Regeneron Announces Investor Conference Presentations

On February 12, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, FEB 12, 2021, View Source [SID1234575030]):

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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

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SVB Leerink 10th Annual Global Healthcare Conference at 10:40 a.m. EST on Wednesday, February 24, 2021
Cowen 41st Annual Health Care Conference at 9:10 a.m. EST on Tuesday, March 2, 2021
Barclays Global Healthcare Conference at 8:00 a.m. EST on Wednesday, March 10, 2021
Oppenheimer 31st Annual Healthcare Conference at 8:00 a.m. EDT on Tuesday, March 16, 2021
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

Heat Biologics to Present at 2021 BIO CEO & Investor Digital Conference

On February 12, 2021 Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, reported that it will be presenting at the 2021 BIO CEO & Investor Digital Conference being held virtually between February 16-18, 2021 (Press release, Heat Biologics, FEB 12, 2021, View Source [SID1234575029]).

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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

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A webcast of Heat’s presentation will be available on-demand to registered attendees beginning Tuesday, February 16th, and will be accessible for 30 days via the conference platform. Subsequent to the conference, the presentation will be made available on the investor relations section of Heat Biologics’ website at View Source

At the BIO CEO & Investor Digital Conference attendees will hear key biotech and pharma leaders discuss the most pertinent industry trends, the market outlook, and best practices for executive leadership. For more information about the BIO CEO & Investor Conference, please visit the conference website at View Source

Astellas and Seagen Announce Phase 3 Trial Results Demonstrating Survival Advantage of PADCEV® (enfortumab vedotin-ejfv) in Patients with Previously Treated Advanced Urothelial Cancer

On February 12, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq: SGEN) reported primary results from the phase 3 EV-301 trial comparing PADCEV (enfortumab vedotin-ejfv) to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor (Press release, Astellas, FEB 12, 2021, View Source [SID1234575028]). At the time of pre-specified interim analysis, patients who received PADCEV in the trial lived a median of 3.9 months longer than those who received chemotherapy. Median overall survival was 12.9 vs. 9.0 months, respectively (HR=0.70 [95 percent Confidence Interval (CI): 0.56-0.89], p=0.001). For patients in the PADCEV arm of the trial, maculopapular rash, fatigue and decreased neutrophil count were the most frequent Grade 3 or greater treatment-related adverse events (TRAEs) occurring in more than 5 percent of patients.

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Urothelial cancer is the most common type of bladder cancer and can also be found in the renal pelvis, ureter and urethra.1

The findings were published in the New England Journal of Medicine and presented during the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) (Abstract 393).

"Improving survival is especially meaningful in patients who have had their cancer progress following chemotherapy or other treatment," said Daniel P. Petrylak, M.D., Professor of Medicine and of Urology, Yale Cancer Center, and corresponding author of the published study.

"Enfortumab vedotin is the first medicine to reduce the risk of death compared to chemotherapy in patients with locally advanced or metastatic urothelial cancer who have received a platinum-containing chemotherapy and an immunotherapy," said Professor Thomas Powles, M.D., Director, Barts Cancer Centre, Queen Mary University of London, who presented results at ASCO (Free ASCO Whitepaper) GU.

Patients who received PADCEV in the trial also showed improvement in the following secondary endpoints:

Median progression-free survival, which is the time without progression of cancer, was 5.6 months for PADCEV vs. 3.7 months for chemotherapy (HR=0.62 [95 percent CI: 0.51-0.75]; p<0.00001).
Overall response rate, the percentage of patients with either complete or partial response, was 40.6 percent vs. 17.9 percent of patients in the chemotherapy arm (p<0.001).
Disease control rate (DCR), which is the percentage of patients who have achieved complete response, partial response or had stable disease, was 71.9 percent for PADCEV and 53.4 percent for chemotherapy (p<0.001).
Other safety findings included:

Rates of serious TRAEs were comparable between treatment arms (23 percent of patients receiving PADCEV vs. 23 percent receiving chemotherapy).
Grade 3 or greater TRAEs were experienced by approximately 50 percent of patients in both study arms. Grade 3 or greater TRAEs occurring in more than 5 percent of patients receiving PADCEV were maculopapular rash (occurring in 7 percent of patients receiving PADCEV vs. 0 percent of patients receiving chemotherapy), fatigue (6 percent vs. 4.5 percent) and decreased neutrophil count (6 percent vs. 13 percent).
"Patients who received PADCEV lived longer than those who received chemotherapy – an important finding, especially in light of the high unmet need faced by people with advanced urothelial cancer," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.

"Since its accelerated approval by the FDA in late 2019, physicians have adopted PADCEV into their practice, and these confirmatory results provide additional evidence of its benefit for people living with advanced bladder cancer," said Roger Dansey, M.D., Chief Medical Officer, Seagen.

Results of EV-301 are expected to be submitted to the U.S. Food and Drug Administration by the end of March as the confirmatory trial following the drug’s accelerated approval in 2019. The results of EV-301 will also be included in submissions to global health authorities.

About Urothelial Cancer
Urothelial cancer is the most common type of bladder cancer (90 percent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.1 Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually.2

About the EV-301 Trial
The EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician’s choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.

About PADCEV (enfortumab vedotin-ejfv)
PADCEV was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA’s Accelerated Approval Program based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.3

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.3,4 Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).4 PADCEV is co-developed by Astellas and Seagen.

PADCEV Important Safety Information

Warnings and Precautions

Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those with and without pre-existing diabetes mellitus. The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. In one clinical trial, 8% of patients developed Grade 3-4 hyperglycemia. Patients with baseline hemoglobin A1C ≥8% were excluded. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.
Peripheral neuropathy (PN), predominantly sensory, occurred in 49% of the 310 patients treated with PADCEV in clinical trials; 2% experienced Grade 3 reactions. In one clinical trial, peripheral neuropathy occurred in patients treated with PADCEV with or without preexisting peripheral neuropathy. The median time to onset of Grade ≥2 was 3.8 months (range: 0.6 to 9.2). Neuropathy led to treatment discontinuation in 6% of patients. At the time of their last evaluation, 19% had complete resolution, and 26% had partial improvement. Monitor patients for symptoms of new or worsening peripheral neuropathy and consider dose interruption or dose reduction of PADCEV when peripheral neuropathy occurs. Permanently discontinue PADCEV in patients that develop Grade ≥3 peripheral neuropathy.
Ocular disorders occurred in 46% of the 310 patients treated with PADCEV. The majority of these events involved the cornea and included keratitis, blurred vision, limbal stem cell deficiency and other events associated with dry eyes. Dry eye symptoms occurred in 36% of patients, and blurred vision occurred in 14% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.9 months (range: 0.3 to 6.2). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.
Skin reactions occurred in 54% of the 310 patients treated with PADCEV in clinical trials. Twenty-six percent (26%) of patients had maculopapular rash and 30% had pruritus. Grade 3-4 skin reactions occurred in 10% of patients and included symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. In one clinical trial, the median time to onset of severe skin reactions was 0.8 months (range: 0.2 to 5.3). Of the patients who experienced rash, 65% had complete resolution and 22% had partial improvement. Monitor patients for skin reactions. Consider appropriate treatment, such as topical corticosteroids and antihistamines for skin reactions, as clinically indicated. For severe (Grade 3) skin reactions, withhold PADCEV until improvement or resolution and administer appropriate medical treatment. Permanently discontinue PADCEV in patients that develop Grade 4 or recurrent Grade 3 skin reactions.
Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 310 patients, 1.3% of patients experienced skin and soft tissue reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. One percent (1%) of patients developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.
Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.
Adverse Reactions
Serious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (≥3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (≥20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade ≥3 adverse reactions (≥5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab Abnormalities
In one clinical trial, Grade 3-4 laboratory abnormalities reported in ≥5% were: lymphocytes decreased (10%), hemoglobin decreased (10%), phosphate decreased (10%), lipase increased (9%), sodium decreased (8%), glucose increased (8%), urate increased (7%), neutrophils decreased (5%).

Drug Interactions

Effects of other drugs on PADCEV Concomitant use with a strong CYP3A4 inhibitor may increase free MMAE exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with strong CYP3A4 inhibitors.
Specific Populations

Lactation Advise lactating women not to breastfeed during treatment with PADCEV and for at least 3 weeks after the last dose.
Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.
For more information, please see the full Prescribing Information for PADCEV here.

Sanofi launches recommended cash offer for all shares in Kiadis

On February 12, 2021 Sanofi (Euronext: SAN and NYSE: SNY) and Kiadis (Euronext Amsterdam and Brussels: KDS), with reference to the publication of the Offer Memorandum , reported that the Offeror is making a recommended all-cash offer to all holders of Shares (the "Shareholders"), to acquire their Shares at an offer price of EUR 5.45 (cum dividend) in cash per Share (the "Offer"), as announced on 2 November 2020 (Press release, Sanofi, FEB 12, 2021, View Source [SID1234575027]). In total, approximately 36.6% of the issued and outstanding Shares, calculated on a Fully Diluted basis, have been irrevocably committed under the Offer. The management board of Kiadis (the "Management Board") and the supervisory board of Kiadis (the "Supervisory Board" and, together with the Management Board, the "Kiadis Boards"), unanimously support and recommend the Offer. Terms not defined in this press release will have the meaning as set forth in the Offer Memorandum.

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Timing and offer materials
The Acceptance Period commences at 09.00 hours CET, on 15 February 2021 and will, unless extended, expire at 17.40 hours CET on 12 April 2021. Completion of the Offer is currently expected in the second quarter of 2021.

The Offer Memorandum and a position statement by Kiadis (the "Position Statement"), providing further information to the Shareholders, including the agenda for the EGM are available on the corporate website of Kiadis (www.kiadis.com).

John Reed, M.D., Ph.D., Global Head of Research and Development of Sanofi, commented, "We believe Kiadis’ ‘off the shelf’ K-NK cell technology platform will have a broad application against liquid and solid tumors, and create synergies with Sanofi’s emerging immune-oncology pipeline, providing opportunities for us to pursue potential best-in-disease approaches."

Arthur Lahr, Chief Executive Officer of Kiadis, commented, "The Kiadis Boards unanimously believe that Sanofi has the resources and financial strength to accelerate development of our NK-cell products, to the benefit of patients. We believe this transaction represents compelling value to shareholders and offers a fair reflection of the potential of our platform and pipeline, given the risk/reward profile typical to biotech and the capital required to execute our business plan."

The Offer
The Offeror is making the Offer on the terms and subject to the conditions and restrictions contained in the Offer Memorandum. Shareholders tendering their Shares under the Offer will be paid the Offer Price in consideration for each Share validly tendered (or defectively tendered provided that such defect has been waived by the Offeror) for acceptance pursuant to the Offer prior to or on the Closing Date (each such Share, a "Tendered Share") that is not validly withdrawn and which is transferred to the Offeror.

The Offer Price is ‘cum dividend’. Consequently, if any distribution on the Shares is declared by Kiadis whereby the record date for entitlement to such distribution is on or prior to the Settlement Date, then the Offer Price will be decreased by the full amount of any such distribution made by Kiadis in respect of each Share (before any applicable withholding tax).

Rationale for the Offer
Kiadis’ NK cell platform and resulting therapeutic pipeline is complementary to Sanofi’s in-house pipeline including CD-38 (isatuximab) and early-stage NK cell engager bispecific programs.

Sanofi and Kiadis have the intention to accelerate the development and commercialization of Kiadis’ trajectory and pipeline programs by leveraging Sanofi’s global infrastructure and capabilities in research, CMC, development, manufacturing and commercialization, as well as Sanofi’s financial strength. This will result in making products rapidly and economically available for a broad patient population across a wide range of indications.

Non-financial covenants
Kiadis and Sanofi have agreed to certain non-financial covenants which are set out below in respect of, inter alia, corporate governance, strategy, employees, financing and disposals for a duration of 18 months after the Settlement Date.

Strategic rationale
By combining their businesses, Sanofi and Kiadis have the intention to accelerate the development and commercialization of Kiadis’ pipeline programs by leveraging Sanofi’s global infrastructure and capabilities in research, CMC, development, manufacturing and commercialization, as well as Sanofi’s financial strength.

Sanofi and Kiadis intend to set up a hybrid integration model with corporate R&D activities of Kiadis and Sanofi integrated, details of which will be treated on a case-by-case basis.

Governance
As long as the Shares remain listed on Euronext Amsterdam, Kiadis shall continue to comply with the current Dutch Corporate Governance Code, except for (i) current deviations from the Dutch Corporate Governance Code and (ii) deviations from the Dutch Corporate Governance Code that find their basis in the Merger Agreement as disclosed in the Offer Memorandum.

Organization / location
There will be research and CMC activities at Kiadis’ offices in Amsterdam, the Netherlands.

Sanofi is focused on ensuring that the Kiadis Group’s key management and key staff is retained and offered suitable career opportunities.

Sanofi fosters a culture of excellence, where qualified employees are offered suitable training and career progression.

Employees
There will be no material redundancies with respect to the Kiadis Group’s employees as a direct consequence of the Offer and necessary redundancies going forward will be part of the Integration Committee process.

The existing rights and benefits of the Kiadis Group’s employees shall be respected by Sanofi, including existing rights and benefits under their individual employment agreements and (at least) existing redundancy practices applied by the Kiadis Group.

Any redundancies that need to occur will be done in accordance with all legal requirements.

The existing pension rights of the Kiadis Group’s current and former employees shall be respected by Sanofi.

Following the Settlement Date, the nomination, selection and appointment of staff for functions within the Sanofi’s NK activities will, subject to the applicable rules, be based on the "best person for the job" principle, or, where not feasible or appropriate, on a non-discriminatory, fair and business-oriented transparent set of criteria.

Minority Shareholders
The following resolutions by the Supervisory Board shall require the prior approval of the Supervisory Board with the affirmative vote of at least one of the Independent Members:

issuing additional shares in the capital of Kiadis for cash without offering pre-emption rights to minority shareholders in Kiadis;

agreeing and entering into a related party transaction between the Offeror or any member of the Sanofi Group on the one hand and any member of the Kiadis Group on the other hand or any other agreement, in each case, which is not at arm’s length; and

the proposal to the general meeting of shareholders of Kiadis of any other resolutions which disproportionally prejudices the value of, or the rights relating to, the shares held by the minority shareholders in Kiadis.
Integration Committee
The preparation of the integration of Kiadis and Sanofi’s overlapping business units will be prepared by an integration committee consisting of four members, two of whom are senior managers of Kiadis and two are senior managers of Sanofi (the "Integration Committee"). Until the Settlement Date, the Integration Committee will report to the Head of R&D of Sanofi and to the CEO of Kiadis, and after the Settlement Date, to the Head of R&D of Sanofi.

Financing
It is intended that Kiadis remains prudently financed to safeguard the continuity of the business and to continue Kiadis’ current business strategy including R&D and pipeline.

Sanofi will allocate suitable resources for Kiadis’ R&D and CMC activities.

Corporate governance
At successful completion of the Offer and subject to the adoption of all respective resolutions thereto at the EGM, the Supervisory Board will be composed of:

three persons to be appointed upon nomination by the Offeror, being Frank Nestle, Kripa Ram and Jérémie Girard, who are non-independent from the Offeror within the meaning of the Dutch Corporate Governance Code; and

Mark Wegter and Rob Soiffer as two current members of the Supervisory Board, qualifying as independent within the meaning of the Dutch Corporate Governance Code, to continue to serve on the Supervisory Board (including their successors, the "Independent Members").
Frank Nestle will serve as chairman of the Supervisory Board.

The Independent Members (or after their replacement, their successors) will continue to serve on the Supervisory Board for at least until the first anniversary of the Settlement Date.

At successful completion of the Offer and subject to the adoption of all respective resolutions thereto at the EGM, the Management Board will be composed of Arthur Lahr and Marion Zerlin, who is to be appointed upon nomination by the Offeror.

Recommendation by the Boards
Upon the receipt of a non-binding offer letter from Sanofi on 16 October 2020, the Kiadis Boards frequently met to be updated on the latest developments, monitor the process and discuss the Offer and alternatives thereto.

The Kiadis Boards, after having received extensive legal and financial advice, and having given due and careful consideration to all aspects of the Offer, have reached the conclusion that the Offer is fair to the Shareholders from a financial point of view and in the best interests of Kiadis and all its stakeholders, also considering the risks and uncertainties of the alternatives available to Kiadis.

Accordingly, the Kiadis Boards (i) support the Transactions, (ii) recommend that the Shareholders accept the Offer and tender their Shares in the Offer, and (iii) recommend that the Shareholders vote in favor of the Resolutions.

Extraordinary general meeting of Kiadis
Today, Kiadis has convened a general meeting of Shareholders, which will be held at 10:00 hours CET on 30 March 2021. At this EGM, the Offer will be discussed in accordance with the provisions of Article 18 paragraph 1 of the Decree and the Resolutions will be proposed to the general meeting of Shareholders.

The required information for Shareholders is included in the Position Statement, which also includes the convocation notice and agenda for the EGM, which has been made available as of today at Kiadis’ website (www.kiadis.com).

Competition condition
On 9 December 2020, Sanofi and Kiadis jointly announced that the competition condition for completion of the Offer had been satisfied.

Financing of the Offer and Kiadis
The Offer values 100% of the Shares at approximately EUR 308 million.1 The Offeror shall pay the Offer Price fully through readily available cash resources.

Pursuant to a heads of terms agreed upon on the date of the Merger Agreement, on 13 January 2021 Sanofi Finance Ireland Limited as lender and Kiadis as borrower have entered into a facilities agreement (the "Bridge Loan") for a total principal amount of EUR 27,700,000. EUR 20,000,000 of the Bridge Loan, which was drawn on 14 January 2021, is for general corporate and working capital purposes of the Kiadis Group, and allows the Kiadis Group to continue operating its business in the ordinary course following execution of the Merger Agreement, avoiding delay in the operations of its business, and to ensure the continuity of the Kiadis Group. The other part of the Bridge Loan, in the amount of EUR 7,700,000, can be used to refinance the debt under the Kreos Capital Facility Agreements and prepay the convertible bonds with Kreos Capital.

Irrevocable undertakings by Shareholders
In total, approximately 36.6% of the issued and outstanding Shares, calculated on a Fully Diluted basis, have been irrevocably committed under the Offer.

Life Sciences Partners
Funds managed by Life Sciences Partners have irrevocably undertaken on customary terms and conditions and conditional upon the Offer being declared unconditional and the Merger Agreement not being terminated (i) to tender their respective Shares, amounting to approximately 12% of the issued share capital of Kiadis on a Fully Diluted basis under the Offer; and (ii) to vote on the Shares in favor of the Resolutions at the EGM.

Holders of 2025 Warrants
Kiadis has five classes of warrants to acquire Shares in issue (the "Warrants"). Settlement will constitute a change of control under the agreements in relation to the Warrants, upon which (i) three classes of Warrants will expire and (ii) two classes of Warrants that are exercisable until 30 April 2025 (the "2025 Warrants") would have to be purchased by Kiadis from their holders in exchange for a cash amount equal to the Black Scholes value of the remaining unexercised portion of the 2025 Warrants. Instead, Kiadis, Sanofi and the holders of the 2025 Warrants have agreed, pursuant to two separate agreements on customary terms and conditions and conditional upon the Offer being declared conditional and the Merger Agreement not being terminated: (i) to adjust the exercise price payable by the holders of the 2025 Warrants to Kiadis for the exercise of the 2025 Warrants to EUR 0.38 per Warrant, such that the net proceeds to be received by the holders of the 2025 Warrants per Warrant, being EUR 5.07 per Warrant, is equal to the Black Scholes value of the Warrant, which would otherwise have been due and payable upon Settlement; (ii) that the 2025 Warrants will be exercised by the holders thereof for the aforementioned exercise price; and (iii) that upon the exercise of the Warrants, the corresponding Shares will be tendered under the Offer in exchange for payment of the Offer Price per Share by the Offeror. As a result, all Shares issued and tendered pursuant to the exercise of the 2025 Warrants qualify as Tendered and Committed Shares. The total commitment by the holders of the 2025 Warrants amounts to 8.58% of the Shares on a Fully Diluted basis.

Kreos Capital
On 30 September 2020, Kiadis entered into an agreement with Kreos Capital constituting the issuance of EUR 5,000,000 9% secured convertible bonds of Kiadis.

Kiadis and Kreos Capital have agreed that Kreos Capital will convert into Shares, at an exercise price of EUR 2, its entire convertible bond of EUR 5,000,000, plus an additional amount of EUR 171,014 in interest, effective as per 15 February 2021. In addition, Kiadis, Sanofi and Kreos Capital have agreed, on customary terms and conditions and conditional upon the Offer being declared unconditional and the Merger Agreement not being terminated, that Kreos Capital: (i) will vote with its holdings of Shares in favor of the Resolutions at the EGM; and (ii) commits to tender all its holdings of Shares under the Offer in exchange for payment of the Offer Price per Share by the Offeror. The irrevocable undertaking given by Kreos Capital relates to its entire holding of Shares, representing, upon conversion, 4.35% of the total number of Shares on a Fully Diluted basis.

Former holders of CytoSen shares
Former CytoSen shareholders and option holders are, pursuant to the agreement made in relation to Kiadis’ acquisition of CytoSen in June 2019, eligible to a potential future consideration of additional Shares, upon the achievement of six clinical development and regulatory milestones, which milestones will, subject to the terms described below, be accelerated in light of the Kiadis change of control, subject to a discount mechanism (the "Milestone Shares").

Kiadis, Sanofi and the former holders of CytoSen shares and options have agreed, on customary terms and conditions and conditional upon the Offer being declared unconditional and the Merger Agreement not being terminated: (i) that the Milestone Shares shall accelerate and become immediately payable by Kiadis; and (ii) that upon such acceleration, the corresponding Milestone Shares will be tendered in exchange for the Offer Price. The irrevocable undertakings given by the former holders of shares and options in CytoSen relate to their entire holdings of Shares, representing 11.19% of the total number of Shares on a Fully Diluted basis. The former holders of CytoSen shares and options have also agreed to vote, with their current holding of Shares, in favor of the Resolutions at the EGM.

Irrevocable undertakings by members of the Kiadis Boards
All members of the Kiadis Boards who hold Shares for their own account have irrevocably undertaken to tender those Shares under the Offer and to vote in favor of the Resolutions at the EGM, subject to (i) the Offer being declared unconditional, and (ii) the Merger Agreement not having been terminated in accordance with its terms.

The funds managed by Life Sciences Partners, the holders of the 2025 Warrants, Kreos Capital, the former holders of shares and options in CytoSen, and the relevant members of the Kiadis Boards did not receive any information from Sanofi, the Offeror or Kiadis relevant for a Shareholder in connection with the Offer that is not included in the Offer Memorandum and will tender their Shares under the Offer under the same terms and conditions as the other Shareholders.

Acceptance Period
The acceptance period will commence on 15 February 2021 at 09:00 hours CET and will expire on 12 April 2021 at 17:40 hours CET (such period, as it may be extended from time to time, the "Acceptance Period"), unless the Acceptance Period is extended. The day on which the Acceptance Period expires, whether or not extended, is the "Closing Date".

Any Shares tendered on or prior to the Closing Date may not be withdrawn, subject to the right of withdrawal of any tender of Shares during the Acceptance Period in accordance with the provisions of Article 5b paragraph 5, Article 15 paragraphs 3 and 8 and Article 15a paragraph 3 of the Decree.

Acceptance
Shareholders are requested to make their acceptance known through their custodian, bank or stockbroker no later than by the closing time, being 17:40 hours CET on the Closing Date (the "Closing Time"). The relevant custodian, bank or stockbroker may set an earlier deadline for communication by holders of such Shares in order to permit the custodian, bank or stockbroker to communicate the acceptance to ING Bank N.V. (the "Settlement Agent") in a timely manner. Accordingly, Shareholders should contact their financial intermediary to obtain information about the deadline by which such Shareholder must send instructions to the financial intermediary to accept the Offer and should comply with the dates set by such financial intermediary, as such dates may differ from the dates and times noted in the Offer Memorandum.

The institutions admitted to Euronext Amsterdam or Euronext Brussels (an "Admitted Institution") can tender Shares only to the Settlement Agent and only in writing.

Subject to Article 5b paragraph 5, Article 15 paragraphs 3 and 8 and Article 15a paragraph 3 of the Decree, the tendering of Shares in acceptance of the Offer will constitute irrevocable instructions by the relevant Shareholder to the relevant Admitted Institution to (i) block any attempt to transfer Shares, so that on or before the Settlement Date no transfer of such Shares can be effected (other than any action required to effect the transfer to the Offeror), (ii) debit the securities account in which such Shares are held on the Settlement Date in respect of all of the Tendered Shares, against payment of the Offer Price for such Tendered Shares by the Settlement Agent on the Offeror’s behalf, and (iii) effect the transfer of such Tendered Shares to the Offeror.

Declaring the Offer unconditional
The obligation of the Offeror to declare the Offer unconditional is subject to the satisfaction or waiver of the offer conditions set out in Section 6.6(a) of the Offer Memorandum (Offer Conditions) (the "Offer Conditions"). The Offer Conditions may be waived, to the extent permitted by applicable law or by agreement, as set out in Section 6.6(b) of the Offer Memorandum (Waiver). If the Offeror, Kiadis, or each of the Offeror and Kiadis where relevant, wishes to (wholly or partly) waive one or more Offer Conditions according to Section 6.6(b) of the Offer Memorandum (Waiver), the Offeror will inform the Shareholders as required by applicable law.

No later than the third business day following the Closing Date (such date being the "Unconditional Date"), the Offeror will determine whether the Offer Conditions have been satisfied or waived as set out in Section 6.6(a) of the Offer Memorandum (Offer Conditions), to the extent permitted by applicable law. In addition, the Offeror will announce on the Unconditional Date whether (i) the Offer is declared unconditional, (ii) the Offer will be extended in accordance with Article 15 of the Decree, or (iii) the Offer is terminated as a result of the Offer Conditions not having been satisfied or waived, all in accordance with Section 6.6 of the Offer Memorandum (Offer Conditions, waiver and satisfaction) and Article 16 of the Decree. In the event that the Offer is not declared unconditional, the Offeror will explain such decision.

Extension of the Acceptance Period
If any of the Offer Conditions is not satisfied or waived on the then scheduled Closing Date, the Offeror may, after consultation with Kiadis and in accordance with Article 15 of the Decree, extend the Acceptance Period, provided that (i) the extension of the Acceptance Period shall be no less than two weeks and no more than ten weeks calculated from the initial Closing Date, and (ii) any subsequent extension shall be subject to the receipt of an exemption granted by the AFM.

If the Acceptance Period is extended, as a result of which the obligation pursuant to Article 16 of the Decree to announce whether the Offer is declared unconditional is postponed, a public announcement to that effect will be made ultimately on the third business day following the Initial Closing Date in accordance with the provisions of Article 15 paragraphs 1 and 2 of the Decree. If the Offeror extends the Acceptance Period, the Offer will expire on the latest time and date to which the Offeror extends the Acceptance Period.

During an extension of the Acceptance Period, any Shares previously tendered and not withdrawn in accordance with Section 5.7 of the Offer Memorandum (Withdrawal Rights) will remain tendered under the Offer. Any Shares tendered during the extension of the Acceptance Period cannot be withdrawn, subject to the withdrawal rights set forth in Section 5.7 of the Offer Memorandum (Withdrawal Rights).

Settlement
If the Offeror declares the Offer unconditional, the Offeror will accept the transfer of all Tendered Shares on the terms of the Offer. The Offeror will pay the Offer Price in respect of each Tendered Share tendered during the Acceptance Period and transferred to the Offeror by a Shareholder to such Shareholder’s Admitted Institution, on the terms set out in the Offer Memorandum. The Offeror shall acquire each Tendered Share, within five business days following the Unconditional Date ("Settlement", and the day on which the Settlement occurs, the "Settlement Date").

As of the Settlement Date, revocation, dissolution, or annulment of the tendering, sale or transfer of any Share tendered during the Post-Closing Acceptance Period is not possible.

Post-Closing Acceptance Period
If the Offeror declares the Offer unconditional, the Offeror shall publicly announce a post-Offer acceptance period of two weeks to enable Shareholders who did not tender their Shares during the Acceptance Period to tender their Shares on the same terms and subject to the same conditions and restrictions as the Offer (the "Post-Closing Acceptance Period").

The Offeror will publicly announce the results of the Post-Closing Acceptance Period, accompanied by the number and percentage of Shares that have been tendered during the Post-Closing Acceptance Period and the total number and total percentage of Shares held by it in accordance with Article 17 paragraph 4 of the Decree no later than on the third business day following the last day of the Post-Closing Acceptance Period.

The Offeror shall continue to accept the transfer all Shares validly tendered (or defectively tendered, provided that such defect has been waived by the Offeror) during such Post-Closing Acceptance Period and shall pay for such Shares as soon as reasonably practicable after the last day of the Post-Closing Acceptance Period and in any case no later than on the fifth business day following the last day of the Post-Closing Acceptance Period.

During the Post-Closing Acceptance Period, Shareholders have no right to withdraw Shares from the Offer, whether validly tendered (or defectively tendered, provided that such defect has been waived by the Offeror) during the Acceptance Period or during the Post-Closing Acceptance Period.

As of the relevant settlement date, revocation, dissolution, or annulment of the tendering, sale or transfer of any Share tendered during the Post-Closing Acceptance Period is not possible.

Liquidity and delisting
The purchase of Shares by the Offeror pursuant to the Offer will reduce the number of Shareholders, as well as the number of Shares that might otherwise be traded publicly. As a result, the size of the free float in Shares may be substantially reduced following Settlement and trading volumes and liquidity of Shares may be adversely affected. The Offeror does not intend to compensate the Shareholders for such adverse effect.

Should the Offer be declared unconditional, the Offeror and Kiadis shall as soon as possible after the settlement of the Offer seek to procure the delisting of the Shares on Euronext Amsterdam and Euronext Brussels as soon as possible under applicable rules. This may further adversely affect the liquidity and market value of any Shares not tendered.

Delisting of the Shares from Euronext Amsterdam and Euronext Brussels may be achieved on the basis of at least 95% of the Shares having been acquired by the Offeror or on the basis of the Post-Offer Restructuring or any other possible post-closing measure as set out in the Offer Memorandum.

Acquisition of 100%
The Offeror’s willingness to pay the Offer Price and pursue the Transactions is predicated on the acquisition of 100% of the Shares or the entirety of Kiadis’ assets and operations (including the Kiadis Group’s entire business), the ability to delist Kiadis and to fully integrate the respective businesses of the Kiadis Group and the Sanofi Group and realize the operational, commercial, organizational, financial and tax benefits of the combination of the parties. Such benefits could not, or would only partially, be achieved if Kiadis were to continue as a standalone entity with a minority shareholder base.

As further described in the Offer Memorandum, Sanofi and Kiadis have agreed in principle to certain arrangements to facilitate the Offeror acquiring 100% of the Shares and/or full ownership of Kiadis as soon as practically possible after completion of the Offer and upon the fulfilment of certain conditions. One of these arrangements is the Post-Offer Restructuring.

Buy-Out
If, following the Settlement Date and, if applicable, the settlement of the Shares tendered during the Post-Closing Acceptance Period, the Offeror holds at least 95% of the issued ordinary share capital of Kiadis, the Offeror shall commence (i) a compulsory acquisition procedure in accordance with Article 2:92a or 2:201a of the Dutch Civil Code ("DCC") to buy out the holders of Shares that have not tendered their Shares, and/or (ii) a takeover buy-out procedure in accordance with Article 2:359c of the DCC to buy out the holders of Shares that have not tendered their Shares under the Offer (the "Buy-Out"), unless the Offeror elects to pursue the Post-Offer Restructuring and the Kiadis Boards agree to pursue the Post-Offer Restructuring, in which case the Post-Offer Restructuring shall be implemented.

Post-Offer Restructuring
Subject to (i) the adoption of the relevant Resolutions at the EGM; (ii) the Tendered Shares representing at least 80% and less than 95% of Kiadis’ aggregate issued and outstanding ordinary share capital, in each case on a Fully Diluted basis (the "Post-Offer Restructuring Threshold"), or such higher or lower percentage as may be agreed between the Offeror and Kiadis; and (iii) the Offer having been declared unconditional, the Offeror may, after consultation with Kiadis, decide to pursue the Post-Offer Restructuring, being a post-offer asset sale, whereby Kiadis will sell and transfer all of its assets and liabilities to the Offeror against payment of a purchase price equal to the Offer Price (the "Asset Sale"). Upon completion of the Asset Sale, Kiadis will be dissolved and liquidated (the "Company Dissolution" and together with the Asset Sale, the "Post-Offer Restructuring"). Upon the Company Dissolution taking place, all cash will be distributed as an advance liquidation distribution to the minority shareholders, in an amount that is to the fullest extent possible equal to the consideration that would have been made available to them if they had tendered their Shares under the Offer (no withholding taxes will be due in respect of such (advance) liquidation distribution).

Please refer to Section 6.11(d) of the Offer Memorandum (Post-Offer Restructuring) for further details.

Indicative Timetable

Expected date and time
(all times are CET) Event
09:00 hours 15 February 2021 Commencement of the Acceptance Period
30 March 2021 EGM, at which meeting the Offer, among other matters, will be discussed and the Resolutions will be voted on
17:40 hours 12 April 2021 Initial Closing Date:

Deadline for Shareholders wishing to tender Shares, unless the Offer is extended in accordance with Article 15 of the Decree as described in Section 5.10 of the Offer Memorandum (Extension)
No later than three Business Days after the Closing Date Unconditional Date:

The date on which the Offeror will publicly announce whether the Offer is declared unconditional in accordance with Article 16 of the Decree
No later than five Business Days after the Unconditional Date Settlement Date:

The date on which, in accordance with the terms and conditions of the Offer, the Offeror will pay the Offer Price for each Tendered Share2
No later than three Business Days after the Unconditional Date Post-Closing Acceptance Period:

If the Offer is declared unconditional, the Offeror will announce a Post-Closing Acceptance Period for a period of two weeks
Announcements
Any further announcement in relation to the Offer, including whether or not the Offeror declares the Offer unconditional and announcements in relation to an extension of the Acceptance Period, if any will be made by press release. Any press release issued by the Offeror will be made available on the website of the Offeror (www.sanofi.com). Any press release issued by Kiadis will be made available on the website (www.kiadis.com).

Offer Memorandum, Position Statement and further information
The Offeror is making the Offer on the terms and subject to the conditions and restrictions contained in the Offer Memorandum that is available as of today. In addition, as of today, Kiadis has made available the Position Statement, containing the information required by Article 18 paragraph 2 and Annex G of the Decree in connection with the Offer.

This press release contains selected, condensed information regarding the Offer and does not replace the Offer Memorandum and/or the Position Statement. The information in this press release is not complete and additional information is contained in the Offer Memorandum and the Position Statement. Shareholders are advised to review the Offer Memorandum and the Position Statement in detail and to seek independent advice where necessary. In addition, Shareholders are urged to consult with their own tax advisor regarding the tax consequences of acceptance or non-acceptance of the Offer.

Digital copies of the Offer Memorandum are available on the website of the Offeror (www.sanofi.com) and digital copies of the Position Statement are available on the website of Kiadis (www.kiadis.com). Such websites do not constitute part of, and are not incorporated by reference into, the Offer Memorandum. Copies of the Offer Memorandum and the Position Statement are on request also available free of charge at the offices of Kiadis and the Settlement Agent at the addresses below:

Moelis & Company LLC is acting as financial advisor and Allen and Overy LLP (Amsterdam) is acting as legal advisor to Kiadis. PJT Partners (UK) Limited is acting as financial advisor and NautaDutilh N.V. is acting as legal advisor to Sanofi.

Boston Scientific Announces February and March 2021 Conference Schedule

On February 12, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will participate in two upcoming investor conferences (Press release, Boston Scientific, FEB 12, 2021, View Source [SID1234575024]).

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On February 25, 2021, Dan Brennan, executive vice president and chief financial officer, and Susie Lisa, vice president, Investor Relations, will participate in a 30-minute question-and-answer session with the host analyst at the virtual SVB Leerink 10th Annual Global Healthcare Conference. The session will begin at approximately 10:40 a.m. EST.

On March 1, 2021, Meghan Scanlon, senior vice president and president, Urology and Pelvic Health, and Susie Lisa will participate in a 30-minute question-and-answer session with the host analyst at the virtual Cowen 41st Annual Health Care Conference. The session will begin at approximately 2 p.m. EST.

A live webcast and replay of the webcast for each event will be accessible at investors.bostonscientific.comView Source The replay will be available beginning approximately one hour following the completion of each event.