BFRA Biofrontera AG

6.12
-0.14  -2%
Previous Close 6.26
Open 6.44
52 Week Low 4.67
52 Week High 55
Market Cap $173,555,195
Shares 28,358,692
Float 27,643,402
Enterprise Value $165,348,192
Volume 12,896
Av. Daily Volume 20,880
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Drug Pipeline

Drug Stage Notes
Ameluz
Actinic keratosis
Phase 3
Phase 3
Phase 3 data met primary endpoint - March 20, 2019. Additional trials required with patient recruitment to commence 1H 2022.
Ameluz
Basal cell carcinoma
Phase 3
Phase 3
Phase 3 trial enrolling. 60% complete as of June 2021.
Ameluz
Acne
Phase 2b
Phase 2b
Phase 2b trial planned for 2H 2021.
Ameluz
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase 3
Phase 3
Phase 3 planned.

Latest News

  1. Leverkusen, Germany, July 23, 2021 (GLOBE NEWSWIRE) -- Biofrontera Pharma GmbH, a wholly owned subsidiary of Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))), and Medac Gesellschaft für klinische Spezialpräparate mbH. (Medac), signed an exclusive license and supply agreement for the marketing of both Ameluz® and BF-RhodoLED® in Poland. The agreement has a term of 5 years commencing with the start of sales in Poland.

    Under the terms of the agreement, Medac will make an immediate one-time upfront payment of EUR 50,000 to the Company, plus an additional one-time payment of EUR 150,000 following receipt of the drug's reimbursement eligibility from the Polish health insurance providers. According to the agreement, Medac receives…

    Leverkusen, Germany, July 23, 2021 (GLOBE NEWSWIRE) -- Biofrontera Pharma GmbH, a wholly owned subsidiary of Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))), and Medac Gesellschaft für klinische Spezialpräparate mbH. (Medac), signed an exclusive license and supply agreement for the marketing of both Ameluz® and BF-RhodoLED® in Poland. The agreement has a term of 5 years commencing with the start of sales in Poland.

    Under the terms of the agreement, Medac will make an immediate one-time upfront payment of EUR 50,000 to the Company, plus an additional one-time payment of EUR 150,000 following receipt of the drug's reimbursement eligibility from the Polish health insurance providers. According to the agreement, Medac receives exclusive distribution rights for Poland. Once reimbursement eligibility has been granted in Poland, Biofrontera will supply Ameluz® to Medac at a fixed transfer price based on the expected net revenues.

    As with all of the company's other licensing agreements, Biofrontera will be responsible for regulatory affairs as well as manufacturing and quality control, while Medac will handle all aspects of commercialization and local regulatory and reimbursement in Poland.

    Prof. Dr. Hermann Lübbert, CEO of Biofrontera AG, commented, "We are pleased to have a strong partner on our side to offer photodynamic therapy for the treatment of actinic keratosis and basal cell carcinoma by using Ameluz® and the BF-RhodoLED® in Poland."

    Medac Gesellschaft für klinische Spezialpräparate mbH is a global pharmaceutical company based in Germany, which has been specializing in the treatment and diagnosis of oncological, urological and autoimmune diseases. In Poland, Medac operates a leading sales structure in dermatology and, with this agreement, expands its dermatology portfolio with the addition of Ameluz®.

    Background:

    In 2011, the prescription drug Ameluz® received a centralized EU marketing authorization from the European Commission, which since then has repeatedly been expanded. Ameluz® is approved for use in photodynamic therapy (PDT) of mild to moderate actinic keratoses, field cancerization, and superficial and nodular basal cell carcinomas. Ameluz® is approved for the use in conventional PDT with our special red-light lamp BF-RhodoLED® as well as for daylight PDT.

    -End-

    Biofrontera AG

    Pamela Keck, Head of Investor Relations



    +49-214-87632-0

    About Biofrontera:

    Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.

    The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin. The company's lead product is the combination of Ameluz®, a topical prescription drug, and medical device BF-RhodoLED® for the photodynamic therapy of certain superficial skin cancers and their precursors. Ameluz® has been marketed in the EU since 2012 and in the United States since May 2016. In addition, the company markets the prescription medication Xepi® for the treatment of impetigo in the United States. In the EU, the company also sells the dermocosmetics series Belixos®, which offers specialized care for damaged or diseased skin.

    Biofrontera is the first German founder-led pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the US NASDAQ.www.biofrontera.com.

    Forward-Looking Statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the public offering and the intended use of proceeds from the offering.

    These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. Such forward-looking statements are based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of the Company, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors are set forth in the annual report on Form 20-F filed with the SEC, including Item 3.D. "Key Information - Risk Factors," and in future reports filed with the SEC. Given these risks, uncertainties and other factors, prospective investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake an obligation to update or revise any forward-looking statement.



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  2. Leverkusen, Germany, July 06, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG currently holds 100 % of the shares of the US-based Biofrontera Inc.

    Biofrontera AG had already announced that opportunities for capital raises were being evaluated including a potential initial public offering ("IPO") of Biofrontera Inc. in the United States.

    The main objectives of an IPO of Biofrontera Inc. would be to raise additional capital to fund its growth of operations, to create a public market for its shares and to facilitate future access to the capital market.

    A registration statement relating to the securities to be offered in the IPO has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not…

    Leverkusen, Germany, July 06, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG currently holds 100 % of the shares of the US-based Biofrontera Inc.

    Biofrontera AG had already announced that opportunities for capital raises were being evaluated including a potential initial public offering ("IPO") of Biofrontera Inc. in the United States.

    The main objectives of an IPO of Biofrontera Inc. would be to raise additional capital to fund its growth of operations, to create a public market for its shares and to facilitate future access to the capital market.

    A registration statement relating to the securities to be offered in the IPO has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen

    ISIN: DE0006046113

    WKN: 604611

    Contact:

    Biofrontera AG

    Tel: +49 (0214) 87 63 2 0, Fax: +49 (0214) 87 63 290

    Email:

    Forward-Looking Statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the public offering and the intended use of proceeds from the offering.

    These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. Such forward-looking statements are based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of the Company, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors are set forth in the annual report on Form 20-F filed with the SEC, including Item 3.D. "Key Information - Risk Factors," and in future reports filed with the SEC. Given these risks, uncertainties and other factors, prospective investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake an obligation to update or revise any forward-looking statement.



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  3. Leverkusen, Germany, July 06, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))) (the "Company"), an international biopharmaceutical company, today reported preliminary, unaudited revenue for the month of June 2021.

    The Company's preliminary, unaudited revenue from product sales in June 2021 amounted to approximately EUR 2,626 thousand, compared to EUR 1,701 thousand in June 2020, an increase of 50%.

    Preliminary revenues from product sales in the US were around EUR 1,375 thousand compared to EUR 1,235 thousand in June 2020, an increase of 11%. In Germany, revenues from product sales amounted to approximately EUR 417 thousand, compared to EUR 370 thousand in June 2020, an increase of 12%. In the rest of…

    Leverkusen, Germany, July 06, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))) (the "Company"), an international biopharmaceutical company, today reported preliminary, unaudited revenue for the month of June 2021.

    The Company's preliminary, unaudited revenue from product sales in June 2021 amounted to approximately EUR 2,626 thousand, compared to EUR 1,701 thousand in June 2020, an increase of 50%.

    Preliminary revenues from product sales in the US were around EUR 1,375 thousand compared to EUR 1,235 thousand in June 2020, an increase of 11%. In Germany, revenues from product sales amounted to approximately EUR 417 thousand, compared to EUR 370 thousand in June 2020, an increase of 12%. In the rest of Europe, the Company generated product sales of around EUR 834 thousand, compared to EUR 96 thousand in June 2020, a plus of 770%. Sales in June this year include the first batch of Ameluz® for reintroduction in the Scandinavian market by Galenica AB.

    Preliminary unaudited revenues

     JuneQ2
    in EUR thousands202120202019202120202019
    USA1,3751,2351,5394,8612,1665,060
    Germany4173703091,2851,0541,081
    Europe (ex Germany)834963611,448146793
    Total revenue from product sales2,6261,7012,1997,5953,3666,934
    Revenues from R&D projects and license payments0485406,278162
    Total revenue2,6261,7502,2537,5959,6447,096

    Due to commercial rounding, rounding differences may occur in tables.

    Due to the pandemic, the monthly and quarterly sales development is compared with sales in 2019 for increased transparency. As such, an increase of 19% in June 2021 total product sales was achieved in all markets compared to June 2019. In more detail, June 2021 sales were up by 35% in Germany and by 131% in the remaining European markets compared to June 2019. In the USA, product sales decreased by 10%. The decline was mainly caused by no or lower sales of Aktipak® and Xepi®, respectively, while sales of Ameluz® were at a comparable level.

    In Q2 2021, product sales in all markets were up by around 10% compared to Q2 2019. Sales in Q2 2021 increased by around 19% in Germany and by almost 83% in the rest of the European market compared to Q2 2019. Revenue in the US market was down 4%, mainly due to the lack of or lower sales of Aktipak® and Xepi®, while sales of Ameluz® showed a slight increase compared to Q2 2019.

    -End-

    Biofrontera AG

    Pamela Keck, Head of Investor Relations



    +49-214-87632-0

    About Biofrontera:

    Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.

    The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin. The company's lead product is the combination of Ameluz®, a topical prescription drug, and medical device BF-RhodoLED® for the photodynamic therapy of certain superficial skin cancers and their precursors. Ameluz® has been marketed in the EU since 2012 and in the United States since May 2016. In addition, the company markets the prescription medication Xepi® for the treatment of impetigo in the United States. In the EU, the company also sells the dermocosmetics series Belixos®, which offers specialized care for damaged or diseased skin.

    Biofrontera is the first German founder-led pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the US NASDAQ.www.biofrontera.com.

    Forward-Looking Statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the public offering and the intended use of proceeds from the offering.

    These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. Such forward-looking statements are based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of the Company, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors are set forth in the annual report on Form 20-F filed with the SEC, including Item 3.D. "Key Information - Risk Factors," and in future reports filed with the SEC. Given these risks, uncertainties and other factors, prospective investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake an obligation to update or revise any forward-looking statement.



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  4. Leverkusen, Germany, June 22, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))) (the "Company"), an international biopharmaceutical company, today provides an update on its clinical developments.

    In February and March 2021, the Company announced two submissions to the U.S. Food and Drug Administration (FDA), enabling the simultaneous use of up to three tubes of Ameluz® per photodynamic therapy (PDT) on the one hand, while seeking approval for a larger red-light lamp, the BF-RhodoLED® XL, on the other. In June 2021, the meeting with the FDA previously announced for both submissions took place, in which the further proceeding was determined. With regard to the approval process of BF-RhodoLED®, the FDA…

    Leverkusen, Germany, June 22, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))) (the "Company"), an international biopharmaceutical company, today provides an update on its clinical developments.

    In February and March 2021, the Company announced two submissions to the U.S. Food and Drug Administration (FDA), enabling the simultaneous use of up to three tubes of Ameluz® per photodynamic therapy (PDT) on the one hand, while seeking approval for a larger red-light lamp, the BF-RhodoLED® XL, on the other. In June 2021, the meeting with the FDA previously announced for both submissions took place, in which the further proceeding was determined. With regard to the approval process of BF-RhodoLED®, the FDA has confirmed that the data are sufficient for the submission and that the evaluation process will be initiated.

    The other submission, the application for amendment of the product information to extend the posology allowing the simultaneous use of three tubes of Ameluz®, was discussed intensively in talks with the FDA. The regulatory agency did not express any concerns related to efficacy or to the results from the phase I pharmacokinetics study underlying the application. However, to amend the product information, which currently limits the use to one tube of Ameluz® per treatment, the FDA recommended the submission of expanded safety data. The FDA agreed with the proposal to observe systemic and local side effects during treatment with three tubes of Ameluz® in 100 patients. This safety study is scheduled to start in the second half of 2021.

    With regard to the potential expansion of the Ameluz® approval to moderate and severe acne in the USA, the Company has finalized the design of the phase IIb trial, taking into account the regulatory recommendations agreed upon with the FDA in 2020. A multicenter, randomized, double-blind study with four arms is planned for conventional PDT with Ameluz® involving 126 patients aged 16 years and older. Ameluz® incubation times of one and three hours will be compared with placebo. The aim of the study is to collect data on the efficacy and safety when using Ameluz® PDT for moderate and severe acne. As previously announced, the trial is scheduled to start in the second half of 2021.

    Comparable to the European approval expansion of Ameluz® for the treatment of mild and moderate actinic keratoses (AK) on the extremities and trunk/neck with PDT, the Company is currently preparing phase III trials for this approval expansion in the USA. Patient recruitment is expected to start in the first half of 2022.

    Also scheduled to begin in the second half of 2021 in the USA is a study evaluating an illumination protocol for which Biofrontera has filed a patent application. The goal of the study is to reduce pain during illumination in conventional PDT for actinic keratoses on the face and scalp.

    Patient recruitment has picked up again for the clinical trial for the treatment of superficial basal cell carcinoma (BCC) with Ameluz® in conjunction with the BF-RhodoLED® lamp in the USA. To date, approximately 60% of the planned 186 patients have been enrolled in the study. Due to the demanding study protocol, the recruitment process has been very lengthy and was heavily influenced by the pandemic last year.

    -End-

    Biofrontera AG

    Pamela Keck, Head of Investor Relations



    +49-214-87632-0

    About Biofrontera:

    Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.

    The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin. The company's lead product is the combination of Ameluz®, a topical prescription drug, and medical device BF-RhodoLED® for the photodynamic therapy of certain superficial skin cancers and their precursors. Ameluz® has been marketed in the EU since 2012 and in the United States since May 2016. In addition, the company markets the prescription medication Xepi® for the treatment of impetigo in the United States. In the EU, the company also sells the dermocosmetics series Belixos®, which offers specialized care for damaged or diseased skin.

    Biofrontera is the first German founder-led pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the US NASDAQ.www.biofrontera.com.

    Forward-Looking Statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the public offering and the intended use of proceeds from the offering.

    These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. Such forward-looking statements are based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of the Company, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors are set forth in the Registration Statement on Form F-1 filed with the SEC, including in the section "Risk Factors," and in future reports filed with the SEC. Given these risks, uncertainties and other factors, prospective investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake an obligation to update or revise any forward-looking statement.



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  5. Leverkusen, Germany, June 07, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))) (the "Company"), an international biopharmaceutical company, today reported preliminary, unaudited revenue for the month of May 2021.

    The Company's preliminary, unaudited revenue from product sales in May 2021 amounted to approximately EUR 2,437 thousand, compared to EUR 1,172 thousand in May 2020, an increase of 108%.

    Preliminary revenues from product sales in the US were around EUR 1,638 thousand compared to EUR 599 thousand in May 2020, an increase of 174%. In Germany, revenues from product sales amounted to approximately EUR 425 thousand, compared to EUR 540 thousand in May 2020, a decrease of 21%. Despite the…

    Leverkusen, Germany, June 07, 2021 (GLOBE NEWSWIRE) -- Biofrontera AG (NASDAQ:BFRA, Frankfurt Stock Exchange: B8F))) (the "Company"), an international biopharmaceutical company, today reported preliminary, unaudited revenue for the month of May 2021.

    The Company's preliminary, unaudited revenue from product sales in May 2021 amounted to approximately EUR 2,437 thousand, compared to EUR 1,172 thousand in May 2020, an increase of 108%.

    Preliminary revenues from product sales in the US were around EUR 1,638 thousand compared to EUR 599 thousand in May 2020, an increase of 174%. In Germany, revenues from product sales amounted to approximately EUR 425 thousand, compared to EUR 540 thousand in May 2020, a decrease of 21%. Despite the pandemic, sales in Germany had developed positively last year, and in May in particular, we saw catch-up effects from the lock-down month of April 2020. In the rest of Europe, the Company generated product sales of around EUR 374 thousand, compared to EUR 33 thousand in May 2020, a plus of 1,041%.

    Preliminary unaudited revenues

     MayJanuary - May
    in EUR thousands202120202019202120202019
    USA1,6385991,7647,2885,1128,702
    Germany4255404192,2721,9931,844
    Europe (ex Germany)37433241867869996
    Total revenue from product sales2,4371,1722,42410,4277,97511,543
    Revenues from R&D projects and license payments01206406,392108
    Total revenue2,4371,2922,48810,42714,36711,651

    Due to commercial rounding, rounding differences may occur in tables.

    Due to the pandemic, the monthly sales development is compared with sales in 2019 for increased transparency. As such, a slight increase of 1% in May 2021 total product sales was achieved in all markets compared to May 2019. In more detail, May 2021 sales were up by 1% in Germany and by 55% in the remaining European markets compared to May 2019. In the USA, product sales decreased by 7%. The decline was mainly caused by no or lower sales of Aktipak® and Xepi®, respectively, while sales of Ameluz® were at a comparable level.

    The recovery in product sales compared to 2020 as well as to 2019, which has been perceived since mid-March 2021, thus continued in May 2021. This indicates a significant recovery of the COVID-19 situation.

    -End-

    Biofrontera AG

    Pamela Keck, Head of Investor Relations



    +49-214-87632-0

    About Biofrontera:

    Biofrontera AG is a biopharmaceutical company specializing in the development and sale of dermatological drugs and medical cosmetics.

    The Germany-based company, with over 150 employees worldwide, develops and markets innovative products for the care, protection and treatment of the skin. The company's lead product is the combination of Ameluz®, a topical prescription drug, and medical device BF-RhodoLED® for the photodynamic therapy of certain superficial skin cancers and their precursors. Ameluz® has been marketed in the EU since 2012 and in the United States since May 2016. In addition, the company markets the prescription medication Xepi® for the treatment of impetigo in the United States. In the EU, the company also sells the dermocosmetics series Belixos®, which offers specialized care for damaged or diseased skin.

    Biofrontera is the first German founder-led pharmaceutical company to receive a centralized European and a US approval for a drug developed in-house. The Biofrontera Group was founded in 1997 by the current CEO Prof. Dr. Hermann Lübbert and is listed on the Frankfurt Stock Exchange (Prime Standard) and on the US NASDAQ.www.biofrontera.com.

    Forward-Looking Statements: Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the public offering and the intended use of proceeds from the offering.

    These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. Such forward-looking statements are based on the currently held beliefs and assumptions of the management of Biofrontera AG, which are expressed in good faith and, in their opinion, reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, financial condition, performance, or achievements of the Company, or industry results, to differ materially from the results, financial condition, performance or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and other factors are set forth in the Registration Statement on Form F-1 filed with the SEC, including in the section "Risk Factors," and in future reports filed with the SEC. Given these risks, uncertainties and other factors, prospective investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake an obligation to update or revise any forward-looking statement.



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