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HCW Biologics and WY Biotech Announce Closing of First Round of Financing For Newly Formed Joint Venture Trimmune
Globenewswire· 2026-02-13 13:30
Core Insights - HCW Biologics has entered into an exclusive worldwide license agreement with WY Biotech for the development and commercialization of the proprietary molecule HCW11-006, valued at $7 million [1][2] - The Phase 1 clinical study for HCW11-006 is expected to begin in the first half of 2027, targeting solid tumors [3][4] - HCW Biologics retains a royalty-free option to reclaim rights for the Americas territory after the Phase 1 trial [4] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative immunotherapies targeting chronic inflammation and related diseases [6] - The company has developed over 50 molecules using its TRBC drug development platform, which aims to create immunotherapeutics for various diseases, including cancer and autoimmune disorders [6][7] Partnership and Financials - A new entity, Beijing Trimmune Biotech Co., Ltd., has been established to manage the development and commercialization of HCW11-006, backed by CITIC Medical Fund and TigerYeah Capital Fund [2][3] - Trimmune has initiated payment of $1.75 million as part of a $3.5 million upfront cash license fee to HCW Biologics, with additional milestone payments and royalties expected from future sales [3][4] Development Strategy - Trimmune plans to leverage the expertise of HCW Biologics and its own management team to advance the clinical development of HCW11-006, aiming to address significant unmet medical needs in the Chinese market [2][5] - The collaboration is expected to facilitate the exploration of business development opportunities with multinational corporations once key clinical data is generated [4][5]
Alto Neuroscience Announces Completion of Enrollment in Phase 2 Proof-of-Concept Study of ALTO-101 in Cognitive Impairment Associated with Schizophrenia
Businesswire· 2026-02-13 13:04
Core Viewpoint - Alto Neuroscience, Inc. has completed patient enrollment in its Phase 2 proof-of-concept clinical trial for ALTO-101, targeting cognitive impairment associated with schizophrenia [1] Company Summary - Alto Neuroscience is a clinical-stage biopharmaceutical company focused on developing novel precision medicines for neuropsychiatric disorders [1] - The company is evaluating ALTO-101, a transdermal phosphodiesterase-4 (PDE4) inhibitor, in its clinical trial [1] Industry Context - The trial aims to address cognitive impairment associated with schizophrenia, a significant area of need in neuropsychiatric treatment [1]
Aardvark Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2026-02-13 13:00
SAN DIEGO, Feb. 13, 2026 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, today announced that (i) on February 9, 2026, five new employees were granted inducement awards consisting of stock options to purchase an aggregate of 147,213 shares of common stock and (ii) on February 11, 2026, one new employee ...
Citius Pharmaceuticals, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™
Prnewswire· 2026-02-13 13:00
stockholders$(8,220,785)$(9,768,246)Net Loss Per Share - Basic and Diluted$(0.38)$(1.30)Weighted Average Common Shares OutstandingBasic and diluted (include pre-funded warrants from the October 2025 offering)21,495,2747,492,460CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024(Unaudited)20252024Cash Flows From Operating Activities:Net loss$(9,393,889)$(10,281,246)Adjustments to reconcile net loss to net cash used in operating acti ...
vTv Therapeutics to Participate in Upcoming Investor Conferences
Globenewswire· 2026-02-13 13:00
HIGH POINT, N.C., Feb. 13, 2026 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company focused on the development of cadisegliatin, a novel, potential first-in-class oral adjunctive therapy to insulin being investigated for the treatment of type 1 diabetes (T1D), today announced that management will participate in the following upcoming investor conferences: Oppenheimer 36th Annual Healthcare Life Sciences ConferenceDate: Thursday, February 26, 2026Time: 11:20 AM ET ...
Opus Genetics Announces $25 Million Private Placement
Globenewswire· 2026-02-13 12:30
Core Viewpoint - Opus Genetics, a clinical-stage biopharmaceutical company, has announced a private placement of 7,374,632 shares of Series B Non-Voting Convertible Preferred Stock at a price of $3.39 per share, aiming to raise approximately $25 million to fund its gene therapy programs and general corporate purposes [1][2]. Group 1: Private Placement Details - The private placement involves the issuance of 7,374,632 shares of Series B Non-Voting Convertible Preferred Stock, which will convert into common stock upon stockholder approval [1]. - The gross proceeds from the private placement are expected to be $25 million before deducting offering expenses [1]. - The financing is led by Adage Capital Management, with participation from Trails Edge Capital Partners and Marshall Wace [1]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized to advance gene therapy clinical programs, as well as for working capital and general corporate purposes [2]. - The company anticipates that its pro forma cash balance of $70 million at year-end 2025 will fund operations into the first half of 2028, excluding potential proceeds from callable warrants or future milestone payments [2]. Group 3: Closing and Legal Aspects - The offering is expected to close on February 18, 2026, subject to customary closing conditions [3]. - Sidley Austin LLP is serving as counsel to Opus Genetics for this transaction, and the company did not use a placement agent [3]. - The shares issued in the private placement have not been registered under the Securities Act and may not be offered or sold in the U.S. without proper registration or exemption [4]. Group 4: Company Overview - Opus Genetics is focused on developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs) [6]. - The company is working on seven AAV-based programs targeting various genetic causes of severe retinal disorders, including OPGx-LCA5 and OPGx-BEST1 [6]. - Additionally, Opus Genetics is advancing Phentolamine Ophthalmic Solution 0.75% for pharmacologically induced mydriasis, with potential applications in presbyopia and low-light visual disturbances [6].
Beyond Air® Reports Fiscal Third Quarter 2026 Financial Results and Provides Corporate Update
Globenewswire· 2026-02-13 12:30
Core Insights - Beyond Air, Inc. reported a significant increase in quarterly revenue, achieving $2.2 million for the fiscal quarter ended December 31, 2025, which represents a 105% increase compared to $1.1 million in the same quarter last year [4][12]. - The company maintained its fiscal year 2026 revenue guidance of $8-10 million [19]. - Beyond Air has signed a binding letter of intent for XTL Biopharmaceuticals to acquire 85% of its subsidiary NeuroNOS, with potential proceeds of up to $32.5 million [1]. Financial Performance - The company reported a gross profit of $0.3 million for the quarter ended December 31, 2025, compared to a gross loss of $0.2 million for the same period in 2024 [12]. - Research and development expenses decreased by 19% to $2.4 million, while selling, general, and administrative expenses dropped by 42% to $4.5 million [13]. - The net loss attributed to common stockholders for the quarter was $7.3 million, or a loss of $0.85 per share, compared to a net loss of $13.0 million, or a loss of $2.96 per share, in the same quarter of the previous year [15]. Cash Position and Funding - As of December 31, 2025, Beyond Air had a pro forma cash balance of approximately $22.3 million, which includes cash, cash equivalents, restricted cash, and marketable securities [5][17]. - The company completed a private placement that generated net proceeds of approximately $4.5 million, providing a cash runway into calendar year 2027 [5][17]. Commercial Developments - Beyond Air's LungFit PH system has seen increased demand, with the first sale to a VA Medical Center, indicating potential for broader adoption within the VA system [8]. - The company has expanded its global distribution network for LungFit PH, now covering 40 countries with a combined population of over three billion people [8]. Clinical and Regulatory Updates - Phase 1a data from the UNO program in solid tumors is set to be presented at the AACR Annual Meeting in April 2026 [1][4]. - The company is awaiting FDA clearance for its second-generation LungFit PH system, expected before the end of calendar 2026 [4]. Corporate Governance - Dan Moorhead was appointed as Chief Financial Officer effective January 5, 2026, bringing over 20 years of finance leadership experience [7]. - Bob Carey will assume the role of Chairman of the Board, focusing on strengthening governance and supporting the company's growth [16].
AtaiBeckley Inc. (ATAI) Gains Momentum With Promising BPL-003 Data and Strong Analyst Support
Yahoo Finance· 2026-02-13 12:13
Core Insights - AtaiBeckley Inc. (NASDAQ:ATAI) is recognized as a top penny stock by Goldman Sachs, with promising clinical data for its drug BPL-003 aimed at treatment-resistant depression [1][8]. Group 1: Clinical Data and Development - The Phase 2b study for BPL-003 demonstrated significant and sustained antidepressant effects, indicating potential commercial viability for the treatment of resistant depression [2]. - AtaiBeckley has received Breakthrough Therapy designation from the FDA for BPL-003, highlighting its potential in the mental health therapy landscape [2]. Group 2: Analyst Ratings and Market Position - Guggenheim initiated coverage of AtaiBeckley with a Buy rating and an $11 price target, emphasizing the company's strong position in next-generation psychiatry due to its lead drug BPL-003 [4]. - Cantor Fitzgerald reiterated an Overweight rating on AtaiBeckley, expressing optimism that BPL-003 will be a key player in the psychedelic treatment market [5]. Group 3: Company Overview - AtaiBeckley Inc. is a clinical-stage biopharmaceutical company focused on developing innovative psychedelic-based treatments for mental health disorders, including treatment-resistant depression and social anxiety [5].
Insmed To Present at March 2026 Investor Conferences
Prnewswire· 2026-02-13 12:00
Insmed To Present at March 2026 Investor Conferences [Accessibility Statement] Skip NavigationBRIDGEWATER, N.J., Feb. 13, 2026 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that management will present at the following investor conferences:- Leerink Partners Global Healthcare Conference in Miami, on Tuesday, March 10, 2026, a ...
ANI Pharmaceuticals to Discuss Fourth Quarter and Full Year 2025 Financial Results on February 27, 2026, at 8:00 a.m. ET
Globenewswire· 2026-02-13 11:50
Group 1 - ANI Pharmaceuticals, Inc. will release its fourth quarter and full year 2025 financial results on February 27, 2026, prior to market opening [1] - A conference call will be hosted by key executives including the CEO and CFO to discuss the financial results [1] - The conference call is scheduled for 8:00 a.m. ET and will be accessible via toll-free number and webcast [1] Group 2 - ANI Pharmaceuticals is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics [2] - The company aims for sustainable growth through its Rare Disease business, which includes products in ophthalmology, rheumatology, nephrology, neurology, and pulmonology [2] - ANI also operates a Generics business leveraging R&D expertise and U.S.-based manufacturing [2]