.2 million from €32 million in Q1 2023.
Clinical updates include promising results from the LuminICE-203 study, showing an 85.7% ORR in Hodgkin Lymphoma patients and 33% CR/CRi rate in the AFM28 monotherapy study. AFM24-a combination with atezolizumab in NSCLC patients showed a 71% disease control rate and a 5.9-month mPFS.
Financially, Affimed has a cash runway into H2 2025 with €48.5 million in cash and equivalents as of March 31, 2024.
- Improved net loss for Q1 2024 to €19.2M from €32M in Q1 2023.
- Reduced R&D expenses to €15.4M from €29.5M.
- Reduced general administrative expenses to €4.5M from €6.9M.
- Cash runway extended into H2 2025 with €48.5M in cash and equivalents.
- 85.7% ORR and 57% CR rate in the LuminICE-203 study for Hodgkin Lymphoma.
- 33% CR/CRi rate in AFM28 monotherapy study.
- 71% disease control rate in AFM24-a combination with atezolizumab in NSCLC.
- mPFS of 5.9 months in AFM24-a combination with atezolizumab in NSCLC.
- Total revenue declined sharply to €0.2M from €4.5M in Q1 2023.
- High net cash used in operating activities of €23.8M in Q1 2024.
- Decreased revenue due to lower collaboration payments.
- Continued significant net losses despite improvements.
Insights
Affimed's clinical updates present promising developments in their immuno-oncology pipeline. The LuminICE-203 study for acimtamig (AFM13) combined with AlloNK® cells shows an
The AFM24 trial combining atezolizumab in NSCLC patients, both EGFR wild-type and mutant subgroups, reveals a
AFM28 monotherapy in AML also showed a promising CR/CRi rate of
In summary, these clinical results spotlight Affimed's strength in developing innovative immunotherapies. Investors should watch for more data releases to validate these early successes and monitor the transition from promising clinical outcomes to broader market approvals.
From a financial perspective, Affimed’s first quarter financial results show a mixed picture. The company's cash runway into H2 2025 with
On the revenue side, a substantial drop from
Investors should be cautious but optimistic, keeping an eye on upcoming data readouts and financial strategy adjustments.
Affimed's recent clinical data points towards strategic advancements in the immuno-oncology market. The high
The FDA Fast Track designation for AFM24/atezolizumab in EGFRwt NSCLC patients underscores potential expedited review and market entry, which could enhance Affimed's competitive edge and market share if successful. Furthermore, the company's plan to explore AFM28 in combination with NK cells aligns with emerging trends in personalized and combination therapies within oncology.
While Affimed shows potential, market penetration will depend on maintaining clinical trial success, navigating regulatory pathways and securing strategic partnerships to bolster commercialization efforts.
- Initial data from the LuminICE-203 study shows
- AFM28 shows single agent efficacy with 2 CR/CRi and 3 stable disease (SD) in 6 patients treated at dose level of 300 mg weekly -
- Acimtamig (AFM13) combination with AlloNK® (AB-101) natural killer (NK) cells: Recruitment in cohorts 1 and 2 completed. In the first 7 treatment refractory Hodgkin Lymphoma (HL) patients, an ORR of
85.7% observed, with 4 CRs and 2 partial responses (PRs) were observed by independent read. - AFM24 combination with atezolizumab: In 17 EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) patients who failed chemotherapy and PD-1/PD-L1 treatment, 1CR, 3PRs and 8 SDs were observed. Disease control was
71% . - 3 of the 4 responses were ongoing for more than 7 months and median progression free survival (mPFS) was 5.9 months.
- Initial efficacy data from the EGFR mutant (EGFRmut) NSCLC cohort showed objective responses in 4 out of 13 response-evaluable patients; 1 CR, 3 PRs and 6 SDs. Disease control was
77% . All responses confirmed by follow-up scans. - AFM28 monotherapy phase 1 dose-escalation study: Completed enrollment of patients in the sixth and final cohort of the study without any unexpected safety signals or dose limiting toxicities. Of the 6 patients treated at dose level 6, a CR/CRi rate of
33% was reported (1 CR, 1 CRi and 3 SDs were observed). - Cash runway into H2 2025: As of March 31, 2024, cash, cash equivalents and investments were
€48.5 million .
MANNHEIM, Germany, June 12, 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 quarter ended March 31, 2024.
“We continue to make remarkable progress across our three clinical programs, AFM24, acimtamig, and AFM28,” said Dr. Andreas Harstrick, Chief Medical Officer, and acting Chief Executive Officer of Affimed. “The data that we are presenting today mark an important point for our company as we see clinical validation of our strategy to use the power of the innate immune system to fight cancer with all three assets. The initial data for the LuminICE-203 study, combining acimtamig and allogeneic NK cells (AlloNK®) are impressive with nearly
Program Updates
Acimtamig (AFM13; CD30 / CD16A)
Independent read data from the first 7 patients show an ORR of 85.7 % with 4 CRs and 2 PRs.
- All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7 patients) had also failed after prior autologous stem cell transplantation (ASCT).
- Treatment related adverse events were consistent with previous experience and were mainly mild to moderate IRR/CRS in nearly two thirds of the patients (4/7). One patient developed a short-lasting grade 3 CRS but was also diagnosed to have acute cytomegalovirus infection. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK® related adverse events. No cases of bleeding, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were observed. Enrollment in cohorts 1 and 2 is completed; cohorts 3 and 4 are now open and enrolling.
- Continued updates from the study to be provided on upcoming earnings calls and scientific conferences.
AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab): 4 confirmed responses (1CR, 4PR) and 8SD in 17 heavily pretreated EGFRwt NSCLC patients; mPFS of 5.9 months; 3 out of 4 responses ongoing for more than 7 months.
- All patients were pretreated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1.
- On May 29, the Company announced that it received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients.
- In 13 response-evaluable, heavily pretreated EGFRmut NSCLC patients, the combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 CR, 3 PRs and 6 SDs. All responses are ongoing and have been confirmed by follow up scan.
- ORR and PFS data from the 25 patient EGFRmut NSCL cohort is expected in Q3 2024; data from the 40 patient EGFRwt cohort is expected in Q4 2024.
AFM28 (CD123 / CD16A)
Completed enrollment of 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 acute myeloid leukemia (AML).
- Of 6 patients treated at dose level 6 at 300mg, 1 patient showed a CR, 1 patient a CRi and 3 patients achieved SD, a CR/CRi rate of
33% . - Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, ongoing after 5 months; 5 patients achieved a SD as best response.
- No dose-limiting toxicities were reported in dose levels 5 and 6.
- Data from the study is expected to be presented at a future scientific conference.
- Further clinical development of AFM28 to be pursued in combination with an allogeneic, off-the-shelf NK cell product.
Upcoming Milestones:
- Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK® cells) study in Q3 2024.
- ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024.
- ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024.
First Quarter 2024 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 March 31, 2024, cash, cash equivalents and short-term investments totaled
Net cash used in operating activities for the quarter ended March 31, 2024 was
Total revenue for the quarter ended March 31, 2024, was
Research and development expenses for the quarter ended March 31, 2024, were
General and administrative expenses for the quarter ended March 31, 2024, were
Net finance income/costs for the quarter ended March 31, 2024 were
Net loss for the quarter ended March 31, 2024, was
The weighted number of common shares outstanding for the quarter ended March 31, 2024, was 15,129,952 shares.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of March 31, 2024, 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 June 12, 2024, at 8:30 a.m. EDT / 14:30 CET to discuss first quarter 2024 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 https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link: https://register.vevent.com/register/BId697f70815a8448d80b68becf533be98, 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: www.affimed.com.
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 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 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 AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 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. | ||||||
| Unaudited consolidated statements of comprehensive loss | ||||||
| (in € thousand) | ||||||
| For the three months ended March 31 | ||||||
| 2024 | 2023 | |||||
| Revenue | 155 | 4,510 | ||||
| Other income – net | 177 | 410 | ||||
| Research and development expenses | (15,391 | ) | (29,531 | ) | ||
| General and administrative expenses | (4,476 | ) | (6,850 | ) | ||
| Operating loss | (19,535 | ) | (31,461 | ) | ||
| Finance income / (costs) – net | 360 | (519 | ) | |||
| Loss before tax | (19,175 | ) | (31,980 | ) | ||
| Income taxes | 0 | (3 | ) | |||
| Loss for the period | (19,175 | ) | (31,983 | ) | ||
| Total comprehensive loss | (19,175 | ) | (31,983 | ) | ||
| Basic and diluted loss per share in € per share (undiluted = diluted) | (1.27 | ) | (2.14 | ) | ||
| Weighted number of common shares outstanding | 15,129,952 | 14,933,934 | ||||
| Affimed N.V. | ||||||
| Consolidated statements of financial position | ||||||
| (in € thousand) | ||||||
| March 31, 2024 (unaudited) | December 31, 2023 | |||||
| ASSETS | ||||||
| Non-current assets | ||||||
| Intangible assets | 22 | 25 | ||||
| Leasehold improvements and equipment | 2,404 | 4,905 | ||||
| Right-of-use assets | 5,970 | 8,039 | ||||
| 8,396 | 12,969 | |||||
| Current assets | ||||||
| Cash and cash equivalents | 14,348 | 38,529 | ||||
| Investments | 34,158 | 33,518 | ||||
| Other financial assets | 869 | 851 | ||||
| Trade and other receivables | 6,038 | 5,327 | ||||
| Inventories | 0 | 463 | ||||
| Other assets and prepaid expenses | 6,044 | 5,500 | ||||
| Assets held for sale | 700 | 0 | ||||
| 62,157 | 84,188 | |||||
| TOTAL ASSETS | 70,553 | 97,157 | ||||
| EQUITY AND LIABILITIES | ||||||
| Equity | ||||||
| Issued capital | 1,523 | 1,500 | ||||
| Capital reserves | 595,674 | 593,666 | ||||
| Fair value reserves | (1,231 | ) | (1,231 | ) | ||
| Accumulated deficit | (555,303 | ) | (536,128 | ) | ||
| Total equity | 40,663 | 57,807 | ||||
| Non-current liabilities | ||||||
| Borrowings | 4,966 | 6,319 | ||||
| Contract liabilities | 309 | 464 | ||||
| Lease liabilities | 4,300 | 6,660 | ||||
| Total non-current liabilities | 9,575 | 13,443 | ||||
| Current liabilities | ||||||
| Trade and other payables | 12,891 | 18,916 | ||||
| Borrowings | 5,833 | 5,833 | ||||
| Lease liabilities | 972 | 539 | ||||
| Contract liabilities | 619 | 619 | ||||
| Total current liabilities | 20,315 | 25,907 | ||||
| TOTAL EQUITY AND LIABILITIES | 70,553 | 97,157 | ||||
| Affimed N.V. | |||||||
| Unaudited consolidated statements of cash flows | |||||||
| (in € thousand) | |||||||
| For the three months ended March 31 | |||||||
| 2024 | 2023 | ||||||
| Cash flow from operating activities | |||||||
| Loss for the period | (19,175 | ) | (31,983 | ) | |||
| Adjustments for the period: | |||||||
| - Income taxes | 0 | 3 | |||||
| - Depreciation and amortization | 2,090 | 289 | |||||
| - Net loss on disposal of leasehold improvements and equipment | 46 | 0 | |||||
| - loss from write-down of inventories | 456 | 0 | |||||
| - Share-based payments | 789 | 4,158 | |||||
| - Finance income / (costs) – net | (360 | ) | 519 | ||||
| (16,154 | ) | (27,014 | ) | ||||
| Change in trade and other receivables | (700 | ) | 655 | ||||
| Change in inventories | 7 | (39 | ) | ||||
| Change in other assets and prepaid expenses | (269 | ) | (2,781 | ) | |||
| Change in trade, other payables, provisions and contract liabilities | (6,460 | ) | (4,235 | ) | |||
| (23,576 | ) | (33,414 | ) | ||||
| Interest received | 104 | 520 | |||||
| Paid interest | (346 | ) | (347 | ) | |||
| Paid income tax | 0 | (3 | ) | ||||
| Net cash used in operating activities | (23,818 | ) | (33,244 | ) | |||
| Cash flow from investing activities | |||||||
| Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets | (1 | ) | (8 | ) | |||
| Net cash used for investing activities | (1 | ) | (8 | ) | |||
| Cash flow from financing activities | |||||||
| Proceeds from issue of common shares, including exercise of share-based payment awards | 1,270 | 0 | |||||
| Transaction costs related to issue of common shares | (24 | ) | 0 | ||||
| Repayment of lease liabilities | (205 | ) | (124 | ) | |||
| Repayment of borrowings | (1,458 | ) | (510 | ) | |||
| Net cash used for financing activities | (417 | ) | (634 | ) | |||
| Exchange-rate related changes of cash and cash equivalents | 55 | (552 | ) | ||||
| Net changes to cash and cash equivalents | (24,236 | ) | (33,886 | ) | |||
| Cash and cash equivalents at the beginning of the period | 38,529 | 190,286 | |||||
| Cash and cash equivalents at the end of the period | 14,348 | 155,848 | |||||
| Affimed N.V. | |||||||||||||
| Unaudited consolidated statements of changes in equity for the year | |||||||||||||
| (in € thousand) | |||||||||||||
| Issued capital | Capital reserves | Fair Value reserves | Accumulated deficit | Total equity | |||||||||
| Balance as of January 1, 2023 | 1,493 | 582,843 | (1,231 | ) | (430,190 | ) | 152,915 | ||||||
| Equity-settled share-based payment awards | 4,158 | 4,158 | |||||||||||
| Loss for the period | (31,983 | ) | (31,983 | ) | |||||||||
| Balance as of March 31, 2023 | 1,493 | 587,001 | (1,231 | ) | (462,173 | ) | 125,090 | ||||||
| Balance as of January 1, 2024 | 1,500 | 593,666 | (1,231 | ) | (536,128 | ) | 57,807 | ||||||
| Issue of common shares | 23 | 1,219 | 1,242 | ||||||||||
| Equity-settled share-based payment awards | 789 | 789 | |||||||||||
| Loss for the period | (19,175 | ) | (19,175 | ) | |||||||||
| Balance as of March 31, 2024 | 1,523 | 595,674 | (1,231 | ) | (555,303 | ) | 40,663 | ||||||
FAQ
What were Affimed's Q1 2024 revenue and net loss?
What clinical results did Affimed report in Q1 2024?
What is the current financial runway for Affimed?
How did the AFM24 and atezolizumab combination perform?
What were the R&D expenses for Affimed in Q1 2024?
What caused the decline in Affimed's revenue in Q1 2024?
