1stOncology™: Cancer Intelligence Service – Page 5743 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

OSE Immunotherapeutics Receives a €10 Million Payment Corresponding to the Second Tranche of the Financing Granted by the European Investment Bank

On December 16, 2022 OSE Immunotherapeutics reported a €10 million drawdown corresponding to the second tranche of the financing granted by the European Investment Bank (EIB) (Press release, OSE Immunotherapeutics, DEC 16, 2022, View Source [SID1234646947]). The finance contract was signed on February 12, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

After the drawdown of the first tranche in July 20211 , the Company had an option to access further 10 million euros, subject to the achievement of certain milestones. Following the achievement of those milestones, the Company wishes to reinforce its financial position until Q3 2023 by drawing on the second tranche of the facility, to finance its preclinical and clinical programs.

This second tranche will carry a fixed interest of 5% per year paid annually, with a maturity of five years.

The second tranche is linked to the issuance of warrants to the EIB giving right, in the event of exercise, to the subscription of 550,000 shares of the Company (i.e., 2.97% of the share capital on an undiluted basis). Warrants are not the subject to an application for admission to trading on any market.
The subscription price is €0.01 per warrant, i.e., €5,500.

In order to limit the dilutive impact and except in the event of the occurrence of an early exercise event (notably a change of control, including the loss of a significant holding by the current management shareholders, or other events of default, including a significant change in the current governance not approved by the EIB), the warrants will only be exercisable from 16 December 2027, i.e. five years from the drawdown of the relevant tranche and at the latest at the end of a period of twelve years following their issue (i.e. 16 December 2034).

The subscription price for the new shares upon exercise of the warrants was set at 7.19 euros per share, i.e. corresponding to the volume-weighted average of the three trading days preceding the pricing, without discount.

In accordance with the warrant agreement, as with the first tranche, the EIB has an anti-dilution clause allowing it to benefit from additional warrants, in the event of a capital increase of the Company at a price less than €20 per share, after application of a deductible on the first 1,500,000 shares to be issued. In such a case, the Company would have to allocate additional warrants to the EIB allowing it to remain at a potential capital level of 2.97% (corresponding to its theoretical holding percentage post-allocation of these 550.00 warrants and exercise of these warrants subscribed in the context of the second tranche of funding).

The shares to be issued upon exercise of the warrants will be subject to an application for admission to trading on Euronext Paris. On the basis of 550,000 new Company’s shares issued upon exercise of all the warrants at a price of 7.19 euros per new share, the gross proceeds of the issue, issue premium included, will amount to 3,954,500 euros, thereby strengthening the Company’s equity.

On 16 December 2027, the EIB has the option to ask the Company to buy back its warrants at market value (less the exercise price of the warrants) up to a maximum of 15 million euros provided that the Company retains a cash level of at least 10 million euros. Otherwise, the EIB’s put option will be exercised on a number of warrants allowing the Company to maintain a cash level of 10 million euros. This put option also applies in the event of a change of control, understood as the holding of more than 33% of the capital or the taking of control by a third party (other than the current key managers). The Company may substitute an existing shareholder or a third party to buy back these warrants at market value. The Company has a call option allowing it to buy back the EIB warrants at market value (less the exercise price of the warrants) in the event of a public offer by a third party resulting in the exit of the management shareholders, for a period of one month following such exit. The Company also has a right of first refusal allowing it to buy back the EIB’s warrants if the latter wishes to sell them to a third party.

Following the drawdown of this second tranche, the financial debt amounts to 26 M€.

iPSirius Wins $2M Award from European Innovation Council to Develop a Novel Stem Cell Vaccine to Help Cancer Patients Worldwide

On December 19, 2022 iPSirius reported the company got $2M Award from European Innovation Council to Develop a Novel Stem Cell Vaccine to Help Cancer Patients Worldwide (Press release, iPSirius, DEC 16, 2022, https://bioinformant.com/ipsirius/ [SID1234640999]).

Pivotal to the company bringing these new cancer vaccines to the clinic is the innovative technology that won a very competitive Pathfinder Award from the European Innovation Council. This secured $2M to translate the technology to the clinic. The European Innovation Council gives out the EIC Pathfinder award to "support research teams to develop emerging breakthrough technologies".

"We are very grateful to European Innovation Council for this necessary financial support that will accelerate access of our stem cell vaccine pipeline to the clinic. Our team at iPSirius is eager to develop off-the-shelf, cell-based vaccines that can improve the quality of life for patients with aggressive cancers worldwide. We hope that these new cancer vaccines will be transformative to the field of cancer therapy," said co-Founder and Chief Medical Officer, Prof Ali Turhan.

iPSirius is addressing key challenges in treating non-immunogenic solid tumors, based on the immunogenic properties of stem cells.

More details can be found at the company website, www.iPSirius.com.

Hervolution has been awarded an EU grant to further explore the role of IPT001 in oncological immunotherapy approaches against hard to treat cancers

On December 16, 2023 Hervolution Therapeutics reported that the company advance its understanding of the potential applications of IPT001 in enhancing oncological immunotherapy, ultimately contributing to the development of more effective treatment strategies for cancer patients (Press release, Hervolution Therapeutics, DEC 16, 2022, View Source [SID1234637207]).

"Significant progress has been made as Hervolution secures a substantial EU fund to expand its research efforts into utilizing IPT001 within the field of oncological immunotherapy. This funding is part of the Eurostars-3 collaborative project, in conjunction with esteemed partners ORYZON and the University of Copenhagen. The project, boasting a total budget of 1.4 million euros, has allocated up to 300,000 euros to Hervolution. The primary objective of this initiative is to evaluate the effectiveness of IPT001 when combined with checkpoint inhibitors and/or oncological vaccines for the treatment of diverse solid tumors.

December 16th, 2022, marked an important milestone for Danish institution Hervolution as it announced the approval of funding for the BRAVE Project (Breaking immune Resistance of Advanced cancers by HERV-K Vaccination and Epigenetic modulation) by the EU-intergovernmental organization EUREKA secretariat, under the Eurostars-3 program. Collaborating with ORYZON and the University of Copenhagen, Hervolution is embarking on a comprehensive investigation into the role of IPT001 within various immunotherapy strategies targeting solid tumors. These strategies include leveraging checkpoint inhibitors and oncological vaccines.

The project is set to commence on May 1, 2023, and will be executed over a span of two years.

Dr. Peter Holst, Chief Scientific Officer of Hervolution, highlighted the potential of checkpoint inhibitors and targeted oncological vaccines as viable alternatives for solid tumors that demonstrate poor response to chemotherapy or limited responsiveness. However, the effectiveness of these strategies largely depends on the successful immune presentation of antigens by tumor cells. Certain tumors, known as "cold tumors," manage to evade this requirement. Through the utilization of IPT001, an immunotherapy agent that specifically targets Human Endogenous Retro Virus, researchers anticipate enhanced immune response, opening doors for improved efficacy when combined with these immunotherapy approaches. These approaches has the potential to revolutionize the treatment of a number of cancer types that have not yet benefitted substantially from immunotherapies.

Entry into a Material Definitive Agreement

On December 16, 2022, Humanigen, Inc. (the "Company"), and Catalent Pharma Solutions, LLC ("Catalent") reported that it has entered into a Settlement Agreement (the "Settlement Agreement") resolving certain previously reported disputes between the Company and Catalent that had arisen under the Multiple Facility Clinical Supply and Services Agreement (the "MSA") dated July 31, 2020, by and between Catalent and the Company, pursuant to which Catalent had agreed to perform certain services relating to the manufacturing of lenzilumab, the Company’s lead product candidate (Filing, 8-K, Humanigen, DEC 16, 2022, View Source [SID1234625539]).

Pursuant to the Settlement Agreement, the Company agreed to make a one-time payment of $12 million (the "Settlement Payment") to Catalent in full satisfaction of all of the Company’s payment obligations under the MSA for products and prior services, as well as cancellation fees Catalent claimed to be owed. In consideration of its receipt of the Settlement Payment, which the Company made on December 22, 2022, Catalent waived and released Catalent’s rights to pursue all payments, claims, or invoices for such products and services and cancellation fees, as well as for some limited additional work to be performed by Catalent, quantified at approximately $23.5 million in the aggregate.

The terms and conditions of the MSA generally will remain in full force and effect with respect to any ongoing activities and additional work to be performed by Catalent.

The foregoing description of the material terms of the Settlement Agreement does not purport to be complete and is qualified in its entirety by reference to the Settlement Agreement, to be filed with the Securities and Exchange Commission as an exhibit to the Company’s 2022 Annual Report on Form 10-K.

Purchase Agreement Amendment

On December 16, 2022, Midatech Pharma PLC (the "Company") and a certain institutional investor (the "Investor") entered into a first amendment (the "Purchase Agreement Amendment") to the securities purchase agreement (the "Purchase Agreement"), dated as of December 13, 2022, by and between the Company and the Investor (Filing, 6-K, Midatech Pharma, DEC 19, 2022, View Source [SID1234625408]). Pursuant to the Purchase Agreement Amendment, the Company and the Investor agreed (i) to increase the exercise price of the Series A warrants and Series B warrants that are expected to be issued to the Investor at the second closing provided for therein (the "Second Closing") to $1.10; (ii) to change the purchase price of the Company’s American Depositary Shares expected to be issued to the Investor at the Second Closing to the lesser of (x) $1.00 or (y) 20-Day VWAP (as defined in the Purchase Agreement Amendment) minus 10.0%; (iii) that the Company may terminate the Purchase Agreement and the Registration Rights Agreement, dated as of December 13, 2022, by and between the Company and the Investor, if the 20-Day WVAP on the proposed date of the Second Closing is less than $1.00; and (iv) that the Investor shall not execute any short sales of the Company’s securities prior to the occurrence of the Second Closing.

In addition, on December 18, 2022, the Company and Bioasis Technologies Inc. ("Bioasis") entered into a first amendment (the "Arrangement Agreement Amendment") to the arrangement agreement (the "Arrangement Agreement"), dated as of December 13, 2022, by and between the Company and Bioasis. Pursuant to the Arrangement Agreement Amendment, the Company and Bioasis agreed that (i) the loan to Bioasis shall now be made in three tranches of $250,000 payable on each of December 19, 2022, January 3, 2023 and February 6, 2023 as opposed to one payment of the loan in full; and (ii) provide the Company the sole discretion to seek shareholder consent to the proposed cancellation of the Company’s ordinary shares to trading on AIM, a market of the London Stock Exchange.

The foregoing descriptions of the Purchase Agreement Amendment and Arrangement Agreement Amendment are not complete and are qualified in their entirety by reference to the full text of the form of Purchase Agreement Amendment and the Arrangement Agreement Amendment, which are filed as Exhibits 10.1 and 10.2, respectively, to this Report on Form 6-K and are incorporated by reference herein.

On December 19, 2022, the Company issued a press release announcing the closing of its previously announced registered direct offering and the amendments to the Purchase Agreement and Arrangement Agreement. A copy of such press release is attached as Exhibit 99.1 hereto and is incorporated herein by reference.