(mPFS) for the 525 mg – 700 mg
cohort was 6.2 months (95% CI 2.6 months - 7.5 months). There were
9 subjects dosed at 350 mg, mPFS was 2.2 months (95% CI 0.7 months
- 12+ months). There was a meaningful PFS advantage at the higher
doses when compared with the lower, 350 mg dose cohort.
Furthermore, the preliminary results of the leronlimab studies also
showed similarity in the PFS outcomes of mTNBC patients treated
with leronlimab + carboplatin compared to overall leronlimab
treated population. Of the 28 subjects enrolled, 13 subjects
received leronlimab + carboplatin treatment. The mPFS for
leronlimab + carboplatin population was 3.9 months (95% CI 2.3
months - 6.0 months).
The subgroup analysis of PFS
based on the individual subjects in each study were also reviewed.
The mPFS for Phase 1b/2 study was 3.9 months (95% CI 2.3 months –
6.2 months), mPFS for the Compassionate Use study was 3.3 months
(95% CI 1.3 months – 7.5 months), and mPFS for the Basket Study was
2.8 months (95% CI N/A).
Combined, the overall mPFS for all 28 patients treated with
leronlimab in the population of mTNBC patients regardless of
dosage, conjunction therapy type, brain or bone metastases that
have failed more than one line of previous therapy was 4.1 months
(95% CI 2.5 months – 7.0 months). The mean PFS was 3.7 ± 2.93
standard deviation (SD).
To explore the impact of leronlimab in the mTNBC patients’ disease
progression, Overall Survival (OS) was analyzed in the same 28
subjects. The median OS (mOS) for leronlimab + carboplatin
population was 12+ months (95% CI 5.4 months - 12+ months).
The mOS for the 350 mg cohort was 4.6 months (95% CI 1.1 months
-12+ months). The mOS for the 525-700 mg cohort was 12+ months (95%
CI 5.5 months – 12+ months).
The overall median OS for leronlimab treated population of mTNBC
patients regardless of brain or bone metastases that have failed
more than one line of previous therapy was 6.5 months (95% CI 5.0
months – 12+ months). The mean value for OS was 5.5 ±4.31 standard
The Company has made the business decision to currently discontinue
its investigation of leronlimab for the COVID-19 indications due to
challenges in clinical enrollment in the severe/critical COVID-19
population, and the unclear path for regulatory approval of
COVID-19 post-acute sequelae SARS-CoV-2 infection (PASC).
In June 2022, the Company concluded a private placement of common
stock and warrants through a placement agent, selling approximately
50.7 million additional shares of common stock for gross proceeds
of $12.9 million and net proceeds of $11.3 million. Refer to Note
6, Equity Awards and Warrants -
Private Placement of Common Stock and Warrants through Placement
Agent for details.
Effective July 9, 2022, Cyrus Arman, Ph.D. was appointed President,
and Antonio Migliarese ceased his role as interim President. Dr.
Arman previously held positions with a number of biotechnology
companies, most recently serving as Chief Business Officer of
Nimble Therapeutics, Inc., a company focused on engineering
peptides. Prior to Nimble he was Vice President of Corporate
Development and Strategy of NEUVOGEN, Inc., an 29mmune-oncology company, developing
therapeutic whole cell cancer vaccines, from 2019 until 2021.
Beginning in 2017, he served as co-founder and managing partner of
BioVega Capital, LLC, a life sciences hedge fund. From 2014 through
2019, he served in a variety of strategy roles at Amgen (NASDAQ:
AMGN), a leading independent biotechnology company, including as
Director of Corporate Strategy and Global Director and Head of
Competitive Intelligence and Strategy. Prior to Amgen he was a
Principal at Deallus Consulting, a global lifesciences competitive
strategy consulting firm. He received an M.S. degree in biomedical
engineering and a Ph.D. in neuroscience from the University of
Southern California and an M.B.A from the UCLA Anderson School of
On August 24, 2022, Ryan Dunlap
was appointed to the Company Board of Directors and was
subsequently appointed chair of the Audit Committee. Mr. Dunlap has
over 25 years’ experience in accounting, finance and operations
leadership, developing significant expertise in strategy setting,
improving operational efficiency and effectiveness, fundraising and
investor relations, financial reporting and compliance, and risk
management. Mr. Dunlap currently serves as the CFO of Gurobi
Optimization, a private, equity backed software company offering
customers decision intelligence solutions utilizing mathematical
optimization, where he started in October 2019. Prior to that, he