LTS LOHMANN Therapie-Systeme AG

Awakn Designates Program AWKN-002 for Alcohol Use Disorders in the US Market Toronto, Ontario--(News - January 24, 2024) - Awakn Life Sciences Corp. (CBOE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn"), a clinical-stage biotechnology company developing medication-assisted treatments for addiction with a near-term focus on Alcohol Use Disorder ("AUD"), is pleased to announce that it has successfully completed an investigative study to establish the dissociative effect of a proprietary and patent pending S-ketamine formulation, administered sublingually via an oral thin film ("OTF"). Today's news builds on Awakn's announcement on December 20, 2023 of a global licensing agreement with LTS Lohmann Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company. The agreement was for a proprietary and patent pending S-ketamine OTF, with global exclusivity in the treatment of Addiction, Anxiety Disorders, and Eating Disorders. LTS has successfully completed a Phase 1 ("Ph1") clinical trial and filed patents in the US and key international markets of China, Europe, and Japan for the S-ketamine OTF. Under the terms of the license, Awakn has secured access to this Ph1 data and patents thereby ensuring strong intellectual property protection and potential to rapidly progress to late clinical stage trials. The mechanistic study, comprising 28 people who were harmful drinkers, investigated the impact of a single dose of the S-ketamine OTF on dissociation and alcohol cravings. The S-ketamine OTF was well-tolerated by all participants, with no reports of serious adverse effects. The S-ketamine OTF exhibited significantly greater dissociative effects than placebo, which were of a magnitude observed with doses of intravenous racemic ketamine given in clinical treatment. the S-ketamine OTF also demonstrated a statistically significant reduction in alcohol cravings in participants compared to placebo. Following the successful completion of the investigative study and the signing of the license agreement with LTS, Awakn is pleased to designate this program AWKN-002, S-ketamine OTF plus manualized relapse prevention cognitive behavioural therapy ("CBT") for AUD. AWKN-002 is focusing on the US market, with Awakn planning a pre-IND meeting with the U.S. Food and Drug Administration ("FDA") during the first half of 2024. AWKN-002 will be complimented by Awakn's existing AWKN-001 program, intravenous ("IV") racemic ketamine plus manualized relapse prevention CBT for Severe AUD, which will now focus on the UK market only. Prof. Celia Morgan, the principal Investigator on the study commented "The rapid onset and offset of action of AWKN-002 and the ease of clinical use that we observed in our investigative study, compared to IV ketamine has galvanized our view that this represents a way to dramatically widen access to ketamine treatment. AWKN-002 means that we may reach more of the patients that desperately need this life-saving addiction treatment". The Company has granted a total of 496,666 deferred share units ("DSUs") and 993,334 restricted share units ("RSUs") to certain directors, officers, employees and consultants of the Company in accordance with the Company's Omnibus Long-Term Incentive Plan. The RSUs will vest in two stages, with 50% vesting on the date that is one year from the date of grant, and the remaining 50% vesting on the date that is two years from the date of grant. Each DSU and, once vested, each RSU, represents the right to receive one common share of the Company. About Awakn Life Sciences Corp. Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing medication-assisted treatments for addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 51 million people in the US and key European markets and 285 million people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. | Twitter | LinkedIn Notice Regarding Forward-Looking Information This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement. Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at . The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law. This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company's and Awakn's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available. Enquiries: Anthony Tennyson, CEO, Awakn Life Sciences anthony.tennyson@awaknlifesciences.com To view the source version of this press release, please visit

Agreement Includes Exclusive Rights for Treatment of Addiction, Anxiety and Eating Disorders Also Includes Access to Phase 1 Data and Patents Filed in US and Key International Markets Toronto, Ontario--(News - December 20, 2023) - Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn"), a clinical-stage biotechnology company developing Medication-Assisted Treatments to treat addiction with a near-term focus on Alcohol Use Disorder (AUD), announces it has signed a global licensing agreement with LTS Lohmann Therapie-Systeme AG ("LTS"), a leading pharmaceutical technology company. The agreement is for a proprietary S-ketamine formulation, administered sublingually via an oral thin film (OTF). Awakn will have global exclusivity of its use in the treatment of Addiction, Anxiety Disorders, and Eating Disorders. LTS has successfully completed a Phase 1 clinical trial and filed patents in the US and key international markets of China, Canada, Europe, and Japan for this novel formulation of S-ketamine. Under the terms of the Agreement Awakn has secured access to this Phase 1 data and exclusive global rights to the proprietary formulation for use in the above indications. Thereby ensuring strong intellectual property protection and potential to rapidly progress to late clinical stage trials. The sublingual S-ketamine formulation signifies a remarkable potential advancement in addiction treatment. Its sublingual administration offers potentially a faster onset of action, more precise dosing, and reduced potential for adverse effects compared to conventional delivery methods. Safety, efficacy, and patient well-being are paramount in Awakn and LTS's commitment to transforming the treatment of addiction. The licensing agreement includes terms related to milestone payments, royalties, and commercial manufacturing of the drug product by LTS. Commenting on this agreement, Anthony Tennyson, CEO of Awakn, stated, "This exclusive global licensing agreement represents a significant milestone in our mission to provide innovative and effective treatments for addiction, while also providing scope for other mental health disorders. We are confident that LTS' pioneering sublingual S-ketamine formulation will be a game-changer for those suffering from these conditions. We are excited to lead the way in this mental healthcare revolution." "At LTS, we are unrelenting in our commitment to make life better for patients," commented Bas van Buijtenen, CEO of LTS. "Under this agreement, we will deploy our full expertise and experience to the development and commercial manufacturing of this new therapeutic option in an area that fits perfectly with our strategic focus. The cooperation with Awakn is an opportunity to demonstrate once again how LTS creates commercial value at every stage: from product development to launch." About Awakn Life Sciences Corp. Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing Medication-Assisted Treatments targeting addiction. Awakn has a near-term focus on Alcohol Use Disorder (AUD), a condition affecting approximately 50 million people in the US, UK, and EU4 markets, and 285m people globally for which the current standard of care is inadequate. Our goal is to provide breakthrough treatments to addiction sufferers in desperate need and our strategy is focused on commercializing our R&D pipeline across multiple channels. | Twitter | LinkedIn About LTS We CARE. We CREATE. We DELIVER. The driving philosophy behind LTS. As a trusted technology partner for the pharmaceutical industry, we develop and manufacture innovative drug delivery systems such as Transdermal Patches ("TTS") and Oral Thin Films ("OTF") as well as wearable drug delivery devices ("OBDS"). LTS ́ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 40 development projects targeting multiple disease indications. LTS's innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Microneedle Array Patches ("MAP") for the transdermal delivery of small and large molecules, biological actives and vaccines. With its SorrelTM wearable drug delivery platform LTS offers patient friendly solutions for complex drugs delivery at home. Founded in 1984, LTS operates today from four sites: in Andernach, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA and Netanya, Israel. LTS also has a representative office in Shanghai, China. Notice Regarding Forward-Looking Information This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement. Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to:COVID-19; fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at . The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law. This news release does not constitute an offer to sell, or a solicitation of an offer to buy, any securities in the United States. The Company's and Awakn's securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available. Investor Enquiries: Anthony Tennyson, CEO, Awakn Life Sciences anthony.tennyson@awaknlifesciences.com To view the source version of this press release, please visit

ANDERNACH, Germany, Dec. 19, 2023 /PRNewswire/ -- LTS, a leading pharmaceutical technology company, announced today that it has received a grant from the Bill & Melinda Gates Foundation. The purpose of the grant is to support the development of microneedle array patches (MAP) for self-administration of contraceptives for women in low- and middle-income countries (LMICs). The grant will fund $4.3 million over a duration of 25 months. Poor access to contraceptives presents a significant burden for women living in LMICs. According to a 2022 study, one in 14 women worldwide who want to use contraceptives cannot access them*. This amounts to an unmet need of 162 million women, the majority of whom live in sub-Saharan Africa and South Asia. MAPs are an innovative drug delivery technology that offers advantages in comparison to established drug delivery applications for contraception such as fewer side effects and potentially improved bioavailability with therapeutic and cost benefits. The MAP contraceptive is planned as a long-acting application (6 month). In comparison to other existing long-acting forms it can be self-administered, is discreet and does not require healthcare provider visits. Bas van Buijtenen, CEO of LTS, comments: "At LTS, we care passionately about bringing patient friendly drug delivery to people worldwide. We are honoured to receive support from the Gates Foundation in creating solutions for populations that would otherwise be at risk of being left behind. With this program, we aim to deliver improved access to contraception, boosting health and empowering women." "The LTS MAP team is excited to have support from the Gates Foundation for the development of a long-acting contraceptive Microneedle Array Patch with LTS", said Dr. Frank Theobald, Head of MAP Program at LTS. "LTS has made great progress recently with respect to pre-clinical and clinical data, taking major steps towards the up-scaling and commercialization of the MAP technology. Based upon those progresses made, we would like to emphasize that our MAP technology is no longer a vision, but real alternative for drug delivery of small molecules, vaccines, biologics, and mRNA. Support from the foundation will help to develop the MAP technology further and bring it to the next level of maturity and it will allow women in LIMCs to get access to a reliable and effective way of contraception and improve their economic situation. That will support them in establishment of gender equality in their communities." LTS has also received funding from the Bill & Melinda Gates Foundation to support new formulation methods for mRNA, such as dissolvable microneedle array patches. About LTS We CARE. We CREATE. We DELIVER. The driving philosophy behind LTS. As a trusted technology partner for the pharmaceutical industry, we develop and manufacture innovative drug delivery systems such as Transdermal Patches ("TTS") and Oral Thin Films ("OTF") as well as wearable drug delivery devices ("OBDS"). LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 40 development projects targeting multiple disease indications. LTS's innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Microneedle Array Patches ("MAP") for the transdermal delivery of small and large molecules, biological actives and vaccines. With its SorrelTM wearable drug delivery platform LTS offers patient friendly solutions for complex drugs delivery at home. Founded in 1984, LTS operates today from four sites: in Andernach, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA and Netanya, Israel. LTS has also a representative office in Shanghai, China. Picture is available at AP *Haakenstad A, Angelino O, Irvine C, Bhutta ZA, Bienhoff K, Bintz C, Causey K, Dirac MA, Fullman N, Gakidou E, Glucksman T, Hay SI, Henry NJ, Martopullo I, Mokdad AH, Mumford JE, Lim SS, Murray CJL, Lozano R. 2022. Measuring contraceptive method mix, prevalence, and demand satisfied by age and marital status in 204 countries and territories, 1970–2019: a systematic analysis for the Global Burden of Disease Study 2019. Online: The Lancet. Available at: (22)00936-9/fulltext Contact Dr Iris Schnitzler [email protected] +49 2632 992589 SOURCE LTS Lohmann Therapie-Systeme AG