In today’s briefing:
- Is Akeso’s Sell-Off a Long Waited Opportunity or a Long Overdue Correction?
- JTEC Corp (3446) – Facing Some Challenges over Lead Times
- Sichuan Kelun-Biotech Biopharm (6990.HK) – Current High Valuation Is Not Secure
- Pre-IPO Jiangxi Rimag Group (PHIP Updates) – Some Points Worth the Attention
- ABEO: BLA Resubmission in 2H24
- EDSA: Preparing IND for Phase 2 Trial of EB06 in Vitiligo
- NRBO: Preclinical Data on DA-1241 with Semaglutide to be Presented at EASL Congress 2024
- EPIX: Updated Data from Phase 1 Trial of Masofaniten and Enzalutamide Expected in 2H24
Is Akeso’s Sell-Off a Long Waited Opportunity or a Long Overdue Correction?
- Disputable Phase III result of Akeso’s (9926 HK) flagship pipeline Ivonescimab (AK112) caused Akeso’s share price to drop 28% in three days, reaching the bottom of a year-long trading range;
- The fundamental difference of opinions is around Ivonescimab’s global prospects against (1) Merck’s Keytruda, (2) J&J’s Rybrevant, (3) Kelun’s SKB264 and domestic prospect against (4) Innovent’s IBI305;
- Some answers are clear while others are now. What can provide answers are (1) SKB264‘s Phase III data, and to a lesser degree (2) AK112’s head-to-head trial against Keytruda.
JTEC Corp (3446) – Facing Some Challenges over Lead Times
- Lengthening order lead times impacting revenue recognition – Q1-3 FY6/24 results were behind expectations in our view, with sales declining 27.6% YoY.
- Whilst a negative optic, the reason stems from lengthening lead times for shipment, given customer demands for more high-end and exacting technical requirements for custom-made products requiring more time for delivery.
- We believe this highlights the value-added technical expertise of the company and delays in revenue recognition.
Sichuan Kelun-Biotech Biopharm (6990.HK) – Current High Valuation Is Not Secure
- The imagination space and good stories for Sichuan Kelun-Biotech Biopharm (6990 HK) at this stage mainly come from SKB264. The market has higher expectations for SKB264’s clinical data on NSCLC/TNBC.
- The better the clinical results of SKB264 +PD1/L1, the greater the negative impact on AK112’s future expectations/market space in NSCLC. ADC +PD-1 seems more “convincing” than the logic of BsAb.
- This July, restricted shares of major shareholders will be lifted, which may lead to big share price fluctuation if they reduce their shareholdings. Investors need not rush to be long.
Pre-IPO Jiangxi Rimag Group (PHIP Updates) – Some Points Worth the Attention
- Considering the dominant position of medical imaging centers in public hospitals and challenges from other players, future development space of Rimag would be squeezed,and even will soon encounter growth bottlenecks.
- Although Rimag turned losses into profits, we still have doubts about its future profitability due to increasing costs and potential price decline.This business may fail to bring investors decent profits.
- Rimag’s post-investment valuation after last round financing isn’t cheap.Given the uncertainty of future revenue growth prospects and the real market space, P/S of below 3 is a more comfortable range.
ABEO: BLA Resubmission in 2H24
- On May 15, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the first quarter of 2024 and provided a business update.
- The company is planning to resubmit the Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB) in the second half of 2024 following the receipt of a Complete Response Letter (CRL) in April 2024.
- The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data but did request additional CMC information.
EDSA: Preparing IND for Phase 2 Trial of EB06 in Vitiligo
- On May 10, 2024, Edesa Biotech, Inc. (EDSA) announced financial results for the second quarter of fiscal year 2024 that ended March 31, 2024 and provided a business update.
- Edesa is planning to seek regulatory approval for a Phase 2 trial of its anti-CXCL10 mAb in patients with moderate-to-severe nonsegmental vitiligo.
- For EB05, the company has expanded site selection activities for the Phase 3 study in acute respiratory distress syndrome (ARDS) caused by COVID-19 and has begun transitioning the day-to-day management of the trial to a new clinical research organization (CRO).
NRBO: Preclinical Data on DA-1241 with Semaglutide to be Presented at EASL Congress 2024
- On May 22, 2024, NeuroBo Pharmaceuticals, Inc. (NRBO) announced that preclinical data of DA-1241 in combination with semaglutide in mouse models of metabolic dysfunction-associated steatohepatitis (MASH) will be presented at the EASL Congress 2024 on Thursday, June 6, 2024.
- Two abstracts will be presented: one using the GAN diet-induced obese and biopsy-confirmed mouse model of MASH and one using the CCl4 induced liver fibrosis model.
- The company shared some of the results that showed an additive effect on different parameters of liver health in both models, with the posters being available following the presentations.
EPIX: Updated Data from Phase 1 Trial of Masofaniten and Enzalutamide Expected in 2H24
- On May 14, 2024, ESSA Pharma Inc. (EPIX) announced financial results for the second quarter of fiscal year 2024 that ended March 31, 2024 and provided a business update.
- ESSA is currently studying its lead compound, masofaniten (EPI-7386), in two clinical trials: EPI-7386-CS-001 and EPI-7386-CS-010.
- The -001 trial consists of Part A monotherapy treatment and Part B combination therapy of masofaniten plus abiraterone acetate/prednisone (Cohort 1 mHSPC or mCRPC) or with apalutamide following 12 weeks of monotherapy therapy (Cohort 2 nmCRPC).
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