Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - Elong Power Holding Limited (ELPW) is up 57% at $5.65 - Citizens, Inc. (CIA) is up 17% at $5.78 - The Oncology Institute, Inc. (TOI) is up 17% at $3.08 - Everbright Digital Holding Limited (EDHL) is up 12% at $3.89 - Universal Electronics Inc. (UEIC) is up 10% at $4.06 - Korro Bio, Inc. (KRRO) is up 9% at $12.57 - Silvaco Group, Inc. (SVCO) is up 9% at $3.60 - Clene Inc. (CLNN) is up 7% at $6.38 - AleAnna, Inc. (ANNA) is up 7% at $3.91 - Klarna Group plc (KLAR) is up 5% at $15.40 [3] Premarket Losers - KinderCare Learning Companies, Inc. (KLC) is down 32% at $2.30 - PAR Technology Corporation (PAR) is down 23% at $12.22 - EverCommerce Inc. (EVCM) is down 23% at $9.25 - SenesTech, Inc. (SNES) is down 21% at $1.78 - Once Upon A Farm, PBC (OFRM) is down 18% at $16.60 - PagerDuty, Inc. (PD) is down 12% at $6.35 - SciSparc Ltd. (SPRC) is down 10% at $4.25 - Agape ATP Corporation (ATPC) is down 9% at $5.09 - OIO Group (OIO) is down 9% at $3.28 - Lifetime Brands, Inc. (LCUT) is down 6% at $3.24 [4]

Exhibit 99.1 CLENE REPORTS FULL YEAR 2025 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS SALT LAKE CITY, Mar. 12, 2026 -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, "Clene") and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced its full year 2025 ...

Core Insights - Clene Inc. reported its full year 2025 financial results and updates on its CNM-Au8 programs, focusing on treatments for neurodegenerative diseases like ALS and MS [1][2]. Financial Performance - Clene's total revenue for 2025 was $200 million, a decrease from $342 million in 2024, primarily due to lower product and royalty revenues [18]. - Research and development expenses decreased to $14 million in 2025 from $20.1 million in 2024, attributed to the completion of certain trials and reduced regulatory activity [10]. - General and administrative expenses also fell to $9.2 million in 2025 from $13.3 million in 2024, mainly due to lower insurance and legal fees [11]. - The net loss for 2025 was $26.2 million, or $2.65 per share, compared to a net loss of $39.4 million, or $5.67 per share, in 2024 [13]. Clinical Developments - Clene is preparing for a Type C meeting with the FDA to discuss biomarker and survival data for CNM-Au8, which could lead to an NDA filing for ALS by the end of June 2026 [2][3]. - The company reported significant reductions in neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) biomarkers, correlating with improved survival in ALS patients [4]. - CNM-Au8 has shown a favorable safety profile with no significant safety concerns reported across over 1,100 patient years of exposure [5]. Corporate Updates - Clene completed an oversubscribed registered direct offering of over $28 million in January 2026, with an initial tranche of over $6 million expected to fund operations through the third quarter of 2026 [6][8]. - As of December 31, 2025, Clene's cash and cash equivalents totaled $5.2 million, down from $12.2 million in 2024, but expected to be supplemented by the recent financing [9]. Future Outlook - Clene aims to initiate a confirmatory Phase 3 trial in ALS and continue working with the FDA on a Phase 3 trial in MS, with the expectation that patients with various neurodegenerative conditions may benefit from CNM-Au8 treatment [2][3].

Clene Inc. Conference Call Summary Company Overview - **Company Name**: Clene Inc. - **Ticker Symbol**: CLNN - **Industry**: Biopharmaceuticals - **Focus**: Improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, particularly ALS (Amyotrophic Lateral Sclerosis) [1] Core Points and Arguments - **Regulatory Engagement**: Clene is actively engaging with the FDA to seek regulatory flexibility for ALS treatments, emphasizing the urgent need for effective therapies in light of recent tragedies involving ALS patients [6][30]. - **Product Description**: The primary product, CNM-Au8, is described as a nanotherapeutic suspension that can cross the blood-brain barrier, aiming to enhance neuronal housekeeping functions [7][8]. - **Biomarker Significance**: Neurofilament levels are highlighted as critical biomarkers for assessing neurodegenerative diseases, particularly ALS. Elevated neurofilament levels correlate with disease progression and shorter survival [9][11]. - **Clinical Trial Results**: Clene's clinical trials have shown a 94% risk reduction in clinical worsening as a secondary endpoint in the HEALEY study. However, the primary endpoint (ALSFRS) was not met [13][14]. - **FDA Feedback**: The FDA has requested additional evidence regarding neurofilament data and its correlation with survival benefits. Clene is preparing to provide this data [25][26]. - **Future Plans**: Clene plans to file a New Drug Application (NDA) by mid-2026, with potential commercialization by early 2027, contingent on FDA approval [29][40]. Financial Overview - **Funding**: Clene raised $6 million at $6.50 per share, with additional tranches of $7 million and $13 million tied to regulatory milestones, ensuring financial stability through key upcoming events [34][35]. - **Cash Runway**: The company has sufficient cash to navigate through critical milestones, including the FDA Type C meeting and NDA filing [33][34]. Upcoming Milestones - **FDA Type C Meeting**: Expected by the end of March 2026, which will determine the next steps for the NDA submission [36][39]. - **NDA Filing**: Anticipated by the end of the second quarter of 2026, with a potential PDUFA date in the third quarter [40][41]. Additional Insights - **Market Need**: Clene emphasizes the urgent need for ALS therapies, highlighting the devastating impact of the disease and the importance of early diagnosis and treatment [30]. - **Broader Applications**: While the focus is on ALS, Clene also has plans for multiple sclerosis (MS) treatments, indicating a broader pipeline potential [31][32]. - **Regulatory Flexibility**: The company is advocating for regulatory flexibility from the FDA, particularly for orphan diseases like ALS, which have limited treatment options [30][43]. This summary encapsulates the key points discussed during the Clene Inc. conference call, focusing on the company's strategic direction, product development, regulatory interactions, and financial health.

Core Insights - Clene Inc. is focused on developing treatments for neurodegenerative diseases, particularly ALS, through its investigational drug CNM-Au8, with key regulatory and clinical milestones anticipated in 2026 [1][2] Financial Position - The company completed an oversubscribed registered direct offering of over $28 million in January 2026, providing sufficient cash to fund operations into the fourth quarter of 2026 [4][7] - Additional financing tranches totaling over $22 million are structured to align with NDA acceptance and FDA approval milestones, expected to support operations into 2027 [4] Regulatory Steps and Clinical Milestones - Clene has engaged with the FDA regarding CNM-Au8, with an in-person Type C meeting scheduled by the end of Q1 2026 to discuss data submitted in late 2025 [5][7] - The company plans to submit a New Drug Application (NDA) for CNM-Au8 via an accelerated regulatory pathway in Q2 2026, with potential FDA acceptance and PDUFA date issuance in the second half of 2026 [5][7] Clinical Data and Efficacy - CNM-Au8 has shown prolonged survival in ALS patients, with a median life expectancy of 2-4 years post-diagnosis, and demonstrated statistically significant reductions in mortality risk and clinical worsening [6][8] - The treatment has also shown favorable safety and tolerability, with no serious adverse events reported across over 1,000 patient years of treatment [9] Future Trials - A confirmatory Phase 3 RESTORE-ALS trial is planned to begin later in 2026 to further evaluate the survival benefit of CNM-Au8 [10] Broader Pipeline - CNM-Au8 is also being explored for potential benefits in multiple sclerosis (MS) and Parkinson's disease, with plans to finalize Phase 3 clinical trial designs for MS in 2026 [12]

Clene Inc. Conference Call Summary Company Overview - Clene Inc. is a clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS (Amyotrophic Lateral Sclerosis) and MS (Multiple Sclerosis) [1] Key Accomplishments and FDA Interactions - Clene has achieved an in-person meeting with the FDA this quarter, marking the fifth meeting in 14 months to discuss extensive biomarker and survival data [2] - The company presented significant biomarker analyses showing reductions in neurofilament and GFAP (glial fibrillary acidic protein), which are associated with longer survival in ALS patients [3][4] - Clene aims to file a new drug application (NDA) under the accelerated approval pathway, utilizing biomarker data as a surrogate endpoint due to missed primary endpoints in previous studies [5][6] Biomarker Data and Clinical Evidence - The company has demonstrated that reductions in neurofilament levels are quantitatively associated with improved survival, with a noted reduction of 9%-10% linked to lower mortality risk [8] - Clene is pursuing a three-pronged approach to validate the biomarker benefits, including proving substantial biomarker benefit, establishing an independent association with mortality, and demonstrating consistent clinical benefits [7][9] Future Plans and Timeline - The FDA meeting is scheduled for later this quarter, with the intent to file the NDA in the second quarter of 2024 if the FDA concurs with the data presented [11][12] - If accepted, commercialization could begin by early 2025, with aspirations to approve CNM-Au8 for ALS patients [13] Financing and Cash Runway - Clene raised approximately $6 million at a price of $6.50 per share through a tranche financing, extending its cash runway by an additional quarter [17] - Future tranches are planned, with potential raises of $7 million at $7 per share and $15 million at a $12.50 strike price upon approval [18] Industry Context and Need for New Treatments - There are over 30,000 ALS patients in the U.S., with a uniform mortality rate of 2-4 years without treatment, highlighting the urgent need for new drugs [19] - Clene is also working to reauthorize funding for ALS research at the Congressional level, emphasizing the critical need for advancements in treatment options [19] Conclusion - Clene Inc. is positioned to make significant strides in ALS treatment through its ongoing FDA interactions and biomarker research, with a clear plan for future drug application and funding strategies [20]

Core Viewpoint - Clene Inc. has received an in-person Type C Meeting from the FDA to discuss its biomarker and survival data related to its investigational treatment CNM-Au8 for neurodegenerative diseases, particularly ALS [1][8][13] Group 1: FDA Interaction and Meeting - The FDA has granted Clene an in-person Type C meeting scheduled for the first quarter of 2026 to review evidence supporting the use of neurofilament light chain (NfL) as a candidate biomarker for accelerated approval [1][8] - Clene has submitted a pre-meeting briefing package to the FDA, addressing previous requests regarding the clinical significance of NfL declines and their reproducibility [2][4] Group 2: Biomarker Evidence and Analysis - Clene's analyses indicate that longitudinal changes in NfL are associated with survival outcomes in ALS patients, independent of baseline disease severity [3][5] - Statistically significant reductions in NfL levels were observed in patients treated with CNM-Au8, demonstrating consistent pharmacodynamic effects across multiple studies [6][9] Group 3: Clinical Outcomes and Survival Benefits - Modest reductions in NfL (approximately 9-10%) were associated with an 8-13% lower risk of death in ALS patients, highlighting the potential clinical relevance of NfL as a surrogate endpoint [7][9] - In responders with IGFBP7 biomarker decline, CNM-Au8 treatment was associated with a 78% reduced mortality risk, indicating a strong link between biomarker changes and survival [8][10] Group 4: Mechanistic Insights and Future Directions - IGFBP7 has been identified as a key pharmacodynamic biomarker, with its decline correlating with improved survival and other disease-relevant biomarkers [11][12] - The findings suggest a mechanistic pathway linking CNM-Au8's action to neuroprotection, supported by genetic evidence related to IGFBP7 expression [12]

Core Viewpoint - Clene Inc. has announced a registered direct offering priced above market, raising over $28 million from new and existing investors to support its clinical-stage biopharmaceutical efforts in treating neurodegenerative diseases, particularly ALS and MS [1][2][3] Financing Details - The offering includes an oversubscribed registered direct offering to new, existing, and insider investors, with an initial financing tranche of over $6 million expected to fund operations into Q3 2026 [3] - Two additional financing tranches totaling over $22 million are contingent on the acceptance and approval of the New Drug Application (NDA) by the FDA, providing sufficient capital into early 2027 for potential commercialization of CNM-Au8 in ALS [3] - The gross proceeds from the offering are expected to be approximately $28 million, with BTIG, LLC acting as the sole placement agent [7] Warrant Details - The offering includes Series A Warrants and Series B Warrants, both with an initial exercise price of $6.00 per share, which can increase based on specific conditions related to the company's stock price and FDA announcements [4][5][6] - The potential gross proceeds from the exercise of the Series A Warrants total approximately $6.7 million, while the Series B Warrants could generate around $15.6 million, expected to fund commercialization efforts [5][6] Company Overview - Clene Inc. is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including ALS, Parkinson's disease, and MS [10] - CNM-Au8 is an investigational therapy designed to enhance neuronal health by increasing energy production and reducing oxidative stress [11]

Company Overview - Clene Inc. (NASDAQ: CLNN) is a biotechnology company focused on developing innovative treatments for neurodegenerative diseases, particularly through nanotherapeutics [1] - The company competes with other biotech firms such as Biogen and Novartis in the same therapeutic area [1] Shareholder Activity - On January 7, 2026, significant shareholder Ugwumba Chidozie sold 3,938 shares at $6.29 each, following a previous sale of 4,138 shares on December 30 at $6.03, totaling approximately $24,952 [2] - After the January 7 transaction, Chidozie holds 753,562 shares, a decrease from 783,590 shares held after the December 30 sale, but he remains a major shareholder with holdings valued at around $4.7 million [3] Stock Performance - The current price of CLNN is $6.28, reflecting a 2.28% increase, with intraday fluctuations between $6.06 and $6.56 [4] - Over the past year, CLNN's stock price ranged from a high of $13.50 to a low of $2.28, and the company's market capitalization is approximately $58.4 million [4] - The trading volume on the NASDAQ exchange is 51,957 shares [4]

Summary of Conference Call for Clene Inc. and Faraday Future Intelligent Electric Inc. Clene Inc. (Ticker: CLNN) Industry Overview - Clene is a clinical stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, specifically ALS (Amyotrophic Lateral Sclerosis) [1][2]. Core Points and Arguments - Clene has released biomarker data requested by the U.S. FDA, which is crucial for the accelerated approval pathway for its lead asset, CNMA-08 [2]. - The FDA has outlined a path for Clene to use biomarker data as part of the commercialization process, with a meeting scheduled for the first quarter of the upcoming year [2][3]. - Clene is pursuing three methods to validate biomarker data: finding additional biomarkers, verifying existing data, and obtaining new data from the Healy Harvard program [3]. - The two key biomarkers discussed are neurofilament light chain and glial fibrillary protein (GFAP), both of which showed statistically significant data in Clene's studies [5][6]. - Clene is preparing a New Drug Application (NDA) to be submitted in the first half of the year, with the possibility of commercialization by late 2026 or early 2027 [9][10]. - The accelerated approval process allows for conditional market entry based on surrogate endpoints, with a confirmatory phase 3 study to follow [12][13]. - The current market for ALS treatments is limited, with only a few drugs available, highlighting the significant opportunity for Clene if approved [14][15]. - Previous approvals in the ALS space have led to substantial market caps for companies, indicating a potential for Clene's market cap to grow significantly upon FDA approval [16]. Other Important Information - The FDA's accelerated approval process is particularly relevant for uniformly fatal diseases like ALS, allowing for quicker access to treatments based on biomarker data [13]. - Clene's approach to treatment and data collection is critical for establishing a correlation between biomarker changes and survival benefits [10][11]. Faraday Future Intelligent Electric Inc. (Ticker: FFAI) Industry Overview - Faraday Future is a California-based company focused on creating a user-centric electric vehicle (EV) ecosystem, aiming to disrupt the automotive industry [19][20]. Core Points and Arguments - The company has invested $3.5 billion in R&D and CapEx, resulting in over 600 patents and a unique business model that partners with Chinese OEMs [20][21]. - Faraday Future's vehicle lineup includes the ultra-premium FF91 and the more affordable FX Super 1, with plans for a lower-priced FX4 model [22][23]. - The FX Super 1 is priced at $84,000 and is designed for high performance, featuring advanced technology and luxury elements [23][24]. - The company has a manufacturing site in Hanford, California, with an initial capacity of 10,000 vehicles annually, which can ramp up to 30,000 [21]. - Faraday Future's business model includes advantages such as lower tariffs on parts due to local assembly, proprietary software development, and an established dealership network [26][27]. Other Important Information - The company has received 11,000 pre-orders for the FX Super 1, indicating strong market interest [29]. - Recent partnerships, including one with Tesla for access to their supercharging network, enhance Faraday Future's competitive position in the EV market [29]. - Upcoming milestones include the production of pre-production vehicles and further announcements from the manufacturing site [30].