Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain
Officers.
On March 23, 2021, Richard Bryce notified Puma Biotechnology, Inc. ("Puma" or
the "Company") of his decision to resign as the Chief Medical and Scientific
Officer of the Company, effective April 5, 2021. Dr. Bryce's responsibilities
will be assumed by the members of the Company's clinical development team and
clinical sciences team.
The Company thanks Dr. Bryce for his time at Puma and wishes him well in his new
position as the Chief Medical Officer of a biotechnology company that is
developing drugs for the treatment of cancer.
The Company continues to anticipate the following key milestones: (i) completing
enrollment in the randomized cohort in the Phase II SUMMIT trial of neratinib in
hormone receptor positive breast cancer that has a HER2 mutation in the second
quarter of 2021; (ii) reporting top line data from the randomized cohort in the
Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer
that has a HER2 mutation in 2021; (iii) conducting a pre-NDA meeting with the
U.S. Food and Drug Administration (the "FDA") to discuss accelerated approval of
neratinib in HER2-mutated hormone receptor positive breast cancer and
HER2-mutated cervical cancer in 2021; (iv) reporting Phase II data from the
SUMMIT trial of neratinib in non-small cell lung cancer patients with epidermal
growth factor receptor ("EGFR") exon 18 mutations in the second half of 2021;
(v) reporting data from the Phase II TBCRC-022 trial of the combination of
Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain
metastases who have previously been treated with Kadcyla in the second half of
2021; (vi) conducting a meeting with the FDA to discuss the potential for an
accelerated approval pathway for neratinib in non-small cell lung cancer
patients with EGFR exon 18 mutations who have been previously treated with an
EGFR tyrosine kinase inhibitor in 2021; and (vii) receiving regulatory decisions
for the extended adjuvant HER2-positive early stage breast cancer indication in
additional countries in 2021.
Forward-Looking Statements:
This Current Report includes forward-looking statements, including statements
regarding the Company's anticipated milestones. All forward-looking statements
involve risks and uncertainties that could cause the Company's actual results to
differ materially from the anticipated results and expectations expressed in
these forward-looking statements. These statements are based on current
expectations, forecasts and assumptions, and actual outcomes and results could
differ materially from these statements due to a number of factors, which
include, but are not limited to, any adverse impact on the Company's business or
the global economy and financial markets, generally, from the global COVID-19
pandemic, and the other risk factors disclosed in the periodic and current
reports filed by the Company with the Securities and Exchange Commission from
time to time, including the Company's Annual Report on Form 10-K for the year
ended December 31, 2020. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date hereof. Puma
assumes no obligation to update these forward-looking statements, except as
required by law.
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses