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ORYZON Receives Intention to Grant Communication for Patent Relating to the Use of Vafidemstat in Borderline Personality Disorder

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MADRID and CAMBRIDGE, Mass., Sept. 11, 2024 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the European Patent Office (EPO) has issued an intention to grant communication for Oryzon’s European patent application EP20712565.9 entitled Methods of treating borderline personality disorder related to vafidemstat, Oryzon’s LSD1 inhibitor in clinical development for the treatment of psychiatric disorders like borderline personality disorder (BPD) and schizophrenia.

The intention to grant is a formal communication from the EPO in which it indicates that the patent application has reached the status where it is allowed for issuance as a patent. This European patent, once granted, will not expire until at least 2040, excluding any potential patent term extensions that may provide additional protection. Decision to grant communications have also recently been received in corresponding patent applications in Japan and Mexico, and patent applications are pending in other relevant markets.

We are delighted to have received this decision to grant from the EPO. This European patent application further strengthens the company’s patent portfolio for vafidemstat in CNS, and together with our European patent application allowed earlier this year covering the use of vafidemstat for the treatment of aggression and social withdrawal, will significantly prolong vafidemstat’s commercial life in Europe, said Neus Virgili, Oryzon’s Chief IP Officer.

About Oryzon  
Founded in 2000 in Barcelona, Spain, Oryzon (ISIN Code: ES0167733015) is a clinical stage biopharmaceutical company and the European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is composed of highly qualified professionals from the pharma industry located in Barcelona, Boston, and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in CNS and iadademstat in oncology, in several Phase II clinical trials. The company has other pipeline assets directed against other epigenetic targets like HDAC-6 where a clinical candidate ORY-4001, has been nominated for its possible development in CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for a variety of malignant and neurological diseases. For more information, visit www.oryzon.com

About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong, and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 and 12 months of treatment, and the pilot, small-scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where anti-inflammatory activity has also been observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Vafidemstat is being investigated in neuropsychiatric disorders in two double-blind, randomized, placebo-controlled Phase IIb trials: one in schizophrenia, named EVOLUTION (recruitment ongoing), and another one in Borderline Personality disorder (BPD), named PORTICO, finalized and with published topline data (final data will be presented at ECNP-2024 in September). Based on PORTICO’s results, the company has requested an End-of-Phase II meeting with the FDA to discuss options for a registrational Phase III trial in BPD. The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders and is preparing a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes.

FORWARD-LOOKING STATEMENTS    
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words expects, anticipates, believes, intends, estimates and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del Mercado de Valores (CNMV), which are accessible to the public. Forward-looking statements are not guarantees of future performance and have not been reviewed by the auditors of Oryzon. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date they were made. All subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees, or any persons acting on its behalf are expressly qualified in their entirety by the cautionary statement above. All forward-looking statements included herein are based on information available to Oryzon on the date hereof. Except as required by applicable law, Oryzon does not undertake any obligation to publicly update or revise any forwardlooking statements, whether as a result of new information, future events, or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States absent registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus that may be obtained from Oryzon or the selling security holder, as applicable, that will contain detailed information about Oryzon and management, as well as financial statements.

Spain  Oryzon  IR, US  IR & Media, Europe  
Patricia Cobo/Mario Cordera  Emili Torrell  Ashley R. Robinson  Sandya von der Weid  
Atrevia  Chief Business Officer  LifeSci Advisors, LLC  LifeSci Advisors, LLC  
+34 91 564 07 25  
+34 673 33 97 65  
+34 93 515 1313  +1 617 430 7577  +41 78 680 05 38    
pcobo@atrevia.com  
mcordera@atrevia.com  
etorrell@oryzon.com  arr@lifesciadvisors.com  svonderweid@lifesciadvisors.com  

Source: Oryzon Genomics, S.A.

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Allbirds stock touches 52-week low at $7.65 amid market challenges

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In a challenging market environment, Allbirds Inc. (NASDAQ:) stock has recorded a new 52-week low, dipping to $7.65. The eco-friendly footwear company has faced significant headwinds over the past year, reflected in a substantial 1-year change with a decline of -55.8%. Investors have shown concern as the brand navigates through a competitive retail landscape and supply chain issues, which have pressured the stock to its current low. The company’s efforts to rebound will be closely watched by market participants looking for signs of a turnaround or further indications of industry-wide pressures.

In other recent news, Allbirds disclosed its Q3 2024 financial results, reporting a net revenue of $43 million. This figure reflects a downturn due to reduced unit sales and transitions to a distributor model in certain regions. Despite these challenges, the company managed to increase its gross margin to 44.4%, attributed to lower freight costs and improved inventory management.

The company also launched two new products, the Tree Glider and Lounger Lift, which have been positively received by consumers. Allbirds revised its full-year revenue guidance to between $187 million and $193 million and anticipates an adjusted EBITDA loss of $75 million to $71 million.

Additionally, Allbirds has signed two new international distributor agreements, expanding its reach in Latin America and Europe from mid-2025. The company’s management, led by CEO Joe Vernachio and CFO Annie Mitchell, remains optimistic about future growth, driven by forthcoming product launches and strategic marketing efforts.

InvestingPro Insights

Allbirds Inc. (BIRD) continues to face significant challenges, as reflected in its recent stock performance and financial metrics. According to InvestingPro data, the company’s revenue growth has declined by 22.67% over the last twelve months as of Q3 2024, with a quarterly revenue decline of 24.89% in Q3 2024. This aligns with the InvestingPro Tip that analysts anticipate sales decline in the current year.

The company’s financial health is also concerning, with an operating income margin of -48.08% for the same period. An InvestingPro Tip highlights that Allbirds is quickly burning through cash, which is particularly worrisome given the current market conditions.

Despite these challenges, InvestingPro Tips indicate that Allbirds holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations. This could provide some financial flexibility as the company navigates its turnaround efforts.

For investors seeking a more comprehensive analysis, InvestingPro offers 17 additional tips for Allbirds, providing a deeper understanding of the company’s financial position and market performance.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Quipt Home Medical stock hits 52-week low at $2.55

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Quipt Home Medical (TASE:) Corp. (QIPT) stock has reached a new 52-week low, trading at $2.55. This latest price point marks a significant downturn for the company, which has experienced a 46.87% decline over the past year. Investors are closely monitoring the home medical equipment provider as it navigates through a challenging period marked by this notable decrease in stock value. The 52-week low serves as a critical indicator for the market, reflecting investor sentiment and potential shifts in the company’s financial health and operational performance.

In other recent news, Quipt Home Medical Corp has been making notable strides despite facing several challenges. The company’s third fiscal quarter report revealed a steady increase in revenue, reaching $64 million, a 6.1% rise from the previous year. The customer base also expanded by 9%, serving 153,223 unique patients, and adjusted EBITDA grew by 2.7% to $14.2 million.

Benchmark revised its stock price target for Quipt Home Medical, reducing it to $7 from the previous $9, but maintained a Buy rating for the stock. This adjustment was influenced by several factors including the expiration of Medicare’s 75/25 rate relief, a diminished Managed Care contract, and the repercussions of the Change Healthcare (NASDAQ:) cyberattack. However, the firm predicts that Quipt could achieve an 8%-10% organic growth rate by the second quarter of fiscal year 2025.

In the face of these challenges, Quipt Home Medical has reported a 9% increase in resupply revenue for sleep therapy and supplies, which accounts for half of the company’s revenues. The company’s management has also indicated an active mergers and acquisitions pipeline, which could provide further growth opportunities. These are the recent developments that investors should keep an eye on.

InvestingPro Insights

Despite Quipt Home Medical Corp. (QIPT) hitting a new 52-week low, InvestingPro data reveals some interesting insights that may provide context for investors. The company’s revenue growth remains strong, with a 29.31% increase over the last twelve months as of Q3 2024, reaching $244.23 million. This growth suggests that QIPT continues to expand its market presence in the home medical equipment sector.

However, profitability remains a concern. InvestingPro Tips highlight that QIPT has not been profitable over the last twelve months, with a negative P/E ratio of -24.61. On a more positive note, analysts predict that the company will become profitable this year, which could potentially reverse the stock’s downward trend.

The current market valuation implies a strong free cash flow yield, according to another InvestingPro Tip. This could indicate that the stock may be undervalued at its current price, especially considering that it’s trading near its 52-week low. Investors looking for a deeper analysis can find 7 additional InvestingPro Tips for QIPT, offering a more comprehensive view of the company’s financial situation and market position.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Muslims who voted for Trump upset by his pro-Israel cabinet picks

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By Andrea Shalal

WASHINGTON (Reuters) – U.S. Muslim leaders who supported Republican Donald Trump to protest against the Biden administration’s support for Israel’s war on Gaza and attacks on Lebanon have been deeply disappointed by his Cabinet picks, they tell Reuters.

“Trump won because of us and we’re not happy with his Secretary of State pick and others,” said Rabiul Chowdhury, a Philadelphia investor who chaired the Abandon Harris campaign in Pennsylvania and co-founded Muslims for Trump. Muslim support for Trump helped him win Michigan and may have factored into other swing state wins, strategists believe.

Trump picked Republican senator Marco Rubio, a staunch supporter of Israel for Secretary of State. Rubio said earlier this year he would not call for a ceasefire in Gaza, and that he believed Israel should destroy “every element” of Hamas. “These people are vicious animals,” he added.

Trump also nominated Mike Huckabee, a former Arkansas governor and staunch pro-Israel conservative who backs Israeli occupation of the West Bank and has called a two state solution in Palestine “unworkable”, as the next ambassador to Israel.

He has picked Republican Representative Elise Stefanik, who called the UN a “cesspool of antisemitism” for its condemnation of deaths in Gaza, to serve as U.S. ambassador to the United Nations.

Rexhinaldo Nazarko, executive director of the American Muslim Engagement and Empowerment Network (AMEEN), said Muslim voters had hoped Trump would choose Cabinet officials who work toward peace, and there was no sign of that.

“We are very disappointed,” he said. “It seems like this administration has been packed entirely with neoconservatives and extremely pro-Israel, pro-war people, which is a failure on the on the side of President Trump, to the pro-peace and anti-war movement.”

Nazarko said the community would continue pressing to make its voices heard after rallying votes to help Trump win. “At least we’re on the map.”

Hassan Abdel Salam, a former professor at the University of Minnesota, Twin Cities and co-founder of the Abandon Harris campaign, which endorsed Green Party candidate Jill Stein, said Trump’s staffing plans were not surprising, but had proven even more extreme that he had feared.

“It’s like he’s going on Zionist overdrive,” he said. “We were always extremely skeptical…Obviously we’re still waiting to see where the administration will go, but it does look like our community has been played.”

The Trump campaign did not immediately respond to an email seeking comment.

Several Muslim and Arab supporters of Trump said they hoped Richard Grenell, Trump’s former acting director of national intelligence, would play a key role after he led months of outreach to Muslim and Arab American communities, and was even introduced as a potential next secretary of state at events.

Another key Trump ally, Massad Boulos, the Lebanese father-in-law of Trump’s daughter Tiffany, met repeatedly with Arab American and Muslim leaders.

Both promised Arab American and Muslim voters that Trump was a candidate for peace who would act swiftly to end the wars in the Middle East and beyond. Neither was immediately reachable.

Trump made several visits to cities with large Arab American and Muslim populations, include a stop in Dearborn, a majority Arab city, where he said he loved Muslims, and Pittsburgh, where he called Muslims for Trump “a beautiful movement. They want peace. They want stability.”

© Reuters. FILE PHOTO: Richard Grenell, a top advisor to former U.S. President Donald Trump and former Acting Director of National Intelligence, speaks to the attendees of a Muslims and Bangladeshi Americans for Trump  outreach event in Hamtramck, Michigan, U.S. November 2, 2024.  REUTERS/Rebecca Cook/File Photo

Rola Makki, the Lebanese American, Muslim vice chair for outreach of the Michigan Republican Party, shrugged off the criticism.

“I don’t think everyone’s going to be happy with every appointment Trump makes, but the outcome is what matters,” she said. “I do know that Trump wants peace, and what people need to realize is that there’s 50,000 dead Palestinians and 3,000 dead Lebanese, and that’s happened during the current administration.”

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