Ascelia Pharma
NOTICE OF ANNUAL GENERAL MEETING IN ASCELIA PHARMA AB (MFN)
The shareholders in Ascelia Pharma AB, Reg. No. 556571-8797, are hereby invited to the annual general meeting (Sw. årsstämma) to be held at the premises of Setterwalls Advokatbyrå at Stortorget 23 in Malmö on Thursday 4 May 2023 at 2.00 p.m. CEST.
Right to participate and notice of participation
Shareholders wishing to attend the annual general meeting must:
- be registered in the company’s share register kept by Euroclear Sweden AB (the Swedish Securities Register Center) as of Tuesday 25 April 2023; and
- have notified their participation to the company no later than Thursday 27 April 2023, by mail to Ascelia Pharma AB, att: Déspina Georgiadou Hedin, Hyllie Boulevard 34, SE-215 32 Malmö, Sweden, by e-mail to despina.georgiadou@ascelia.com or by phone +46 (0)765 697 873. The notice should specify the complete name of the shareholder, personal identity number or company registration number, the number of shares held by the shareholder, address, telephone number during work hours and, when applicable, information on the number of advisors (two at the most).
Trustee-registered shares
Shareholders whose shares are trustee-registered in the name of a bank or other trustee must, to be able to exercise their voting rights at the annual general meeting, request the trustee to register their shares in their own name with Euroclear Sweden AB (so called “voting rights registration”). Such voting rights registration must be implemented by the trustee no later than as of Thursday 27 April 2023. Accordingly, shareholders must well in advance before this date notify their trustee of their request of such voting rights registration.
Proxies etc.
Shareholders intending to participate by proxy must issue a written, signed and dated power of attorney. The validity term of the power of attorney may not be more than one year, unless a longer validity term is specifically stated in the power of attorney (however at the longest five years). If the power of attorney is issued by a legal entity, the representing proxy must also present an up-to-date certificate of registration (Sw. registreringsbevis) or equivalent document for the legal entity. In order to facilitate the entrance at the meeting, a copy of the power of attorney and other authorization documents should preferably be attached to the shareholder’s notification to participate in the annual general meeting. A template power of attorney is available at the company’s website (www.ascelia.com) and will be sent by mail to the shareholders who request it and state their address.
Proposed agenda
0.Opening of the meeting.
1.Election of chairman of the meeting.
2.Preparation and approval of the voting list.
3.Approval of the agenda.
4.Election of one or two persons who shall approve the minutes of the meeting.
5.Determination of whether the meeting was duly convened.
6.Presentation by the CEO.
7.Submission of the annual report and the audit report and the consolidated annual report and consolidated audit report as well as the statement by the auditor on the compliance of the applicable guidelines for remuneration to senior executives.
8.Resolutions regarding:
a)adoption of the income statement and the balance sheet and the consolidated income statement and the consolidated balance sheet;
b)allocation of the company’s profits in accordance with the adopted balance sheet; and
c)discharge of the members of the board of directors and the CEO from liability.
9.Determination of the number of members of the board of directors, auditors and deputy auditors.
10.Determination of remuneration for the members of the board of directors and for the auditors.
11.Election of members of the board of directors, chairman of the board of directors and auditor.
12.Resolution on remuneration of the Nomination Committee for work ahead of the annual general meeting in 2024.
13.Resolution on approval of remuneration report.
14.Resolution on authorization for the board of directors regarding issues.
15.Resolution on implementation of a long-term incentive program by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization for repurchase of series C shares; and (D) resolution on transfer of own ordinary shares.
16.Resolution on authorization for the board of directors regarding transfer of own ordinary shares.
17.Closing of the meeting.
Proposed resolutions
Item 1: Election of chairman of the meeting
The Nomination Committee, that has consisted of Jørgen Thorball (chairman), appointed by Sunstone Life Science Ventures II K/S, Håkan Nelson, appointed by Øresund-Healthcare Capital K/S, Marianne Flink, appointed by Fjärde AP-fonden (AP4), and Peter Benson, chairman of the board of directors, proposes that lawyer Ola Grahn is elected as chairman of the annual general meeting.
Item 8 b: Resolution regarding allocation of the company’s profits in accordance with the adopted balance sheet
The board of directors proposes that no dividends are paid to the shareholders and that the available funds of SEK 180,110,584 are carried forward.
Item 9: Determination of the number of members of the board of directors, auditors and deputy auditors
The Nomination Committee proposes that the board of directors shall be composed of five members.
Furthermore, the Nomination Committee proposes, in accordance with the recommendation from the Audit Committee, that one registered accounting firm is appointed as auditor.
Item 10: Determination of remuneration for the members of the board of directors and for the auditors
The Nomination Committee proposes that board remuneration shall be paid with SEK 525,000 to the chairman of the board and with SEK 262,500 to each of the other board members who are not employed by the Company. It is further proposed that remuneration for committee work shall be paid with SEK 100,000 to the chairman of the Audit Committee, with SEK 25,000 to each of the other members of the Audit Committee , with SEK 100,000 to the chairman of the Commercialization Committee ,with SEK 25,000 to each of the other members of the Commercialization Committee, with SEK 50,000 to the chairman of the Remuneration Committee and with SEK 25,000 to each of the other members of the Remuneration Committee. It is finally proposed that, in addition to the above, board members residing outside of Europe shall be paid additional board remuneration with SEK 10,000 per physical board meeting attended.
All proposed remunerations are unchanged from previous year.
Furthermore, the Nomination Committee proposes, in accordance with the recommendation from the Audit Committee, that remuneration for the auditor shall be paid in accordance with customary norms and approved invoice.
Item 11: Election of members of the board of directors, chairman of the board of directors and auditor
The Nomination Committee proposes that Peter Benson, Niels Mengel, Helena Wennerström, Hans Maier and Lauren Barnes are re-elected as ordinary board members, and that Peter Benson is re-elected as chairman of the board of directors. The Nomination Committee is in the process of identifying an additional new candidate to be elected as ordinary board member alongside the board members proposed for re-election. In case such candidate is identified, the Nomination Committee will present a revised proposal for the board composition (including the number of board members to be elected) through a separate press release ahead of the annual general meeting.
Information on the board members proposed for re-election can be found at the company’s website (www.ascelia.com) and in the annual report.
Furthermore, the Nomination Committee proposes, in accordance with the recommendation from the Audit Committee, that Öhrlings PricewaterhouseCoopers AB is re-elected as accounting firm. Öhrlings PricewaterhouseCoopers AB has informed that the authorized public accountant Carl Fogelberg will continue to be the auditor in charge.
Item 12: Resolution on remuneration of the Nomination Committee for work ahead of the annual general meeting in 2024
The Nomination Committee proposes that remuneration shall be paid with SEK 50,000 to the chairman of the Nomination Committee for the work up and until the annual general meeting to be held in 2024 (unchanged from previous year).
Item 13: Resolution on approval of remuneration report
The board of directors proposes that the annual general meeting resolves to approve the board of directors’ remuneration report for the financial year 2022.
Item 14: Resolution on authorization for the board of directors regarding issues
The board of directors proposes that the annual general meeting resolves to authorize the board of directors, at one or several occasions, during the time up until the next annual general meeting, with or without deviation from the shareholders’ preferential rights, and with or without provisions regarding payment in kind or through set-off or other provisions, to resolve to issue new ordinary shares, convertibles and/or warrants. The reason for that deviation from the shareholders’ preferential rights shall be permitted is to enable the company to raise working capital, to execute acquisitions of companies or operating assets as well as to enable issues to industrial partners within the framework of partnerships and alliances. The total number of ordinary shares that that may be issued pursuant to the authorization (alternatively be issued through conversion of convertibles and/or exercise of warrants) shall be limited to a number that leads to a maximum dilution of 20 per cent (calculated after full utilization of the now proposed authorizations) of the total number of ordinary shares outstanding in the company at the time of the first issue resolution pursuant to the authorization. To the extent an issue is made with deviation from the shareholders’ preferential rights, the issue should be made on market terms.
The CEO shall be authorized to make minor formal adjustments of the resolution which may be required for registration with the Swedish Companies Registration Office (Sw. Bolagsverket).
Item 15: Resolution on implementation of a long-term incentive program by way of (A) implementation of a performance-based share saving program; (B) authorization on directed issues of series C shares; (C) authorization for repurchase of series C shares; and (D) resolution on transfer of own ordinary shares
The board of directors proposes that the annual general meeting resolves to implement a long-term incentive program in the form of a performance-based share saving program (the “LTI 2023”) for employees in accordance with A below. The resolution is conditional upon that the annual general meeting also resolves on hedging measures in accordance with B – D below.
A.Implementation of a performance-based share saving program
Background
The overall purpose with LTI 2023 is to align the interests of the employees with those of the shareholders and thus ensure a maximum long-term value adding commitment. LTI 2023 is also considered to create a long-term focus on increase in earnings and growth among the participants. LTI 2023 is further considered to facilitate for the company to recruit and retain employees.
At previous annual general meetings, it has been resolved to implement corresponding incentive programs for employees in the company, and currently LTI 2020, LTI 2021 LTI 2022 are outstanding.
Terms and conditions for LTI 2023
1.LTI 2023 shall comprise senior executives and other employees divided into six categories.
2.LTI 2023 means that the participants will invest in or allocate already owned ordinary shares in the company (”Saving Shares”). Following a predefined time period, the participants will, free of charge, have the right to receive additional shares in the company (“Matching Shares”). In addition, conditional upon fulfilment of a goal related to the development of the share price, the participants will further, free of charge, have the right to receive additional shares in the company (“Performance Shares”). The conditions for receipt of Matching Shares and Performance Shares are set out below.
3.The maximum number of Saving Shares that each participant shall be entitled to invest in or allocate shall amount to the following:
Position and Maximum number of Saving Shares
CEO 31,000
Deputy CEO 25,000
Other senior executives (2 persons) 20,000
Vice Presidents (up to 5 persons) 11,250
Directors (up to 15 persons) 6,750
Other employees (up to 20 persons) 2,000
4.The board of directors shall, within the limits stated above, resolve on the maximum number of Saving Shares that each individual participant may acquire/allocate.
5.The investment in Saving Shares shall be made through acquisition of ordinary shares on the stock market or by allocating ordinary shares held by the participant and which have not been used as saving shares in an already existing incentive program (except for previous share saving programs which have expired). Investment or allocation shall have taken place at the latest on 30 September 2023 at the latest (the “Investment Period”). The board of directors shall be entitled to prolong the Investment Period in case participants have been unable to acquire shares due to applicable insider regulations.
6.For each Saving Share, the participant shall be entitled to receive 1 Matching Share. In addition, the participant shall have the possibility to receive up to 5 Performance Shares for each Saving Share.
7.The total number of Matching Shares will not exceed 236,000 and the total number of Performance Shares will not exceed 1,180,000, meaning that the total number of shares that can be issued to the participants in connection with LTI 2023 will not exceed 1,416,000. The number of shares that can be issued in connection with LTI 2023 might be recalculated in accordance with what is set out in Section 11 below.
8.Receipt of both Matching Shares and Performance Shares is conditional upon the fulfilment of the following conditions:
(a)that the participant has retained all Saving Shares during the period from the expiration of the Investment Period to 30 September 2026 (the “Saving Period”); and
(b)that the participant has continued to be employed by the company (or another company in its group) throughout the Saving Period.
As regards the employment condition as per (b) above, the board of directors shall in certain cases be entitled to resolve on proportionate allocation in case the employment is terminated prior to the expiration of the Saving Period as set out in Section 14 below.
9.Receipt of Performance Shares is further, in addition to the conditions following from Section 8 above, conditional upon that the requirement related to the development of the company’s share price from the date of the annual general meeting on 4 May 2023 up to and including 30 September 2026 (the “Performance Target”) is fulfilled. The Performance Target will be measured based on the volume weighted average share price 30 trading days immediately following the annual general meeting on 4 May 2023 and 30 trading days immediately preceding 30 September 2026. An increase in the share price with less than 20 per cent does not entitle to any vesting of any of the Performance Shares, an increase in the share price with 20 per cent entitles to vesting of 1 Performance Share per Saving Share and an increase in the share price with 80 per cent or more entitles to vesting of all the 5 Performance Shares per Saving Share. In the event of an increase in the share price of between 20 and 80 per cent, vesting of the Performance Shares will occur linearly between 1 and 5.
10.Before the number of Performance Shares to be allocated is finally determined, the board of directors shall evaluate if allocation pursuant to the principles set out above is reasonable, having regard to the company’s results and financial standing, to conditions on the stock market and to other circumstances in general. If the board of directors finds that it is not reasonable, then the board of directors may decrease the number of Performance Shares to be allocated to the lower number of shares that the board of directors finds reasonable.
11.The number of Matching Shares and Performance Shares that may be allotted by virtue of Saving Shares as well as the Performance Target shall be subject to recalculation in consequence of a bonus issue, split or reverse split, rights issue, and/or other similar company actions.
12.Allotment of Matching Shares and Performance Shares shall take place within 30 days from the publication of the financial report for the period July – September 2026.
13.Participation in LTI 2023 is conditional upon that the participation is legally possible and that the participation in the company’s sole opinion can be made with reasonable administrative costs for the company.
14.LTI 2023 shall be governed by separate agreements with the respective participant. The board of directors shall be responsible for the preparation and management of LTI 2023 within the above mentioned principal terms and guidelines. In connection herewith, the board of directors shall be entitled to resolve on diverging terms for the allocation of Matching Shares and Performance Shares in connection with cessation of employment during the Saving Period due to death, early retirement or similar occasions or due to termination by the company that is not related to misconduct by the participants. In these cases the board of directors may resolve that the participant will be entitled to receive a proportionate part of the Matching Shares and the Performance Shares. Furthermore, in the event of a public take-over offer, a sale of the company’s business, liquidation, merger or any other such transaction affecting the company, the board of directors shall, at its sole discretion, be entitled to resolve that the Matching Shares and Performance Shares (partially or in full) shall vest and be allotted on completion of such transaction. The board of directors will make this resolution based on the level of achievement of the Performance Target, the remainder of the Saving Period and any other factors deemed relevant by the board of directors.
B.Authorization on directed issues of series C shares
The board of directors proposes that the annual general meeting resolves to authorize the board of directors, for the period up until the next annual general meeting, on one or several occasions, to issue a maximum of 1,440,011 series C shares. The new shares may, with deviation from the shareholders' preferential rights, only be subscribed for by a bank or a securities company at a subscription price which corresponds to the quota value of the shares. The purpose of the authorization and the reason for the deviation from the shareholders’ preferential rights in connection with an issue of shares is to secure delivery of Matching Shares and Performance Shares under LTI 2023 and, in terms of liquidity, to hedge payments of future social security contributions related to LTI 2023. It is noted that this shall be achieved through the company repurchasing the series C shares issued pursuant to the authorization in accordance with section C below whereafter the repurchased series C shares will be converted to ordinary shares and transferred in accordance with section D below.
In determining the number of series C-shares to be issued, it has been taken into account that the company currently holds in the aggregate 1,148,415 series C-shares which have been issued in relation to existing share saving programs. Based on the current participation in the existing programs, the maximum number of ordinary shares that will be needed in relation to existing share saving programs amounts to 844,674.
C.Authorization on repurchase of series C shares
The board of directors proposes that the annual general meeting resolves to authorize the board of directors, for the period up until the next annual general meeting, on one or several occasions, to repurchase its own series C shares. Repurchase may only be effected through a public offer directed to all holders of series C shares and shall comprise all outstanding series C shares. Repurchase may also be made of so-called interim shares, by Euroclear Sweden AB designated as a Paid Subscribed Share (Sw. Betald Tecknad Aktie (BTA)), regarding a series C share. Repurchase shall be made at a purchase price per share which corresponds to the quota value of the share. The purpose of the proposed repurchase authorization is to secure delivery of Matching Shares and Performance Shares under LTI 2023 and, in terms of liquidity, to hedge payments of future social security contributions related to LTI 2023.
The board of directors’ statement pursuant to Chapter 19, Section 22 of the Swedish Companies Act (Sw. aktiebolagslagen) is presented in a separate document provided with this proposal.
D.Resolution on transfer of own ordinary shares
In order to fulfil the company’s obligations towards participants in LTI 2023, the board of directors proposes that the annual general meeting resolves that the company shall be entitled to transfer the company’s own ordinary shares as follows:
1. The company shall have the right to transfer the number of ordinary shares that the company has a maximum obligation to allocate as Matching Shares and Performance Shares to participants in LTI 2023, at most 1,416,000 shares.
2. The shares that can be transferred in accordance with paragraph 1 above may consist of either shares newly issued and repurchased in accordance with B – C above, shares which have been issued and repurchased in connection with corresponding LTI programs, but which are no longer required for the performance of the company’s commitments under such programs, or shares which have been repurchased by the company through other repurchase authorizations.
3. The number of shares that may be transferred pursuant to LTI 2023 shall be subject to recalculation in consequence of a bonus issue, split or reverse split, rights issue, and/or other similar corporate action which affects the number of shares in the company.
4. The right to acquire ordinary shares shall, with deviation from the shareholders’ preferential rights, vest in participants in LTI 2023 who are entitled to be allotted Matching Shares and Performance Shares in accordance with the terms and conditions of the program.
5. Transfer of shares to participants in LTI 2023 shall be made free of charge and be executed at the relevant time specified in the terms and conditions for LTI 2023.
The reason for the deviation from the shareholders’ preferential rights in connection with the transfers of own ordinary shares is to enable the company’s delivery of Matching Shares and Performance Shares to participants in LTI 2023.
Since LTI 2023 is not expected to initially give rise to any costs for social security contributions for the company (and since a resolution on transfer is valid only until the next annual general meeting), the board of directors has decided not to propose that the annual general meeting 2023 resolves on an authorization for the board of directors to transfer the company’s own ordinary shares on a regulated market for hedging of cash flow for social security payments in relation to LTI 2023. However, before any transfers of shares to participants in LTI 2023 are made, the board of directors intends to propose to a later general meeting to resolve on an authorization for the board of directors to transfer own ordinary shares on a regulated marked in order to hedge such payments.
Costs, impact on key ratios, existing incentive programs and dilution
The board of directors has made a preliminary cost calculation for LTI 2023. The costs for LTI 2023 are accrued over the vesting period which runs until 30 September 2026. The calculation has been made using the generally accepted modelling technique Monte-Carlo simulation based on the quoted closing price for shares in the company as per 24 March 2023, i.e. SEK 16.08 per share, and with the following assumptions: (i) all participants acquire the maximum number of Saving Shares; (ii) an annual dividend yield of 0 per cent; (iii) an estimated annual employee turnover of 0 per cent; and (iv) a share price volatility of 58 per cent. Based on these assumptions, the total costs for LTI 2023 are estimated to amount to approximately SEK 10.8 million, excluding social security contributions. The costs for social security contributions are estimated to amount to approximately SEK 2.0 million, based on the above assumptions, and an average tax rate of 18.2 per cent for social security contributions.
The anticipated annual costs of approximately SEK 4.3 million, including social security contributions, correspond to approximately 10.6 per cent of the company’s total employee costs for the financial year 2022. Based on the calculation of costs as described above, the key figure earnings per share for the financial year 2022 had been changed from SEK – 3.77 to SEK – 3.89. It should be noted that the calculations are based on the assumptions stated above and are only intended to provide an illustration of the outcome.
As per the date of the notice, the number of shares in the company amounts to 34,871,177 shares, of which 33,722,762 are ordinary shares and 1,148,415 are series C shares which were issued in connection with outstanding share saving programs resolved upon at previous annual general meetings, and which will be converted into ordinary shares prior to delivery to the participants.
The maximum number of shares that can be issued in relation to LTI 2023 is 1,743,752, whereof 1,416,000 for delivery of Matching Shares and Performance Shares to the participants and in the aggregate 327,752 related to hedging of cash flow for social security payments, which corresponds to a dilution of approximately 4.92 per cent of the company’s ordinary shares after full dilution, calculated on the number of ordinary shares that will be added upon full issuance of shares in connection with LTI 2023.
Since previously, there are incentive programs in the form of three performance-based share saving programs outstanding in the company. Based on the current participation in the existing programs, the maximum number of ordinary shares that will be issued in relation to existing share saving programs, including for hedging of cash flow for social security payments, amounts to 844,674. The aggregate maximum number of ordinary shares that can be issued in relation to all outstanding incentive programs as well as the proposed LTI 2023 amounts to 2,588,426, which corresponds to an aggregate dilution of approximately 7.13 per cent of the company’s ordinary shares after full dilution, calculated on the number of ordinary shares that may be issued in relation to all outstanding incentive programs as well as the suggested LTI 2023.
The above calculations regarding dilution are subject to re-calculation of the warrants in accordance with the customary recalculation terms included in the complete applicable warrant terms.
Preparation of the proposal and other information
The proposal for LTI 2023 has been prepared by the Remuneration Committee together with external consultants. The final proposal has been resolved upon by the board of directors.
The board of directors’ proposal on implementation of a long-term incentive program in accordance with Sections A to D above constitutes an overall proposal which shall be resolved upon as one resolution.
The chairman of the board of directors, or anyone appointed by him, shall be authorized to make minor formal adjustments of the resolution which may be required for registration with the Swedish Companies Registration Office (Sw. Bolagsverket) or Euroclear Sweden AB.
Item 16: Resolution on authorization for the board of directors regarding transfer of own ordinary shares
The board of directors proposes that the annual general meeting resolves to authorize the board of directors to, for the period up until the next annual general meeting, resolve on transfer of not more than 44,664 own ordinary shares, for the purpose of hedging cash flow for social security payments that may occur in relation to LTI 2020. Transfer of shares shall be effected on Nasdaq Stockholm at a price within the, at each time, prevailing price interval for the share. The number of shares that may be transferred shall be subject to recalculation in consequence of an intervening bonus issue, split or reverse split, rights issue, and/or other similar corporate action which affects the number of shares in the company.
Particular majority requirements
For valid resolutions on the proposals pursuant to items 14 and 16, the proposals have to be supported by shareholders representing at least two-thirds of the votes cast as well as of all shares represented at the annual general meeting. For a valid resolution on the proposal pursuant to item 15, the proposal has to be supported by shareholders representing at least nine-tenths of the votes cast as well as of all shares represented at the annual general meeting.
Shareholders’ right to information
At the annual general meeting, the board of directors and the CEO shall, if any shareholder so requests and the board of directors believes that it can be done without significant harm to the company, provide information regarding circumstances that may affect the assessment of items on the agenda, circumstances that can affect the assessment of the company’s or its subsidiaries’ financial position and the company’s relation to other companies within the group.
Meeting documents
Financial statements, the audit report, the board of directors’ remuneration report, the statement by the auditor on the compliance of the applicable guidelines for remuneration to senior executives, complete proposals for resolutions and other documents for the annual general meeting, will be kept available at the company’s office, at Hyllie Boulevard 34, SE-215 32 Malmö, Sweden, and at the company’s website (www.ascelia.com) as from no later than three weeks before the annual general meeting. Copies of the documents will be sent to shareholders who request it and provide their address, and will also be available at the annual general meeting.
Number of shares and votes in the company
As per the date of the notice to the annual general meeting, the total number of shares in the company amounts to 34,871,177 shares, of which 33,722,762 are ordinary shares with one vote per share and 1,148,415 are series C shares with one-tenth of a vote per share. The number of votes in the company amounts to 33,837,603.5 votes. The company holds all 1,148,415 outstanding series C shares, corresponding to 114,841.5 votes, which cannot be represented at the meeting.
Processing of personal data
For information on how your personal data is processed, see https://www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.
____________________
Malmö in April 2023
Ascelia Pharma AB (publ)
The Board of Directors
Contacts
Magnus Corfitzen, CEO
Email: moc@ascelia.com
Tel: +46 735 179 118
Déspina Georgiadou Hedin, CFO and Investor Relations
Email: despina.georgiadou@ascelia.com
Tel: +46 765 697 873
This information was submitted for publication, through the agency of the contact persons set out above.
About Us
Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates – Orviglance (previously referred to as Mangoral) and Oncoral – in clinical development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.
About Orviglance (previously referred to as Mangoral)
Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A pivotal clinical program of nine studies, including the global Phase 3 study SPARKLE, have been completed. Headline results from the Phase 3 study are expected mid-2023.
About Oncoral
Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development.