On December 9, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that efficacy results of neratinib in HER2-positive early stage breast cancer (eBC) from the Phase III ExteNET trial were presented at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place (Press release, Puma Biotechnology, DEC 9, 2020, View Source [SID1234572545]). The presentation entitled, "Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer: Final overall survival analysis from the randomized phase 3 ExteNET trial," is being presented at a Spotlight Poster Discussion Session by Frankie Ann Holmes, M.D., FACP, Texas Oncology Houston – US Oncology Research, an investigator of the trial. A copy of this poster presentation is available on the Puma website.

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ExteNET was a multicenter, randomized, double-blind, Phase III trial of 2,840 HER2-positive eBC patients who received neratinib after neoadjuvant and/or adjuvant therapy with chemotherapy and trastuzumab. Patients were stratified by hormone receptor status and randomly assigned to one year of treatment with either oral neratinib 240 mg/day or placebo. The primary endpoint of the trial was invasive disease-free survival (iDFS). Secondary endpoints include overall survival and cumulative incidence of CNS metastases. A descriptive analysis that evaluated CNS disease free survival, which was defined as time from randomization to any CNS recurrence or death from any cause, was performed.

Within the European Union, neratinib is approved in patients with hormone receptor positive (HR+) breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen.

The endpoints were analyzed for three groups of clinical interest: (i) the intent to treat (ITT) population; (ii) patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen; and (iii) patients with HR+ breast cancer who initiated treatment within one year of completing an adjuvant trastuzumab containing regimen and who did not achieve a pathological complete response (no pCR) after neoadjuvant treatment and therefore were at a high risk of disease recurrence. Results from the Phase III ExteNET trial were published in the October 5, 2020 issue of Clinical Breast Cancer. The manuscript is accessible online at View Source(20)30258-5/fulltext.

In the ITT population, 127 of 1420 patients (8.9%) in the neratinib group and 137 of 1420 patients (9.6%) in the placebo group died, as of the analysis cut-off date (July 2019). The estimated 8-year overall survival (OS) rates were 90.1% in the neratinib group and 90.2% in the placebo group (stratified HR 0.95; 95% confidence interval [CI] 0.75-1.21; p=0.69). The cumulative incidence of CNS metastases at 5 years was 1.3% (95% CI 0.8-2.1) in the neratinib arm and 1.8% (95% CI 1.2-2.7%) in the placebo arm, while the estimated CNS disease free survival at 5 years was 97.5% in the neratinib group and 96.4% in the placebo group (stratified HR 0.73; 95% CI 0.45-1.17).

In the HR+ /< 1 yr patient population, 53 of 670 patients (7.9%) in the neratinib group and 68 of 664 patients (10.2%) in the placebo group died. The estimated 8-year OS rates were 91.5% in the neratinib group and 89.4% in the placebo group, corresponding to a 2.1% absolute benefit (HR 0.79; 95% CI 0.55‒1.13). The cumulative incidence of CNS metastases at 5 years was 0.7% (95% CI 0.2-1.7) in the neratinib arm and 2.1% (95% CI 1.1-3.5) in the placebo arm, while the estimated CNS disease free survival at 5 years was 98.4% in the neratinib group and 95.7% in the placebo group (stratified HR 0.41; 95% CI 0.18-0.85).

In the HR+/ <1 yr, no pCR subgroup of patients (n=295), 8-year OS rates were 91.3% in the neratinib group and 82.2% in the placebo group, corresponding to a 9.1% absolute benefit (HR 0.47; 95% CI 0.23–0.92). In the HR+/ <1 yr, with a pCR (n=38), 8-year OS rates were 93.3% in the neratinib group and 73.7% in the placebo group, corresponding to a 19.6% absolute benefit (HR 0.40; 95% CI 0.06–1.88). The cumulative incidence of CNS metastases at 5 years was 0.8% (95% CI 0.1-4.0) in the neratinib arm and 3.6% (95% CI 1.3-7.8%) in the placebo arm, while the estimated CNS disease free survival at 5 years was 98.4% in the neratinib group and 92.0% in the placebo group (stratified HR 0.24; 95% CI 0.04-0.92).

Dr. Frankie Ann Holmes said, "These descriptive analyses in HR+ patients who received neratinib within one year of completing trastuzumab and did not achieve a pCR post neoadjuvant therapy suggest that neratinib may be associated with improved OS in this high-risk group (HR 0.47, absolute benefit 9.1%). Importantly, neratinib is the first HER2-directed agent to show a trend towards improved CNS outcomes in early stage HER2-positive breast cancer, with consistently fewer CNS events observed in the neratinib arm compared with placebo in all groups evaluated."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "Descriptive analyses suggest that neratinib may be associated with longer overall survival in subgroups of clinical interest and in the high-risk patient subgroup with residual disease after neoadjuvant therapy who are at a high risk of disease recurrence. Although there have been many new treatment options for patients with early stage HER2-positive breast cancer, the risk of disease recurrence and more specifically CNS recurrence remains significant and more must be done. These newly published data demonstrate that neratinib provides a clinically meaningful reduction in the risk of recurrence and CNS recurrence and provides a very important option for these high risk patients."

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

On December 9, 2020, Innovation Pharmaceuticals Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Securities Purchase Agreement") with an investor for the sale of an aggregate of 5,089 shares of the Company’s newly-created Series B-2 5% convertible preferred stock (the "preferred stock"), for aggregate gross proceeds of approximately $5.0 million (Filing, 8-K, Innovation Pharmaceuticals, DEC 9, 2020, View Source [SID1234572581]). Under the Securities Purchase Agreement, the Company will also issue to the investor warrants to purchase up to an additional 10,178 shares of preferred stock. An initial closing relating to the sale of 3,053 shares of preferred stock and accompanying warrants occurred on December 9, 2020, and a second closing relating to the sale of 2,036 shares of preferred stock and accompanying warrants is expected to occur sixty trading days following the date of the first closing, subject to the trading price for the Company’s common stock being greater than $0.07 per share and the value of the daily trading volume for the Company’s common stock being greater than $50,000, in each case for each of the ten trading days prior to the second closing date, and subject to satisfaction of customary closing conditions as set forth in the Securities Purchase Agreement.

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The rights and preferences of the preferred stock are set forth in a Certificate of Designation of Preferences, Rights and Limitations of Series B-2 5% Convertible Preferred Stock (the "Certificate of Designation") filed with the Nevada Secretary of State on December 7, 2020. Each share of preferred stock has an initial stated value of $1,080 and may be converted at any time at the holder’s option into shares of the Company’s common stock at a conversion price equal of the lower of (i) $0.35 per share on or before August 15, 2021, and $0.50 per share thereafter, and (ii) 85% of the lowest volume weighted average price of the Company’s common stock on a trading day during the ten trading days prior to and ending on, and including, the conversion date. The conversion price may be adjusted following certain triggering events and subsequent equity sales and is subject to appropriate adjustment in the event of stock splits, stock dividends, recapitalization or similar events affecting the Company’s common stock.

The holders of the preferred stock are limited in the amount of stated value of the preferred stock they can convert on any trading day. The conversion cap limits conversions by the holders to the greater of $75,000 and an amount equal to 30% of the aggregate dollar trading volume of the Company’s common stock for the five trading days immediately preceding, and including, the conversion date. However, the conversion cap will be increased if the trading volume in the first 30 minutes of any trading session exceeds certain trailing average daily volume amounts. In addition, the holders of the preferred stock may not convert shares of preferred stock if, after giving effect to the conversion, a holder together with its affiliates would beneficially own in excess of 9.99% of the outstanding shares of the Company’s common stock.

Following 90 days after the second closing, the Company may elect to redeem the preferred stock for 120% of the aggregate stated value then outstanding, plus all accrued but unpaid dividends and all liquidated damages and other amounts due in respect of the preferred stock. The Company’s right to redeem the preferred stock is contingent upon it having complied with a number of conditions, including compliance with its obligations under the Certificate of Designation. Shares of preferred stock will generally have no voting rights, except as required by law and except that the Company shall not take certain actions without the consent of the holders of the preferred stock.

Each share of preferred stock will be sold together with two warrants: (i) a Series 1 warrant, which will entitle the holder thereof to purchase one share of preferred stock at $982.50 per share, or 5,089 shares of preferred stock in the aggregate for approximately $5.0 million in aggregate exercise price, for a period of up to 18 months following issuance, and (ii) a Series 2 warrant, which will entitle the holder thereof to purchase one share of preferred stock at $982.50 per share, or 5,089 shares of preferred stock in the aggregate for approximately $5.0 million in aggregate exercise price, for a period of up to 24 months following issuance.

Subject to the satisfaction of certain circumstances, the Company may call for cancellation any or all of the warrants following 90 days after their issuance, for a payment in cash equal to 8% of the aggregate exercise price of the warrants being called. The warrants subject to any such call notice will be cancelled ten days following the Company’s payment of the call fee, provided that the warrant holders have not exercised the warrants prior to cancellation.

The Company intends to use the net proceeds from the offering for general corporate purposes, including research and development.

The securities were registered pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-239817) (the "Registration Statement") and the related base prospectus included in the Registration Statement, as supplemented by the prospectus supplement dated December 9, 2020. The legal opinions and consents of Gary Henrie and Hogan Lovells US LLP addressing the validity of the securities (including shares of the Company’s preferred stock underlying the warrants and shares of the Company’s common stock issuable upon conversion of the preferred stock) are filed as Exhibit 5.1 and Exhibit 5.2, respectively, to this Current Report on Form 8-K and are incorporated into the Registration Statement.

The foregoing descriptions of the terms and conditions of the Securities Purchase Agreement, Certificate of Designation and warrants are not complete and are qualified in their entirety by the full text of the Securities Purchase Agreement, Certificate of Designation and form of warrant, which are filed herewith as Exhibits 10.1, 3.1 and 4.1, respectively, and incorporated into this Item 1.01 by reference.

The Securities Purchase Agreement contains customary representations and warranties, covenants, conditions to closing and indemnification provisions that the parties made to, and solely for the benefit of, each other in the context of all of the terms and conditions of such agreement and in the context of the specific relationship between the parties. The provisions of the Securities Purchase Agreement, including the representations and warranties contained therein, are not for the benefit of any party other than the parties to such agreement or parties expressly permitted to rely on such provisions and are not intended for investors and the public to obtain factual information about the current state of affairs of the parties thereto. Rather, investors and the public should look to other disclosures contained in the Company’s filings with the Securities and Exchange Commission.

This Current Report on Form 8-K contains "forward-looking" statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, including statements related to the closings under the Securities Purchase Agreement and the use of proceeds therefrom. The words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. While the Company believes its plans, intentions and expectations reflected in those forward-looking statements are reasonable, these plans, intentions or expectations may not be achieved. The Company’s actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements. For information about the factors that could cause such differences, please refer to the Company’s SEC filings. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The Company assumes no obligation to update any forward-looking statement.

On December 9, 2020 Zionexa US Corp., a wholly owned subsidiary of Zionexa SAS, specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, reported that the first Cerianna (Fluroroestradiol F-18) doses have been distributed to two oncology imaging centers in the San Francisco area (Press release, Zionexa, DEC 9, 2020, View Source [SID1234572511]). These two doses of Cerianna represent the future for two breast cancer patients to be able to receive PET scans that will have a more direct impact on the course of their therapy, and overall provide them with more informed and better care.

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Cerianna (fluoroestradiol F-18) injection is a new molecular imaging agent approved by the Food and Drug Administration (FDA) indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer (MBC). Cerianna (fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging biomarker specifically indicated for use in patients with recurrent or metastatic breast cancer. The permanent HCPCS code, A9591 "Fluoroestradiol F 18, diagnostic, 1 millicurie" will be effective January 2021.

"This is a momentous day: our international team worked everyday since the creation of Zionexa to achieve this tremendous milestone. Our mission is to continue this impressive work in order to help improve patient’s quality of life and guiding therapies. Cerianna can help guide therapies for recurrent and MBC patients and our ambition is to provide all patients who have the need for it in the United States," said Peter Webner, CEO of Zionexa US Corp. "Cerianna is already being produced and distributed in San Francisco and we expect to extend to Los Angeles, New York, Philadelphia, Raleigh Durham and Jacksonville next month."

"Siemens’ Healthineers PETNET Solutions is pleased to be the exclusive commercial US manufacturer and distributor of Cerianna" says Barry Scott, Head of PETNET Solutions. "The ability to be able to deliver Cerianna and help provide answers for these patients is a key milestone. Furthermore, PETNET is providing solutions that address society’s most challenging diseases, like breast cancer. Our continued investment in our network will enable us to extend access to a greater population in the coming months."

About Metastatic Breast Cancer

Metastatic breast cancer is the most advanced stage of breast cancer. Also called stage IV or advanced breast cancer, MBC means that the cancer has spread beyond the breast to other parts of the body. MBC affects more than 168,000 patients in the United-States (source: Mariotto et al, 2017).

On December 9, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that it will be participating in the Targeted Radiopharmaceuticals Summit being held virtually December 8th – 10th (Press release, Actinium Pharmaceuticals, DEC 9, 2020, View Source [SID1234572527]). During the event, Dale Ludwig, Ph.D., Actinium’s Chief Scientific and Technology Officer will participate in a panel titled "Beyond PSMA – How Do We Realistically Identify New Targets to Take on with Radioligand Therapy."

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"Targeted radiotherapy is witnessing a renaissance driven by strong clinical data emerging in multiple indications. This has resulted in acquisitions, new company formation and investments in new targets to pursue with radiotherapy," said Sandesh Seth, Actinium’s Chairman and CEO. He continued, "Actinium is proud to have not only established ourselves as a leader in the targeted radiotherapy field and is the only company pursuing well validated targets in hematology with late stage clinical programs. Both our Iomab-B and Actimab-A programs have yielded promising clinical data in the relapsed/refractory Acute Myeloid Leukemia (AML) setting that was prominently highlighted at ASH (Free ASH Whitepaper) demonstrating the potential of our ARCs for targeted conditioning in the case of Iomab-B and as a backbone for therapeutic combinations with Actimab-A. We intend to build upon our leadership position in targeted radiotherapy by leveraging our AWE technology platform including our gold standard linker, our robust IP portfolio and know-how, our clinical and supply chain expertise and our recently enhanced research infrastructure and capabilities. Our team is enthused to be spreading awareness about our activities with this exciting and valuable approach to drug development at this important industry conference."

Panel Details
Title: Beyond PSMA – How Do We Realistically Identify New Targets to Take on with Radioligand Therapy
Date: December 10, 2020
Time: 10:20 ET

Dr. Dale Ludwig, Actinium’s Chief Scientific and Technology Officer, said, "The targeted radiotherapy field has produced several successful drug candidates of late, however, they have been focused on a select number of targets and indications. It is critical that innovation continues to truly capitalize on the potential of targeted radiation. I look forward to highlighting Actinium’s efforts to leverage our AWE platform and clinical development experience to lead the field in its next evolution through the development of novel targeted radiotherapies for patients with unmet needs not addressed by current standards of care."

Members of Actinium’s executive and R&D teams will be in attendance at the virtual meeting. To schedule a meeting with Actinium please email [email protected].

This year, Actinium announced the expansion of its R&D capabilities with a new research facility to capitalization on the increased interest in targeted radiotherapy and to enhance its development of next generation Antibody Radiation Conjugates (ARC) candidates, ARC therapeutic combination strategies, and supporting AWE platform research collaborations. Actinium’s R&D efforts will employ a multidisciplinary approach leveraging its team’s expertise and experience in cancer cell biology, radiochemistry, radiation sciences, immunology and oncology drug development. The proprietary AWE technology platform, protected by over one hundred and thirty patents, is the foundation for Actinium’s R&D and exploits multiple different radioisotope payloads including the potent alpha-emitter, Actinium-225. Actinium is a leader in the field of targeted radiotherapy with several hundred patients treated to date with its ARCs, patent protection to 2037 and beyond for its drug candidates, patent protected "gold standard" linker technology, an established clinical supply chain at over 30 leading hospitals and a research collaboration with Astellas.

On December 9, 2020 NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN : FR0011341205 – the ‘‘Company’’), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported the filing of an amended registration on form F-1 in connection with its intention to issue and sell, subject to market and other conditions, 6,500,000 ordinary shares of the Company in an initial public offering of American Depositary Shares ("ADSs"), each representing the right to receive one ordinary share, in the United States (the "U.S. Offering") and a concurrent offering of ordinary shares in certain jurisdictions outside the United States to certain investors (the "European Offering" and together with the U.S. Offering, the "Global Offering") (Press release, Nanobiotix, DEC 9, 2020, View Source [SID1234572546]). The offering price per ADS is expected to be between $13.50 and $14.50, or between €11.15 and €11.97 per ordinary share (assuming an exchange rate of €1.00 = $1.2109, the exchange rate published by the European Central Bank on December 9, 2020).

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Assuming an offering price of $14.00 per ADS in the U.S. Offering and €11.56 per ordinary share in the European Offering, which are the midpoints of the respective price ranges, the Company expects to receive net proceeds of approximately $79.6 million (€65.8 million) from the Global Offering. The Company intends to grant the underwriters a 30-day option to purchase, at the same price, additional ADSs and/or ordinary shares in an aggregate amount of up to 15% of the total number of ADSs and ordinary shares proposed to be sold in the Global Offering. If such option is exercised in full, the expected net proceeds to the Company will increase to approximately $92.3 million (€76.2 million).

All securities to be sold in the Global Offering will be offered by the Company. The ADSs have been approved for listing on the Nasdaq Global Select Market under the ticker symbol "NBTX." The Company’s ordinary shares are listed on the regulated market of Euronext Paris under the ticker symbol "NANO."

The Company plans to use the net proceeds of the Global Offering to advance the overall development of NBTXR3, prioritizing the treatment of locally advanced head and neck cancers, including approximately $58.1 million to advance its clinical trial of NBTXR3 in the United States and Europe for the treatment of locally advanced head and neck cancers through an interim analysis of efficacy data, and approximately $20.6 million to advance the development of its other clinical and pre-clinical programs. The Company expects to use the remainder of the net proceeds, if any, from the Global Offering for working capital funding and other general corporate purposes.

The Company expects that the net proceeds from the Global Offering, together with its cash and cash equivalents of €42.4 million as of September 30, 2020, will be sufficient to fund its operating expenses and capital expenditure requirements through the end of 2022.

Jefferies LLC is acting as global coordinator and joint book-running manager for the Global Offering, and Evercore Group, L.L.C. and UBS Securities LLC are acting as joint book-running managers for the U.S. Offering. Jefferies International Limited and Gilbert Dupont are acting as managers for the European Offering.

The final offering price per ADS in U.S. dollars and the corresponding offering price per ordinary share in euros, as well as the final number of ADSs and ordinary shares to be sold in the Global Offering, will be determined by the Company’s executive board following a bookbuilding process commencing immediately. The offering price per ADS and per ordinary share will be at least equal to the volume weighted average price of the Company’s ordinary shares on the regulated market of Euronext in Paris over the last three trading days preceding the start of the offering (i.e., December 7, 8 and 9, 2020), subject to a maximum discount of 10%.

On an indicative basis, the completion of the Global Offering would result in a dilution of approximately 25% of the Company’s outstanding share capital on a non-diluted basis (excluding the exercise by the underwriters of the option to purchase additional ordinary shares) and approximately 28% of the Company’s outstanding share capital on a non-diluted basis (in the event that the underwriters exercise in full their option to purchase additional ordinary shares (including in the form of ADSs)).

The ADSs and/or ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights by way of a public offering excluding offerings referred to in Article L. 411-2 1° of the French Monetary and Financial Code (Code monétaire et financier) and under the provisions of Article L.225-136 of the French Commercial Code (Code de commerce) and pursuant to the 2nd and 7th resolutions of the Company’s extraordinary general shareholders’ meeting held on November 30, 2020. The European Offering will be open only to qualified investors as such term is defined in article 2(e) of the regulation (EU) 2017/1129 of the European Parliament and of the Council of June 14, 2017.

The Company plans to announce the result of the Global Offering as soon as practicable after pricing thereof in a subsequent press release.

The existing liquidity contract between the Company and Gilbert Dupont is suspended until the end of the stabilization period.

The securities referred to in this press release will be offered only by means of a prospectus. When available, copies of the preliminary prospectus relating to and describing the terms of the Global Offering may be obtained from Jefferies LLC, 520 Madison Avenue New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or from Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at 888-474-0200, or by email at [email protected]; or from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by telephone at 888-827-7275, or by email at [email protected].

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the U.S. Securities and Exchange Commission ("SEC") but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The registration statement can be accessed by the public on the website of the SEC.