Smartkarma Daily Briefs

• Onesource Specialty Pharma (ONESOURC IN) reported a solid Q1 FY26, with a 12% YoY revenue increase, accelerated capacity expansion, and momentum toward global growth through potential acquisitions.
• The proposed acquisition of sterile injectable and carbapenem facilities, coupled with the company’s existing biologics platform, positions OneSource to become a formidable, multi-modality CDMO.
• This quarter marks a strategic inflection point for OneSource, signaling a confident transition from a focused CDMO to a globally competitive specialty pharma player with an eye on high-value segments.

Basilea Pharmaceutica has strengthened its antibacterial pipeline with the acquisition of global rights to the novel, orally administered, Phase-III ready asset, ceftibuten-ledaborbactam etzadroxil. The drug, licensed from Venatorx Pharmaceuticals, is a combination of an oral beta-lactam (cephalosporin) and a beta-lactamase inhibitor (a prodrug of ledaborbactam), aiming to target complicated urinary tract infections (cUTI), including pyelonephritis, caused by multidrug-resistant Enterobacterales. Basilea intends to launch a registrational Phase III programme in c 18 months and expects c CHF15m in incremental R&D spend in FY25 (including an upfront payment and pre-commercial milestones). The deal also includes tiered mid-single-digit royalties and up to US$325m in additional commercial milestones to Venatorx. We are encouraged by the deal and believe an oral and potentially outpatient asset (following intial hospital treatment) broadens the scope of Basilea’s otherwise hospital-focused antibacterial franchise. We will provide updated estimates following the H125 results on 19 August.

• BioLineRx is a commercial stage biopharmaceutical company with a development portfolio advancing motixafortide, a platform molecule targeting indications in stem cell mobilization (SCM) & in the treatment of advanced pancreatic cancer.
• The candidate is approved in the US for SCM and is undergoing studies for use in gene therapy and in pancreatic cancer.
• Partner Gloria Biosciences is developing motixafortide in Asia & is expected to be conducting bridging studies in the near term for SCM & longer-term studies for other indications.

• BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies.
• The company announced its 2Q2025 preliminary financial results.
• The company continues to execute at a high level but faces reimbursement uncertainty.

• Bone Biologics is pursuing a better and more effective way of dealing with back pain requiring surgery by developing bone regeneration in spinal fusion using the recombinant human protein known as NELL-1/DBX, or NB1.
• The company continues with human trials and reported 2Q2025 financial results that showed good cash balances that should allow testing results to bolster BBLG.

• On August 14, 2025, BrainStorm Cell Therapeutics, Inc. (BCLI) announced financial results for the second quarter of 2025 and provided a business update.
• The company continues to be focused on initiating the Phase 3b ENDURANCE trial of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).
• Following the filing of the Citizen’s Petition in July 2025, we await a decision from the FDA regarding that petition and whether the agency will invite BrainStorm to resubmit the Biologics License Application (BLA) for NurOwn in ALS.

• Dentium announced that it has decided to cancel all of its 2.44 million treasury shares (22% of its outstanding shares).
• This is massive and should have a positive impact on Dentium’s share price.
• Although the company reported a disappointing results in 2Q 2025 and its exports to China are slowing down, the company still generates healthy operating margins (18.9% in 2Q 2025).

• Dyadic has developed C1, its proprietary fungal expression system that can produce a variety of recombinant proteins.
• C1 has been commercialized in industrial applications and is in development for production of pharmaceutical grade proteins.
• C1 exhibits potential to economically produce recombinant proteins, biologic vaccines, virus like particles, antibodies, Fc-fusion, enzymes, AAVs and other biopharmaceuticals.

• In Q1 FY12/23, revenue was JPY2.3bn (+4.8% YoY), operating profit JPY132mn (+37.6% YoY), pre-tax profit JPY128mn (+47.0% YoY).
• 1H revenue reached 51.7% of FY12/25 forecast, with operating profit at 88.0% and recurring profit at 85.0%.
• Revenue from Medical Personnel Placement Services was JPY1.7bn (+2.2% YoY), Other Services revenue totaled JPY646mn (+12.3% YoY).

• Protalix is a clinical and commercial pharmaceutical company using its proprietary ProCellEx plant-based expression system to pro duce thera peutic proteins for global markets.
• The company has two commer cialized products, Elelyso that is marketed by Fiocruz in Brazil & Pfizer in the rest of the world for Gaucher Disease and Elfabrio which was approved in May 2023.
• Chiesi Rare Disease will commercialize Elfabrio globally.