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Friday, August 9, 2019

-=Nektar Therapeutics (NKTR) reported earnings on Thur 8 Aug 2019 (a/h)

  • Reported mixed Q2 results. Co then disclosed a manufacturing issue: a suboptimal batch of in-process intermediate was used to produce two lots of bempegaldesleukin, which ultimately led to the softening of response rates in the PIVOT-02 study. The issue was restricted to the single batch of intermediates using lots two and five. Co has developed a comprehensive control strategy to limit variances in raw materials, intermediates, and the final product going forward. Downgraded at Mizuho, Jefferies, and JP Morgan. At two-year lows.

Nektar Therapeutics beats by $0.17, misses on revs
  • Reports Q2 (Jun) loss of $0.63 per share, $0.17 better than the S&P Capital IQ Consensus of ($0.80); revenues fell 97.9% year/year to $23.32 mln vs the $26.65 mln S&P Capital IQ Consensus.
  • "Nektar is making good progress advancing our multiple programs in immuno-oncology, immunology and pain," said Howard W. Robin, President and CEO of Nektar. "With our partner Bristol-Myers Squibb, although we've experienced some delays, we are working to finalize the development program for bempegaldesleukin in combination with nivolumab in a number of tumor types and which are designed to support registration for this unique I-O doublet. We have a number of registrational trials already started and we recently received a breakthrough designation from FDA for bempeg and nivo in the setting of first-line untreated metastatic melanoma. Our partner Eli Lilly will be initiating several new studies later this year for NKTR-358, our T regulatory stimulator candidate. These studies will expand the program with additional indications beyond lupus. We recently filed an IND with the FDA for NKTR-255, our IL-15 agonist, and will initiate our first-in-human clinical study this quarter in patients with relapsed, refractory NHL and in patients with multiple myeloma."
  • Nektar is hosting a conference call with analysts and investors today on which it will discuss quarterly results. On the call, the company will provide a specific update and discussion on its bempegaldesleukin clinical development program, including recent developments related to the manufacturing of bempegaldesleukin.

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