Moberg Pharma AB

STOCKHOLM, Sept. 13, 2024 /PRNewswire/ -- Moberg Pharma AB (OMX: MOB) announces that the company has received information about clinical cure in a subset of patients in the ongoing North American Phase 3 study for MOB-015 against nail fungus. The number of patients who have achieved clinical cure in this blinded subset of patients is lower than the company's expectations, which necessitates that Moberg Pharma inform the market about this fact. The North American Phase 3 study is ongoing at 33 study centers in the US and Canada, including a total of 384 patients. The study constitutes an essential part of the clinical data required for the registration and commercialization of MOB-015 in the US and differs from previous studies with MOB-015, which is the basis for drug approval in 13 EU countries, by reducing the dosage – 8 weeks daily dosing followed by weekly maintenance treatment for 40 weeks, compared to daily dosing throughout the entire treatment period. In the process of preparing the database for upcoming topline data, the company has received information regarding clinical cure in a subset of patients in the study. Clinical cure is one of three parameters that together constitute the study's primary treatment goal, complete cure. All three parameters; clinical cure, negative fungal culture, and negative microscopy, need to be met for a patient to be considered completely cured. No information has been obtained about the other study parameters included in complete cure. The information obtained is blinded; no information has been received regarding which patient received active treatment or how many patients in the data subset received active treatment (patients in the study are randomized 2:1 to treatment with MOB-015 and vehicle). The total number of patients who have achieved clinical cure in this subset of patients is lower than the company's expectations, and Moberg Pharma assesses that the risk of not being able to commercialize the product in the US based on this study has significantly increased, which requires the company to inform the market of this fact. It is an absolute priority to protect the integrity of the study data, both as not to undermine the possibilities of using study results in discussions with regulatory authorities, and as there are patients with ongoing treatment in the study. Moberg Pharma will not speculate on possible outcomes or what this means for the future potential of MOB-015 and will await topline results to avoid drawing premature conclusions. "Our main priority is to protect the data integrity of the study. Together with our CRO, we will do our utmost to minimize the time from the last patient's last visit to top-line data, and our expectation is that these may be brought forward compared to the timelines previously communicated, before year-end" says Anna Ljung, CEO of Moberg Pharma. On September 13th, 2024, at 15:00 (CET), Moberg Pharma's CEO Anna Ljung, CMO Anders Bröijersén, and CSO Amir Tavakkol will answer questions during a telephone conference. The Q&A session will be held in English. To participate in the conference, please dial in on one of the numbers below before the conference starts: SE: +46 8 10 884 80 16. Access Code: 961943 US: +1 855 979 6654. Access Code: 961943 For additional information, please contact: Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: [email protected] Anders Bröijersén, Chief Medical Officer, telephone: + 46 76 001 15 76, e- mail: [email protected] Amir Tavakkol, Chief Scientific Officer, telephone: +1 973 307 4856, e- mail: [email protected] About this information This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 8.00 am CEST on September 13th, 2024, through the contact persons above. About MOB-015 and Onychomycosis Approximately 10% of the general population suffer from onychomycosis and a majority of those afflicted go untreated. The global market opportunity is significant with more than hundred million patients worldwide and a clear demand for better products. MOB-015 is an in-house developed topical formulation of terbinafine, enabling effective concentrations of terbinafine to the nail and nail bed while avoiding the risk of systemic exposure seen with oral terbinafine use. Oral terbinafine is currently the gold standard for treating onychomycosis but associated with safety issues, including drug interactions and liver damage. MOB-015 has been granted marketing authorization in 13 countries. The approval is supported by two Phase 3 trials where MOB-015 demonstrated superior levels of mycological cure (76% vs up to 42% for comparators), and a significantly better complete cure rate compared to vehicle, without any serious adverse reactions. A North American Phase 3 study is ongoing at 33 study centers in the USA and Canada, with a total of 384 patients. The patients are being evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. About Moberg Pharma, Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's drug MOB-015, is a novel topical treatment for onychomycosis (nail fungus) with market approval in 13 EU countries. MOB-015 is sold in Sweden under the brand name Terclara® and is available at all pharmacy chains. Phase 3 clinical trials for MOB-015 involving more than 800 patients indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB). 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MISSISSAUGA, ON , Sept. 13, 2024 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: CPH) (OTCQX: CPHRF) (“ Cipher ” or the “ Company ”) announced today that its partner, Moberg Pharma AB (“Moberg”), issued a news release earlier today stating that it has received information about clinical cure in a subset of patients in the ongoing North American Phase 3 study for MOB-015, a product for the treatment of nail fungus. Moberg has noted that the number of patients who have achieved clinical cure in this blinded subset of patients is lower than its expectations, which necessitates that Moberg inform the market about this fact. Moberg’s full press release can be found here . Cipher owns the Canadian marketing rights to Moberg’s MOB-015 through a licensing agreement (the “Agreement”) dated September 18, 2018 , to commercialize, promote, sell and distribute the product exclusively in Canada . On signing the Agreement, the Company paid an upfront amount of US$0.5 million and any future additional payments of up to US$14.1 million are contingent upon successful achievement of certain clinical data results as well as development, regulatory and commercial sales milestones. Cipher has no further financial obligations in respect of the Agreement if the applicable development and regulatory milestones outlined in the Agreement are not attained. The Company will continue to collaborate with its partner Moberg as full results from their clinical trial become available, however this pipeline product does not impact the sales and earnings pro Cipher’s existing business today. The Company continues to be focused on its recent acquisition of the Natroba TM business from ParaPRO LLC as announced on July 29, 2024 , as well as other potential growth opportunities. The Company believes the growth potential for the Natroba TM product in the U.S. market and other markets internationally is significant, and the integration of this business into its existing profitable North American platform remains Cipher’s focus and priority in the near term. About Cipher Pharmaceuticals Inc. Cipher Pharmaceuticals (TSX: CPH) (OTCQX: CPHRF) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products, mainly in dermatology. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products in Canada, the U.S., and South America. For more information, visit . Forward-Looking Statements and Non-IFRS Measures This document includes forward-looking statements within the meaning of applicable securities laws. These forward-looking statements include, among others, statements with respect to the clinical studies being conducted by Moberg, the results of such studies and their potential impact on the Company, the Company’s expectations for Natroba TM and the Company’s plans for Natroba TM , our objectives and goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions. The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, “hope” and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements. By nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, publication of negative results of clinical trials; our ability to enter into development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on a limited number of products; our dependency on protection from patents that will expire; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain products; product approval process by regulators which can be highly unpredictable; the timing of completion of clinical trials, regulatory submissions and regulatory approvals; reliance on third parties to manufacture our products and events outside of our control that could adversely impact the ability of our manufacturing partners to supply products to meet our demands; we may be subject to future product liability claims; unexpected product safety or efficacy concerns may arise; we generate license revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive with new competing product entrants; requirements for additional capital to fund future operations; products may be subject to pricing regulation; dependence on key managerial personnel and external collaborators; certain of our products are subject to regulation as controlled substances; limitations on reimbursement in the healthcare industry; extent and impact of health pandemic outbreaks on our business; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; compliance with privacy and security regulation; our policies regarding product returns, allowances and chargebacks may reduce revenues; additional regulatory burden and controls over financial reporting; general commercial litigation, class actions, other litigation claims and regulatory actions; the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States ; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent laws; inability to protect our trademarks from infringement; shareholders may be further diluted if we issue securities to raise capital; volatility of our share price; the fact that we have a significant shareholder; our operating results may fluctuate significantly; and our debt obligations will have priority over the common shares of the Company in the event of a liquidation, dissolution or winding up. We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the “Risk Factors” section of our MD&A for the year ended December 31, 2023 and the Company’s Annual Information Form, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language. SOURCE Cipher Pharmaceuticals Inc.

STOCKHOLM, June 24, 2024 /PRNewswire/ -- ("Moberg Pharma" or the "Company") announces that 17,776,856 warrants of series 2023:1 ("TO 2") were exercised for subscription of in total 17,776,856 ordinary shares for approximately SEK 320 million, corresponding to a subscription rate of approximately 98%. As announced by the Company on June 11th, 2024, subscription and top guarantee commitments had been made for TO 2, free of charge, with certain external professional investors, and today the board of directors has resolved on a directed issue of 863,333 ordinary shares amounting to approximately SEK 16 million to the top guarantors to fulfil the top guarantee commitments (the "Share Issue"). Through the exercise of TO 2 and the Share Issue, Moberg Pharma thus receives approximately SEK 336 million before issue costs. "When we designed the oversubscribed rights issue of units last summer, the intention was to raise approximately SEK 200 million, half of which through the TO 2 warrants. The outcome of TO 2, where the company raises 336 million SEK, is a testament to our strength and is expected to promote growth and shareholder value. TO 2 has also provided an opportunity to further strengthen our shareholder base. We appreciate the trust and look forward to dedicating our full efforts to execute on our launch plans for the drug MOB-015, with approval in 13 EU countries, and where our partner Allderma has brought the product to a market-leading position in Sweden under the brand Terclara®. The launch is proceeding as planned, and we welcome the new shareholders who have joined the company via TO 2 to share in our exciting journey ahead." says Anna Ljung, CEO at Moberg Pharma TO 2 Exercised warrants have been converted to interim shares until the new ordinary shares have been registered with the Swedish Companies Registration Office. The interim shares are not subject to organized trading. The planned date for the conversion of interim shares to ordinary shares is on or about July 5th, 2024. The exercise price for the warrants was set at 70 percent of the average volume-weighted trading price of the Company's ordinary share on Nasdaq Stockholm during the period from May 20th, 2024, to May 31st, 2024. Thus, the subscription price was set at SEK 18.00 per share. Shares and the share capital When the new shares issued through the exercise of TO 2 and the Share Issue have been registered with the Swedish Companies Registration Office, the total number of shares and votes in Moberg Pharma will amount to 47,879,854 and the share capital will amount to approximately SEK 47,879,856.39. This entails a dilution of approximately 39 percent based on the number of shares and votes in Moberg Pharma after the exercise of TO 2 and the Share Issue. The Share Issue As announced by the Company on June 11th, 2024, subscription of ordinary shares under the top guarantee commitments takes place through subscription in a directed issue of ordinary shares. Since a total of 17,776,856 TO 2 were exercised for subscription of ordinary shares, the board of directors has today, by virtue of the authorization from the annual general meeting on May 14th, 2024, resolved on a directed issue of 863,333 ordinary shares to the top guarantors in order to execute the top guarantee commitments. Subscription in the Share Issue is made at the same subscription price as for TO 2, i.e. SEK 18.00 per ordinary share. The investors who had entered into top guarantee commitments and therefore are participating in the Share Issue are Special Situations Fund, Fredrik Lundgren and Wilhelm Risberg. The board of directors has carefully considered the possibility of raising capital through a rights issue and makes the assessment that it is currently for several reasons more advantageous for the Moberg Pharma and its shareholders to raise capital by ensuring the exercise of TO 2 and to carry out the Share Issue. Moberg Pharma wished to ensure in advance that the Company receives a certain minimum amount from the exercise of the warrants and therefore entered into top guarantee commitments with the investors participating in the Share Issue. As a result of the top guarantee commitments, the investors were guaranteed allotment of ordinary shares corresponding to at least 20 percent of their respective guarantee commitments. Accordingly, the size of the Share Issue was dependent on the holders' exercise of TO 2. Holders were free to exercise their TO 2 and thereby limit the size of the Share Issue. The Company also believes that a rights issue under the current volatile market conditions would entail higher costs related to any underwriting. Finally, the Company wishes to expand and strengthen its base of institutional and professional shareholders to, among other things, improve the liquidity of the Company's share. In light of this, the board of directors' overall assessment is that the reasons for ensuring the exercise of TO 2 and to carry out the Share Issue with deviation from the shareholders' preferential rights clearly and with sufficient strength outweigh the reasons that justify the main rule that new issues shall be carried out with the shareholders preferential rights. The subscription price in the Share Issue has been determined in consultation with the Company's financial advisor, Vator Securities AB, through arm's length negotiations with a number of institutional and professional investors over time. Therefore, the board of directors of the Company considers that the subscription price has been determined on market terms and correctly reflects current market conditions and demand. All ordinary shares in the Share Issue have been subscribed and allotted to the investors who had entered into top guarantee commitments. For additional information, please contact: Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: [email protected] Mark Beveridge, Vice President Finance, telephone: +46 76 805 82 88, e-mail: [email protected] About this information This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 17:35 CEST on June 24th, 2024, through the contact persons above. About Moberg Pharma, Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's drug MOB-015, is a novel topical treatment for onychomycosis (nail fungus) with market approval in 13 EU countries. MOB-015 is sold in Sweden under the brand name Terclara® and is available at all pharmacy chains. Phase 3 clinical trials for MOB-015 involving more than 800 patients indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in various regions including Europe and Canada. Moberg Pharma is headquartered in Stockholm and the company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB). Important information The information in this press release does not contain or constitute an offer to acquire, subscribe for or otherwise trade in shares, warrants or other securities in Moberg Pharma. The invitation to the persons concerned to subscribe for units consisting of shares and warrants in Moberg Pharma has only been made through the prospectus published by Moberg Pharma on August 14th, 2023. This information was brought to you by Cision The following files are available for download: SOURCE Moberg Pharma