(A joint stock company incorporated in the People's Republic of China with limited liability) WARNING The publication of this Application Proof is required by The Stock Exchange of Hong Kong Limited (the "Stock Exchange") and the Securities and Futures Commission (the "Commission") solely for the purpose of providing information to the public in Hong Kong. This Application Proof is in draft form. The information contained in it is incomplete and is subject to change which can be material. By viewing this do ...

Core Viewpoint - SciSparc Ltd. announced that its majority-owned subsidiary NeuroThera Labs Inc. received a U.S. patent for a proprietary combination of antimicrobials and cannabinoids aimed at enhancing the efficacy of existing antibiotics against resistant bacterial strains [1][2]. Group 1: Patent and Technology - The newly granted U.S. patent complements existing patents in the U.S. and Europe, reinforcing global intellectual property protection for NeuroThera's antimicrobial-potentiating platform [2]. - The patented technology combines established antibiotics with cannabinoids like Δ⁹-Tetrahydrocannabinol (THC) and Cannabidiol (CBD), showing enhanced antimicrobial activity in pre-clinical studies against resistant Gram-positive pathogens such as MRSA [3][5]. - The platform aims to leverage the long-term safety data of these antibiotics to minimize risks while providing an effective and affordable therapeutic solution [3]. Group 2: Market Context and Need - Prolonged antibiotic use has led to the emergence of resistant bacterial strains, with MRSA causing approximately 130,000 deaths worldwide in 2021, a significant increase from 57,000 deaths in 2019 [4]. - The global antibiotics market is projected to reach approximately $58 billion in 2026, driven by the rising challenge of antimicrobial resistance [6]. - The "antimicrobial-sparing" effect of NeuroThera's combination may reduce the need for new antibiotics, addressing serious side effects associated with resistance development and organ toxicity [7]. Group 3: Industry Challenges - Pharmaceutical companies are increasingly reluctant to develop new antibiotics due to long development timelines, high costs, and rapid bacterial resistance, leading to a decline in innovation in this field [8].

Core Viewpoint - Neurothera Labs Inc. has received a U.S. patent for its proprietary combination of antimicrobials and cannabinoids aimed at enhancing the efficacy of existing antibiotics against resistant bacterial strains [1][2]. Company Summary - Neurothera Labs Inc. is a clinical-stage biotech company focused on developing innovative therapeutics, particularly in the area of antimicrobial resistance [10]. - The company is a majority-owned subsidiary of SciSparc Ltd. [1]. Technology and Innovation - The patented technology combines established antibiotics with cannabinoids like THC and CBD, demonstrating enhanced antimicrobial activity against resistant pathogens such as MRSA in preclinical studies [3][5]. - The platform aims to restore the effectiveness of antibiotics that are ineffective as monotherapy against resistant Gram-positive pathogens [3]. Market Context - The global antibiotics market is projected to reach approximately $58 billion in 2026, driven by the rising challenge of antimicrobial resistance [6]. - The emergence of resistant bacterial strains, particularly MRSA, has led to a significant increase in healthcare-acquired infections, with a reported 30% rise in the U.S. [6]. Antimicrobial Resistance Challenge - Prolonged antibiotic use has resulted in the emergence of resistant strains, with MRSA causing approximately 130,000 deaths worldwide in 2021, more than double the 57,000 deaths in 2019 [4]. - Overall, bacterial antimicrobial resistance caused 1.14 million deaths and was associated with 4.71 million deaths globally in 2021 [4]. Industry Dynamics - Pharmaceutical companies are increasingly reluctant to develop new antibiotics due to high costs and lengthy development timelines, leading to a gap in innovation as major firms exit the field [8][9]. - The need for innovative solutions that enhance the efficacy of existing antibiotics while improving safety is critical in the current landscape of antimicrobial resistance [6][7].

Core Insights - SCYNEXIS, Inc. is presenting data on its second-generation fungerp drug candidate, SCY-247, at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI) from January 28 to 30, 2026, in Las Vegas, Nevada [1][2] - The company emphasizes the potential of SCY-247 as a critical weapon against drug-resistant fungal infections, highlighting its potent antifungal activity and favorable safety profile observed in clinical investigations [2][4] - IMARI is a joint conference organized by the American Society for Microbiology and the Infectious Diseases Society of America, focusing on the challenge of antimicrobial resistance [3] Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat infections, particularly those that are increasingly drug-resistant [4] - The company’s antifungal platform, "fungerps," includes Ibrexafungerp, which has been approved by the FDA for treating vulvovaginal candidiasis and reducing recurrent cases [4] - SCY-247 is currently in clinical development and has received QIDP and Fast Track designations from the FDA, with additional antifungal assets in pre-clinical and discovery phases [4]

As filed with the U.S. Securities and Exchange Commission on January 9, 2026. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ________________________________________ Lakewood-Amedex Biotherapeutics Inc. (Exact Name of Registrant as Specified in its Charter) ________________________________________ | Nevada | 2834 | 20-5274304 | | --- | --- | --- | | (State or Other Jurisdiction of | (Primary Stand ...

Core Viewpoint - Prokaryotics Inc. has entered into a collaboration with Basilea Pharmaceutica Ltd to develop a first-in-class broad-spectrum antifungal aimed at treating severe invasive infections caused by resistant fungal strains [1][2][4]. Company Overview - Prokaryotics Inc. is a biopharmaceutical company focused on discovering and developing novel anti-infectives, particularly targeting life-threatening microbial infections caused by multidrug-resistant bacteria and fungi [7][8]. - Basilea Pharmaceutica Ltd is a commercial-stage biopharmaceutical company dedicated to developing innovative drugs for severe bacterial and fungal infections, with successful products like Cresemba and Zevtera already launched [6]. Collaboration Details - The partnership will focus on antifungal molecules with a novel mode of action to address the unmet medical needs of patients suffering from invasive infections caused by Candida, Aspergillus, and rare molds [2][4]. - Basilea will provide an undisclosed upfront payment and milestone payments to Prokaryotics, with potential total payments reaching up to USD 48.5 million, along with tiered low single-digit royalties on global net sales [4]. Market Need - The World Health Organization has highlighted the urgent need for new antifungal agents due to increasing resistance to existing treatments, with serious fungal infections causing approximately 1.7 million deaths annually, comparable to tuberculosis and malaria [3][5].

Financial Data and Key Metrics Changes - The cash balance and restricted cash as of September 30, 2025, were $8.1 million, down from $18 million as of December 31, 2024, primarily due to net cash used in operating activities [11] - Research and development expenses net were $6.1 million for Q3 2025, compared to $7.3 million for Q3 2024, driven by reduced salary expenses and lower rent expenses [12] - General and administrative expenses were $2.4 million for Q3 2025, down from $3.2 million for Q3 2024, mainly due to reduced salary and share-based compensation expenses [13] - The net loss for Q3 2025 was $9.2 million, compared to a net income of $9.6 million for Q3 2024, primarily due to changes in the fair value of warrants [13] Business Line Data and Key Metrics Changes - The BX004 program for cystic fibrosis patients made significant progress despite regulatory challenges, with first patient dosing in the phase IIB trial [5] - The BX011 program targeting Staphylococcus aureus infections in diabetic foot infections received positive FDA feedback, supporting its development as an off-the-shelf formulation [8][9] Market Data and Key Metrics Changes - Approximately 160,000 lower limb amputations occur annually in diabetic patients in the U.S., with 85% stemming from diabetic foot infections or osteomyelitis, highlighting a significant unmet medical need [9] Company Strategy and Development Direction - The company is focused on advancing both BX004 and BX011 through key upcoming milestones, with a clear phase III development pathway for BX004 and a strong regulatory opportunity for BX011 [14] - The strategy includes leveraging existing clinical data and addressing critical unmet medical needs in the diabetic foot infection market [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about resuming enrollment in the BX004 trial following FDA feedback, viewing the clinical hold as a technical challenge rather than a fundamental concern [6][7] - The company sees strong momentum in the phage therapy field and increasing validation of phage-based approaches, which strengthens confidence in upcoming trial readouts [10] Other Important Information - The FDA provided constructive guidance for BX011, outlining a clear potential pathway toward a biologics license application without the need for additional non-clinical studies [9] Q&A Session Summary Question: Clarification on the defense potential for BX011 - Management indicated that the U.S. Defense Health Agency supports the approval of BX011 through a commercial indication first, with potential expansion later [17][19] Question: Outstanding questions regarding DFI design or inclusion criteria - Management confirmed that there are some fine-tuning aspects but generally good clarity on the clinical study design and endpoints [21][22] Question: Speculation on the FDA's initial clinical hold for BX004 - Management speculated that the hold was due to new requirements for the nebulizer device, viewing it as a technical issue rather than a concern about the drug itself [34] Question: General ideas on the size and duration of the potential phase III study for BX004 - Management indicated that while specifics are still being defined, there is a clear understanding of the phase III study's direction, pending positive data from the phase IIB trial [36]

Core Insights - BioVersys AG's lead asset BV100 has been selected for the ADVANCE-ID clinical trial network to address hospital infections caused by multidrug-resistant Acinetobacter baumannii, including carbapenem-resistant strains [1][4] - The Phase 2b study aims to generate additional clinical data to support future new drug applications and will be conducted in Southeast Asia, a region with high levels of drug resistance [2][3] - Wellcome's contribution of SGD 22 million (approximately USD 17 million) has facilitated this trial, increasing the number of treatment arms and evaluable patients [3][5] Company Overview - BioVersys AG is a clinical-stage biopharmaceutical company focused on developing novel antibacterial products for serious infections caused by multidrug-resistant bacteria [16] - BV100 is a novel formulation of rifabutin designed for intravenous administration, targeting infections caused by Acinetobacter baumannii [9] - The company has received QIDP designation from the U.S. FDA for BV100, which allows for priority review and extended market exclusivity upon approval [9] Clinical Trial Details - The Phase 2b trial will include three treatment arms: BV100 combined with Ceftazidime/avibactam, BV100 with Cefiderocol, and Best Available Therapy, increasing the patient size from 60 to 90 [3][5] - The trial is expected to begin dosing patients in the first half of 2026, with interim data read-out anticipated in the second half of 2026 [4][5] - The ADVANCE-ID network aims to conduct high-quality clinical trials that impact global infection management, having already engaged over 10,000 patients in previous studies [5][11] Industry Context - Acinetobacter baumannii is classified as a "Critical" priority pathogen by WHO, with high mortality rates associated with infections due to limited treatment options [4][10] - The incidence of carbapenem-resistant A. baumannii infections is rising, with estimates suggesting over one million cases globally, exacerbated by the COVID-19 pandemic [10] - The ADVANCE-ID network, based at the National University of Singapore, aims to enhance clinical trial capacity and address antimicrobial resistance challenges [11][7]

Core Insights - A systematic review of 15 studies has been conducted focusing on the epidemiology and antimicrobial resistance of pneumococcal serotypes covered by CAPVAXIVE in U.S. adults [1] Group 1 - The review highlights the importance of understanding the prevalence and resistance patterns of pneumococcal serotypes in the context of public health [1] - CAPVAXIVE is identified as a significant factor in addressing pneumococcal infections among adults in the U.S. [1] - The findings from the studies may inform future strategies for vaccination and treatment options against pneumococcal diseases [1]

Core Insights - Spero Therapeutics and GSK announced positive results from the pivotal phase 3 PIVOT-PO trial for tebipenem HBr, an oral treatment for complicated urinary tract infections (cUTIs) [1][5] Industry Overview - Complicated UTIs are a significant health issue, with approximately 2.9 million cases treated annually in the U.S., leading to over $6 billion in healthcare costs each year [2] - These infections are often caused by multidrug-resistant pathogens, resulting in serious health risks such as organ failure and sepsis [2] Trial Results - The PIVOT-PO trial demonstrated non-inferiority of tebipenem HBr compared to intravenous imipenem-cilastatin, with an overall success rate of 58.5% for tebipenem HBr versus 60.2% for imipenem-cilastatin [3][6] - Clinical cure rates were 93.5% for tebipenem HBr compared to 95.2% for imipenem-cilastatin, while microbiological response rates were 60.3% and 61.3%, respectively [6] Regulatory and Market Implications - GSK plans to submit data to U.S. regulatory authorities in Q4 2025, aiming for tebipenem HBr to become the first oral carbapenem antibiotic for cUTIs in the U.S. [7] - The development of tebipenem HBr is supported by federal funds from the U.S. Department of Health and Human Services [8] Company Collaboration - Spero Therapeutics has licensed tebipenem HBr to GSK for development and commercialization, with GSK responsible for regulatory filings [7][9] - The collaboration aims to address the challenges of antimicrobial resistance and expand GSK's anti-infectives portfolio [7]