PHARVARIS N.V. | ||||||
Date: September 12, 2022 |
By: |
/s/ Berndt Modig | ||||
Name: |
Berndt Modig | |||||
Title: |
Chief Executive Officer |
Exhibit No. |
Description | |
99.1 |
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99.2 |
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99.3 |
Exhibit 99.1
Pharvaris Reports Second Quarter 2022 Financial Results and Provides Business Update
| Formal letters received from FDA relating to the previously announced hold on clinical studies of PHA121 in the U.S. |
| Top-line data anticipated in 4Q22 for RAPIDe-1, a global Phase 2 study of PHVS416 for the acute treatment of HAE attacks ongoing outside the U.S. |
| Executing from a strong financial position with cash and cash equivalents of 201 million as of June 30, 2022 |
Zug, Switzerland, September 12, 2022 Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today reported financial results for the second quarter ended June 30, 2022, and provided a business update.
Pharvaris is dedicated to bringing therapeutic alternatives to people living with HAE and we maintain our belief in the potential of PHA121. Our team is committed to working with the FDA to resolve the hold on clinical trials involving PHA121 in the U.S. and we deeply appreciate the patience of the HAE community during this time, said Berndt Modig, Chief Executive Officer of Pharvaris. Having evaluated the impact of the clinical hold, we anticipate announcing top-line Phase 2 data for RAPIDe-1 in the fourth quarter of this year. As we work to address the FDAs concerns and continue interactions with other regulatory authorities, we maintain a disciplined operational approach with our strong cash position expected to provide runway through the first quarter of 2024.
Recent Business Updates
| Pharvaris announced that it has received formal clinical hold letters from the U.S. Food and Drug Administration (FDA). This follows the previously announced verbal notification of a hold on the clinical trials of PHA121 in the U.S. under Investigational New Drug (IND) applications for the on-demand and prophylactic treatment of HAE attacks. The FDA requested that Pharvaris conduct an additional long-term rodent toxicology study and update the Investigators Brochure. The letters stated that the nonclinical observations are unlikely due to B2 receptor antagonism. Pharvaris plans to request a Type A meeting to discuss on-demand and prophylactic proposals to address the clinical holds. |
| RAPIDe-1, a global Phase 2 study of PHVS416 for the on-demand treatment of HAE, continues evaluating enrolled patients outside the U.S. with top-line data anticipated in 4Q22. The previously announced target enrollment of 72 people with HAE across 33 sites in Canada, Europe, Israel, the UK, and the U.S. was achieved. Subsequent to the clinical hold, the company continues to evaluate PHVS416 for HAE attacks in patients enrolled outside the U.S. The goal of RAPIDe-1 is to assess PHVS416 as an oral acute treatment of HAE attacks by comparing safety and symptom relief (skin pain, skin swelling, and abdominal pain) during HAE attacks across three doses and placebo. The primary endpoint of RAPIDe-1 is the change of the composite of the three measured symptoms (skin pain, skin swelling and abdominal pain) using a visual analogue scale (VAS-3) four hours after treatment. One of the measured symptoms must have a VAS score of 30 before treatment to be considered a qualified HAE attack. Other key secondary endpoints include the time to onset of symptom relief, as well as safety and tolerability. Given the current dataset of evaluable attacks, Pharvaris anticipates announcing top-line data in the fourth quarter of 2022. |
| Working with country-specific regulatory authorities regarding ongoing CHAPTER-1 Phase 2 study of PHVS416 for the prophylactic treatment of HAE attacks. Pharvaris has notified country-specific regulatory authorities in Canada, Europe, Israel, and the UK of the clinical hold in the U.S. When the company has more clarity regarding the impact of the U.S. clinical hold and additional feedback from global regulatory authorities, Pharvaris will provide guidance on the timing of announcing top-line data for the CHAPTER-1 trial. The study is designed to enroll 30 patients globally in CHAPTER-1 with a goal of evaluating proof of concept of PHVS416 for oral prophylaxis against HAE attacks. The safety and efficacy of two doses and placebo will be evaluated by comparing the number of investigator-confirmed attacks during participants 12-week treatment period. Data from this study is expected to inform design of an anticipated Phase 3 study utilizing PHVS719, an extended-release formulation of PHA121. |
| Strengthened executive team. With the appointment of Joan Schmidt, J.D., as Chief Legal Officer, effective June 2022, the company further strengthened its capabilities in legal, compliance, and governance. |
| Held Annual Meeting of Shareholders and appointed Elisabeth Björk, M.D., and Anne Marie de Jonge Schuermans, Ph.D., to the Board of Directors. On June 29, 2022, the company held an Annual Meeting of Shareholders at which all proposals were approved. Dr. Björk and Dr. de Jonge Schuermans were appointed as Non-Executive Directors. |
Upcoming Events
| Pharvaris will attend the upcoming Morgan Stanley 20th Annual Global Healthcare Conference, which is being held in New York from September 12-14, 2022. Mr. Modig and Morgan Conn, Ph.D., Chief Business Officer, will participate in a fireside chat on Monday, September 12, at 4:15 p.m. ET. A live audio webcast will be available on the Investors section of the Pharvaris website at https://ir.pharvaris.com/news-events/events-presentations. A replay will be available on Pharvaris website for 30 days following the fireside chat. |
Second Quarter 2022 Financial Results
| Liquidity Position. Cash and cash equivalents were 201 million as of June 30, 2022, compared to 209 million as of December 31, 2021. The net cash position reflects increased operating expenses, offset by favorable foreign exchange effects. |
| Research and Development (R&D) Expenses. R&D expenses were 13.7 million for the quarter ended June 30, 2022, compared to 8.1 million for the quarter ended June 30, 2021. |
| General and Administrative (G&A) Expenses. G&A expenses were 7.7 million for the quarter ended June 30, 2022, compared to 4.7 million for the quarter ended June 30, 2021. |
| Loss for the period. Loss for the quarter ended June 30, 2022 was 12.6 million, or basic and diluted loss per share of 0.38, compared to 15.2 million, or basic and diluted loss per share of 0.46, for the quarter ended June 30, 2021. |
Note on International Financial Reporting Standards (IFRS)
Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency.
About PHVS416
PHVS416 is an investigational softgel capsule formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris aims to develop this formulation to provide fast and reliable symptom relief, through rapid exposure of attack-mitigating therapy in a convenient, small oral dosage form. In healthy volunteers, a single dose of PHVS416 showed rapid exposure exceeding predicted therapeutically efficacious levels within 15 minutes. PHVS416 is currently in Phase 2 clinical development for the on-demand treatment of HAE.
About PHA121
PHA121 (PHA-022121) is a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor that has completed Phase 1 clinical development. PHA121 utilizes the same mechanism as icatibant, the leading therapy for on-demand treatment of HAE. Pharvaris is developing this novel small molecule for on-demand and prophylactic treatment of HAE and other bradykinin-mediated diseases through formulations optimized for each setting. Data from single- and multiple-ascending-dose Phase 1 studies in healthy volunteers demonstrate rapid exposure and linear pharmacokinetics at doses up to 50 mg. In a bradykinin-challenge study in healthy volunteers, PHA121 showed significant inhibition of bradykinin-induced hemodynamic changes with an average composite EC50 of 2.4 ng/mL and EC85 of 13.8 ng/mL, approximately four-fold more potent than historical data for icatibant. Quantitative modeling indicates that single oral doses of PHA121 will maintain pharmacological effectiveness for a substantially longer time than 30 mg of subcutaneous icatibant. In clinical studies, PHA121 has been observed to be well-tolerated at all doses studied to date.
About Pharvaris
Pharvaris is a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent HAE attacks, building on its deep-seated roots in HAE. By directly targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all sub-types of HAE effective and convenient alternatives to treat attacks, both on-demand and prophylactically. The company brings together the best talent in the industry with deep expertise in rare diseases and HAE. For more information, visit https://pharvaris.com/.
Forward-Looking Statements
This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements containing the words believe, anticipate, expect, estimate, may, could, should, would, will, intend and similar expressions. These forward-looking statements are based on managements current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other
important factors that may cause Pharvaris actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA with respect to the clinical hold on PHA121 clinical trials in the U.S.; the expected timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in mid-stage global clinical trials and are currently on hold in the U.S. as a result of the clinical hold; risks associated with the COVID-19 pandemic, which may adversely impact our business, nonclinical studies, and clinical trials; the timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates PHVS416 and PHVS719, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws, our ability to successfully remediate the material weakness in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; changes in general market, political and economic conditions, including as a result of the current conflict between Russia and Ukraine; and the other factors described under the headings Cautionary Statement Regarding Forward-Looking Statements and Item 3. Key InformationD. Risk Factors in our Annual Report on Form 20-F and other periodic filings with the Securities and Exchange Commission.
These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris views as of any date subsequent to the date of this press release.
Contacts
Pharvaris
Maryann Cimino
Director of Corporate Relations
+1-617-710-7305
maryann.cimino@pharvaris.com
Exhibit 99.2
Managements Discussion and Analysis of Financial Condition and Results of Operations
This managements 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 discussion together with our unaudited condensed consolidated interim financial statements, including the notes thereto, for the three and six months ended June 30, 2022 and 2021 included as Exhibit 99.3 to the Report on Form 6-K to which this discussion is attached as Exhibit 99.2. We also recommend that you read Item 4. Information on the Company, Item 5. Operating and Financial Review and Prospects and our audited consolidated financial statements for fiscal year 2021, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2021 (the Annual Report) filed with the U.S. Securities and Exchange Commission (the SEC). In addition, we recommend that you read any public announcements made from time to time by Pharvaris N.V.
The following discussion is based on our financial information prepared in accordance with the International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (the IASB), which may differ in material respects from generally accepted accounting principles in the United States and other jurisdictions. We maintain our books and records in euros. Unless otherwise indicated, all references to currency amounts in this discussion are in euros.
The following discussion includes forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described under Item 3. Key InformationD Risk factors in the Annual Report.
Unless otherwise indicated or the context otherwise requires, all references to Pharvaris or the Company, we, our, ours, us, or similar terms refer to Pharvaris N.V. and its subsidiaries.
Overview
We are a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for rare diseases with significant unmet need, initially focused on angioedema and other bradykinin-mediated diseases. Our first molecule, PHA121, is a novel, small-molecule bradykinin B2-receptor antagonist for the treatment of hereditary angioedema, or HAE. Bradykinin-B2-receptor inhibition is a clinically validated mechanism for the treatment of HAE, as demonstrated by icatibant, which is a bradykinin B2-receptor antagonist approved in Europe in 2008 and in the United States in 2011 (as FIRAZYR®). We designed PHA121 to improve upon the therapeutic profile of existing therapies and, through oral delivery, to provide patients with quality of life and convenience that is superior to current standard-of-care HAE treatments, which are injectables. We believe PHA121 has the potential to provide a safe, effective and convenient option for both acute and prophylactic treatments of HAE, in the form of our PHVS416 on-demand rapid exposure product candidate, and for prophylaxis of HAE, in the form of our PHVS719 small daily dose extended-release product candidate. We believe that our product candidates may address a broader range of angioedema attacks than other available treatments since PHA121 blocks the actual signal that leads to angioedema (the interaction of bradykinin, or BK, with the bradykinin B2 receptor), rather than an upstream signal. By blocking the action of bradykinin, we can prevent its aberrant signaling regardless of the pathway that generates it.
In our completed Phase 1 trials to-date, we have observed that PHA121 was orally bioavailable and well tolerated at all doses studied, with approximately dose-proportional exposure. We also have demonstrated proof-of-mechanism through a clinical pharmacodynamics, or PD, assessment with the bradykinin challenge, which had been utilized as a validated surrogate assessment for dose selection in the icatibant development program. The data also allowed us to compare the projected therapeutic performance of PHA121 in comparison with that of icatibant, but we do not yet have data from a PHA121 Phase 2 study. We plan to progress PHA121 through clinical development for on-demand and prophylactic use with our on-demand product candidate, PHVS416, and extended-release product candidate, PHVS719, respectively.
We commenced our RAPIDe-1 Phase 2 clinical trial of PHVS416 in February 2021. We also commenced CHAPTER-1, a Phase 2 clinical trial for prophylaxis in 2021 using twice-daily dosing of the PHVS416 softgel capsules. Our primary objective with CHAPTER-1 is to assess the safety profile of PHVS416 dose regimens for prophylactic treatments in HAE patients. Please see Recent Announcements for an update regarding these clinical trials. We also initiated a Phase 1 clinical trial with PHVS719 in 2021 to assess pharmacokinetics of the extended-release formulation and reported results in the first quarter of 2022. In healthy volunteers, a single dose of PHVS719 was well tolerated with an extended-release profile supporting once-daily dosing.
A wide variety of events beyond our control, including natural or man-made disasters, power shortages, fires, extreme weather conditions, pandemics, epidemics or outbreaks of infectious diseases, political instability or other events could disrupt our business or operations or those of our development partners, manufacturers, regulators or other third parties with whom we conduct business now or in the future. These events may cause businesses and government agencies to be shut down, supply chains to be interrupted, slowed, or rendered inoperable, and individuals to become ill, quarantined, or otherwise unable to work and/or travel due to health reasons or governmental restrictions.
In response to the COVID-19 outbreak, the governments of many countries, states, cities and other geographic regions have taken preventative or protective actions, such as imposing restrictions on travel and business operations and advising or requiring individuals to limit or forego their time outside of their homes. We have also taken steps to identify and mitigate the adverse effects and risks to the Company as a result of the pandemic. We have modified our business practices, including implementing work from home arrangements for employees able to perform their duties remotely and practicing safe social distancing in our operations. We expect to continue to take actions as may be required or recommended by government authorities or in the best interests of our employees and business partners. While the impact of COVID-19 on the Companys operations and financial performance has so far been limited, the extent to which COVID-19 may impact our financial condition or results of operations in the future is uncertain. For instance, the ongoing spread of variants of the COVID-19 virus may continue to interrupt, or delay, our clinical trial activities, regulatory reviews, manufacturing activities and supply chain. The extent to which the COVID-19 pandemic impacts our business will depend on future developments, which are uncertain and cannot be predicted, including new information which may emerge concerning the severity of the COVID-19 pandemic and the actions to contain COVID-19 or treat its impact, including among other things, the effectiveness and outreach of COVID-19 vaccines.
In addition, the invasion of Ukraine and the retaliatory measures that have been taken, or could be taken in the future, by the United States, NATO, and other countries have created global security concerns that could result in a regional conflict and also adversely affect our ability to conduct ongoing and future clinical trials of our product candidates. For example, our RAPIDe-1 study includes a significant number of patients in Germany, Poland, and Bulgaria. A further escalation of the conflict in Ukraine may potentially impact our ability to complete our ongoing and planned clinical trials in these countries on a timely basis, or at all. Clinical trials in these countries could be suspended or terminated, and we may be prevented from obtaining data on patients already enrolled at affected sites. Any of the foregoing could impede the execution of our clinical development plans.
Recent Announcements
On May 11, 2022, we announced the appointment of Joan Schmidt, J.D., to the newly created position of Chief Legal Officer, effective June 1, 2022.
On August 22, 2022, we announced that the U.S. Food and Drug Administration (the FDA) had verbally informed us that, based on its review of nonclinical data, it is placing a clinical hold on the clinical trials of PHA121 in the United States (the clinical hold). The FDA indicated it will provide a formal clinical hold letter to Pharvaris within approximately 30 days following the verbal notice.
On September 12, 2022, we announced that we have received formal clinical hold letters from the FDA. The FDA requested that we conduct an additional long-term rodent toxicology study and update the Investigators Brochure. The letters stated that the nonclinical observations are unlikely due to B2 receptor antagonism, the primary mechanism of action of our compound. We plan to request a Type A meeting with the FDA to discuss on-demand and prophylactic proposals to address the clinical holds. In the RAPIDe-1 study, subsequent to the clinical hold in the U.S., we continue to evaluate PHVS416 for HAE attacks in patients enrolled outside the U.S. Given the current dataset of evaluable attacks, we anticipate announcing top-line data for the RAPIDe-1 study in the fourth quarter of 2022. We are working with country-specific regulatory authorities regarding the ongoing CHAPTER-1 Phase 2 study of PHVS416 for the prophylactic treatment of HAE attacks. We have notified country-specific regulatory authorities in Canada, Europe, Israel, and the UK of the U.S. clinical hold. When we have more clarity regarding the impact of the U.S. clinical hold and additional feedback from global regulatory authorities, we will provide guidance on the timing of announcing top-line data for the CHAPTER-1 trial.
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Financial Operations Overview
Revenues
We did not record any revenues during the period covered by the historical financial information included in this Report. We do not expect to recognize any revenues before we are able to commercialize our first product.
Research and development expenses
We are focused on the clinical development of PHA121. Since our inception, we have devoted substantially all our resources to research and development efforts relating to the development of PHA121 and our product candidates PHVS416 and PHVS719. We expect that we will continue to incur significant research and development expenses as we seek to complete the clinical development of, and achieve regulatory approval for, our product candidates PHVS416 and PHVS719, and in connection with discovery and development of any additional product candidates.
Research and development expenses consist of the following:
| employee benefits expenses, which includes salaries, pensions, share-based compensation expenses, bonus plans and other related costs for research and development staff; |
| nonclinical expenses, which include costs of our outsourced discovery and nonclinical development studies; |
| clinical expenses, which includes costs of conducting and managing our sponsored clinical trials, including clinical investigator cost, costs of clinical sites, and costs for CROs assisting with our clinical development programs; |
| manufacturing expenses, which include costs related to manufacturing of active pharmaceutical ingredients and manufacturing of the products used in our clinical trials and research and development activities; |
| costs related to regulatory activities, including collecting data, preparing and submitting filings, communicating with regulatory authorities and reviewing the design and conduct of clinical trials for compliance with applicable requirements; |
| costs in connection with investigator-sponsored clinical trials and evaluations; |
| advisers fees, including discovery, nonclinical, clinical, chemistry, manufacturing, and controls- related and other consulting services; |
| intellectual property costs, which includes costs associated with obtaining and maintaining patents and other intellectual property; and |
| license costs. |
We anticipate that our total research and development expenses will continue to increase as we continue to progress PHVS416 and PHVS719 through clinical development.
There is a risk that any clinical development or product discovery program may not result in commercial approval. To the extent that we fail to obtain approval to commercialize our product candidate in a timely manner, we would need to continue to conduct nonclinical studies or clinical trials over a longer period of time, and we anticipate that our research and development expenses may further increase.
Clinical development timelines and associated costs may vary significantly and the successful development of our product candidate is highly uncertain. At this time, we cannot reasonably estimate the nature, timing and estimated costs of the efforts, including patient recruitment and selection that will be necessary to complete the development of, or the period, if any, in which material net cash inflows may commence from, our product candidates.
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Moreover, we cannot assure that we will be able to successfully develop or commercialize our product candidates, if approved for marketing. This is due to numerous risks and uncertainties associated with developing drugs. See Item 3. Key InformationD. Risk factors in our Annual Report for a discussion of these risks and uncertainties.
Selling and distribution expenses
Historically, we have not incurred any selling and distribution expenses. If our product candidates are approved for registration and marketing, we anticipate incurring substantial selling and distribution expenses in future periods in order to establish an infrastructure for marketing and distribution, obtain supplies of active pharmaceutical ingredients, and manufacture commercial quantities of our product candidate.
General and administrative expenses
We anticipate that we will continue to incur significant general and administrative expenses as we advance our research and development portfolio. General and administrative expenses consist of the following:
| employee benefits, including salaries, pensions, share-based compensation expenses, bonus plans and other related costs for staff and independent contractors in executive and operational functions; |
| independent auditors and advisers fees, including accounting, tax, legal, and other consulting services; |
| rental expenses, facilities and IT expenses, and other general expenses relating to our operations; and |
| expenses related to the build-out of our commercial organization, including assessments of the HAE market landscape, pricing research, and congress attendance. |
We anticipate that the continuing development of our business and the expense of maintaining directors and officers liability insurance, will contribute to future increase in general and administrative expenses. We also expect that general and administrative expenses will increase in the future as we incur additional costs associated with being a public company in the United States.
Share-based compensation expenses
In 2016, we implemented an Equity Incentive Plan, or the Plan, in order to advance the interests of our shareholders by enhancing our ability to attract, retain and motivate persons who are expected to make important contributions to us and by providing such persons with performance-based incentives that are intended to better align the interests of such persons with those of our shareholders. In order to incentivize our directors and employees, our Board adopted the Pharvaris N.V. 2021 Equity Incentive Plan (the 2021 Plan) for employees, consultants and directors prior to the completion of our initial public offering (IPO). The 2021 Plan became effective upon our conversion from Pharvaris B.V. into Pharvaris N.V., which occurred prior to the consummation of our IPO. The 2021 Plan provides for the grant of options, stock appreciation rights, restricted stock, RSUs, performance stock awards, other stock-based awards, performance cash awards and substitute awards. The fair values of these instruments are recognized as personnel expenses in either research and development expenses or general and administrative expenses.
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Result of operations
The financial information shown below was derived from our unaudited condensed consolidated interim financial statements for the three and six months ended June 30, 2022 and 2021 included as Exhibit 99.3 to this Report on Form 6-K. The discussion below should be read along with these condensed consolidated interim financial statements, and it is qualified in its entirety by reference to them.
Comparison of the three months ended June 30, 2022 and 2021
For the three months ended June 30 |
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2022 | 2021 | Change | % | |||||||||||||
(in ) | ||||||||||||||||
Research and development expenses |
(13,721,637 | ) | (8,060,599 | ) | (5,661,038 | ) | 70 | % | ||||||||
General and administrative expenses |
(7,660,133 | ) | (4,664,726 | ) | (2,995,407 | ) | 64 | % | ||||||||
Total operating expenses |
(21,381,770 | ) | (12,725,325 | ) | (8,656,445 | ) | 68 | % | ||||||||
Operating loss |
(21,381,770 | ) | (12,725,325 | ) | (8,656,445 | ) | 68 | % | ||||||||
Finance income/(expense) |
11,501,804 | (2,474,483 | ) | 13,976,287 | (565 | )% | ||||||||||
Loss before tax |
(9,879,966 | ) | (15,199,808 | ) | 5,319,842 | (35 | )% | |||||||||
Income taxes |
(2,741,102 | ) | (2,965 | ) | (2,738,137 | ) | 92349 | % | ||||||||
Loss for the period |
(12,621,068 | ) | (15,202,773 | ) | 2,581,705 | (17 | )% |
Revenues
We did not generate any revenues for the three months ended June 30, 2022 and June 30, 2021.
Research and development expenses
For the three months ended June 30 |
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2022 | 2021 | Change | % | |||||||||||||
(in ) | ||||||||||||||||
Personnel expenses |
(3,061,036 | ) | (1,759,669 | ) | (1,301,367 | ) | 74 | % | ||||||||
Clinical expenses |
(7,175,545 | ) | (3,496,223 | ) | (3,679,322 | ) | 105 | % | ||||||||
Nonclinical expenses |
(1,016,793 | ) | (1,181,660 | ) | 164,867 | (14 | )% | |||||||||
Manufacturing costs |
(2,419,143 | ) | (1,601,980 | ) | (817,163 | ) | 51 | % | ||||||||
Intellectual Property costs |
(49,120 | ) | (21,067 | ) | (28,053 | ) | 133 | % | ||||||||
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Total research and development expenses |
(13,721,637 | ) | (8,060,599 | ) | (5,661,038 | ) | 70 | % | ||||||||
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Research and development expenses increased from 8,060,599 for the three months ended June 30, 2021 to 13,721,637 for the three months ended June 30, 2022. The increase in the research and development expenses is mainly driven by the progress made in the PHVS416 and PHVS719 development programs in the three months ended June 30, 2022. Clinical expenses increased by 3,679,322 for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 due to the progress on and expansion of the on-demand and prophylactic programs. Nonclinical expenses decreased by 164,867 for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 due to completion of certain nonclinical studies supporting the PHVS416 and PHVS719 clinical trial programs. Manufacturing costs relating to the API and pharmaceutical development of PHVS416 and PHVS719 increased by 817,163 for the three months ended June 30, 2022 compared to the three months ended June 30, 2021 due to supply costs associated with both clinical programs, the post-Phase 3 nonclinical study package and preparations for commercial supply. In the personnel expenses for the three months ended June 30, 2022 and 2021 an amount of 1,014,655 and 694,084, respectively, was included which related to share-based payments compensation arrangements. The increase in the share-based compensation is due to the new grants awarded in the three months ended June 30, 2022 and the cumulative charges of the awards granted up the three months ended March 31, 2022. The remaining increase in personnel expenses is driven by the growth of our organization resulting in additional employees hired, and yearly merit adjustments.
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General and administrative expenses
For the three months ended June 30 |
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2022 | 2021 | Change | % | |||||||||||||
(in ) | ||||||||||||||||
Personnel expenses |
(3,825,151 | ) | (1,795,721 | ) | (2,029,430 | ) | 113 | % | ||||||||
Consulting fees |
(254,899 | ) | (161,559 | ) | (93,340 | ) | 58 | % | ||||||||
Professional fees |
(911,170 | ) | (324,793 | ) | (586,377 | ) | 181 | % | ||||||||
Accounting, tax and auditing fees |
(290,159 | ) | (648,626 | ) | 358,467 | (55 | )% | |||||||||
Facilities, communication and office expenses |
(1,618,732 | ) | (1,510,566 | ) | (108,166 | ) | 7 | % | ||||||||
Travel expenses |
(260,446 | ) | (2,563 | ) | (257,883 | ) | 10062 | % | ||||||||
Other expenses |
(499,576 | ) | (220,898 | ) | (278,678 | ) | 126 | % | ||||||||
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Total general and administrative expenses |
(7,660,133 | ) | (4,664,726 | ) | (2,995,407 | ) | 64 | % | ||||||||
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General and administrative expenses increased from 4,664,726 for the three months ended June 30, 2021 to 7,660,133 for the three months ended June 30, 2022. The increase in general and administrative expenses was mainly driven by the growth of the Company following the completion of the IPO, which also led to additional expenses inherent to being a public company and increasing costs related to our commercial buildout. In the personnel expenses for the three months ended June 30, 2022 and 2021 an amount of 2,128,184 and 1,078,654 respectively, was included which related to share-based compensation arrangements. The increase in the share-based compensation expenses is due to the new grants (options and RSUs) made in three months ended June 30, 2022 and the cumulative charges of the awards already granted in the three months ended March 31, 2022. The remaining increase in personnel expenses is driven by the growth of our organization resulting in additional employees hired, and yearly merit adjustments.
Finance income/(expense)
Finance income/(expense) for the three months ended June 30, 2022 and 2021 were 11,501,804 and (2,474,483) respectively, a change of 13,976,287. The amount mainly relates to unrealized foreign exchange income, which is the result of translating the Companys bank balances held in USD to EUR. The foreign exchange rates changed in favor of the Company in the second quarter of 2022.
Income taxes
Income taxes are accounted for in line with IAS 34. The interim period is considered part of a larger financial year, where the income tax is recognized in each interim period based on the best estimate of the weighted average annual income tax rate expected for the full financial year. The estimated tax expenses are determined based on a full year basis and subsequently allocated using the expected full year effective tax rate. The one-off items are recognized in full in the interim period in which they emerge. In the total interim tax charge, no distinction is made between current and deferred tax expenses/income.
The total tax expense over the three months ended June 30, 2022 principally relates to the Dutch fiscal unity for the utilization of a deferred tax asset (DTA) on carry forward losses which previously was not recognized, and a current tax expense which is calculated over the six months ended June 30, 2022, mainly driven by foreign exchange gains.
6
Comparison of the six months ended June 30, 2022 and 2021
For the six months ended June 30 |
||||||||||||||||
2022 | 2021 | Change | % | |||||||||||||
(in ) | ||||||||||||||||
Research and development expenses |
(27,236,126 | ) | (16,132,053 | ) | (11,104,073 | ) | 69 | % | ||||||||
General and administrative expenses |
(13,525,138 | ) | (8,436,415 | ) | (5,088,724 | ) | 60 | % | ||||||||
Total operating expenses |
(40,761,264 | ) | (24,568,468 | ) | (16,192,796 | ) | 66 | % | ||||||||
Operating loss |
(40,761,264 | ) | (24,568,468 | ) | (16,192,796 | ) | 66 | % | ||||||||
Finance income |
14,892,983 | 3,344,373 | 11,548,610 | 345 | % | |||||||||||
Loss before tax |
(25,868,281 | ) | (21,224,095 | ) | (4,644,186 | ) | 22 | % | ||||||||
Income taxes |
(2,779,817 | ) | (21,554 | ) | (2,758,263 | ) | 12797 | % | ||||||||
Loss for the period |
(28,648,098 | ) | (21,245,649 | ) | (7,402,449 | ) | 35 | % |
Revenues
We did not generate any revenues for the six months ended June 30, 2022 and June 30, 2021.
Research and development expenses
For the six months ended June 30 |
||||||||||||||||
2022 | 2021 | Change | % | |||||||||||||
(in ) | ||||||||||||||||
Personnel expenses |
(5,590,207 | ) | (3,768,165 | ) | (1,822,042 | ) | 48 | % | ||||||||
Clinical expenses |
(13,741,610 | ) | (6,761,928 | ) | (6,979,682 | ) | 103 | % | ||||||||
Nonclinical expenses |
(1,832,918 | ) | (2,143,713 | ) | 310,795 | (14 | )% | |||||||||
Manufacturing costs |
(5,883,668 | ) | (2,920,172 | ) | (2,963,496 | ) | 101 | % | ||||||||
License costs |
| (500,000 | ) | 500,000 | (100 | )% | ||||||||||
Intellectual Property costs |
(187,723 | ) | (38,075 | ) | (149,648 | ) | 393 | % | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total research and development expenses |
(27,236,126 | ) | (16,132,053 | ) | (11,104,073 | ) | 69 | % | ||||||||
|
|
|
|
|
|
|
|
Research and development expenses increased from 16,132,053 for the six months ended June 30, 2021 to 27,236,126 for the six months ended June 30, 2022. The increase in the research and development expenses is mainly driven by the progress made in the PHVS416 and PHVS719 development programs in the first six months of 2022. Clinical expenses increased by 6,979,682 for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 due to the progress on and expansion of the on-demand and prophylactic programs. Nonclinical expenses decreased by 310,795 for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 due to completion of certain nonclinical studies supporting the PHVS416 and PHVS719 clinical trial programs. Manufacturing costs relating to the API and pharmaceutical development of PHVS416 and PHVS719 increased by 2,963,496 for the six months ended June 30, 2022 compared to the six months ended June 30, 2021 due to supply costs for both clinical programs, the post-Phase 3 nonclinical study package and preparations for commercial supply. For the six months ended June 30, 2021 license costs reflected a milestone payment of 500,000 that was paid to Analyticon upon the start of the clinical Phase 2. In the personnel expenses for the six months ended June 30, 2022 and 2021 an amount of 1,943,566 and 2,052,787, respectively, was included related to the share-based compensation arrangements. The decrease in the share-based compensation expenses is due to a remeasurement of the fair values of the stock options related to the performance periods 2021 and 2022 that occurred in the six months ended June 30, 2021 and the offset due to the new grants during the 6-month period, and the cumulative charges for the grants up to December 31, 2021. The remaining increase in personnel expenses was driven by the growth of our organization and yearly merit adjustments.
7
General and administrative expenses
For the six months ended June 30 |
||||||||||||||||
2022 | 2021 | Change | % | |||||||||||||
(in ) | ||||||||||||||||
Personnel expenses |
(6,270,034 | ) | (3,036,786 | ) | (3,233,248 | ) | 106 | % | ||||||||
Consulting fees |
(432,811 | ) | (390,872 | ) | (41,939 | ) | 11 | % | ||||||||
Professional fees |
(1,795,170 | ) | (1,132,706 | ) | (662,464 | ) | 58 | % | ||||||||
Accounting, tax and auditing fees |
(594,657 | ) | (1,086,756 | ) | 492,099 | (45 | )% | |||||||||
Facilities, communication and office expenses |
(3,246,830 | ) | (2,462,147 | ) | (784,683 | ) | 32 | % | ||||||||
Travel expenses |
(404,200 | ) | (3,357 | ) | (400,843 | ) | 11941 | % | ||||||||
Other expenses |
(781,436 | ) | (323,791 | ) | (457,645 | ) | 141 | % | ||||||||
|
|
|
|
|
|
|
|
|||||||||
Total general and administrative expenses |
(13,525,138 | ) | (8,436,415 | ) | (5,088,724 | ) | 60 | % | ||||||||
|
|
|
|
|
|
|
|
General and administrative expenses increased from 8,436,415 for the six months ended June 30, 2021 to 13,525,138 for the six months ended June 30, 2022. This is mainly driven by the growth of our organization following the completion of the IPO, which also led to additional expenses related to the operations of a public company and increasing costs related to our commercial buildout. In the personnel expenses for the six months ended June 30, 2022 and 2021 an amount of 3,146,211 and 1,816,561 respectively, was included which related to share-based compensation arrangements. The increase in the share-based compensation expenses is due to the grants made in the first six months of 2022. The remaining increase in personnel expenses is driven by the growth of our organization resulting in additional employees hired, and yearly merit adjustments.
Finance income/(expense)
Finance income for the six months ended June 30, 2022 and 2021 were 14,892,983 and 3,344,373 respectively, a change of 11,548,610. The amount mainly relates to unrealized foreign exchange income, which is the result of translating the groups bank balances held in USD to EUR. The EUR/USD exchange rate has changed to our favor for the six months ended June 30, 2022.
Income taxes
Income taxes are accounted for in line with IAS 34. The interim period is considered part of a larger financial year, where the income tax is recognized in each interim period based on the best estimate of the weighted average annual income tax rate expected for the full financial year. The estimated tax expenses are determined based on a full year basis and subsequently allocated using the expected full year effective tax rate. The one-off items are recognized in full in the interim period in which they emerge. In the total interim tax charge, no distinction is made between current and deferred tax expenses/income.
The total tax expense over the six months ended June 30, 2022 principally relates to the Dutch fiscal unity for the utilization of a DTA on carry forward losses which previously was not recognized, and a current tax expense which is calculated over the six months ended June 30, 2022, mainly driven by foreign exchange gains.
Liquidity and Capital Resources
Since inception, we have incurred significant operating losses. For the six months ended June 30, 2022 and 2021 we incurred losses of 28,648,098 and 21,245,649 respectively. Since inception, we have not generated any revenues or net cash flows from sales. We will not receive any revenues or net cash flows from sales of our product candidate until it has been approved by regulatory authorities and we have commercialized it. There is no assurance that we will be able to do so.
To date, we have relied solely on the issuance of equity securities to finance our operations and internal growth. On March 1, 2022, we entered into a sales agreement with SVB Securities LLC, or SVB Securities, pursuant to which we may sell ordinary shares having an aggregate offering price of up to $75 million from time to time through SVB Securities. During the six months ended June 30, 2022, we sold a total of 588,100 ordinary shares in two different transactions under the sales agreement generating total net proceeds of $9,698,504, after deducting $299,954 which was payable to SVB Securities as commission in respect of such sales. As of June 30, 2022 we had cash and cash equivalents of 201.4 million. Our cash and cash equivalents consist solely of cash at bank.
We do not expect positive operating cash flows in the foreseeable future and remain dependent on additional financing to fund our research and development expenses, general and administrative expenses and financing costs. We believe that the available cash balances are sufficient to execute our operating plan and strategies and to meet the anticipated working capital requirements and settle all expected liabilities for at least twelve months from the issuance date of our unaudited condensed consolidated interim financial statements for the three and six months ended June 30, 2022 and 2021. Accordingly, the unaudited condensed consolidated interim financial statements have been prepared on a going concern basis.
Our future viability is dependent on our ability to raise additional capital to finance operations. We will need to finance our operations through public or private securities offerings, debt financings or other sources, which may include licensing, collaborations or other strategic transactions or arrangements. Although we have been successful in raising capital in the past, there is no assurance that we will be successful in obtaining such additional financing on terms acceptable to us, if at all. If we are unable to obtain funding, we could be forced to delay, reduce, or eliminate some or all of our research and development programs for product candidates, product portfolio expansion or commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations.
8
Our contractual obligations and commitments as of June 30, 2022 amounted to 16 million, primarily related to research and development commitments.
Cash Flows
Comparison for the six months ended June 30, 2022 and June 30, 2021
The following table sets forth our primary sources and uses of our cash and cash equivalents for each of the periods set forth below:
For the six months ended June 30 |
||||||||||||||||
2022 | 2021 | Change | % | |||||||||||||
(in ) | ||||||||||||||||
Net cash flows used in operating activities |
(31,568,574 | ) | (22,058,913 | ) | (9,509,661 | ) | 43 | % | ||||||||
Net cash flows used in investing activities |
(49,739 | ) | (33,554 | ) | (16,185 | ) | 48 | % | ||||||||
Net cash flows provided by financing activities |
8,823,313 | 144,306,260 | (135,482,947 | ) | (94 | )% | ||||||||||
Net increase (decrease) in cash and cash equivalents |
(22,794,999 | ) | 122,213,793 | (145,008,792 | ) | (119 | )% | |||||||||
Cash and cash equivalents at the beginning of the period |
209,353,132 | 98,628,871 | 110,724,261 | 112 | % | |||||||||||
Effect of exchange rate changes |
14,824,955 | 3,475,076 | 11,349,879 | 327 | % | |||||||||||
Cash and cash equivalents at the end of the period |
201,383,087 | 224,317,740 | (22,934,653 | ) | (10 | )% |
Operating activities
Net cash used in operating activities reflects our results for the period adjusted for, among other things, depreciation, unrealized foreign exchange results, share-based compensation, changes in working capital and interest accruals and payments.
Net cash used in operating activities was 31,568,574 for the six months ended June 30, 2022, an increase of 9,509,661, compared to 22,058,913 for the six months ended June 30, 2021, primarily reflecting the increase in research and development expenses and other operating expenses, due to progression made in the PHVS416 and PHVS719 development programs and the growth of our organization in 2021 and 2022.
Investing activities
Net cash flows used in investing activities increased by 16,185 from 33,554 for the six months ended June 30, 2021 to 49,739 for the six months ended June 30, 2022, primarily as a result of capital expenditure related to office equipment in 2022.
Financing activities
Net cash flows provided by financing activities decreased by 135,482,947 from 144,306,260 for the six months ended June 30, 2021 to 8,823,313 for the six months ended June 30, 2022. The net cash inflow in 2021 was the result of the proceeds from the IPO net of underwriting discount and other transaction costs. The cash inflow in six months ended June 30, 2022 relates to the sale of the ordinary shares under the sales agreement with SVB Securities offset by cash flows related to financial lease and transaction costs.
9
Off-Balance Sheet Arrangements
As of June 30, 2022, we did not have any off-balance sheet arrangements other than the disclosed commitments.
Quantitative and Qualitative Disclosures About Market Risk
During the six months ended June 30, 2022, 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 Market Risk in the Annual Report.
Critical Accounting Estimates and Judgments
There have been no material changes to the significant accounting policies and estimates described in Note 2.19 to our consolidated financial statements in the Annual Report.
Cautionary Statement Regarding Forward-Looking Statements
Certain statements in this managements discussion and analysis are or may be forward-looking statements with respect to us, our industry and our business that involve substantial risks and uncertainties. All statements other than statements of historical fact contained in this managements discussion and analysis, including statements regarding our future financial condition, results of operations and/or business achievements, including, without limitation, statements containing the words believe, anticipate, expect, estimate, may, could, should, would, will, intend and similar expressions are forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Such forward-looking statements involve unknown risks, uncertainties and other factors which may cause our actual results, financial condition, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that might cause such a difference include, but are not limited to:
| uncertainty in the outcome of our interactions with regulatory authorities, including the FDA with respect to the clinical hold on PHA121 clinical trials in the U.S; |
| the expected timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in mid-stage global clinical trials and are currently on hold in the U.S. as a result of the clinical hold; |
| risks associated with the COVID-19 pandemic, which may adversely impact our business, nonclinical studies and clinical trials, the timing of regulatory approvals and the value of our ordinary shares; |
| the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates PHVS416 and PHVS719 or any other product candidate that we may develop in the future; |
| our ability to market, commercialize and achieve market acceptance for our product candidates PHVS416 and PHVS719 or any of our other product candidates that we may develop in the future, if approved; |
| our ability to establish commercial capabilities or enter into agreements with third parties to market, sell and distribute our product candidates; |
| our dependence on third parties to perform critical activities related to the research, nonclinical safety and toxicology studies, development and manufacturing of our product candidates; |
| disruptions at the FDA and other government agencies; |
| the expense, time and uncertainty involved in the development and consistent manufacturing and supply of our product candidates, some or all of which may never reach the regulatory approval stage; |
10
| our ability to raise capital when needed and on acceptable terms; |
| our ability to enter into any new licensing agreements or to maintain any licensing agreements with respect to our product candidates; |
| our reliance on collaboration partners and licensees, whose actions we cannot control; |
| the willingness of private insurers and other payors to provide reimbursement for our products; |
| regulatory developments in the United States, the European Union and other jurisdictions; |
| the outcome and timing of price negotiations with governmental authorities; |
| our ability to compete in the pharmaceutical industry and with competitive generic products; |
| our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; |
| side effects or adverse events associated with the use of our product candidates; |
| our ability to defend against costly and damaging liability claims resulting from the testing of our product candidates in the clinic or, if, approved, any commercial sales; |
| a loss of any of our key personnel; |
| our estimates of market sizes and anticipated uses of our product candidates; |
| our estimates of future performance; |
| our estimates regarding anticipated operating losses, future revenues, expenses, capital requirements and our needs for additional financing; |
| our ability to comply with existing or future laws and regulations in a cost-efficient manner; |
| our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws; |
| our ability to successfully remediate the material weaknesses in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; |
| our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act or a foreign private issuer; and |
| changes in general market, political and economic conditions, including as a result of inflation and the current conflict between Russia and Ukraine. |
You should refer to ITEM 3. Key informationD. Risk factors. section of our Annual Report for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this managements discussion and analysis will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material.
11
In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame or at all.
We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
In addition, statements that we believe and other similar statements reflect our belief and opinions on the relevant subject. These statements are based upon information available to us as of the date of this managements discussion and analysis, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.
12
|
3 |
| ||
|
4 |
| ||
|
5 |
| ||
|
6 |
| ||
|
7 |
|
Three months ended June 30 |
Six months ended June 30 |
|||||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||||
Notes |
€ |
€ |
€ |
€ |
||||||||||||||
Research and development expenses |
3 | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||
General and administrative expenses |
4 | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total operating expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Finance income/(expense) |
6 | ( |
) | |||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss before income tax |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Income taxes |
7 | ( |
) | ( |
) | ( |
) | ( |
) | |||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss for the period |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Other comprehensive income/(Loss) |
||||||||||||||||||
Exchange gains arising on translation of foreign operations |
( |
) | ( |
) | ||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Total comprehensive loss attributable to: |
||||||||||||||||||
Equity holders of the Company |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
|
|
|
|
|
|
|
|
|||||||||||
Loss per share attributable to the equity holders of the Company during the periods |
||||||||||||||||||
Basic and diluted loss per share: |
19 | ( |
) | ( |
) | ( |
) | ( |
) |
June 30, 2022 |
December 31, 2021 |
|||||||||
Notes | € | € | ||||||||
Assets |
||||||||||
Non-current assets |
||||||||||
Property, plant and equipment |
8 | |||||||||
Right of use assets |
9 | |||||||||
Current assets |
||||||||||
Deferred tax assets |
7 | |||||||||
Receivables |
10 | |||||||||
Other current assets |
11 | |||||||||
Cash and cash equivalents |
12 | |||||||||
|
|
|
|
|||||||
Total assets |
||||||||||
|
|
|
|
|||||||
Equity and liabilities |
||||||||||
Equity |
||||||||||
Share capital |
13 | |||||||||
Share premium |
||||||||||
Other reserves |
||||||||||
Currency translation reserve |
( |
) | ||||||||
Accumulated loss |
( |
) | ( |
) | ||||||
|
|
|
|
|||||||
Total equity |
||||||||||
|
|
|
|
|||||||
Long term liabilities |
||||||||||
Non-current lease liability |
9 | |||||||||
Current liabilities |
||||||||||
Trade and other payables |
14 | |||||||||
Accrued liabilities |
15 | |||||||||
Current lease liability |
9 | |||||||||
Current tax liability |
||||||||||
|
|
|
|
|||||||
Total liabilities |
||||||||||
|
|
|
|
|||||||
Total equity and liabilities |
||||||||||
|
|
|
|
Share capital |
Share premium |
Other reserves |
Currency translation reserve |
Accumulated losses |
Total Equity |
|||||||||||||||||||||||
Notes | € | € | € | € | € | € | ||||||||||||||||||||||
Balance at January 1, 2021 |
( |
) | ( |
) | ||||||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||
Increase in par value |
13 | ( |
) | — | — | — | — | |||||||||||||||||||||
Issue of share capital |
13 | — | — | — | ||||||||||||||||||||||||
Transaction costs on issue of shares |
— | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||
Currency translation reserve |
— | — | — | — | ||||||||||||||||||||||||
Shares issued upon exercise of RSUs |
18 | — | ( |
) | — | ( |
) | ( |
) | |||||||||||||||||||
Share-based payments |
18 | — | — | — | — | |||||||||||||||||||||||
Shares issued upon exercise of options |
18 | ( |
) | — | — | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at June 30, 2021 |
( |
) | ( |
) | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at January 1, 2022 |
( |
) | ||||||||||||||||||||||||||
Net loss |
— | — | — | — | ( |
) | ( |
) | ||||||||||||||||||||
Issue of share capital |
13 | — | — | — | ||||||||||||||||||||||||
Transaction costs on issue of shares |
— | ( |
) | — | — | — | ( |
) | ||||||||||||||||||||
Currency translation reserve |
— | — | — | ( |
) | — | ( |
) | ||||||||||||||||||||
Share-based payments |
18 | — | — | — | — | |||||||||||||||||||||||
Settlement of share-based payments |
( |
) | — | ( |
) | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at June 30, 2022 |
( |
) | ( |
) | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
2022 | 2021 | |||||||||||
Notes | € | € | ||||||||||
Operating activities |
||||||||||||
Loss before tax |
( |
) | ( |
) | ||||||||
Non-cash adjustments to reconcile loss before tax to net cash flows from operations: |
||||||||||||
Share-based payment expense |
18 | |||||||||||
Depreciation expense |
4 | |||||||||||
Net foreign exchange (gain)/loss |
6 | ( |
) | ( |
) | |||||||
Finance costs |
6 | |||||||||||
Changes in working capital: |
||||||||||||
Decrease/(Increase) in receivables |
( |
) | ||||||||||
(Increase) in other current assets |
( |
) | ( |
) | ||||||||
Increase in trade and other payables |
||||||||||||
Increase in accrued liabilities |
||||||||||||
Paid interest |
( |
) | ( |
) | ||||||||
Income taxes paid |
( |
) | ||||||||||
|
|
|
|
|||||||||
Net cash flows used in operating activities |
( |
) | ( |
) | ||||||||
|
|
|
|
|||||||||
Investing activities |
||||||||||||
Purchase of property, plant and equipment |
8 | ( |
) | ( |
) | |||||||
|
|
|
|
|||||||||
Net cash flows used in investing activities |
( |
) | ( |
) | ||||||||
|
|
|
|
|||||||||
Financing activities |
||||||||||||
Proceeds from issue of shares |
13 | |||||||||||
Transaction costs |
( |
) | ( |
) | ||||||||
Decrease in financial liability |
( |
) | ( |
) | ||||||||
|
|
|
|
|||||||||
Net cash flows provided by financing activities |
||||||||||||
|
|
|
|
|||||||||
Net increase (decrease) in cash and cash equivalents |
( |
) | ||||||||||
Cash and cash equivalents at the beginning of the period |
||||||||||||
Effect of exchange rate changes |
||||||||||||
|
|
|
|
|||||||||
Cash and cash equivalents at the end of the period |
12 | |||||||||||
|
|
|
|
Legal seat | Country of incorporation |
% of equity interest as June 30, |
||||||||||
Name |
2022 | 2021 | ||||||||||
% | % | |||||||||||
% | % | |||||||||||
% | % | |||||||||||
% | % |
As reported weighted average number of shares (Quarterly) |
As reported weighted average number of shares (YTD) |
Revision of weighted average number of shares (Quarterly) |
Revision of weighted average number of shares (YTD) |
|||||||||||||
Q1 2021 |
||||||||||||||||
Q2 2021 |
||||||||||||||||
Q3 2021 |
||||||||||||||||
Q1 2022 |
As reported basic and diluted loss per share (Quarterly) |
As reported basic and diluted loss per share (YTD) |
Revision of basic and diluted loss per share (Quarterly) |
Revision of basic and diluted loss per share (YTD) |
|||||||||||||
Q1 2021 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Q2 2021 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Q3 2021 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Q1 2022 |
( |
) | ( |
) | ( |
) | ( |
) |
For the three months ended June 30 |
For the six months ended June 30 |
|||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
€ | € | € | € | |||||||||||||
Personnel expenses (Note 5) |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Clinical expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Nonclinical expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Manufacturing costs |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
License costs |
( |
) | ||||||||||||||
Intellectual Property costs |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
|
|
|
|
|
|
|
|
|||||||||
( |
) | ( |
) | ( |
) | ( |
) | |||||||||
|
|
|
|
|
|
|
|
For the three months ended June 30 | For the six months ended June 30 | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
€ | € | € | € | |||||||||||||
Personnel expenses (Note 5) |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Consulting fees |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Professional fees |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Accounting, tax and auditing fees |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Facilities, communication & office expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Travel expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
( |
) | ( |
) | ( |
) | ( |
) | |||||||||
For the three months ended June 30 | For the six months ended June 30 | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
€ | € | € | € | |||||||||||||
Wages and salaries |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Pension charges |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other social security charges |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Share-based payments |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
( |
) | ( |
) | ( |
) | ( |
) | |||||||||
For the three months ended June 30 | For the six months ended June 30 | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
€ | € | € | € | |||||||||||||
Foreign exchange differences |
( |
) | ||||||||||||||
Interest expenses over bank balances |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Other finance expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
( |
) | |||||||||||||||
For the three months ended June 30 | For the six months ended June 30 | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
€ | € | € | € | |||||||||||||
Income tax expense |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
( |
) | ( |
) | ( |
) | ( |
) | |||||||||
For the three months ended June 30 | For the six months ended June 30 | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
€ | € | € | € | |||||||||||||
Income/(loss) before tax |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Income tax at statutory income tax rate in The Netherlands ( |
||||||||||||||||
Effect of tax rates in other countries |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Temporary differences for which no deferred tax assets/liabilities have been recognized |
( |
) | ( |
) | ||||||||||||
Nondeductible expenses |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Current period losses for which no deferred tax asset has been recognized |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Income tax expense |
( |
) | ( |
) | ( |
) | ( |
) |
Notes | Office equipment |
|||||||
€ | ||||||||
Balance at January 1, 2022 |
||||||||
Additions |
||||||||
Depreciation expense |
4 | ( |
) | |||||
|
|
|||||||
Balance at June 30, 2022 |
||||||||
|
|
|||||||
Balance at June 30, 2022 |
||||||||
Cost |
||||||||
Accumulated depreciation |
( |
) | ||||||
|
|
|||||||
Net book amount |
||||||||
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
€ | € | |||||||
Balance at January 1 |
||||||||
Addition |
— | |||||||
Depreciation charges |
( |
) | ( |
) | ||||
Impact of transaction of foreign currency |
— | |||||||
|
|
|
|
|||||
Balance at June 30, 2021 |
||||||||
|
|
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
€ | € | |||||||
Office lease |
( |
) | ( |
) | ||||
Total lease liability |
( |
) | ( |
) | ||||
Current portion |
( |
) |
( |
) | ||||
Non-current portion |
( |
) |
( |
) | ||||
|
|
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
€ | € | |||||||
Trade Receivables |
||||||||
VAT receivables |
||||||||
|
|
|
|
|||||
|
|
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
€ | € | |||||||
Prepayments |
||||||||
Other assets |
||||||||
|
|
|
|
|||||
|
|
|
|
June 30, 2022 |
December 31, 2021 |
|||||||
Number of shares |
Number of shares |
|||||||
Ordinary shares |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
€ | € | |||||||
Trade payables |
||||||||
Tax and social security liabilities |
||||||||
June 30, 2022 |
December 31, 2021 |
|||||||
€ | € | |||||||
Consulting, professional and audit liability |
||||||||
Clinical accrued liabilities |
||||||||
Manufacturing accrued liabilities |
||||||||
Pre-clinical accrued liabilities |
||||||||
Personnel related accruals |
||||||||
Other accrued liabilities |
||||||||
Stock Options | RSUs | |||||||||||
Outstanding options |
Weighted average exercise price |
Outstanding RSUs |
||||||||||
Outstanding January 1, 2022 |
€ | |||||||||||
Granted |
€ | |
||||||||||
Exercised |
( |
) | € | ( |
) | |||||||
Forfeited |
( |
) | ||||||||||
Outstanding June 30, 2022 |
€ | |||||||||||
June 1, 2022 | April 1, 2022 | January 1, 2022 | ||||||||||
Number of options |
||||||||||||
Fair value of the options |
€ | € | € | |||||||||
Fair value of the ordinary shares |
€ | € | € | |||||||||
Exercise price |
€ | € | € | |||||||||
Expected volatility (%) |
% | % | % | |||||||||
Expected life (years) |
||||||||||||
Risk-free interest rate (%) |
% | % | % | |||||||||
Expected dividend yield |
For the three months ended June 30, |
For the six months ended June 30, | |||||||||||||||
2022 | 2021 (*) | 2022 | 2021 (*) | |||||||||||||
€ | € | € | € | |||||||||||||
Loss attributable to equity holders of the Company |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
Weighted average number of ordinary shares outstanding |
||||||||||||||||
Basic and diluted loss per share |
( |
) | ( |
) | ( |
) | ( |
) |
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
€ | € | € | € | |||||||||||||
Short term employee benefits |
||||||||||||||||
Post employee benefits |
||||||||||||||||
Share-based payments |
||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total |
||||||||||||||||
|
|
|
|
|
|
|
|
B.A.E. Modig |
A.M. de Jonge Schuermans |
E. Björk |
R.H. Glassman |
D.P. Meeker |
J.G.C.P. Schikan |