OMA SAVINGS BANK PLC STOCK EXCHANGE RELEASE, 29 JUNE 2023 AT 13.31 P.M. EET, OTHER INFORMATION DISCLOSED ACCORDING TO THE RULES OF THE EXCHANGE

Oma Savings Bank Plc’s composition of Shareholders’ Nomination Committee

According to the shareholder list on 1 June 2023, representatives of the five largest shareholders have been appointed to the Nomination Committee of Oma Savings Bank Plc (OmaSp):

• Raimo Härmä, appointed by Etelä-Karjalan Säästöpankkisäätiö
• Ari Lamminmäki, appointed by Parkanon Säästöpankkisäätiö
• Jouni Niuro, appointed by Liedon Säästöpankkisäätiö
• Aino Lamminmäki, appointed by Töysän Säästöpankkisäätiö
• Simo Haarajärvi, appointed by Kuortaneen Säästöpankkisäätiö

The Nomination Committee elects a Chairman from among its members.

The Nomination Committee prepares proposals for the election of the Board of Directors and the remuneration of the Board of Directors to the Annual General Meeting and, if necessary, for an Extraordinary General Meeting. OmaSp’s five largest shareholders each have the right to appoint one representative to the Nomination Committee. The Nomination Board should give their recommendations regarding the members of the Board of Directors and their respective compensations to the Board of Directors by the end of January preceding the Annual General Meeting. In the case of an Extraordinary General Meeting, the Nomination Committee should accordingly give their respective recommendations well in advance before the General Meeting, taking into account applicable regulations. The Chairman of the Board of Directors acts as the convener. The Nomination Committee complies with the rules of procedure approved by the Annual General Meeting.

Oma Savings Bank Plc

Additional information:
Minna Sillanpää, CCO, tel. +358 50 66592, minna.sillanpaa@omasp.fi

DISTRIBUTION
Nasdaq Helsinki Ltd
Major media
www.omasp.fi

Oma Savings Bank in short

OmaSp is a growing Finnish bank and the largest savings bank in Finland based on total assets. About 450 professionals provide nationwide services through OmaSp’s 45 branch offices and digital service channels to over 200,000 customers. OmaSp focuses primarily on retail banking operations and provides its clients with a broad range of banking services both through its own balance sheet as well as by acting as an intermediary for its partners’ products. The intermediated products include credit, investment and loan insurance products. OmaSp is also engaged in mortgage banking operations.

OmaSp core idea is to provide personal service and to be local and close to its customers, both in digital and traditional channels. OmaSp strives to offer premium level customer experience through personal service and easy accessibility. In addition, the development of the operations and services is customer-oriented. The personnel is committed and OmaSp seeks to support their career development with versatile tasks and continuous development. A substantial part of the personnel also own shares in OmaSp.

OMA SAVINGS BANK PLC, STOCK EXCHANGE RELEASE 29 JUNE 2023 AT 13.30 P.M. EET, OTHER INFORMATION DISCLOSED ACCORDING TO THE RULES OF THE EXCHANGE

Oma Savings Bank Plc updates its medium-term financial goals regarding comparable return on equity and capital adequacy

At its meeting on 29 June 2023, the Board of Directors of Oma Savings Bank Plc (OmaSp or the Company) has updated its medium-term (3-5 years) financial goals as part of its strategy process and updates its medium-term return on equity and capital adequacy. The Company’s updated target level for comparable return on equity (ROE) is at least 16 percent instead of the previous 10 percent. The updated target level for the Common Equity Tier 1 (CET1) capital ratio is at least 2 percentage points above the regulatory requirement instead of the previous target of at least 14 percent. The updated target levels will be effective from 1 July 2023.

The Company’s Board of Directors has confirmed the following financial goals as of 1 July 2023:

• Growth: 10-15 percent annual growth in total operating income under the current market conditions.
• Profitability: Cost/income ratio less than 45 percent.
• Return on equity (ROE): Long-term return on equity (ROE) over 16 percent.
• Capital adequacy: Common Equity Tier 1 (CET1) capital ratio at least 2 percentage points above the regulatory requirement.

The Board of Directors of Oma Savings Bank Plc

Additional information:
Pasi Sydänlammi, CEO, tel +358 45 657 5506, pasi.sydanlammi@omasp.fi
Sarianna Liiri, CFO, tel +358 40 835 6712, sarianna.liiri@omasp.fi
Minna Sillanpää, CCO, tel +358 50 66592, minna.sillanpaa@omasp.fi

Distribution:
Nasdaq Helsinki Ltd
Major media
www.omasp.fi

OmaSp is a growing Finnish bank and the largest savings bank in Finland based on total assets. About 450 professionals provide nationwide services through OmaSp’s 45 branch offices and digital service channels to over 200,000 private and corporate customers. OmaSp focuses primarily on retail banking operations and provides its clients with a broad range of banking services both through its own balance sheet as well as by acting as an intermediary for its partners’ products. The intermediated products include credit, investment and loan insurance products. OmaSp is also engaged in mortgage banking operations.

OmaSp core idea is to provide personal service and to be local and close to its customers, both in digital and traditional channels. OmaSp strives to offer premium level customer experience through personal service and easy accessibility. In addition, the development of the operations and services is customer-oriented. The personnel is committed and OmaSp seeks to support their career development with versatile tasks and continuous development. A substantial part of the personnel also own shares in OmaSp.

SANTA MONICA, Calif., June 29, 2023 (GLOBE NEWSWIRE) — Macerich (NYSE: MAC), one of the nation’s leading owners, operators and developers of one-of-a-kind retail and mixed-use properties in top markets, today announced that Primark has opened a new Long Island store at Green Acres Mall.

Irish retail brand Primark is a leading international clothing retailer that draws shoppers to the high street worldwide with its wide selection of essentials and fashion favorites built around everyday affordability. At Green Acres, Primark is located in Center Court, adjacent to another prominent international retailer scheduled to open in Fall 2023. The two retailers replace a former JCPenney, revitalizing the space and demonstrating Macerich’s continued success in redeveloping underused property elements across its portfolio.

Green Acres Mall marks Primark’s seventh store at a Macerich property and seventh in New York State. Set just east of New York City on the border of Queens and Nassau counties in the diverse, idyllic Long Island villages, Green Acres Mall is a popular retail destination for residents and visitors alike. At more than 2 million square feet, Green Acres is the nation’s 18^th-largest enclosed shopping center, with over 150 exciting retailers and restaurants to choose from.

“Primark has won over millions of shoppers around the world with its global style for fashion and the home, and we’re excited to be part of Primark’s plan to have 60 U.S. stores by 2026,” said F.K. Grunert, Executive Vice President, Leasing, Macerich. “The enthusiasm for this store opening has been palpable for months. We are pleased that our guests can finally see what Primark is all about as they experience the rest of Green Acres Mall.”

Macerich is one of Primark’s largest U.S. landlords, with Primark stores open at Kings Plaza (Brooklyn), Danbury Fair (Connecticut), Fashion District Philadelphia, and Freehold Raceway Mall (New Jersey), and opening soon at Queens Center (Brooklyn) and Tysons Corner Center (McClean, Virginia).

Located in Valley Stream, New York, Green Acres Mall is ideally situated within the Long Island villages and, along with neighboring Green Acres Commons, offers a wide variety of desirable shopping, dining and entertainment brands around, including stores like Macy’s, Target, Walmart, Burlington, H&M, Old Navy, Victoria’s Secret, Pandora, Home Depot, Aldi, Home Goods, Ulta Beauty, 24 Hour Fitness, DICK’S Sporting Goods and BJ’s Wholesale Club, and restaurants such as BJ’s Restaurant & Brewhouse, Olive Garden, Red Lobster and Buffalo Wild Wings.

About Macerich
Macerich is a fully integrated, self-managed and self-administered real estate investment trust (REIT). As a leading owner, operator and developer of high-quality retail real estate in densely populated and attractive U.S. markets, Macerich’s portfolio is concentrated in California, the Pacific Northwest, Phoenix/Scottsdale, and the Metro New York to Washington, D.C. corridor. Developing and managing properties that serve as community cornerstones, Macerich currently owns 47 million square feet of real estate consisting primarily of interests in 44 regional town centers, many of which contain mixed uses. Macerich is firmly dedicated to advancing environmental goals, social good and sound corporate governance. A recognized leader in sustainability, Macerich has achieved a #1 Global Real Estate Sustainability Benchmark (GRESB) ranking for the North American retail sector for eight consecutive years (2015-2022). For more information, please visit www.Macerich.com.

Macerich uses, and intends to continue to use, its Investor Relations website, which can be found at investing.macerich.com, as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Additional information about Macerich can be found through social media platforms such as LinkedIn. Reconciliations of non-GAAP financial measures, including NOI and FFO, to the most directly comparable GAAP measures are included in the earnings release and supplemental filed on Form 8-K with the SEC, which are posted on the Investor Relations website at investing.macerich.com.

MAC-L
SOURCE: Macerich

MEDIA CONTACT: Karen Maurer, Macerich, 602-708-6311, Website: http://www.macerich.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b673a6a2-5fd7-403e-9090-99ab9a7e740d

 

SEATTLE, June 29, 2023 (GLOBE NEWSWIRE) — (June 29, 2023) Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today the achievement of a development milestone which triggers a $5 million payment from its research and development collaboration with Merck (known as MSD outside the United States and Canada). This collaboration, focused on the discovery and development of novel candidates for the treatment of amyotrophic lateral sclerosis (ALS), originated from an agreement between Yumanity Therapeutics and Merck.

“We are proud to achieve this milestone in our collaboration with Merck,” said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. “This milestone payment also strengthens our financial position and allows the company to continue to focus on the clinical development of our core immuno-oncology assets.”

Following this milestone, Merck will assume sole responsibility for all future development and commercialization of the ALS program. Under the collaboration and license agreement, Kineta is eligible to receive additional milestone payments totaling up to $255 million associated with the successful development of marketed products for pipeline programs, as well as royalties on worldwide net sales.

About Kineta
Kineta (Nasdaq: KA) is a clinical-stage biotechnology company with a mission to develop next-generation immunotherapies that transform patients’ lives. Kineta has leveraged its expertise in innate immunity and is focused on discovering and developing potentially differentiated immunotherapies that address the major challenges with current cancer therapy. For more information on Kineta, please visit www.kinetabio.com, and follow Kineta on Twitter, LinkedIn and Facebook.

Cautionary Statements Regarding Forward-Looking Statements:
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” and other similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Kineta’s current beliefs, expectations and assumptions regarding the future of Kineta’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Such forward-looking statements are subject to a number of material risks and uncertainties including, but not limited to: the adequacy of Kineta’s capital to support its future operations (including its ability to complete the second tranche of the previously disclosed contemplated private placement in the third quarter of 2023) and its ability to successfully initiate and complete clinical trials; the difficulty in predicting the time and cost of development of Kineta’s product candidates; Kineta’s plans to research, develop and commercialize its current and future product candidates, including, but not limited to, KVA12123; the timing and anticipated results of Kineta’s planned pre-clinical studies and clinical trials and the risk that the results of Kineta’s pre-clinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials; the timing of the availability of data from Kineta’s clinical trials; the timing of any planned investigational new drug application or new drug application; the risk of cessation or delay of any ongoing or planned clinical trials of Kineta or its collaborators; the clinical utility, potential benefits and market acceptance of Kineta’s product candidates; Kineta’s commercialization, marketing and manufacturing capabilities and strategy; developments and projections relating to Kineta’s competitors and its industry; the impact of government laws and regulations; the timing and outcome of Kineta’s planned interactions with regulatory authorities; Kineta’s ability to protect its intellectual property position; Kineta’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; the intended use of proceeds from the registered direct offering completed in April 2023; and those risks set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC on March 31, 2023, and Quarterly Report on Form 10-Q filed with the SEC on May 11, 2023, as well as discussions of potential risks, uncertainties and other important factors in Kineta’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Except as required by law, Kineta undertakes no obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Kineta, Inc. :
Jacques Bouchy
EVP Investor Relations & Business Development
+1 206-378-0400
jbouchy@kineta.us

Investor Relations:
John Mullaly
LifeSci Advisors, LLC
jmullaly@lifesciadvisors.com

Source: Kineta, Inc.

COMPANY ANNOUNCEMENT

No. 174/2023

Tvis, 29 June 2023

Major shareholder announcement
Referring to section 30 of the Capital Markets Act, TCM Group A/S (the “Company”), can inform, that Taiga Investment Funds PLC has notified, that their aggregate holding of shares amounts to less than 5% as of 29 June 2023.

For further information please contact:
Torben Paulin, CEO, TCM Group A/S, +45 21 21 04 64

About TCM Group

TCM Group is Scandinavia’s third largest manufacturer of kitchens and furniture for bathrooms and storage. The products are designed and produced in Denmark and rooted in a proud tradition of good quality and good craftsmanship. TCM Group pursues a multi-brand strategy, under which the main brand is Svane Køkkenet and the other brands are Tvis Køkken and Nettoline. Combined, the brands cater for the entire price spectrum, and are sold through c. 140 dealers in Denmark and the rest of the Scandinavia. TCM Group sells private label kitchens through DIY stores in Denmark and independent kitchen stores in Norway. TCM Group is supplier to the 45% owned e-commerce kitchen business Celebert, which operates under the brands kitchn.dk, billigskabe.dk, Celebert and Just Wood. See www.tcmgroup.dk for more information.

• 174. Major shareholder announcement

June 29, 2023

MONTHLY DISCLOSURE OF THE TOTAL NUMBER OF SHARES AND VOTING RIGHTS

Articles L. 233-8 II of the Commercial Code and 223-16 of the General Regulation of the AMF

Date	Shares	Voting rights
		Theoretical*	Exercisable**
31 May 2023	44,253,225	49,733,907	49,142,847

*This number is calculated on the basis of all the shares to which voting rights are attached, including shares which voting rights have been suspended, in accordance with Article 223-11 of the AMF general regulation related to the calculation of the crossing of thresholds with regard to the number of voting rights.

**For information purposes, this number excludes the shares which voting rights have been suspended.

The information is also available in the « Regulated Information » section of the Ipsos website: https://www.ipsos.com/en/regulated-informations/en.

 

• Ipsos_Monthly declaration of voting rights_May 2023

Company announcement no. 16-2023

Copenhagen June 29, 2023

Konsolidator enters market maker agreement with Pareto Securities AB

Today, Konsolidator has entered a market maker agreement with Pareto Securities AB, where Pareto Securities AB will promote the liquidity in the Konsolidator share. The agreement commences on July 3, 2023 and will remain in force until terminated by either Konsolidator or Pareto Securities AB.

Besides promoting the liquidity in the share, the agreement with Pareto Securities AB also undertakes to quote bid- and ask- orders in the Konsolidator share with the intention to reduce the spread between the bid and ask prices. The agreement has been concluded with reference to Nasdaq Nordic’s Member rules.

CFO Jack Skov comments, “With a market maker agreement we will improve the shareholder interest by securing a higher liquidity in the share as well as securing a maximum spread between the bid and ask price. High liquidity and low spread will make it easier for shareholders to trade our share which we believe will benefit all shareholders.”

Contacts

Certified Adviser

About Konsolidator
Konsolidator A/S is a financial consolidation software company whose primary objective is to make Group CFOs around the world better through automated financial consolidation and reporting in the cloud. Created by CFOs and auditors and powered by innovative technology, Konsolidator removes the complexity of financial consolidation and enables the CFO to save time and gain actionable insights based on key performance data to become a vital part of strategic decision-making. Konsolidator was listed at Nasdaq First North Growth Market Denmark in 2019. Ticker Code: KONSOL

• Konsolidator Company announcement no 16-2023

BETHESDA, Md., June 29, 2023 (GLOBE NEWSWIRE) — Eagle Bancorp, Inc. (the “Company”) (NASDAQ: EGBN), the parent company for EagleBank, today announced a cash dividend for the second quarter of 2023, in the amount of $0.45 per share. The cash dividend will be payable on July 28, 2023 to shareholders of record on July 20, 2023.

About Eagle Bancorp: The Company is the holding company for EagleBank, which commenced operations in 1998. The Bank is headquartered in Bethesda, Maryland, and operates through thirteen branch offices, located in Suburban Maryland, Washington, D.C. and Northern Virginia. The Company focuses on building relationships with businesses, professionals and individuals in its marketplace.

Caution About Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended, including statements of goals, intentions, and expectations as to future trends, plans, events or results of Company operations and policies and regarding general economic conditions. These forward-looking statements are based on current expectations that involve risks, uncertainties and assumptions, including the volatility and uncertainty in global markets and economies. Because of these uncertainties and the assumptions on which the forward-looking statements are based, actual future operations and results in the future may differ materially from those indicated herein. Readers are cautioned against placing undue reliance on any such forward-looking statements. For details on factors that could affect these expectations, see the risk factors and other cautionary language included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and other filings with the SEC. Except as required by law, the Company does not undertake to update forward-looking statements contained in this release.

EagleBank Contact
Dave Danielson
240.552.9534

LA JOLLA, Calif., June 29, 2023 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that Principal Investigator, Lara Ray, PhD, Professor, Department of Psychology, University of California Los Angeles (UCLA) presented the results of the Phase 2b trial of MN-166 (ibudilast) in alcohol use disorder (AUD) at the 46th Annual Research Society on Alcoholism (RSA) Scientific Meeting held June 24 – 28, 2023, in Bellevue, Washington.

The clinical trial was a collaborative effort between MediciNova and Dr. Lara Ray, Professor, Department of Psychology and Department of Psychiatry and Biobehavioral Sciences, Brain Research Institute at UCLA, and was funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), a component of the National Institutes of Health (NIH).

This study was a randomized, double-blind, placebo-controlled, Phase 2b clinical trial in treatment-seeking men and women with moderate or severe AUD. Participants took MN-166 (ibudilast) 50 mg or placebo twice a day for 12 weeks. A total of 102 subjects were enrolled in this trial. The primary objective of the trial was to evaluate the effects of MN-166 (ibudilast) vs. placebo on percent heavy drinking days defined as ≥5 drinks for men and ≥4 drinks for women over the course of a 12-week treatment period.

MN-166 (ibudilast) treatment was not superior to placebo for reducing percent heavy drinking days. Also, MN-166 (ibudilast) treatment was not superior to placebo for the secondary endpoints of 1) the number of drinks consumed per day, 2) the number of drinks consumed per drinking day, 3) the percentage of days abstinent, 4) the percentage of subjects with no heavy drinking days, and 5) the percentage of subjects who are abstinent.

Kazuko Matsuda MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, “Unfortunately, there was no evidence of efficacy of MN-166 treatment for AUD in this study population, the first study targeting “treatment-seeking” individuals who met the criteria for moderate or severe AUD. We observed a so-called placebo effect – both placebo and MN-166 treatments decreased heavy drinking by equal magnitudes. We look forward to future discussions with Dr. Ray on further analyses, including subgroup analyses, and the future direction of MN-166 and AUD.”

About the Clinical Trial

This study was a randomized, double-blind, placebo-controlled, outpatient clinical trial that targeted treatment-seeking men and women who met current DSM-5 diagnostic criteria for moderate or severe AUD. Participants took MN-166 (ibudilast) 50 mg or placebo twice a day for 12 weeks and completed the NIAAA-developed computer-delivered program “Take Control” during the study. The primary objective of the trial was to test whether MN-166 (ibudilast) will decrease percent heavy drinking days (defined as ≥5 drinks for men and ≥4 drinks for women), as compared to placebo, over the course of the 12-week treatment period. The secondary objectives were to evaluate the efficacy of MN-166 (ibudilast) on 1) the number of drinks consumed per day, 2) the number of drinks consumed per drinking day, 3) the percentage of days abstinent, 4) the percentage of subjects with no heavy drinking days, and 5) the percentage of subjects who were abstinent, as well as measures of alcohol craving and negative mood, over the course of the 12-week treatment period. Exploratory endpoints included evaluation of whether the effects of MN-166 (ibudilast) on the primary and secondary endpoints are moderated by depressive symptomatology and whether MN-166 (ibudilast) reduces neuroinflammation over the course of the 12-week treatment period.

About Alcohol Use Disorder

Alcohol use disorder (AUD) is a prevalent and disabling psychiatric disorder with limited treatment options.  AUD is a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using alcohol.  According to the National Institute on Alcohol Abuse and Alcoholism (NIAAA), an estimated 29.5 million people in the U.S. have AUD and only 5% received treatment for the disease in the past year. There is a high unmet medical need for better treatments for AUD.

About MN-166

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), Long COVID, and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in glioblastoma, Long COVID, and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2022 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

INVESTOR CONTACT:
	Geoff O’Brien
	Vice President
	MediciNova, Inc.
	info@medicinova.com

 

Trial met primary endpoint with the 60 mcg dose, with BXCL501 demonstrating a statistically significant 39% greater reduction in PEC score from baseline compared to placebo at 2 hours (p=0.0112)

Met key secondary endpoint with statistically significant reduction (p=0.0185) in agitation symptoms versus placebo, as measured by PEC score change from baseline at 1 hour with 60 mcg dose; multiple secondary measures support efficacy

443 episodes for 149 patients were treated over 12 weeks across all doses; dosing with 60 mcg showed a similar reduction in agitation for first and all treated episodes at 1 and 2 hours, as measured by average change in PEC score  

BXCL501 was well tolerated with no drug-related serious adverse events over trial duration

Company intends to engage with FDA in H2 2023 on a potential path to sNDA submission 

BioXcel Therapeutics to host conference call today at 8:00 a.m. ET

NEW HAVEN, Conn., June 29, 2023 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced positive topline results for TRANQUILITY II, a Phase 3 trial of BXCL501, the Company’s proprietary, orally dissolving film formulation of dexmedetomidine under investigation for the acute treatment of Alzheimer’s disease-related agitation.

The Phase 3 trial met its primary efficacy endpoint with the 60 mcg dose; a statistically significant and clinically meaningful 7.5 point reduction from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score was observed at 2 hours versus 5.4 with placebo (p=0.0112). The 60 mcg dose also met the first key secondary endpoint of reducing agitation symptoms at 1 hour during the first episode of agitation (p=0.0185) but did not meet the other key secondary endpoint of change from baseline in PEC score at 30 minutes.

Efficacy for this dose was supported by a number of secondary measures, including CGI-I and ACES. Most patients (76%) responded to the first 60 mcg dose and were determined to be “Very Much” or “Much Improved” (CGI-I of 1 or 2) compared to 50% with placebo. The primary endpoint was not met for the 40 mcg dose, with a 5.7 point reduction from baseline in PEC score.

BXCL501 continued to show a PEC reduction over repeated dosing. A total of 443 episodes were dosed over the 12-week trial period, including 294 episodes occurring after the first treatment across all dose groups. Dosing with 60 mcg showed a reduction in PEC total score from pre-dose versus placebo at 1 hour (p=0.011) and 2 hours (p=0.0044) for all episodes of agitation.

“We believe these results represent a significant milestone for BioXcel Therapeutics and a potential important step forward in our goal to helping those impacted by Alzheimer’s disease,” said Vimal Mehta, CEO of BioXcel Therapeutics. “Today, there are approximately 100 million Alzheimer’s-related agitation episodes in the U.S. annually, and there are no episodic treatment options for these patients. We believe that our data from TRANQUILITY II show that BXCL501 has the potential to treat acute episodes of agitation in patients with mild to moderate Alzheimer’s disease, if approved. This is particularly critical as the prevalence of this disease is expected to nearly double over the next 15 to 20 years. We are excited at the prospect of continuing to expand BXCL501’s market potential.”

BXCL501 was well tolerated, with a side effect profile substantially consistent with prior trials of BXCL501 and the current label for IGALMI. The 60 mcg dose had previously been evaluated in different patient populations and in healthy volunteers. Data from TRANQUILITY II add to this safety database and show that the majority of safety events occurring within 24 hours of dosing in this population were mild or moderate in severity and consistent with the current IGALMI label. In addition, dosing for subsequent episodes did not result in a meaningful increase in the number of adverse events and no treatment-related serious adverse events were observed over the 12-week study period.

For all 443 episodes over the 12-week period, there were no syncope or falls related to trial drug. All falls except one with placebo were outside the 24-hour treatment window (5 falls in the 40 mcg arm, 7 falls in the 60 mcg arm, and 5 falls in the placebo arm).

“I believe that the results from the TRANQUILITY II trial are an exciting development for potentially addressing Alzheimer’s disease-related agitation,” said George Grossberg, M.D., Professor and Director Division of Geriatric Psychiatry in the Department of Psychiatry & Behavioral Neuroscience at St. Louis University School of Medicine. “In this trial, BXCL501 showed a desirable onset of action and a meaningful reduction in agitation at 2 hours with the 60 mcg dose, and was well tolerated in this patient population. I believe it has potential to be a new treatment option for a condition that not only impacts patients but also caregivers and families.”

TRANQUILITY II Topline Results

Efficacy Results at 2 Hours (Primary Endpoint)

	BXCL501 60 mcg  n=50	BXCL501 40 mcg  n=48	Placebo  n=51
Reduction in PEC Total Score  from Baseline LSM (SE)	7.5 (0.6)	5.7 (0.6)	5.4 (0.6)
p-value (vs. placebo)	0.0112*	0.7648

^{*Statistical significance achieved at 0.025}

Adverse Events of Special Interest Reported Within 24 Hours of First Dose**

Adverse Event	Severity	BXCL501 60 mcg n=50 (%)	BXCL501 40 mcg n=48 (%)	Placebo n=51 (%)
Somnolence*	Mild Moderate	8 (16.0) 1 (2.0)	6 (12.5) 2 (4.2)	2 (3.9) 0
Lethargy	Mild Moderate	2 (4.0) 1 (2.0)	1 (2.1) 1 (2.1)	1 (2.0) 0
Hypotension	Mild Moderate	7 (14.0) 1 (2.0)	4 (8.3) 0	2 (3.9) 0
Bradycardia	Mild Moderate	3 (6.0) 1 (2.0)	0 1 (2.1)	0 0
Orthostatic Hypotension	Mild Moderate	2 (4.0) 2 (4.0)	2 (4.2) 1 (2.1)	1 (2.0) 0

^{*Verbatim; drowsy or feeling sleepy}

^{** The adverse events of special interest (AESI) are defined as those related to mechanism of action of the drug. Those that are listed were observed within 24 hours after the first dose and occur with a frequency of at least 2% and greater than with placebo. Subjects are counted once at highest severity for each preferred term}

“We are extremely pleased with the positive topline results of this trial in elderly patients with Alzheimer’s disease-related agitation,” said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. “The favorable safety data, along with the consistent efficacy observed for the 60 mcg dose, underscores BXCL501’s potential in mitigating a condition that impacts millions of patients and their families annually. In addition to our positive topline results with TRANQUILITY II, we have a robust safety database of more than 1,200 subjects across a range of ages, multiple neuropsychiatric conditions, and doses. Additionally, BXCL501 has been granted a Breakthrough Therapy Designation for the acute treatment of dementia-related agitation based on TRANQUILITY I data. We believe this body of evidence lays the foundation to potentially bring a differentiated acute agitation treatment option for patients with Alzheimer’s disease.”  

The Company plans to develop a path to potential sNDA submission for the acute treatment of agitation associated with Alzheimer’s disease in H2 2023, subject to further discussions with the FDA. 

Conference Call

BioXcel Therapeutics will host a conference call and webcast on June 29, 2023 at 8:00 a.m. ET to discuss the Phase 3 TRANQUILITY II trial results. To access the call, please dial 877-407-5795 (domestic) or 201-689-8722 (international). A link to a live webcast and accompanying presentation materials will be available on the Investors section of the corporate website, bioxceltherapeutics.com, and a replay will be available through September 29, 2023. 

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at bioxceltherapeutics.com. In addition, you may sign up to automatically receive email alerts and other information about the Company by visiting the “Email Alerts” option under the News/Events section of the Investors & Media website section and submitting your email address. You can also review our public filings on the SEC’s website at www.sec.gov, including the Current Report on Form 8-K filed with the SEC on June 29, 2023 for additional important information relating to the TRANQUILITY II trial.

About TRANQUILITY II

TRANQUILITY II, a randomized, placebo-controlled, parallel group trial, evaluated the safety and efficacy of BXCL501 for the acute treatment of Alzheimer’s-related agitation in adults 65 years and older in assisted living facilities (ALFs) and residential care settings who required minimal assistance with activities of daily living. The trial dosed 149 patients with mild to moderate dementia. Randomized patients self-administered 40 mcg or 60 mcg of BXCL501 or placebo for agitation episodes that occurred over a 12-week period. The primary endpoint was the change from pre-dose in PEC total score at 2 hours post-dose for the first treated episode of agitation. The key secondary efficacy endpoints were PEC change from pre-dose at 1 hour post-dose of study treatment for the first treated episode of agitation, and PEC change from pre-dose at 30 minutes post-dose of study treatment for the first treated episode of agitation.

For additional information regarding the TRANQUILITY II Phase 3 trial, including data integrity and protocol adherence issues at one of the trial sites, see the Company’s Current Report on Form 8-K filed with the SEC on June 29, 2023, which should be read in conjunction with this press release.

About the Positive and Negative Syndrome Scale-Excitatory Component Score (PEC or PANSS-EC)

The PEC total score is a validated endpoint for use in clinical research to quantify the severity of a patient’s acute agitation. The PEC rating evaluates 5 elements associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC total score is the sum of these 5 elements and thus ranges from 5 to 35.

About the Agitation Calmness Evaluation Scale (ACES)

ACES consists of a single item that rates overall agitation and sedation at the time of evaluation, where 1 indicates marked agitation; 2, moderate agitation; 3, mild agitation; 4, normal behavior; 5, mild calmness; 6, moderate calmness; 7, marked calmness; 8, deep sleep; and 9, unarousable.

About the Clinical Global Impressions – Improvement Scale (CGI-I)

The CGI-I scale is a widely used rating scale to assess overall improvement or change in a patient’s condition. It provides a subjective evaluation of the patient’s global improvement relative to their baseline or previous state. The scale consists of categories ranging from “Very much improved” to “Very much worse,” allowing healthcare professionals or researchers to rate the patient’s progress based on their clinical judgment.

About BXCL501

BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BioXcel Therapeutics believes that BXCL501 potentially targets an important mediator of agitation, and the Company has observed anti-agitation results in multiple clinical studies across several neuropsychiatric disorders. BXCL501 is under investigation for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting, for the acute treatment of Alzheimer’s-related agitation, and as an adjunctive treatment for Major Depressive Disorder. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

About BioXcel Therapeutics, Inc.

BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. The Company’s commercial product, IGALMI (developed as BXCL501), is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose. For more information, please visit igalmi.com and also see the IGALMI full Prescribing Information. BXCL501 is under evaluation for at-home use for the acute treatment of agitation in bipolar and schizophrenia patients, for acute treatment of agitation associated with Alzheimer’s disease, and as an adjunctive treatment for major depressive disorder. The safety and efficacy of BXCL501 for these uses have not been established. The Company is also developing BXCL502 as a potential therapy for chronic agitation in dementia. Under its subsidiary, OnkosXcel Therapeutics, the Company is developing BXCL701, an investigational, oral systemic innate immune activator for the treatment of aggressive forms of prostate cancer and other solid and liquid tumors. The safety and efficacy of BXCL502 and BXCL701 have not been established. For more information, please visit bioxceltherapeutics.com.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the Company’s expected timing of, trial design and data results from, future clinical trials and future regulatory approvals of BXCL501, in particular for treatment of dementia, potential safety and tolerability features of BXCL501, the potential addressable market for BXCL501 and the potential benefits from treatment with BXCL501. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, its ability to receive regulatory approval for its product candidates and the possibility that the FDA does not conclude that its product candidates satisfy the regulatory requirements for approval; dependence on third-party clinical investigators who may not comply with good clinical practice or other regulatory requirement; the outcomes of its internal and third-party investigations into one of the principal investigators on the TRANQUILITY II trial; its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; its limited experience in drug discovery and drug development; its dependence on the success and commercialization of IGALMI, BXCL501, BXCL502 and BXCL701 and other product candidates; its lack of experience in marketing and selling drug products; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; and the other important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release.

Contact Information

Corporate
BioXcel Therapeutics
Erik Kopp
1.203.494.7062
ekopp@bioxceltherapeutics.com

Investor Relations
BioXcel Therapeutics
Brennan Doyle
1.475.355.8462
bdoyle@bioxceltherapeutics.com

Media
David Schull or Scott Stachowiak
Russo Partners
(858) 717-2310
David.schull@russopartnersllc.com
Scott.stachowiak@russopartnersllc.com

Source: BioXcel Therapeutics, Inc.