EX-99.2 3 a20-26176_1ex99d2.htm EX-99.2

Exhibit 99.2

 

AFFIMED N.V.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial statements for the three and six month periods ended June 30, 2020 and 2019 included as Exhibit 99.1 to the Report on Form 6-K in which this discussion is included. We also recommend that you read “Item 4. Information on the Company” and our audited consolidated financial statements for fiscal year 2019, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2019 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”).

 

Unless otherwise indicated or the context otherwise requires, all references to “Affimed” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to Affimed N.V. and its subsidiaries.

 

We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. Our reporting currency is the Euro. We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussions and analysis are in euros.

 

Overview

 

We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy, or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings.

 

To date, we have financed our operations primarily through our public offerings of our common shares, private placements of equity securities, the incurrence of loans including convertible loans and through government grants and payments for collaborative research and development services. Through June 30, 2020, we have raised an aggregate of approximately €280 million (gross proceeds) through the issuance of equity and incurrence of loans. To date, we have not generated any revenues from product sales or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we or any collaboration partner obtain marketing approval for, and commercialize, any of our product candidates.

 

We have generated losses since we began our drug development operations in 2000. As of June 30, 2020, we had an accumulated deficit of €255.0 million.

 

Notwithstanding our collaboration with Genentech and the income earned for the three and six month periods ended June 30, 2020 and anticipated in the remainder of 2020 upon the achievement of specified milestones, we expect to continue incurring losses as we continue our preclinical and clinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval for our product candidates, build a marketing and sales team to commercialize our product candidates. Our profitability is dependent upon the successful development, approval, and commercialization of our product candidates and achieving a level of revenues adequate to support our cost structure. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional cash. We intend to fund future operations through additional equity and debt financings, and we may seek additional capital through arrangements with strategic partners or from other sources.

 

In 2009, we formed AbCheck, our 100% owned, independently run antibody screening platform company, located in the Czech Republic. AbCheck is devoted to the generation and optimization of fully human antibodies. Its technologies include a naïve human antibody library combined with a phage and yeast display antibody library, a proprietary algorithm to optimize affinity, stability and

 

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manufacturing efficiency and a mass humanization technology to discover and optimize high-quality human antibodies. In addition to providing candidates for Affimed projects, AbCheck is recognized for its expertise in antibody discovery throughout the United States and Europe and has been working with globally active pharmaceutical and biotechnology companies such as Tusk Therapeutics, bluebird bio, Eli Lilly, Daiichi Sankyo, Pierre Fabre and others.

 

We have one U.S. subsidiary, Affimed Inc., with senior employees in finance, investor relations, business development, corporate strategy and clinical operations.

 

Recent Developments

 

The Company announced in early February 2020 that Dr. Florian Fischer, Chief Financial Officer (“CFO”) of Affimed, passed away. In June 2020, the Company announced the appointment of Angus Smith as Affimed’s new permanent CFO, completing Affimed’s leadership team. Mr. Smith started his employment on July 13, 2020 and is based out of Affimed’s New York office. In addition, the Company announced the employment of Dr. Andreas Harstrick as Chief Medical Officer, starting in March 2020, and of Dr. Arndt Schottelius as Chief Scientific Officer, effective April 2020.

 

In May 2020, the Company implemented an at-the-market (“ATM”) program providing for the sales over time of up to $50,000,000 of its common shares. The offering is conducted under the Company’s effective shelf registration statement on Form F-3 pursuant to a prospectus supplement and the entry into a sales agreement with Jefferies LLC. As of June 30, 2020, the Company has issued approximately 8.1 million common shares under the ATM program, generating net proceeds of approximately $23.1 million.

 

As circumstances around the COVID-19 pandemic continue to rapidly evolve, Affimed is continuously assessing possible effects on its clinical trials and adapting the risk mitigation measures it has implemented. Affimed is closely monitoring and adhering to relevant federal and local guidelines on COVID-19 to ensure the safety and health of its global workforce and help limit the spread of COVID-19, while maintaining business continuity. The Company has taken mitigation steps to ensure that drug supply and other trial-related materials are ready and available for the patients enrolled in its clinical trials. The Company continues to evaluate the potential impact of the COVID-19 pandemic on patient enrollment and site activation in its clinical studies. Timelines for clinical studies presented herein and in our press release for the second quarter of 2020 represent the Company’s best estimates as of the date hereof, but remain subject to change pending the resolution of the COVID-19 crisis.

 

At the Annual General Meeting held on August 4, 2020, the shareholders of Affimed approved all agenda items, including the reappointment of Supervisory Directors, Dr. Thomas Hecht and Ferdinand Verdonck and the appointment of new Supervisory Directors, Dr. Annalisa Jenkins and Harry Welten. In addition, the shareholders approved the reappointment of Managing Directors, Dr. Adi Hoess and Dr. Wolfgang Fischer and the appointment of Dr. Arndt Schottelius, Dr. Andreas Harstrick and Angus Smith.

 

Upon the achievement of a clinical milestone in July 2020 under its ongoing strategic collaboration with Genentech, Affimed is eligible to receive a payment in an undisclosed amount.

 

Collaboration and License Agreements

 

There have been no material changes to our license agreements from those reported in “Item 4. Information on the Company—B. Business Overview—Collaborations” in the Annual Report.

 

Research and Development Expense

 

We will use our existing liquidity primarily to fund research and development expense. Our research and development expense is highly dependent on the development phases of our research projects and therefore fluctuates highly from period to period. Our research and development expense mainly relates to the following key programs:

 

·        AFM13. In November 2019, we initiated a registration directed phase 2 study of AFM13 as monotherapy in relapsed or refractory patients suffering from peripheral T cell lymphoma (pTCL). The study protocol has been agreed upon with the U.S. Food and Drug Administration (FDA). The study design follows a 2 stage Simon design with a preplanned interim analysis after 40 patients. At the current recruitment rate the Company expects the readout of the interim analysis to happen in mid-2021. In addition, this study will, as a separate cohort, investigate the initial efficacy of AFM13 as monotherapy in patients suffering from transformed mycosis fungoides (T-MF), though this cohort is on hold pending the resolution of the COVID-19 pandemic. In September 2019, the FDA cleared an investigational new drug application (IND) for an investigator-sponsored Phase 1 study, in which the University of Texas MD Anderson Cancer Center (MDACC) plans to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) into patients with relapsed/refractory CD30-positive lymphoid malignancies. In 2017, an investigator-

 

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sponsored Phase 1b/2a study was initiated by Columbia University to investigate AFM13 as monotherapy in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation. In 2016, we initiated a phase 1b study investigating the combination of AFM13 with Merck’s anti-PD1 antibody Keytruda® (pembrolizumab) in patients with relapsed/refractory HL. In this study, enrollment is complete and final data were recently presented. Different dosing protocols are being explored in the investigator-initiated monotherapeutic phase 2a clinical trial of AFM13 in relapsed/refractory Hodgkin Lymphoma, or relapsed/refractory HL, to allow for improved exposure in more heavily pretreated patient populations. The study has now completed recruitment under the new study design. We anticipate that our research and development expenses in 2020 for AFM13 will increase compared to those for 2019 due to the initiation of new clinical studies, pre-clinical studies with collaboration partners and the preparation of the production of AFM13 for commercial purposes.

 

·        AFM11. In line with the strategic focus on our innate cell engager portfolio, we have made the decision to terminate the Phase 1 clinical program of AFM11. This decision took into consideration the competitive landscape of B-cell directed therapies currently in development and associated resources needed for further development of AFM11. We subsequently informed the FDA of our intention to terminate the clinical program.

 

·        AFM24. AFM24, a tetravalent, bispecific epidermal growth factor receptor, and CD16A-binding innate cell engager, is in effect for a phase 1/2a clinical trial in patients with advanced cancers known to express EGFR. We anticipate that our research and development expenses in the remainder of 2020 for AFM24 will increase compared to those for 2019 due to the beginning of the clinical trial of AFM24 in patients.

 

·        Other projects and infrastructure costs. Our other research and development expenses relate to our Genentech collaboration, Affimed owned preclinical programs (AFM28 and AFM32) and early stage development/discovery activities. We have allocated a material amount of our resources to such discovery activities. The expenses mainly consist of salaries, manufacturing costs for pre-clinical study material and pre-clinical studies. In addition, we incur a significant amount of costs associated with our research and development that are non-project specific, including intellectual property-related expenses, depreciation expenses and facility costs. Because these are less dependent on individual ongoing programs, they are not allocated to specific projects. We assume that other projects and infrastructure costs will increase in the remainder of 2020 due to increased early stage development/discovery activities.

 

Results of Operations

 

The financial information shown below was derived from our unaudited interim condensed consolidated financial statements for the three and six month periods ended June 30, 20120 and 2019. The discussion below should be read along with these financial statements, and it is qualified in its entirety by reference to them.

 

Comparison of the three months ended June 30, 2020 and 2019

 

 

 

Three months
ended June 30,

 

 

 

2020

 

2019

 

 

 

(unaudited)

 

 

 

(in €thousand)

 

 

 

 

 

Total Revenue:

 

2,934

 

4,008

 

Other income (expenses)—net

 

85

 

197

 

Research and development expenses

 

(11,697)

 

(11,545)

 

General and administrative expenses

 

(2,606)

 

(2,342)

 

Operating loss

 

(11,284)

 

(9,682)

 

Finance income/(costs)—net

 

(954)

 

(654)

 

Loss before tax

 

(12,238)

 

(10,336)

 

Income taxes

 

(0)

 

(4)

 

Loss for the period

 

(12,238)

 

(10,340)

 

Other comprehensive income

 

(71)

 

(49)

 

Total comprehensive loss

 

(12,309)

 

(10,389)

 

Loss per common share in € per share (undiluted)

 

(0.16)

 

(0.17)

 

Loss per common share in € per share (diluted)

 

(0.16)

 

(0.17)

 

 

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Revenue

 

Revenue decreased to €2.9 million in the three months ended June 30, 2020 from €4.0 million for the three months ended June 30, 2019. Revenue in the three months ended June 30, 2020 predominantly relates to the Genentech collaboration (€2.7 million, 2019: €3.7 million). Revenue from the Genentech collaboration in the three months ended June 30, 2020 was recognized for collaborative research services performed during the quarter.

 

Research and development expenses

 

 

 

Three months ended
June 30,

 

 

 

R&D Expenses by Project

 

2020

 

2019

 

Change %

 

 

 

(unaudited)

 

 

 

 

 

(in € thousand)

 

 

 

 

 

 

 

 

 

 

 

Project

 

 

 

 

 

 

 

AFM13

 

5,903

 

3,965

 

49%

 

AFM11

 

(99)

 

1,637

 

-

 

AFM24

 

1,005

 

1,034

 

(3%)

 

Other projects and infrastructure costs

 

4,488

 

4,678

 

(4%)

 

Share-based payment expense

 

400

 

231

 

73%

 

Total

 

11,697

 

11,545

 

1%

 

 

Research and development expenses amounted to €11.7 million in the three months ended June 30, 2020 compared to research and development expenses of €11.5 million in the three months ended June 30, 2019. The variances in project-related expenses between the three months ended June 30, 2020 and the corresponding period in 2019 are mainly due to the following projects:

 

·                  AFM13. In the three months ended June 30, 2020, we incurred higher expenses (49%) than in the three months ended June 30, 2019 primarily due to higher expenses for the preparation of new clinical trials and manufacturing activities for clinical trial material.

 

·                  AFM11. In the three months ended June 30, 2020, we recognized refunds from service providers following the termination of clinical trials. Expenses in the three months ended June 30, 2019 primarily consist of accrued costs for the termination of the phase 1 clinical program of AFM11.

 

·                  AFM24. In the three months ended June 30, 2020, expenses were nearly unchanged and related to the initiation of the phase 1/2a clinical trial and manufacturing activities for the clinical trial material.

 

·                  Other projects and infrastructure costs. In the three months ended June 30, 2020, expenses were slightly lower (4%) than in the three months ended June 30, 2019. Expenses related to our discovery/early stage development activities and infrastructure costs.

 

General and administrative expenses

 

General and administrative expenses were higher and amounted to €2.6 million in the three months ended June 30, 2020 compared to €2.3 million in the three months ended June 30, 2019.

 

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Finance income / (costs)-net

 

Finance costs for the three months ended June 30, 2020 totaled €1.0 million, compared to €0.7 million for the three months ended June 30, 2019. Finance costs in the three months ended June 30, 2020 and 2019 primarily include foreign exchange losses.

 

Comparison of the six months ended June 30, 2020 and 2019

 

 

 

Six months
ended June 30,

 

 

 

2020

 

2019

 

 

 

(unaudited)

 

 

 

(in € thousand)

 

 

 

 

 

 

 

Total Revenue:

 

8,069

 

15,361

 

Other income/(expenses)—net

 

28

 

283

 

Research and development expenses

 

(23,146)

 

(19,532)

 

General and administrative expenses

 

(6,131)

 

(4,776)

 

Operating loss

 

(21,180)

 

(8,664)

 

Finance income/(costs)—net

 

653

 

180

 

Loss before tax

 

(20,527)

 

(8,484)

 

Income taxes

 

0

 

(4)

 

Loss for the period

 

(20,527)

 

(8,488)

 

Other comprehensive income

 

10

 

24

 

Total comprehensive loss

 

(20,517)

 

(8,464)

 

Loss per common share in € per share (undiluted)

 

(0.26)

 

(0.14)

 

Loss per common share in € per share (diluted)

 

(0.26)

 

(0.14)

 

 

Revenue

 

Revenue decreased from €15.4 million in the six months ended June 30, 2019 to €8.1 million for the six months ended June 30, 2020. Revenue in the six months ended June 30, 2020 predominantly relate to the Genentech collaboration (€7.6 million, 2019: €14.3 million). Revenue from the Genentech collaboration in the six months ended June 30, 2020 was recognized for collaborative research services performed during the first half of the year, while revenue in the in the six months ended June 30, 2019 was recognized for collaborative research services and the achievement of a preclinical milestone.

 

Research and development expenses

 

 

 

Six months ended
June 30,

 

 

 

R&D Expenses by Project

 

2020

 

2019

 

Change %

 

 

 

(unaudited)

 

 

 

 

 

(in € thousand)

 

 

 

 

 

 

 

 

 

 

 

Project

 

 

 

 

 

 

 

AFM13

 

11,186

 

6,608

 

69%

 

AFM11

 

(77)

 

1,995

 

-

 

AFM24

 

2,514

 

2,086

 

21%

 

Other projects and infrastructure costs

 

8,806

 

8,343

 

6%

 

Share-based payment expense

 

717

 

500

 

43%

 

Total

 

23,146

 

19,532

 

19%

 

 

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Research and development expenses increased from €19.5 million in the six months ended June 30, 2019 to €23.1 million in the six months ended June 30, 2020. The variances in project-related expenses between the six months ended June 30, 2020 and the corresponding period in 2019 are mainly due to the following projects:

 

·                  AFM13. In the six months ended June, 2020, we incurred significantly higher expenses (69%) than in the six months ended June 30, 2019 primarily due to higher expenses for the preparation of new clinical trials and manufacturing activities for clinical trial material.

 

·                  AFM11.  In the six months ended June 30, 2020, we recognized refunds from service providers following the termination of clinical trials. The majority of the expenses in the six months ended June 30, 2019 are related to costs for the termination of the phase 1 clinical program of AFM11.

 

·                  AFM24. In the six months ended June 30, 2020, we incurred higher expenses due to the initiation of the phase 1/2a clinical trial and manufacturing activities for the clinical trial material.

 

·                  Other projects and infrastructure costs.  In the six months ended June 30, 2020, expenses were slightly higher compared to the previous year and related to our earlier stage programs and discovery/early stage development activities and infrastructure costs.

 

General and administrative expenses

 

General and administrative expenses for the six months ended June 30, 2020 were €6.1 million, compared with €4.8 million for the six months ended June 30, 2019. The increase is mainly due to higher personnel expenses, higher compliance costs with the Sarbanes-Oxley Act of 2002, and legal, consulting and audit costs.

 

Finance income / (costs)-net

 

Finance income for the six months ended June 30, 2020 was €0.7 million, compared with finance income of €0.2 million for the six months ended June 30, 2019. Finance income in the six months ended June 30, 2020 is primarily related to foreign exchange gains.

 

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Liquidity and Capital Resources

 

Since inception, we have incurred significant operating losses. To date, we have not generated any product sale revenue. We have financed our operations primarily through our public offerings of our common shares, private placements of equity securities and loans, grants and payments from collaboration partners.

 

Cash flows

 

The table below summarizes our consolidated statement of cash flows for the six months ended June 30, 2020 and 2019:

 

 

 

 

Six months ended
June 30,

 

 

 

2020

 

2019

 

 

 

(unaudited)

 

 

 

(in € thousand)

 

 

 

 

 

 

 

Net cash used in operating activities

 

(31,538)

 

(18,941)

 

Net cash used in investing activities

 

811

 

(10,411)

 

Net cash provided by financing activities

 

19,646

 

(1,280)

 

Exchange rate related changes of cash and cash equivalents

 

431

 

(210)

 

Net changes to cash and cash equivalents

 

(11,081)

 

(30,632)

 

Cash and cash equivalents at the beginning of the period

 

95,234

 

94,829

 

Cash and cash equivalents at the end of the period

 

84,584

 

63,987

 

 

Net cash used in operating activities of €31.5 million in the six months ended June 30, 2020 is higher than net cash used in operating activities in the six months ended June 30, 2019 (€18.9 million) primarily due to higher operating expenses and lower cash inflows from revenues. The investing activities in the six months ended June 30, 2020 and 2019 primarily relate to investments in and proceeds from the sale or maturity of financial assets. Net cash provided by financing activities in the six months ended June 30, 2020 relate primarily to the issuance of shares in connection with our at-the-market sales agreement. Net cash used in financing activities in the six months ended June 30, 2019 relate primarily to the repayment of borrowings.

 

Cash and Funding Sources

 

Our cash and cash equivalents and financial assets as of June 30, 2020 were €92.6 million, compared with €104.1 million as of December 31, 2019. Funding sources generally comprise proceeds from the issuance of equity instruments, payments from collaboration agreements, loans and government grants.

 

Funding Requirements

 

We expect that we will require additional funding to complete the development of our product candidates and to continue to advance the development of our other product candidates. If we receive regulatory approval for AFM13, AFM24 or other earlier programs, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also continue to incur substantial costs associated with operating as a public company. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

 

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Based on our current operating and budget assumptions, we believe that our existing liquidity, will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2022. We have based this estimate on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:

 

·                  the scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and other related activities;

 

·                  the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop;

 

·                  the number and characteristics of product candidates that we pursue;

 

·                  the cost, timing, and outcomes of regulatory approvals;

 

·                  the cost and timing of establishing sales, marketing, and distribution capabilities; and

 

·                  the terms and timing of any collaboration, licensing, and other arrangements that we may establish, including any required milestone and royalty payments thereunder.

 

To address our financing needs, we may raise additional capital through the sale of equity or convertible debt securities. In such an event, the ownership interest of our shareholders will be diluted, and the terms of any such securities may include liquidation or other preferences that adversely affect the rights of holders of our common shares.

 

For more information as to the risks associated with our future funding needs, see “Risk Factors” in the Annual Report.

 

Contractual Obligations and Commitments

 

As of the date of this discussion and analysis there are no material changes to our contractual obligations from those reported in “Item 5. Operating and Financial Review and Prospects—F. Tabular disclosure of contractual obligations” in the Annual Report.

 

Off-balance Sheet Arrangements

 

As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements other than operating leases as described under “Item 5. Operating and Financial Review and Prospects—F. Tabular disclosure of contractual obligations” in the Annual Report.

 

Quantitative and Qualitative Disclosures About Market Risk

 

During the six months ended June 30, 2020 there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “Item 11. Quantitative and Qualitative Disclosures About Risk” in the Annual Report.

 

Critical Judgments and Accounting Estimates

 

There have been no material changes to the significant accounting policies and estimates described in “Item 5. Operating and Financial Review and Prospects—A. Operating Results Overview—Critical Judgments and Accounting Estimates” in the Annual Report.

 

Recent Accounting Pronouncements

 

We refer to note 2 of the notes to the unaudited interim condensed consolidated financial statements for the three and six month periods ended June 30, 2020 and 2019 with regard to the impact of recent accounting pronouncements.

 

Cautionary Statement Regarding Forward Looking Statements

 

Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,”

 

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“estimate” and “potential,” among others. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in the Annual Report. These risks and uncertainties include factors relating to:

 

·                  our operation as a development stage company with a history of operating losses; as of June 30, 2020, our accumulated deficit was €255.0 million;

 

·                  the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials;

 

·                  our reliance on contract manufacturers and contract research organizations over which we have limited control;

 

·                  our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates;

 

·                  our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not exploitable;

 

·                  uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized;

 

·                  the outcome of any, or any discussions we may enter regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings;

 

·                  the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage;

 

·                  if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview;

 

·                  enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization;

 

·              future legislation may materially impact our ability to realize revenue from any approved and commercialized products;

 

·              the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues;

 

·              our reliance on our current strategic relationships with LLS, Merck, The MD Anderson Cancer Center, Genentech, Amphivena and the potential failure to enter into new strategic relationships;

 

·              our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates;

 

·              our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization;

 

·              our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel;

 

·              the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; and

 

·                  other risk factors discussed under “Item 3. Key Information—D. Risk Factors” in the Annual Report.

 

Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations, cash flows or financial condition.

 

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Additionally, some of the risks and uncertainties identified above may be amplified by the recent COVID-19 outbreak. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

 

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