Daily Brief Health Care: The United Laboratories International Holdings Limited, B&K Corporation, Aldeyra Therapeutics , Soligenix , BrainStorm Cell Therapeutics I, AFT Pharmaceuticals, Immix Biopharma Inc and more

• At a 4.6 FPE, you would expect to find some real concerns, however there are no gremlins anywhere?  
• What you are buying is an antibiotic developer and distributor who is performing better than expected, given that the antibiotic market is thriving.
• The extensive pipeline including GLP-1 drugs is still at an early stage/midway through development, however at this valuation, you are probably not paying for it!

• The growth factor drug market is highly competitive. Many competing products have been on the market for many years with NRDL reimbursement coverage and also accumulated rich recognition from doctors/patients.
• Even if Pro-101 is approved for market launch, B&K may have to reduce its price largely and invest heavily in market education/promotion. B&K’s commercialization capability still needs to be verified.
• Valuation of B&K would be lower than peers. It is hard for B&K to receive expected valuation premium since its latest round of post investment valuation is already RMB3.3 billion.

• Mack885 identified buying opportunity in ALDX due to management’s plan to address FDA setback
• Perceptive Advisors increased stake in anticipation of reproxalap approval for dry eye disease
• Potential option agreement with AbbVie could greatly benefit ALDX financially, making its share price undervalued

This content is sourced through publicly available sources and has been machine generated. Information displayed is for general informational purposes only. This article was originally published 3 months ago on Value Investors Club.

• On July 9, 2024, Soligenix, Inc. (SNGX) announced positive interim results for HyBryte in an open-label, investigator-initiated study in patients with early-stage cutaneous T cell lymphoma (CTCL).
• Of the patients that have completed 12 weeks of therapy, 3 of 4 (75%) have achieved “Treatment Success”, which is defined as =50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity).
• Two patients have not reached their first efficacy evaluation visit (i.e., at Week 6) and the last patient had a substantial improvement documented by Week 18 but had not yet achieved the success threshold.

• On July 8, 2024, BrainStorm Cell Therapeutics, Inc. (BCLI) conducted a mid-year conference call to provide an update on the status of the company’s NurOwn program.
• During the call, the company reiterated that it is committed to conducting a Phase 3b trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS) to support a potential Biologics License Application (BLA) filing.
• BrainStorm has reached agreement with the FDA on a Special Protocol Assessment (SPA) and the CMC aspects of the upcoming Phase 3b trial.

AFT Pharmaceuticals continues to make inroads in expanding its strategic market footprint. Most recently, it announced the entry into China with the distribution of Crystaderm (approved by Chinese regulators in November 2023) through an agreement with Hainan Haiyao Co. We expect this to provide AFT with access to China’s offline retail and hospital segments, which represent roughly 75% of the country’s OTC market, a significant bump from AFT’s current Chinese e-commerce presence. This announcement comes on the heels of the news on Maxigesic Rapid securing a non-exclusive distribution partnership in the US with Alexso, a specialist distributor focused on non-opioid pain-management products. Given the notable size of both the US and Chinese markets, we expect these new market launches (both expected within CY24) to support top-line traction internationally.

Immix has announced that the first patient has been dosed in its Phase Ib NEXICART-2 trial of lead CAR-T asset NXC-201, which took place at lead study site, the Memorial Sloan Kettering Cancer Center. This US-based study will evaluate the safety and efficacy of NXC-201 in approximately 40 patients with relapsed/refractory amyloid light chain amyloidosis (r/r ALA). Management expects the trial to be fully enrolled within 18 months, implying that top-line results could be available in H126. In the near term, we anticipate rolling data readouts as seen with the prior NEXICART-1 trial. We also expect more details for the expansion of NXC-201 into additional autoimmune indications by the end of 2024.