On April 1, 2022 Philogen S.p.A., a clinical-stage biotechnology company focused on antibody-and small molecule-based targeted therapeutics, reported an update regarding the Company’s full year 2021 results and recent corporate developments (Press release, Philogen, APR 1, 2022, View Source [SID1234611343]). "We are excited for the great progress we have made following our listing on the Italian Stock Exchange in March 2021.

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The IPO proceeds and revenues from industrial collaborations have provided the financial resources to accelerate clinical trials, develop new products and invest in infrastructure. Philogen has a rich pipeline of late-stage clinical assets and continues to innovate by generating new prototypes", commented Prof. Dr. Dario Neri, Chief Executive Officer of Philogen. "The enrolment rate of Nidlegy in the Phase III European study for the treatment of Stage IIIB/C melanoma has advanced according to plan. Shortly after the IPO, we signed a contract with a CRO to speed up recruitment in the Phase III study in the United States with the opening of new centers.

The Fibromun programs are also making good progress. The trials in soft-tissue sarcoma are ongoing in the U.S., Germany, Poland, Spain, and Italy, with the participation of leading clinical centers. We are also advancing this product for the treatment of glioblastoma, both in first-line and second-line. We are very encouraged by the observation of major objective responses in second-line patients which are normally not seen with standard-of-care drugs. These responses have now been confirmed at long time points (e.g., up to 12 months). We continue to monitor the duration of response and to include more patients in the studies. I am pleased about the significant advancement we have made with our small molecule platforms. We have partnered with Bracco, a world-leading pharmaceutical company in diagnostic imaging, to develop and commercialize a small molecule for diagnostic imaging applications. The excellent targeting performance of OncoFAP in patients with solid tumors was reported in a recent study published in the European Journal of Nuclear Medicine and Molecular Imaging, providing the basis for registration activities. Moreover, pre-clinical data for the 177Lu-labeled therapeutic candidate is supporting the initiation of dedicated clinical developments. Philogen finished 2021 with €101,6M of cash-and-cash equivalents. In 2022, Philogen will limit cash burn (or have no cash burn), due to new and existing partnerships, despite increased spending for clinical trials." Main Office: Loc. Bellaria, 35-53018 Sovicille (SI), Italy e-mail: [email protected] – website: www.philogen.com _

MAIN EVENTS AND RECENT HIGHLIGHTS Proprietary products o Nidlegy is a pharmaceutical product, proprietary to Philogen, consisting of two active ingredients, L19IL2 and L19TNF. The L19 antibody is specific to the B domain of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are inflammatory cytokines with anti-tumor activities o Phase III European study in Stage IIIB/C melanoma o 207 out of 214 patients have been recruited. The trial will conclude when 95 events (tumor recurrence or patient death) have occurred, as per protocol o 21 clinical centers opened in Germany, France, Italy, and Poland o Phase III U.S. study in Stage IIIB/C melanoma o 6 clinical sites are currently open. We expect to add up to 20 new sites in 2022 to speed up recruitment o Non-melanoma skin cancer o Progress in Phase II studies ongoing in France, Germany, Poland, and soon in Italy o Fibromun (L19TNF) is a pharmaceutical product, proprietary to Philogen, consisting of the L19 antibody fused to TNF o European pivotal studies in soft-tissue sarcoma o The recruitment rate of patients is progressing according to foreseen timelines o Phase I/II study in glioblastoma at first relapse/recurrence o The Phase I dose escalation part of the study will explore different doses of Fibromun and Lomustine (3-6 subjects per cohort) o Cohort 1 has been completed with 6 patients and durable objective responses are being observed o Recruitment for cohort 2 is ongoing o The historical objective response rate (ORR) for recurrent glioblastoma treated with Lomustine is 4.3-13.9%.

The median progression free survival of these patients is 6 weeks. In unmethylated MGMT tumors objective responses are virtually never observed (0% ORR) (Wick et al., J Clin Oncol 2010, 28,1168; Weller and Le Rhun et al., Cancer Treat Rev 2020, 87,102029) o OncoFAP is a small organic molecule ligand with ultra-high affinity for Fibroblast Activation Protein (FAP) o OncoFAP-radio conjugates § Imaging-excellent targeting properties of OncoFAP68Ga in patients with various tumor types. Data have been published in the European Journal of Nuclear Medicine and Molecular Imaging (Backhaus et al., Eur J Nucl Med Mol Imaging, 2021, 10.21203/rs.3.rs-969176/v1)

§ Therapy – BiOncoFAP177Lu, featuring a bivalent OncoFAP ligand, cures cancer in mice and has been identified as the therapeutic candidate for clinical development o OncoFAP-drug conjugates – these drugs consist of
(i) the OncoFAP ligand,
(ii) a cleavable linker and
(iii) a cytotoxic payload, which is released selectively at the tumor site. Scientists at Philogen’s R&D center have recently discovered and patented an optimal cleavable linker leading to complete tumor eradications in preclinical models of cancer. The new OncoFAP-drug conjugate represents an additional potential clinical candidate with a strong validation and tumor targeting rationale.

Partnered products
• New partnership signed with Bracco Imaging to develop and commercialize a small molecule for diagnostic imaging applications
• Dodekin is a pharmaceutical product consisting of the L19 antibody specific to the B domain of Fibronectin (EDB) fused to interleukin-12 (IL12). EDB is a protein abundantly expressed in different tumors, but it is virtually undetectable in healthy tissues. IL12 is a pro-inflammatory cytokine suitable for the treatment of cancer o The product is currently investigated in a Phase I clinical trial
• Dekavil is a pharmaceutical product, licensed to Pfizer, consisting of the F8 antibody specific to the A domain of Fibronectin (EDA) fused to interleukin-10 (IL10). EDA is a protein abundantly expressed at sites of inflammation, but it is virtually undetectable in healthy tissues. IL10 is an anti-inflammatory cytokine suitable for the treatment of chronic inflammatory diseases o The product will be investigated in novel clinical studies as a potential treatment in patients with certain chronic inflammatory conditions Main Office: Loc. Bellaria, 35-53018 Sovicille (SI), Italy e-mail: [email protected] – website: www.philogen.com
_____

PRESS RELEASE 3 FINANCIAL UPDATE
• Philogen ended FY 2021 with cash and cash equivalents of €101,6M compared to €61,943M on December 31, 2020.
• The net financial position as of December 31, 2021, was €85,184M, compared to a net financial position of €44,238M on December 31, 2020
• The change in the net financial position compared to December 31, 2020, was mainly due to the proceeds raised during the Initial Public Offering on March 3, 2021, amounting to €65,404M net of commissions paid to the syndicate for the institutional placement and costs related to the issue of new shares of approximately €3,635M

On April 1, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ("Vivoryon" or the "Company"), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported that it has successfully completed a private placement by way of accelerated bookbuilding, placing 2,000,000 registered shares at an offering price of EUR 10.50 per share (Press release, Vivoryon Therapeutics, APR 1, 2022, View Source [SID1234611341]). The new shares from the capital increase represent 10% of Vivoryon’s existing issued share capital and have been issued from the Company’s authoritzed capital under exclusion of the existing shareholders’ pre-emptive rights. As a consequence, the Company’s issued share capital will increase to EUR 22,050,482.00.

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The gross proceeds of the offering amount to approximately EUR 21.00 million. Vivoryon intends to use the net proceeds from the offering to support the ongoing clinical development of its lead candidate varoglutamstat, currently in Phase 2 in Europe and the United States for the treatment of patients with Alzheimer’s disease, as well as for general corporate purposes.

The shares were placed to high-quality institutional investors from across Europe and the United States, as well as to certain members of the Board of Directors. "We are grateful to our existing shareholders, including members of our Board of Directors, and our new investors for their support and for recognizing the potential of Vivoryon, our technology and our steady advances in clinical development of varoglutamstat", commented Dr. Ulrich Dauer, CEO of Vivoryon Therapeutics. "We look forward to an exciting year with a number of important milestones on our path towards developing medicines for patients suffering from Alzheimer’s disease around the world."

The new shares are expected to be admitted to trading on Euronext Amsterdam on April 5, 2022. Payment and settlement is expected to take place on April 5, 2022.

On April 1, 2022 Sanofi reported that the French Autorité des marchés financiers (AMF) has approved the listing prospectus prepared by EUROAPI in connection with the intended listing of its shares on the regulated market of Euronext Paris (Press release, Sanofi, APR 1, 2022, View Source [SID1234611340]).

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On March 17th, 2022, Sanofi’s Board of Directors unanimously decided to submit for approval to its shareholders the proposed distribution in kind (the "Distribution") of EUROAPI shares, via an additional extraordinary dividend, exclusively in kind, in addition to the previously proposed €3.33 cash dividend per Sanofi share. The Distribution relates to circa 58% of the share capital and voting rights of EUROAPI. In connection with the proposed Distribution, EPIC Bpifrance has agreed to purchase 12% of EUROAPI shares1 from Sanofi, which confirmed its intention to hold circa 30% of the share capital and voting rights of the company after the Distribution.

The Distribution by Sanofi to its shareholders of EUROAPI shares in the form of an additional extraordinary dividend, exclusively in kind, is subject to the shareholders’ approval at Sanofi’s May 3, 2022 Ordinary and Extraordinary Shareholders’ Meeting.

Subject to certain customary exceptions, the following lock-up periods have been agreed:

2 years for Sanofi and EPIC Bpifrance following the settlement and delivery of the EUROAPI shares to be sold to EPIC Bpifrance; and
1 year for L’Oréal, Sanofi’s largest shareholder and for Karl Rotthier, CEO of the Company, following the settlement of the Distribution.
Main features of the Distribution are as follows:

The Distribution ratio will be one (1) EUROAPI share per twenty three (23) Sanofi shares.

No fractional EUROAPI shares will be issued. Any right to receive a fractional share will not be tradable or transferable. Consequently, when the amount of the Distribution to which a Sanofi shareholder is entitled does not correspond to a whole number of EUROAPI shares (i.e., less than twenty three (23) or a multiple of twenty three (23) Sanofi shares), the shareholder will receive the immediately lower number of EUROAPI shares, plus a cash payment for the whole of the balance arising from the price at which EUROAPI shares corresponding to fractional shares were sold. Each financial intermediary will sell the shares corresponding to the fractional shares of its entitled clients. As a result, the amount of the cash balance may vary depending on the shareholder’s financial intermediary;

The technical reference price of EUROAPI shares is expected to be announced on May 5, 2022 by Euronext Paris after market close;
The admission to trading of the EUROAPI shares and the ex-date (détachement) of the Distribution will occur at 9.00 am (CET) on May 6, 2022;
The record date (the date on which positions are closed) for Sanofi shares to be eligible to the Distribution is scheduled on May 9, 2022;
Payment of the Distribution (delivery and book-entry of the allocated EUROAPI shares) will take place on May 10, 2022.
Following the Distribution and the purchase of 12% of EUROAPI shares by EPIC Bpifrance, the Sanofi group will no longer control EUROAPI, resulting in a slightly accretive impact on Sanofi 2022 business operating income (BOI) margin2.

Documents related to Sanofi shareholders’ meeting will be made available on April 11, 2022 on the Sanofi dedicated web page.

Investors are invited to read EUROAPI’s press release, issued concurrently and available on EUROAPI’s website announcing the AMF’s approval of its prospectus, and the listing prospectus in order to fully understand the potential risks and rewards associated with any decision to invest in EUROAPI shares. EUROAPI draws attention to the risk factors contained in Chapter 3 and Section 22.2 of the listing prospectus. The occurrence of one or more of these risks may have a significant adverse effect on the business, reputation, financial condition, results of operations or prospects of EUROAPI, as well as on the market price of EUROAPI’s shares.

For information on the tax treatment of the Distribution, shareholders are invited to read Paragraph 22.1.6 of the listing prospectus.

Copies of the French-language listing prospectus, approved by the AMF on March 31, 2022 under number 22-076, are available free of charge and on request from EUROAPI at EUROAPI’s registered office, 15 rue Traversière, 75012 Paris, France, as well as on the websites of the AMF (View Source), Sanofi (View Source) and EUROAPI (listing.euroapi.com). An English-language information document for non-French resident shareholders of Sanofi is also available on Sanofi’s and EUROAPI’s website.

BNP Paribas, BofA Securities Europe SA, and J.P. Morgan SE are acting as Lead ECM Advisors to EUROAPI and Sanofi and Crédit Agricole Corporate and Investment Bank, Deutsche Bank, Natixis SA and Société Générale are acting as Other ECM Advisors in the contemplated listing. Rothschild & Co. is acting as independent financial adviser to Sanofi and EUROAPI. Jones Day is acting as a legal advisor to EUROAPI and Sanofi in connection with the Distribution, and White & Case as legal advisor to the Lead ECM Advisors.

Capital Markets Day details

Today, Sanofi will host a EUROAPI-dedicated Capital Markets Day at 1:30 pm CET and will cover the following topics:

Execution of the Play to Win strategy with the spin-off of EUROAPI
Main features of the Distribution
Sanofi’s long-term commitment to EUROAPI: strong business relationship and future ownership structure alongside with EPIC Bpifrance
EUROAPI’s deconsolidation impact for Sanofi
Presentation of EUROAPI, including its business model, strategy and guidance.

On April 1, 2022 Ferring reported its latest Annual Report which shows the company reported revenues of €2,162 million, +11% at AER, +14% at CER and a record level of Net Income at €290 million up +91% AER (Press release, Ferring, APR 1, 2022, View Source [SID1234611339]). These results reflect the company’s strong and leading position in the field of reproductive medicine and maternal health (RMMH), and its growing presence in other specialty areas of medicine. Ferring sales rebounded strongly following the various impacts of COVID-19 during 2020, most particularly within the RMMH franchise in the United States.

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Sales within RMMH grew at 27% CER and achieved a CAGR over the last 2 years of 11% per year driven by our flagship product Menopur, used in ovarian stimulation for women undergoing assisted reproductive technologies. Sales growth within our other specialty franchises in gastroenterology and urology was more muted with some strong individual product performances somewhat offset by product discontinuations and divestments.

Through sustained focus and initiatives on operational efficiency in recent years, increase in operating expenses was constrained to 2% CER benefiting from increased focus and disciplined allocation of resources. Throughout the year important investments were made in protecting our manufacturing infrastructure and the wider supply chain from the volatility caused by COVID-19.

In line with our strategic ambitions, Ferring continued to prioritise investment in progressing our late-stage opportunities and our mid-term growth opportunities which are critical to our future success and achieved many key regulatory milestones during the year.

The combination of strong sales growth and constrained increase in the cost base resulted a significant increase in operating profit growth of 70% CER to reach €358 million. This improved operating profit drove an increase in net cash flow from operations of 38% AER to reach €450 million, and the company maintains its solid financial base from which to realise its strategic agenda over the next years.

"Despite many challenges, 2021 proved to be a year of remarkable progress for Ferring, and we ended the year in a stronger financial position than ever before", said Dominic Moorhead, Chief Financial Officer at Ferring.

The President of Ferring, Per Falk, also commented "2021 was a record year for the company and we are well poised to deliver on the next phase of our growth agenda as we aim to help people live better lives".

CER – Constant Exchange Rates, which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period
AER – Actual Exchange Rates
CAGR – Compound Annual Growth Rate

On April 1, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the completion of the patient enrollment for the 600 mg dose cohort from Alligator’s Phase I, first-in-human clinical trial with the 4-1BB (CD137) targeting drug candidate, ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic cancer (Press release, Alligator Bioscience, APR 1, 2022, https://alligatorbioscience.se/en/alligator-bioscience-announces-completion-of-600-mg-dose-cohort-for-ator-1017-dose-escalation-and-enrollment-for-900-mg-dose-cohort-commences/ [SID1234611338]). The Phase I study with ATOR-1017 is an open-label, dose escalation study in patients with histologically confirmed, advanced and/or refractory solid cancer (NCT04144842). The primary objective of the study is to investigate the safety and tolerability of ATOR-1017, and to determine the recommended dose for subsequent Phase II studies.

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The data indicate that for doses up to 600 mg, there were no significant safety concerns with stable disease as the best tumor response. Patient enrollment and treatment for the highest planned dose cohort, 900 mg, has commenced.

As previously announced in December 2021, results from the early readout for ATOR-1017 showed that the drug candidate has an encouraging safety profile. In this readout, there was no dose-limiting toxicity or severe immune-related adverse events (link to press release).