Detailed narrative
Q1 FY23 Financial Performance and Cash Position
For Q1 FY23 (April-June 2022), SPARC reported a total income of Rs.29 crores (US$3.7 million) and total expenses of Rs.111 crores (US$14.4 million), resulting in a net loss of Rs.82 crores (US$10.7 million). This compares to a net loss of Rs.203 crores (US$27.3 million) for the full FY22. The company expects to receive the balance sum of Rs.703 crores (US$93 million) from warrant conversions by the end of December 2022, contributing to a cash runway extending until the end of FY'24, excluding royalties and milestones. Approximately one-third of the FY23 expenses are budgeted for clinical costs.
Vodobatinib Program Update (CML & Neurodegenerative Diseases)
The vodobatinib CML program, SCO-088, is in a pivotal study targeting last-line patients, with an NDA filing anticipated in 2024. Data from the multiple ascending dose study showed 43% major molecular response rates post-treatment, up from 2.8% at baseline. The Phase-2 PROSEEK trial for Parkinson's Disease has achieved over 70% recruitment of its 504 patients, with accrual expected by the end of the current financial year and top-line data readout in the second half of FY24. A separate 45-patient study for Lewy Body Dementia is halfway through, with results expected around the same time.
Dermatology Pipeline: Vibozilimod and SCD-153
Vibozilimod, a selective S1PR1 agonist, is undergoing two Phase-2 trials for atopic dermatitis and psoriasis, with 240 patients randomized in each study. SPARC positions vibozilimod as a potentially safer alternative to JAK inhibitors, given recent FDA safety warnings for the class. Additionally, SCD-153, a novel first-in-class NCE for alopecia areata, is in preclinical development with an IND filing targeted for early 2023. Preclinical data show SCD-153 stimulates robust hair growth and reduces inflammatory cytokines in animal models.
Oncology Program: SBO-154 (MUC-1 ADC)
SPARC's first biologic therapeutic program, SBO-154, is an antibody-drug conjugate (ADC) targeting MUC-1 alpha/beta heterodimer, a high-interest cancer target. Preclinical evaluations demonstrated that SBO-154 causes dose-dependent inhibition and shrinkage of established pancreatic carcinoma xenografts. The program is advancing to preclinical development with the intent to file an IND in the US by financial year '24, leveraging the success of ADCs as a modality.
Commercialization & Partnered Assets
Elepsia and Xelpros are commercialized through Tripoint Therapeutics and Sun Pharma respectively, showing promising early performance. The benzyl alcohol-free phenobarbital formulation, Sezaby, has a PDUFA date in November 2022 and is in active licensing negotiations, aiming to be the first approved phenobarbital for neonatal seizures. PDP-716 (brimonidine eye drop) and SDN-037 (ophthalmic steroid) are licensed to Visiox Pharma, with SPARC holding 10% equity in Visiox and eligibility for regulatory milestones and low double-digit royalties.
Strategic Focus and External Collaborations
SPARC's portfolio has evolved, with almost 60% now having first-in-class potential and nearly one-fifth outside traditional chemistry, including complex modalities like ADCs. The company emphasizes leveraging novel biological insights and robust early translational work, often through external collaborations with institutions like Johns Hopkins University. This strategy aims to mitigate early-stage risks and build a portfolio of potentially attractive and clinically relevant assets, while maintaining a focus on capital efficiency.