PUMA BIOTECHNOLOGY INC - PBYI STOCK NEWS

Puma Biotechnology (PBYI) reported second quarter 2021 financial results, with NERLYNX revenue at $48.9 million, a slight increase from $48.8 million in Q2 2020. Total revenue was $53.4 million, down from $70.6 million in the same period last year. The company posted a net loss of $5.1 million, or $0.13 per share, compared to a net income of $3.4 million in Q2 2020. Operating expenses rose to $70.0 million from $63.5 million. Cash reserves increased to $108.9 million as of June 30, 2021. Key milestones include upcoming data on neratinib trials and FDA discussions for accelerated approvals.

Puma Biotechnology, Inc. (NASDAQ: PBYI) has entered into a note purchase agreement with Athyrium Capital Management for the issuance of up to $125 million in notes, split into two tranches. The first tranche of $100 million was successfully closed on July 23, 2023, to retire an existing loan with Oxford Finance LLC. The second tranche of $25 million is planned for general corporate use and to support NERLYNX® initiatives. The notes will mature in July 2026, with further details to be filed with the SEC.

Puma Biotechnology (NASDAQ: PBYI) will host a conference call on August 5, 2021, at 1:30 p.m. PDT to discuss its Q2 2021 financial results. Investors can access the call via phone or through a live webcast available on the company's website.

Puma focuses on cancer care innovations, notably the oral and IV formulations of neratinib, marketed as NERLYNX®. The drug has received FDA approvals for breast cancer treatment, highlighting Puma's commitment to enhancing cancer care through its innovative products.

Puma Biotechnology announced the grant of inducement restricted stock unit awards totaling 34,375 shares to five new non-executive employees, effective July 1, 2021. These awards, part of the 2017 Inducement Plan, vest over three years. Additionally, Alvin Wong received an inducement stock option for 90,000 shares at an exercise price of $10.21 in conjunction with his appointment as Chief Scientific Officer. This award also vests over a period of time, contingent on continued employment.

Puma Biotechnology announced FDA approval for a labeling supplement for NERLYNX, incorporating dosing escalation based on findings from the Phase II CONTROL Trial. The new 133 count SKU aims to better meet patient needs. The CONTROL study demonstrated significant improvements, including a 60% reduction in Grade 3 diarrhea and 80% reduction in discontinuation rates, enhancing treatment tolerability. The company believes these changes will extend therapy duration and benefit more HER2-positive breast cancer patients.

Puma Biotechnology (NASDAQ: PBYI) announced on June 2, 2021, the grant of inducement restricted stock unit awards covering 30,375 shares to five new non-executive employees. This grant follows the 2017 Employment Inducement Incentive Award Plan, enabling equity awards to new hires. The shares will vest over three years, with one-third vesting on the first anniversary and one-sixth every six months thereafter, contingent on continued service. These awards are provided as an inducement for new employees, in compliance with Nasdaq Listing Rule 5635(c)(4).

Puma Biotechnology (NASDAQ: PBYI) presented interim results from the Phase II SUMMIT trial at the 2021 ASCO Annual Meeting. The trial evaluated neratinib's efficacy in patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC), particularly those with central nervous system (CNS) involvement. Among 10 evaluable patients, 60% had a partial response, with an overall clinical benefit of 80%. The median duration of response was 7.5 months, and median progression-free survival was 9.1 months. Neratinib was well tolerated, with no grade 3 diarrhea reported, suggesting its potential as a safe treatment option for challenging cases.

Puma Biotechnology (PBYI) presented findings at the 2021 ASCO Annual Meeting regarding the Phase II CONTROL trial, focusing on diarrhea management during neratinib treatment for early-stage HER2-positive breast cancer. The study compared antidiarrheal strategies, revealing that dose escalation (DE) significantly reduced grade 3 diarrhea incidence (13.3% vs. 39.9%) compared to the ExteNET trial. The DE cohort also experienced fewer treatment discontinuations due to diarrhea (3.3% vs. 14.5%) and had a longer average treatment duration. These results advocate for dose escalation as an effective diarrhea management strategy with improved tolerability.

Puma Biotechnology (NASDAQ: PBYI) presented findings from the Phase III ExteNET trial at the 2021 ASCO Annual Meeting, highlighting the positive impact of neratinib on overall survival in patients with early-stage HER2-positive breast cancer. The study involved 2,840 patients and compared outcomes of neratinib versus placebo over 11 months. Results showed improved overall survival rates: 92.2% for neratinib versus 90.2% for placebo in the intention-to-treat population. The findings suggest that extended adjuvant therapy with neratinib can reduce recurrence risk and improve survival outcomes.