NH TherAguix announces the launch of its IPO on the Euronext Growth market in Paris

On September 28, 2021 NH TherAguix, a French biotechnology company specialising in the development of innovative nano medicines for the radiotherapy treatment of cancer indications, reported the launch of its initial public offering with a view to listing its shares on the Euronext Growth market (ISIN code: FR0013105954-ticker: ALNHT) (Press release, NH TherAguix, SEP 28, 2021, View Source [SID1234590544]). On 27 September 2021, the French financial markets authority (Autorité des Marchés Financiers-AMF) approved the Prospectus under number 21-416, comprising the Registration Document, approved on 10 September 2021 under number I.21-048, the supplement to this Registration Document approved on 27 September 2021 under number I.21-055, a Securities Note and a summary of the Prospectus (included in the Securities Note).

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Géraldine Le Duc, Chief Executive Officer of NH TherAguix, says: "NH TherAguix aims to demonstrate that its candidate drug AGuIX increases the effectiveness of radiotherapy on solid tumours, while sparing the surrounding healthy tissues. It offers new hope for cancer patients and our ambition is to make AGuIX the new standard of care in the treatment of certain cancers with radiotherapy. To do this, we have developed AGuIX so that it can be integrated into all current care protocols, without changing patient treatment. The indications that we are primarily targeting include pancreatic cancer, glioblastoma, the most comment brain cancer found in adults, and brain metastases. This planned IPO will allow us, on the one hand, to consolidate the Company’s financial position and, on the other, to obtain additional resources to be able pursue the development of the candidate drug AGuIX, and more specifically to develop the current pipeline of clinical trials (covering in particular glioblastoma, pancreatic cancer and brain metastases) with a view to registration trial, for which the Company would act as sponsor. I hope I can count on the support of many institutional and retail investors in this human and entrepreneurial adventure." Press Release Should not be published, transmitted or distributed directly or indirectly in the United States of America, Canada, Japan or Australia 2 Pushing the current boundaries of radiotherapy In the fight against cancer, radiotherapy is one of the standard care treatments. 60% of patients with cancer are treated with radiotherapy during their care pathway.

However, despite advances in technology and the continuous improvement of equipment, radiotherapy has limitations due to the harmful effects it causes on healthy tissue close to the tumour. These side effects limit the effectiveness of certain treatments and sometimes make radiotherapy unsuitable for certain forms of cancer. A theranostic1 approach for precision radiotherapy Increasing the x-ray dose differential between the tumour and surrounding healthy tissue is now the most promising way of improving radiotherapy.

Based on this observation, NH TherAguix has developed an innovative theranostic1 approach in nanomedicine: AGuIX. Designed to be able to increase the dose differential between the tumour and healthy tissues and therefore to increase the efficacy of radiation therapy, AGuIX also allows more accurate imaging guidance after targeting the tumour. The combination of these three properties (targeting, imaging and treatment) paves the way for a new generation of precision radiotherapy.

The first "triple action" candidate drug By injecting a single dose, AGuIX works in three complementary ways:
1. Targeting: Nanoparticles are injected intravenously. Thanks to their size of 5 nanometers, they accumulate naturally and exclusively in the tumour through a biodistribution process (effect known as EPR2).
2. Imaging: The presence of gadolinium atoms in the structure of AGuIX ensures that the tumour is clearly visible via magnetic resonance imaging prior to radiotherapy, allowing the tumour to be delineated in order to calibrate radiation therapy.
3. Treatment: Its radiosensitising properties enable AGuIX to amplify the effect of radiation directed against the tumour through a physical interaction. By creating a dose differential between the cancer and adjacent tissues, the radiation therapy could become more effective. A candidate drug adapted to the patient care pathway Intravenous administration of AGuIX is a key component of its therapeutic effectiveness as it makes it easy to use by healthcare staff. It does not disrupt the treatment pathway, and does not require any specific equipment or training. It is also possible to combine

AGuIX with all current and future radiotherapy technologies.
1 Theranostics: therapeutic approach combined with better diagnosis.
2 Enhanced Permeability Retention effect: nanoparticles tend to accumulate more in the tumour than in healthy tissues, mainly due to 2 biological phenomena: abnormal blood vessel development and inefficiency of lymphatic drainage in cancerous tissues. Press Release Should not be published, transmitted or distributed directly or indirectly in the United States of America, Canada, Japan or Australia
3 Strong proof of concept The first study in humans was conducted in the Phase 1b trial on brain metastases in 15 patients, NANORAD 1, which first helped to established the absence of toxicity and adverse effects of AGuIX.

In addition to the safety parameters, this study demonstrated a clinical benefit with encouraging overall survival rates and confirmed the triple effect of AGuIX after injection (targeting, imaging and treatment). A dose effect has also been highlighted: the higher the concentration of AGuIX in brain metastases, the lower their size and therefore the better their response to treatment.3 Preliminary observations of the ongoing NANORAD 2, Phase 2 trial on brain metastases show tolerance and contrast entirely consistent with the Phase 1 trial results. It also seems that the activity signals of AGuIX already cited, namely a radiosensitisation response related to improved control of tumour volume and survival, can be observed here. These very preliminary observations reveal a trend that needs to be confirmed or invalidated based on the existence of the control arm and the statistical strength of the trial if sufficient. A potential pan-cancer treatment deployed through 8 Phase 1 and 2 clinical trials, 3 of which are already recruiting, 4 of which have been authorised by health authorities and one of which is being prepared The properties of AGuIX show pan-cancer potential: intravenous injection combined with the ability of AGuIX to accurately target the tumour enables the treatment of cancers that are difficult to access by intratumoral injection. At this stage, all injected tumours have been visible via MRI (49 patients). Markus Loeffler, NH TherAguix Medical Director, comments: "The results of the Phase 1 study are very encouraging. NH TherAguix has now entered Phase 2 with 2 clinical trials focusing on radiotherapy for brain metastases, either by whole brain radiotherapy (NANORAD 2), or as a complementary treatment by radiosurgery (NANOBRAINMETS), and also has a Phase 1 trial on advanced cervical cancer (NANOCOL).

The launch of other trials in Europe and the United States, in partnership with internationally renowned cancer research institutes, is a very important strategic step for NH TherAguix." 3Targeting brain metastases with ultrasmall theranostic nanoparticles, a first-in-human trial from an MRI perspective. Verry C et al. Science Advances. 2020 Theranostic AGuIX nanoparticles as radiosensitizer: A phase I, dose-escalation study in patients with multiple brain metastases (NANO-RAD trial) Verry C. et al. Radiotherapy & Oncology, 2021 Press Release Should not be published, transmitted or distributed directly or indirectly in the United States of America, Canada, Japan or Australia 4 By the end of 2021, AGuIX technology should be in use in 7 Phase 1 and 2 clinical trials, 3 of which are already recruiting and 4 of which have been authorised by health authorities: *ODD (Orphan Drug Designation): orphan candidate drug status obtained in the United States, allowing for fast track recording in case of conclusive outcomes.

Clinical Development Strategy The clinical development strategy of AGuIX aims to exploit its pan-cancer potential with the objective of recording as quickly as possible primary and orphan cancers such as pancreatic cancer or glioblastoma, for which the therapeutic arsenal is very limited and which represent a significant market opportunity. For these indications, the Company operates in partnership with recognised institutes such as Dana-Farber Cancer Institute and Harvard. The Company is also targeting a broader market, namely the treatment of brain metastases, an indication in which the Company has already acquired results and the potential of which is significant due to its impact, and in which the number of competitors is limited.

Finally, the Company is considering the development of AGuIX to treat other indications. It is therefore promoting the implementation of clinical trials funded by research grants as part of academic collaborations to enable it to collect clinical and scientific data while preserving its financial resources. Press Release Should not be published, transmitted or distributed directly or indirectly in the United States of America, Canada, Japan or Australia 5 Financial and industrial support In 2019, the company experienced strong growth, having raised Series A funding of €12.3 million from recognised venture capital funds (BPI Innobio2, Arbevel, Omnes and Supernova). Thanks to this funding, the Company was able to launch its Phase 2 clinical trials and fund the scaling of production of its experimental drug, in partnership with Sanofi, the laboratory that produces the AGuIX nanoparticle. Offering eligible for PEA and PEA-PME equity savings plans NH TherAguix complies with the eligibility criteria for PEA-PME equity savings plans specified by the provisions of Articles L.-221-32-2 and D.221-113-5 et seq. of the French Monetary and Financial Code. As a result, NH TherAguix’s shares can be fully integrated into equity savings plans (PEAs) as well as PEA-PME accounts which enjoy the same tax benefits as traditional PEAs*.

Availability of the Prospectus Copies of the Prospectus approved by the AMF on 27 September 2021 under number 21-416 are available free of charge upon request from the Company and can also be consulted on the websites of the AMF (View Source) and NH TherAguix (View Source). Approval of the Prospectus should not be considered as a favourable opinion on the securities offered or admitted for trading on the Euronext Growth market in Paris. Risk Factors The risks associated with pursuing the effective progress of AGuIX’s clinical development, and more generally the risk factors to which the Company is exposed are presented in Chapter 3 "Risk Factors" of the Registration Document and in Section 3 "Risk factors related to the Offering" in the Securities Note. The occurrence of one or more of these risks is liable to have a significant adverse impact on the activities, assets, financial position, results or outlook of NH TherAguix, as well as on the market price of the Company’s shares.

Financial intermediaries and advisers Global Coordinator and Joint Bookrunner Joint Bookrunner Financial Communication Agency Legal counsel Statutory Auditors Statutory Auditors Press Release Should not be published, transmitted or distributed directly or indirectly in the United States of America, Canada, Japan or Australia

6 MAIN TERMS OF THE TRANSACTION ▪ SHARE CAPITAL BEFORE THE ISSUE A public limited company (société anonyme) with a board of directors, with share capital of €244,081.00 divided into 6,102,025 shares with a par value of €0.04 each.
▪ CHARACTERISTICS OF THE SHARES
• Title: NH TherAguix
• Ticker: ALNHT
• ISIN: FR0013105954
• Listing market: Euronext Growth Paris
• ICB classification: 20103010-Biotechnology
• LEI: 9695007Z8UJ5AFRZQN66
• Eligible for the PME-ETI equity savings plan
▪ INDICATIVE PRICE RANGE Between €15.50 and €18.90 per new share. This information is provided for information purposes only and is in no way indicative of the price of the Offering, which may be set outside this indicative range. ▪ INITIAL SIZE OF THE OFFERING The Offering will be made by placing on the market 1,744,187 new shares to be issued, which may be increased to 2,005,815 new shares in the event of full exercise of the extension clause and 300,872 additional new shares in the event of full exercise of the overallotment option, i.e. a maximum of 2,306,687 shares offered in the event of full exercise of the extension clause and the overallotment option.

▪ GROSS TRANSACTION AMOUNT Approximately €30 million, which may be increased to approximately €34.5 million in the event of full exercise of the extension clause and approximately €39.7 million in the event of full exercise of both the extension clause and the overallotment option (based on the midpoint of the indicative price range of the Offering, i.e. €17.20). ▪ NET PROCEEDS FROM THE OFFERING Approximately €27.2 million, which may be increased to approximately €31.4 million in the event of full exercise of the extension clause and approximately €36.3 million in the event of full exercise of both the extension clause and the overallotment option (based on the midpoint of the indicative price range of the Offering, i.e. €17.20). Press Release Should not be published, transmitted or distributed directly or indirectly in the United States of America, Canada, Japan or Australia

7 ▪ STRUCTURE OF THE OFFERING The offered shares will be distributed as part of a global offering (the "Offering"), comprising:
• An offering to the public in France in the form of an open-price offering, mainly intended for private individuals (the "Open-Price Offering" or "OPO"), where: o the orders will be broken down according to the number of shares requested: A1 order fraction (from 1 share up to 250 shares) and A2 order fraction (over 250 shares); o the A1 order fractions will receive preferential treatment relative to the A2 order fractions in the event that all orders cannot not be entirely satisfied.
• A global placement mainly intended for institutional investors (the "Global Placement"), comprising: o a placement in France; o an international private placement in certain countries, excluding in particular the United States of America, Japan, Canada and Australia; and o a private placement in the United States for a limited number of qualified institutional buyers as defined in Rule 144A of the U.S. Securities Act of 1933 (as amended) (the "Securities Act"), in the context of the exemption of private placements from the registration provisions pursuant to Article 4(a)(2) of the Securities Act. If permitted by the request expressed under the OPO, the number of shares allocated in response to orders issued under the OPO will be at least equal to 10% of the number of shares offered under the Offering (before any exercise of the extension clause and the overallotment option).

▪ LOCK-UP COMMITMENTS AND CONSERVATION Company lock-up agreement: 180 calendar days following the settlement/delivery date of the Offering, subject to certain exceptions. Commitment by the Company’s shareholders to hold on to their shares: all shareholders and holders of securities giving access to the Company’s share capital shall make a commitment to the joint bookrunners to conserve the shares they hold on the date on which the Offering Price is set for a period of 270 calendar days following the settlement-delivery date of the Offering, subject to certain usual exceptions.

▪ SUBSCRIPTION COMMITMENTS FPCI InnoBio 2, represented by Bpifrance Investissement, FCPI Arbevel Life Sciences Crossover I, represented by Financière Arbevel, and FCPI Supernova 2, represented by Supernova Invest, have each committed to place a subscription order in the order book for a maximum amount of €3.00 million, €2.35 million and €1.50 million respectively. In addition, Guerbet, a French company with international expertise in medical imaging (diagnostic and interventional) and listed on Euronext Paris, has made a commitment to place an order of €3.00 million in the order book. These orders, which therefore represent 32.8% of the gross proceeds of the Offering (if the Offering is 100% subscribed and excluding the exercise of the extension clause and the overallotment option) are intended to be served in priority and in their entirety, subject to reduction in accordance with usual allocation principles (mainly if the subscriptions received are way over the number of shares offered).

Press Release Should not be published, transmitted or distributed directly or indirectly in the United States of America, Canada, Japan or Australia 8 Guerbet’s investment comes as both companies have started to work together on artificial intelligence for clinical trials on pancreatic cancer and glioblastoma, as developed by the Company. Last July, the Company and Guerbet tendered together for State funding (as an Important Project of Common European Interest (IPCEI)) in this area. Regardless of the (limited) chances of obtaining such funding, the agreement signed on 23 September 2021 on Guerbet’s subscription commitment suggests that the two companies will discuss the scope of collaboration work on the AGuIX platform and will subsequently negotiate a collaboration agreement to that effect in good faith.

Cue Biopharma Announces Publication in Nature Journal, Scientific Reports, of Immunotherapeutic Platforms Immuno-STAT and Neo-STAT

On September 28, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported the publication of research titled "Peptide-HLA-based immunotherapeutics platforms for direct modulation of antigen-specific T cells" in the peer-reviewed Nature journal, Scientific Reports (Press release, Cue Biopharma, SEP 28, 2021, View Source [SID1234608270]). The article describes Cue Biopharma’s IL-2 based CUE-100 series technology platforms, Immuno-STAT (Selective Targeting and Alteration of T cells) and Neo-STAT, being leveraged for the development of first-in-class biologics that enable selective activation of cancer-killing immune T cells within the patient’s body.

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"We believe our platforms address a significant challenge in immunotherapy of ensuring selective targeting of activation signals to anti-tumor T cells in the patient while sparing the indiscriminate systemic activation of the immune system," said Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma. "Adoptive cell therapy such as chimeric antigen receptor T-cell (CAR-T) therapies have demonstrated highly encouraging results for some patients but remain limited by the need of cellular ex-vivo manipulation and manufacturing challenges. Similarly, systemic approaches with immunostimulatory molecules, such as interleukin 2 (IL-2) or bispecific molecules, activate T cells indiscriminately and are associated with common severe adverse events, significantly limiting clinical benefit and applicability. Cue Biopharma’s approach and resulting platform, represents a potential breakthrough in the ability to selectively and safely modulate the immune system in a highly controlled and targeted manner directly in the patient’s body with the potential to create life-changing therapeutics with demonstrated improved efficacy and reduced toxicities."

Key aspects of Cue Biopharma’s technologies discussed in the article include:

The Immuno-STAT platform enables development of first-in-class off-the-shelf biologic molecules designed to selectively engage and activate disease-relevant T cells via the T cell receptors (TCR), mimicking the natural immune process, through the presentation of complimentary and synergistic signals, or "cues." An Immuno-STAT is engineered to include:
A first signal, or "cue" involving the presentation of a targeted and specific epitope, via a major histocompatibility (MHC)-peptide complex, to T cell receptors, or TCRs, of disease-specific T cells, to selectively engage a repertoire of T cells relevant to a particular disease such as cancer.
A corresponding second signal, or "cue" comprising the immunostimulant IL-2 molecule engineered with particular modifications for activation and expansion of CD8+ cytotoxic T cells, the relevant type of T cells with cancer-killing activity and minimize off-target binding and activation.
The Immuno-STAT is constructed upon a portion of a human antibody (the "Fc portion") that serves as the molecule’s backbone or scaffold and provides manufacturability and structural stability.
Through this design, Immuno-STATs enable disease specificity, targeted selective activation of CD8+ T cells and a larger therapeutic window for IL-2 effectiveness.
Neo-STAT is a plug-and-play variation of the Immuno-STAT platform designed with an empty "pocket" for the peptide presentation signal, enabling easy integration of disease-specific antigens a-posteriori to target a variety of cancers and infectious diseases.
The modular Immuno-STAT framework is compatible with diverse co-modulators, including immuno-suppressive molecules, with potential to address a variety of autoimmune diseases.
Ken Pienta, M.D., acting chief medical officer of Cue Biopharma, added, "We have identified a potential solution to safety and scalability challenges based on natural signals governing T cell function: peptide-HLA and costimulatory ligands, embodied in the Immuno-STAT and Neo-STAT immunotherapy platforms. The versatility and modularity of the platform as described in the paper, in addition to the clinical data to date supports the premise that our approach could be the next-generation solution to utilizing IL-2 as a targeted and selective immune activator for treating multiple cancers."

Cue Biopharma’s lead Immuno-STAT asset, CUE-101 has already shown encouraging results as a monotherapy in a Phase 1 dose escalation trial in late stage second line and beyond patients with HPV+ recurrent/metastatic head and neck cancer, which included a confirmed partial response with approximately 65% durable and ongoing tumor reduction and eight confirmed stable disease responses, controlling tumor growth for at least 12 weeks.

The Company is preparing for an Investigational New Drug filing for their next Immuno-STAT clinical candidate, CUE-102, which targets Wilms Tumor 1 (WT1), expressed in numerous solid tumors and hematological cancers.

The Board of Directors Approves the Half-Yearly Financial Report at 30 June 2021 (Price sensitive) – Courtesy English Translation

On September 28, 2021 Philogen S.p.A. (the "Company" or "Philogen") and, together with its Swiss subsidiary Philochem AG, (the "Group"), reported that which met today under the chairmanship of Dr. Duccio Neri, approved the condensed interim consolidated financial statements as of June 30, 2021 (Press release, Philogen, SEP 28, 2021, View Source [SID1234590386]).

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Dario Neri, CEO of Philogen, commented on the results for the year and the evolution of the business: "On March 3, 2021, we completed the process of listing Philogen on the Mercato Telematico Azionario organized and managed by Borsa Italiana S.p.A.. The transaction provided the Group with the financial resources necessary to execute its business plan. The results for the first half of 2021 continue to reflect the Group’s change in strategy, already initiated in 2019, to focus primarily on the clinical development of its two most advanced proprietary products: Nidlegy and Fibromun. Development is proceeding according to the anticipated plans described in the prospectus.

We expect to complete patient enrollment in the European Phase III clinical trial of Nidlegy in melanoma by mid-2022. With respect to the two European clinical trials of Fibromun in newly diagnosed and second recurrence sarcoma, completion of recruitment of the respective patients is expected by the end of 2023."

CONSOLIDATED FINANCIAL STATEMENTS AT 30 JUNE 2021 The Group’s total Revenues at 30 June 2021 amount to € 1,952 thousand and consist of:
(i) Revenues from contracts with customers amounting to € 1,548 thousand, and
(ii) Other income amounting to € 404 thousand. Compared to the same period of the previous year, there is a percentage decrease of 22.5% which reflects the change in strategy, already initiated in 2019, which has led the Group to focus mainly on the clinical development of the most advanced proprietary products (Nidlegy and Fibromun) while continuing the development activities under the existing contracts. The change shows a decrease in revenues from contracts with customers of approximately Euro 760 thousand mainly due to the completion of some contracts during 2020. Operating costs, amounting to € 10,059 thousand, show an increase of approximately 23.2% compared to the period ended 30 June 2020. The change is mainly attributable to the extraordinary costs incurred in the first six months of 2021 related to the IPO process and partly to the operational and governance structure the company is setting up to execute its business plan. EBITDA decreased by 43.6% compared to June 30, 2020, as a result of the above. Amortisation and depreciation, amounting to € 753 thousand, are in line with the previous period (€ 706 thousand at 30 June 2020). Main Office: Loc. Bellaria, 35-53018 Sovicille (SI), Italy e-mail: [email protected] – website: www.philogen.com ________________________________________________________________________________________________________________________ PRESS RELEASE 2 EBIT, calculated as the difference between EBITDA and depreciation and amortisation, showed a negative balance of €8,860 thousand, a decrease of 39.5% compared to the period ended 30 June 2020, as a result of the reduction in EBITDA described above. In the period ended June 30, 2021, net financial management showed a positive balance of € 586 thousand compared to a negative balance of € 1,628 thousand in the same period of the previous year. The change is mainly due to the fair value of the portfolio which for most of the year 2020 reflected the negative trend of the financial markets related to the effects of the Covid-19 pandemic. It should be noted that the company holds a portfolio of financial investments fed by liquidity in excess of current cash requirements.

As a result of the above, the loss for the period increased by approximately 2.7% compared to the period ended 30 June 2020. The Group closed the first half of 2021 with liquidity of Euro 113,242 thousand compared to Euro 61,943 thousand at 31 December 2020 and a net financial position at 30 June 2021 of Euro 96,077 thousand compared to a net financial position of Euro 44,238 thousand at 31 December 2020 and 104.668 thousand at 31 March 2021, showing an overall percentage increase of more than 100%, as a result of the capital raised during the IPO, amounting to Euro 65,404 thousand, net of commissions paid to the consortium for the institutional placement and costs related to the issue of new shares of approximately Euro 3,635 thousand. Between Q1 and Q2 2021 the net financial position decreased by approximately 8%. Cash and cash equivalents fell from €122,414 thousand at 31 March 2021 to €113,242 thousand at 30 June 2021, a decrease of approximately €9,172 thousand.

This change was due mainly due to
(i) capital expenditure on the construction of the new GMP plant at Rosia (Siena) of approximately €2.877 thousand,
(ii) extraordinary costs related to the IPO process of approximately Euro 1,078 thousand,
(iii) costs for ordinary operations of approximately Euro 5,427 thousand,
(iv) proceeds from ongoing research and development contracts of approximately Euro 105 thousand, and
(v) the net fair value of the securities portfolio of approximately Euro 106 thousand. Current and non-current financial indebtedness decreased from €17,746 thousand at 31 March 2021 to €17,165 thousand at 30 June 2021, a decrease of approximately 3% relative to the progress of the existing amortisation plans. It should be noted that the financial indebtedness of approximately Euro 11,851 thousand is represented by the notional debt relating to the lease contracts for the buildings of the three company sites, represented according to international accounting standards (IFRS 16). The remaining amount relates to the outstanding loan taken out to finance the expansion of the Rosia (Siena) production site. This loan requires compliance with commercial and financial covenants, the breach of which does not necessitate repayment of the loan but results in a 0.50% increase in the interest rate.

MAIN EVENTS OCCURRING AFTER THE PERIOD ENDED 30 JUNE 2021 As of July 20, 2021, the director Dr. Sergio Dompé, through the company Dompé Holding S.r.l., by virtue of the confidence placed in the Company’s possibilities and capabilities, purchased 185,831 Philogen shares on the market. On August 30, the lock-up commitment on the part of the former shareholders of Palio Ordinarie S.p.A., which was merged by incorporation into Philogen with effect from January 2021, came to an end. The lock-up agreement entered into between the companies participating in the merger had as its objective the stabilization of Philogen’s ordinary shares, prohibiting their transfer for a period of 180 days from the start of trading. At the end of this period on August 30, the shares became freely transferable. In addition, also on August 30 (180 days from the start of trading) the lock-up commitment on the part of Philogen’s other minority shareholders (Palio Speciali S.r.l., MRS S.r.l. and Mathias Winter) came to an end. FORESEEABLE EVOLUTION OF OPERATIONS During the first half of 2021, the patient enrollment rate, which had declined slightly in 2020, increased again. In addition to the general variable trend of the patient enrollment rate from year to year and the improvement of the situation related to the COVID-19 pandemic, this increase could be related to the opening of new clinical centers. In order to further accelerate recruitment, the Group intends to open new centers in several European and non-European countries for the various ongoing studies conducted with its proprietary drugs. Main Office: Loc. Bellaria, 35-53018 Sovicille (SI), Italy e-mail: [email protected] – website: www.philogen.com ________________________________________________________________________________________________________________________ PRESS RELEASE 3 As is known, the Group is committed to developing its contractual activities as well as strengthening its internal research and development activities. It also maintains numerous contacts with other potential industrial partners in order to develop its business and seek new opportunistic scientific collaboration agreements. Despite the emergency situation due to COVID-19, the Group has continued its research and development activities on a constant basis. The continuation of the health emergency in the second half of 2021 and the consequent measures, including regulatory measures, that have become necessary and may still become necessary to combat the emergency could have a negative impact on the above activities, slowing them down in part.

OTHER SIGNIFICANT RESOLUTIONS OF THE BOARD OF DIRECTORS Approval of the regulations for the Stock Grant 2024-2026 Incentive Plan, reserved for Group employees and implementation of the Plan With reference to the "Stock Grant Plan 2024-2026", reserved for Group employees, adopted by the Company’s Shareholders’ Meeting on May 31, 2021, the Board of Directors, on the proposal of the Appointments and Remuneration Committee, approved the regulations for this Plan. Pursuant to art. 84-bis of the Issuers’ Regulation adopted by Consob with resolution no. 11971/1999 and subsequent amendments, it is also announced that the Board of Directors implemented the Plan, in particular by identifying the beneficiaries and defining the performance objectives and related targets, and by allocating a total of 145,000 units. The communication table drawn up in compliance with the indications contained in Scheme 7 of Annex 3A and table no. 1 provided for by paragraph 4.24 of Annex 3A, Scheme 7, of the Issuers’ Regulations, which gives an account of the state of execution of the Plan, is attached. The features of the 2024-2026 Stock Grant Plan are explained in the information document available and available on the Company’s website. Assignment of performance objectives and definition of targets within the so-called management by objectives (MBO) incentive plan for executive directors. The Board of Directors, on the proposal of the Appointments and Remuneration Committee, with reference to the so-called management by objectives ("MBO") monetary incentive plan, of which the executive directors are beneficiaries from 1 April 2021, assigned the performance objectives and defined the targets to which the maximum monetary remuneration is associated

Arrowhead Earns $10 Million Phase 1 Milestone Payment

On September 28, 2021 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that it earned a $10 million milestone payment from Janssen Pharmaceuticals, Inc., (Janssen) part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, Arrowhead Pharmaceuticals, SEP 28, 2021, View Source [SID1234590403]). The milestone payment was earned after Janssen dosed the fifth patient in a Phase 1 clinical study of ARO-JNJ1, an investigational RNAi therapeutic candidate which utilizes Arrowhead’s proprietary Targeted RNAi Molecule (TRiM) platform.

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Arrowhead entered into a license and collaboration agreement, and into a research collaboration and option agreement, with Janssen in October 2018. Arrowhead is eligible for additional payments when future milestones are met and is also eligible for royalties on commercial sales of ARO-JNJ1.

Massive Bio, Inc. to Partner With TheSocialMedwork to Help Cancer Patients Find Clinical Trials, Improve Health Outcomes and Accelerate the Adoption of Artificial Intelligence and Digital Health Solutions in Oncology

On September 28, 2021 Massive Bio reported it has entered a partnership with TheSocialMedwork to increase clinical trial and real-world evidence research participation for cancer patients (Press release, Massive Bio, SEP 28, 2021, View Source [SID1234590422]). This collaboration will bolster Massive Bio’s abilities to reach out to more cancer patients globally in need of clinical trials, and will provide TheSocialMedwork with new ways to help their members fight cancer, at no cost and at scale using Massive Bio’s SYNERGY-AI clinical trial matching solution. "This partnership between Massive Bio and TheSocialMedwork provides the patients with a best-in-class search and navigation tool to effectively guide thousands of patients to new treatments and clinical trials, at the click of a button from their computer or mobile phone," stated Selin Kurnaz, Co-Founder and CEO of Massive Bio.

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