Compugen Reports First Quarter 2024 Results

On May 20, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the first quarter ended March 31, 2024 and provided a corporate update (Press release, Compugen, MAY 20, 2024, View Source [SID1234643455]).

"I am proud of our continued progress across our pipeline in the first quarter of 2024, and planned catalyst rich 2024 ahead of us," said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen. "We are on track to present data from our ongoing studies this year. First up, microsatellite stable colorectal cancer (MSS CRC) at ASCO (Free ASCO Whitepaper) followed by platinum resistant ovarian cancer in the fourth quarter of 2024. We are also well advanced in our preparation for a COM503 Phase 1 study. In addition, our partner, AstraZeneca, has advanced its PD-1/TIGIT bispecific, rilvegostomig, into its second Phase 3 program, in nonsquamous NSCLC, bringing us closer to realizing potential future milestone payments and royalties."

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Dr. Cohen-Dayag continued, "Our first data will come from the very difficult to treat MSS CRC patient population, the majority of whom have liver metastases. This patient population historically have not responded to immune-oncology (IO) therapies. We pursued this indication based on an encouraging 12% overall response rate in the liver metastases population supported by immune activation in the tumor microenvironment suggestive of COM701 mediated activity. The data planned to be presented in June at ASCO (Free ASCO Whitepaper) remains supportive of COM701’s activity and safety with some patients continuing treatment at the data cutoff date. However, based on the data planned to be presented at ASCO (Free ASCO Whitepaper), we believe that IO-IO approach in patients with MSS CRC and liver metastases is not the way forward for Compugen at this time."

Dr. Cohen-Dayag added, "Our second data set this year will come from our platinum resistant ovarian cancer study, which is biologically distinct from MSS CRC, and in which our reported data suggest more dominant PVRIG pathway expression levels. We selected this indication to be pursued in the ongoing triplet study based on the deep durable responses, associated immune activation and potential associated biomarker data observed in our prior study, following treatment with our COM701 triple combination. It is important to note that observations made in tumors that are biologically distinct from each other, such as MSS CRC and platinum resistant ovarian cancer, are not indicative of each other. We believe that data showing clinical benefit in platinum resistant ovarian cancer would allow us to pursue the next studies towards a path to registration."

Dr. Cohen-Dayag concluded, "Compugen is a pioneer in computational discovery of novel drug targets. Our discovery platform, powered by AI and machine learning is fueling our pipeline and provides us with a competitive advantage. It has already delivered multiple proprietary clinical assets, multiple validating partnerships with pharma, and multiple early-stage undisclosed assets, all having the potential to deliver long term value creation."

Upcoming Expected Milestones
COM701 +COM902 + pembrolizumab proof-of-concept studies

Microsatellite stable colorectal cancer – ASCO (Free ASCO Whitepaper) poster presentation, June 1, 2024

Platinum resistant ovarian cancer – planned data presentation in the fourth quarter of 2024

COM503 (licenced to Gilead, Compugen lead through Phase 1 development)

IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance

Rilvegostomig (AstraZeneca’s PD-1/TIGIT bispecific, TIGIT component derived from COM902)

Data in the second half of 2024 from Phase 1/2 ARTEMIDE-01 trial in advanced/metastatic NSCLC

First Quarter 2024 Financial Highlights
Cash: As of March 31, 2024, Compugen had approximately $101.3 million cash, cash equivalents, restricted cash, and cash investments, compared with approximately $51.1 million as of December 31, 2023. The cash balance as of March 31, 2024, includes $60 million upfront payment received from Gilead related to the licensing of COM503 and $10 million milestone payment received from AstraZeneca on dosing the first patient in the Phase 3 ARTEMIDE-Biliary01 study in biliary tract cancer. All payments from Gilead are subject to a 15% withholding tax. During the three months ended March 31, 2024, the Company sold approximately 0.3 million ordinary shares, under its at the market offering (ATM) facility pursuant to a sales agreement entered into with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $0.6 million.

Compugen expects that its cash and cash-related balances together with a $30 million milestone payment on COM503 IND clearance expected in 2024, will be sufficient to fund its operating plans into 2027. This does not include any additional cash inflows from partners. The Company has no debt.

Revenue: Compugen reported approximately $2.6 million in revenue for the first quarter ended March 31, 2024, compared to no revenue for the comparable period in 2023. The revenue reported reflects recognition of a portion of the upfront payment from the license agreement with Gilead.

R&D expenses for the first quarter of 2024 were approximately $6.4 million compared with approximately $7.4 million for the comparable period in 2023.

G&A expenses for the first quarter of 2024 were approximately $2.4 million, compared with approximately $2.6 million for the comparable period in 2023.

Net loss for the first quarter of 2024 was approximately $7.3 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $9.3 million, or $0.11 per basic and diluted share, in the first quarter of 2023.

Full financial tables are included below.

Conference Call and Webcast Information
Compugen will hold a conference call today, May 20, 2024, at 8:30 AM ET to review its first quarter 2024 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on Compugen’s website.

Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA

On May 20, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that Atara has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tabelecleucel (tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Atara Biotherapeutics, MAY 20, 2024, View Source [SID1234643454]). For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.

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"The BLA submission for tab-cel represents a significant moment for Atara, our partner Pierre Fabre, and the broader allogeneic T-cell therapy field, and is a critical step towards our goal of delivering this first-of-its-kind treatment to EBV+ PTLD patients in the U.S.," said Pascal Touchon, President and Chief Executive Officer of Atara. "I would like to thank the patients and physicians who participated in the tab-cel clinical trials, our long-time collaborators at Memorial Sloan Kettering Cancer Center, as well as our internal teams for their remarkable dedication and hard work. We now look forward to continued collaboration with the FDA on its review and with Pierre Fabre as they actively prepare for the potential launch of this innovative therapy in the U.S."

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses.

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.

In December 2023, Atara announced the closing of the expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tab-cel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets. With the completion of the tab-cel BLA submission, Atara continues to advance the Pierre Fabre expanded global partnership, which includes potential milestone payments of $20 million and $60 million from Pierre Fabre contingent upon the successful FDA acceptance and approval of the tab-cel BLA, respectively. In addition, Pierre Fabre is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date. Atara is also eligible to receive double-digit tiered royalties on net sales of tab-cel in the U.S. and remaining global commercial markets referenced above.

Tab-cel was granted marketing authorization under the brand name Ebvallo in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In all three territories, Ebvallo is indicated as monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Alligator Bioscience Announces Publication Highlighting Potential of Next-Generation CD40 Agonists in Peer-Reviewed Medical Journal "Expert Opinion on Biological Therapy"

On May 20, 2024 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the publication of a scientific article detailing the potential of next-generation CD40-targeting therapies in immuno-oncology in the peer-reviewed medical journal "Expert Opinion on Biological Therapy" (Press release, Alligator Bioscience, MAY 20, 2024, View Source [SID1234643453]).

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The article, entitled "Next generation CD40 agonists for cancer immunotherapy" highlights how:

Bispecific CD40-targeting antibodies, as those developed using Alligators Neo-X-Prime platform, that maximize the ability of CD40 to both remodel the tumor microenvironment and boost the anti-tumor T cell response have the potential to meet key needs in immuno-oncology

Enhancing efficacy is the most important driver for developing new CD40-targeting therapies while ensuring safety is also critical to allow effective dosing in combination with other treatment modalities
Enhanced understanding of the role of different CD40-expressing immune cells in the tumor microenvironment may facilitate more efficient clinical development of these compounds

"There is a need in oncology for new therapies that can enhance response rates and broaden the number of cancer indications where immunotherapies provide clinical benefit," said Peter Ellmark, CSO of Alligator Bioscience and one of the authors of the article. "CD40-targeting therapies, such as Alligators ATOR-4066 program developed using our Neo-X-Prime platform, provide an opportunity to meet this need by promoting priming of tumor-specific T cells and reverting the immunosuppressive nature of the tumor microenvironment. The coming wave of next-generation CD40 agonists uses new approaches and formats which go beyond monospecific antibodies to improve efficacy and safety and provide great opportunities to benefit cancer patients."

InDex Pharmaceuticals has entered into a conditional agreement regarding a reverse merger with Flerie

On May 20, 2024 InDex Pharmaceuticals Holding AB (publ) ("InDex Pharmaceuticals" or the "Company") reported to have entered into a conditional agreement to acquire all shares in Flerie Invest AB (Press release, InDex Pharmaceuticals, MAY 20, 2024, View Source [SID1234643450]). The acquisition is made through an issue in kind of 6,073,952,948 new shares in the Company, following which Flerie Invest AB’s shareholders will initially hold approximately 91.9 per cent of the shares and InDex Pharmaceuticals’ existing shareholders will initially hold approximately 8.1 per cent of the shares in the Company.

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The transaction in brief

InDex Pharmaceuticals has entered into an agreement with the shareholders of Flerie Invest AB ("Flerie") to acquire all shares in Flerie through an issue in kind of 6,073,952,948 new shares in the Company (the "Consideration Shares", and the "Transaction", respectively). Through the Transaction, Flerie will become a wholly-owned subsidiary of InDex Pharmaceuticals and Flerie’s shareholders will initially hold approximately 91.9 per cent of the total number of shares and votes in the Company, prior to the completion of the Capital Raise (as defined below). As a result of the Transaction, the Company will change its name to Flerie AB ("New Flerie").
Flerie is valued at approximately SEK 3,073 million in the Transaction, based on reported net asset value as of 31 March 2024 with a discount of 10 per cent. InDex Pharmaceuticals is valued at approximately SEK 269 million, corresponding to the Company’s estimated cash position after closing costs with a premium of 20 per cent, which entails a subscription price of approximately SEK 0.506 per Consideration Share.
As part of the Transaction and the continued financing of New Flerie, a number of institutional investors, including the Company’s existing shareholders the Fourth Swedish National Pension Fund, HBM Healthcare Investments, Linc AB and SEB Stiftelsen, have undertaken to subscribe for new shares in the Company in a directed share issue (the "Capital Raise"). Through the Capital Raise, the Company will raise in aggregate approximately MSEK 520 before transaction costs.
The Company intends to convene an Extraordinary General Meeting to be held on 10 June 2024, at 8:30 a.m. CEST, to resolve on approval of the Transaction, issue in kind of the Consideration Shares, authorization to issue shares for the Capital Raise, election of new Board members and auditor, and other resolutions that follow from the Transaction (the "Second EGM"). On 6 May 2024 the Company convened an Extraordinary General Meeting to be held on the same day, 10 June 2024 at 8:00 a.m. CEST, to resolve on the amendments to the articles of association that follow from the Transaction (the "First EGM", and together with the Second EGM, the "EGMs").
HBM Healthcare Investments, Linc AB, SEB Stiftelsen and S-E Bankens Utvecklingsstiftelse, who together represent approximately 27.9 per cent of the shares and votes in InDex Pharmaceuticals, have undertaken to vote in favour of the Transaction and related resolutions at the EGMs. Furthermore, the Fourth Swedish National Pension Fund, representing approximately 9.8 per cent of the shares and votes in the Company, has expressed its intention to vote in favour of the Transaction and related resolutions at the EGMs.
The completion of the Transaction is, among other things, conditional upon resolutions at the EGMs and that the Company receives approval for continued listing on Nasdaq First North Growth Market.
Further information about the Transaction, Flerie and New Flerie will be set out in a company description that is expected to be published no later than 27 May 2024.
Background and motive

Following the discontinuation of cobitolimod development and InDex Pharmaceuticals announcing that the Company will not continue the development of any of its other compounds, various options for the Company’s future have been evaluated to maximize shareholder value. This has resulted in the proposed Transaction.

"I am very pleased that the evaluation has resulted in the proposed Transaction, as Flerie came out as the best option. Flerie has a highly regarded Board and management with excellent track record​ and a balanced risk profile. The attractive deal terms include a possibility for share redemption, in addition to being able to trade which ensures that we can offer shareholders optionality", comments Jenny Sundqvist, CEO of InDex Pharmaceuticals.

"This broadening of our shareholder base and becoming listed is a key step in Flerie’s plan to create a new model for life science investing: We continue our long-term, active investment strategy, while offering new shareholders access to and liquidity in difficult-to-assess biotech companies. The Transaction and the Capital Raise allow accelerated development of a risk-diversified portfolio of product development and commercial growth companies spanning obesity, diabetes, heart disease, cancer and autoimmune disorders to pharmaceutical manufacturing services, diagnostics, medical devices and tools", comments Ted Fjällman, CEO of Flerie and intended CEO of New Flerie.

About the Transaction

InDex Pharmaceuticals has today entered into an agreement with the shareholders of Flerie to acquire all shares in Flerie through an issue in kind of 6,073,952,948 new shares (the Consideration Shares) as consideration for the shares in Flerie. The Transaction is a so-called reverse merger whereby Flerie will become a wholly-owned subsidiary of InDex Pharmaceuticals. Flerie’s current shareholders will initially hold approximately 91.9 per cent of the total number of shares and votes in the Company and InDex Pharmaceuticals’ current shareholders will hold approximately 8.1 per cent of the total number of shares and votes in the Company following completion of the Transaction (prior to completion of the Capital Raise).

Flerie is valued at approximately SEK 3,073 million in the Transaction, based on reported net asset value as of 31 March 2024 with a discount of 10 per cent. InDex Pharmaceuticals is valued at approximately SEK 269 million, corresponding to the Company’s estimated cash position after closing costs with a premium of 20 per cent, which entails a subscription price of approximately SEK 0.506 per Consideration Share. The Board of Directors of InDex Pharmaceuticals considers that the valuation applied and the subscription price that the valuation entails is market-based.

Completion of the Transaction is subject to, inter alia, the following conditions, (i) the shareholders of InDex Pharmaceuticals resolving on approval the Transaction and other proposals at the EGMs, (ii) the Company obtaining approval for continued listing on Nasdaq First North Growth Market, and (iii) the Inspectorate of Strategic Products (Sw. Inspektionen för strategiska produkter, ISP) granting necessary approval for the Transaction pursuant to the Screening of Foreign Direct Investments Act (2023:560).

Description of Flerie and New Flerie

Operations

Flerie is an active and global long-term life science investor, focusing predominantly on biotech and pharmaceutical investments. Flerie is based in Stockholm and London managing a portfolio of 32 investments in Europe, Israel, and the US. The focus is on enabling pioneering organisations operating predominantly in the drug development and services space to succeed by providing them with resources and expertise.

Flerie invests in companies across the entire value chain, providing exposure to opportunities across three segments: Product Development, Commercial Growth, and Limited Partnerships. The portfolio includes investments in a wide range of areas, such as immuno-oncology, metabolic diseases and biologics development and manufacturing organisations, which have the potential to make a significant impact on health and wellbeing.

Through its expertise and network, Flerie provides investors with investment flexibility and exposure to difficult-to-access and difficult-to-assess companies within biological pharma, device, product and service innovations. Flerie utilises its broad network of reputable advisers and co-investors for advice on the choice of investment company, investment synergies and due diligence. Flerie´s Pharma network is large and growing and the portfolio companies have initiated collaborations with several well-established international operators.

Flerie was founded in 2011 by Thomas Eldered, who also co-founded and built Recipharm to becoming one of the world’s top five pharmaceutical contract manufacturers.

Flerie’s portfolio

The Product Development segment covers predominantly early-stage biotech and pharma companies which are in the process of advancing products or technologies to clinical proof of concept and towards marketing approval. Product Development companies are characterised by a high valuation uplifting potential and a pathway to success. Flerie may contribute to the development of such companies by encouraging partnering, licensing and expansion of the investor base to provide resources or opportunities. As an active owner, Flerie participates via boards to ensure product plans, platform technology expansion and product roadmaps are optimised. Flerie remains engaged to the appropriate endpoint, which could include the company taking its product to market, entering Commercial Growth. As of 31 March 2024, Fleries invested capital in the segment amounted to approximately SEK 2.2 billion and the fair value amounted to approximately SEK 2.1 billion, divided into 21 companies.

While companies in the Product Development segment are in an early stage of development, those in the Commercial Growth segment have reached a more mature phase and are generating sales. Since the risks of investing in pharmaceutical companies are primarily associated with the early stages of development, investments in Commercial Growth companies generally entail less technical risks, but also relatively lower returns upon a successful development of the company invested in. Flerie’s role in these companies is to assist them with the sales of their products or services to reach profitability, to support expansion through organic growth and through merger & acquisition opportunities. When a Commercial Growth company reaches maturity and Flerie is no longer adding value or it determines that the investment would be better deployed elsewhere, Flerie exits the company. As of 31 March 2024, Fleries invested capital in the segment amounted to approximately SEK 0.7 billion and the fair value amounted to approximately SEK 0.7 billion, divided into eight companies.

Under certain circumstances, Flerie may become a limited partner in an investment fund. Limited Partnerships primarily allow the Company to access the network, opportunities and skills of another investment company or fund and is primarily a way to de-risk the portfolio by diversifying into sectors that are new to Flerie as well as benefitting from the expertise of the specialists there. This way, Limited Partnerships provide advantages for the other two segments and Flerie’s long-term portfolio expansion possibility. As of 31 March 2024, Fleries invested capital in the segment amounted to approximately SEK 72 million and the fair value amounted to approximately SEK 71 million.

Board of directors, management and shareholders etc.

The Board of Directors of New Flerie shall consist of Flerie’s current Board: Thomas Eldered, Cecilia Edström, Anders Ekblom and Jenni Nordborg, with Thomas Eldered as chairman. Following completion of the Transaction, Flerie’s CEO Ted Fjällman will be appointed CEO of New Flerie and Flerie’s CFO and deputy CEO Cecilia Schéele will be appointed CFO and deputy CEO of New Flerie.

Thomas Eldered’s directly and indirectly wholly-owned companies T&M Förvaltning AB and T&M Participation AB (the "Major Shareholders") jointly hold approximately 97 per cent of the shares and votes of Flerie.[1] The remaining shares of Flerie are mainly held by employees and Board members of Flerie. Following the completion of the Transaction, but prior to completion of the Capital Raise, Thomas Eldered will thus become the largest shareholder of New Flerie with an indirect holding of approximately 89.1 per cent of the total number of shares and votes.

The Major Shareholders as well as Flerie’s Board and management will, towards Carnegie Investment Bank AB (publ) and DNB Markets, a part of DNB Bank ASA, Sweden branch (together the "Joint Bookrunners" in connection with the Capital Raise) undertake, with certain exceptions, not to sell or otherwise transfer or dispose of their shares in New Flerie. This lock-up period will last for 360 days from completion of the Transaction for the Major Shareholders and 180 days from completion of the Transaction for Flerie’s Board and management.

The Capital Raise

As part of the Transaction and the continued financing of Flerie, a number of institutional investors, including the Company’s existing shareholders the Fourth Swedish National Pension Fund, HBM Healthcare Investments, Linc AB and SEB Stiftelsen, have undertaken to subscribe for new shares in the Company for an aggregate amount of approximately SEK 520 millions in a directed share issue at a subscription price of approximately SEK 0.506 per share, corresponding to the subscription price per Consideration Share. These commitments are not secured by a bank guarantee, escrow, pledge or similar arrangements.

The purpose of the Capital Raise, and the reasons for the deviation from the shareholders’ preferential right, is to ensure that the Company meets the liquidity requirements for a listing on Nasdaq Stockholm, to ensure continued financing of New Flerie in immediate connection to the implementation of the Transaction, and to diversify and strengthen the shareholder base with institutional investors. Since the subscription price in the Capital Raise corresponds to the subscription price for the Consideration Shares, which is based on a valuation of InDex Pharmaceuticals that has been subject to arm’s-length negotiations with the sellers of Flerie, the Board of InDex Pharmaceuticals considers that the subscription price is market-based.

Through the Capital Raise, the Company will raise in aggregate approximately SEK 520 millions prior to transaction costs. New Flerie intends to use the net proceeds to fulfil its capital commitments, make add-on investments in current portfolio companies to accelerate their development and to improve the liquidity.

The Capital Raise entails a dilution of approximately 13 per cent of the number of shares and votes in New Flerie after completion of the Transaction by increasing the number of shares and votes by 1,025,959,478, from 6,606,640,598 to 7,632,600,076. The share capital increases by SEK 20,519,189.56 to SEK 152,652,001.52.

The Company intends to investigate the conditions to raise additional capital in connection with the share issue to be carried out for the Capital Raise, within the limits of the issue authorisation proposed to be resolved upon by the Second EGM.

New Flerie will undertake, for a period of 360 days from completion of the Transaction, not to, without the Joint Bookrunners’ approval, propose or take measures that entail an increase in the share capital, new share issues and similar measures, with certain exceptions, for example in connection with acquisitions or establishment of incentive programs.

Voluntary share redemption program

In connection with completion of the Transaction, the Company proposes that an annual voluntary share redemption program is established from and including 2025 in order to increase the liquidity of the New Flerie share. Through the redemption program, shareholders are proposed to have the right during an annual conversion period, to occur during the last week of March, to request the conversion of their ordinary shares into a new class of shares, convertible and redeemable shares of series C. Existing shares will constitute ordinary shares. Conversion can take place of up to five (5) per cent of the total number of outstanding shares. If the number of ordinary shares notified for conversion exceeds this limit, distribution shall be made in proportion to the number of ordinary shares that each shareholder has requested for conversion.

As soon as possible following the announcement of the interim report for the first quarter, New Flerie shall redeem all outstanding shares of series C at a redemption amount per share corresponding to the net asset value (NAV) per share as of 31 March. During 2025, certain different time periods will apply for the redemption program.

Further information about the proposed redemption program will be included in the complete proposal for new articles of association, which are proposed to be adopted by the First EGM.

The Major Shareholders and investors in the Capital Raise have undertaken not to exercise the redemption program prior to 2029 and 2026, respectively.

Continued listing on Nasdaq First North and admission to trading on Nasdaq Stockholm

The transaction is conditional upon Nasdaq Stockholm AB approving the Company for continued listing on Nasdaq First North Growth Market. The Company has initiated a process to obtain such approval.

In connection with completion of the Transaction, the Company intends to carry out an uplisting from Nasdaq First North Growth Market to Nasdaq Stockholm. The Company intends to draw up and publish a prospectus in connection with the admission to trading of shares in New Flerie on Nasdaq Stockholm. The prospectus is intended to be registered by the Swedish Financial Supervisory Authority and published on or around 26 June 2024. The first day of trading on Nasdaq Stockholm is planned to take place around 27 June 2024.

The EGMs

The EGMs will be held on 10 June 2024 in order to make the necessary resolutions for completion of the Transaction and the Capital Raise. The notice of the Second EGM will be published through a separate press release and will be available, together with complete proposals for resolutions for the EGMs, on the Company’s website no later than 27 May 2024.

The resolutions relating to the Transaction and the Capital Raise proposed to be made by the EGMs are (i) approval of the Company’s acquisition of Flerie, (ii) the issue in kind of the Consideration Shares to the shareholders of Flerie, (iii) authorisation to issue shares for the Capital Raise, (iv) adoption of new articles of association, including, among other things, change of name to Flerie AB, introduction of convertible and redeemable shares of series C in order to establish the voluntary share redemption program, and the other amendments to the articles of association that follow from the Transaction, (v) election of new Board members and auditor, (vi) reverse share split (1:100) in order to achieve a more appropriate pricing of the New Flerie share, (vii) adoption of principles for appointment of and instructions to the Nomination Committee, and (viii) adoption of guidelines for remuneration to senior executives.

Voting undertakings

HBM Healthcare Investments, Linc AB, SEB Stiftelsen and S-E Bankens Utvecklingsstiftelse, who together represent approximately 27.9 per cent of the shares and votes in InDex Pharmaceuticals, have undertaken to vote in favour of the Transaction and related resolutions at the EGMs. Furthermore, the Fourth Swedish National Pension Fund, representing approximately 9.8 per cent of the shares and votes in the Company, has expressed its intention to vote in favour of the Transaction and related resolutions at the EGMs.

Exemption from mandatory offer

Thomas Eldered will, as described above under the section Description of Flerie and New Flerie – Board of directors, management and shareholders etc., by way of the subscription of Consideration Shares by the Major Shareholders, achieve an indirect shareholding in the Company corresponding to at least three tenths of the voting rights of all shares in the Company after completion of the Transaction. According to the Takeover rules for certain trading platforms, Thomas Eldered would thus be obliged to make a public tender offer for all shares in InDex Pharmaceuticals (so-called mandatory offer obligation) as a result of the Transaction. Thomas Eldered has therefore applied for, and on 16 May 2024 received, an exemption from the Swedish Securities Council regarding the above-mentioned mandatory offer obligation. For further information, see the Swedish Securities Council’s statement 2024:47.

Company description

Further information about the Transaction, Flerie and New Flerie will be presented in a company description that will be published prior to the EGMs.

Indicative timetable for the Transaction

The timetable below is preliminary and subject to change.

21 May 2024 Investor meeting
27 May 2024 Publication of company description
10 June 2024 The EGMs
11June 2024 Completion of the Transaction
14 June 2024 Execution of the Capital Raise
26 June 2024 Expected date for decision by Nasdaq Stockholm AB’s listing committee on whether New Flerie meets the requirements for listing on Nasdaq Stockholm
26 June 2024 Excepted date for announcement of prospectus for admission to trading on Nasdaq Stockholm and last day of trading on Nasdaq First North Growth Market
27 June 2024 Expected first day of trading on Nasdaq Stockholm
Investor meeting

InDex Pharmaceuticals and Flerie invite to a digital investor meeting on 21 May 2024 at 4:00 p.m. CEST in order to inform shareholders about the Transaction and to provide shareholders and stakeholders with the opportunity to ask questions. The meeting will be held by Jenny Sundqvist, CEO, and Johan Giléus, CFO and deputy CEO of InDex Pharmaceuticals, together with Ted Fjällman, CEO of Flerie and intended CEO of New Flerie after completion of the Transaction. The meeting will take place at Redeye’s office at Mäster Samuelsgatan 42 (10th floor) in Stockholm, Sweden. Additionally, the presentation and the Q&A will be webcast.

To register to participate on site at Redeye in Stockholm, please use the following link: View Source
To follow the event via the webcast, please use this link: View Source
Advisors

Redeye AB is financial advisor and Setterwalls Advokatbyrå is legal advisor to InDex Pharmaceuticals in connection with the Transaction. Carnegie Investment Bank AB (publ) is Global Coordinator and Joint Bookrunner and DNB Markets, a part of DNB Bank ASA, Sweden branch is Joint Bookrunner in connection with the Capital Raise and financial advisors to Flerie in connection with the Transaction. KANTER Advokatbyrå KB is legal advisor to Flerie in connection with the Transaction.

For more information:

Jenny Sundqvist, CEO of InDex Pharmaceuticals
Tel: +46 8 122 038 50
E-mail: [email protected]

Johan Giléus, CFO and deputy CEO of InDex Pharmaceuticals
Tel: +46 8 122 038 50
E-mail: [email protected]

Ted Fjällman, CEO of Flerie
E-mail: [email protected]

This information is information that InDex Pharmaceuticals Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation (MAR). The information was submitted for publication through the agency of the CEO on 20 May 2024, at 09.00 p.m. CEST.

Innovent Announces Oral Presentations at ESMO Plenary and ESMO GI Congress on Clinical Data of IBI363 (PD-1/IL-2) and IBI343 (CLDN18.2 ADC)

On May 19, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the company will deliver oral presentations on clinical data of its first-in-class PD-1/IL-2 bispecific antibody fusion protein (R&D code: IBI363) and novel Topoi anti-Claudin18.2 ADC (R&D code: IBI343) at the upcoming medical conferences in June, including ESMO (Free ESMO Whitepaper) Virtual Plenary and ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress (ESMO GI) 2024. Details are as follows (Press release, Innovent Biologics, MAY 19, 2024, View Source [SID1234643430]):

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ESMO Virtual Plenary, June 13-June 14, 2024

Title: First-in-class PD-1/IL-2 bispecific antibody fusion protein IBI363 in patients (pts) with advanced solid tumors: First-in-human phase I study
Presentation Form: Oral
Presentation Time: 13 Jun 2024 18:30-19:30 CEST & 14 June 2024 13:00-14:10 CEST
Presenting Author: Prof. Xueli Bai, The first affiliated hospital, Zhejiang University School of Medicine

ESMO Gastrointestinal Cancers Congress, June 26-June 29, 2024, Munich, Germany

Title: Anti-claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC) IBI343 in patients (pts) with solid tumors and gastric/gastro-esophageal junction adenocarcinoma (G/GEJ AC): A phase 1 study
Publication Number: 396MO
Presentation Form: Oral
Presentation Time: 29 June 2024 08:45-10:00 CEST
Presenting Author: Jia (Jenny) Liu, St Vincent’s Hospital Sydney

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We will present a robust set of clinical data for our next-generation innovative bispecific antibodies and ADC molecules at multiple conferences in the near term. We observed the preliminary efficacy and safety signals for those innovative candidates, underscoring their potential for further development and clinical value. Innovent leverages our world-class antibody-based platform, differentiated ADC technology and deep scientific understanding to build the new generation innovative pipeline of "IO+ADC". We strive to solve the unmet needs of existing therapies and fill the treatment gap for cancer patients worldwide."