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BioNTech (BNTX) Is Up 170% In 3 Months, Busy Year Ahead

biontech1 jan07 lt

The American depositary shares of BioNTech SE (BNTX), which made market debut as recently as October 10, 2019, are up an impressive 170 percent based on yesterday's closing price of $44.58.

Germany-based BioNTech is a clinical-stage biotechnology company developing specific immunotherapies for the treatment of cancer and other serious diseases.

The Company has a development pipeline of over 20 product candidates, of which nine have entered into clinical trials. The clinical data updates for up to 5 oncology programs are expected by the end of 2020.

The ongoing clinical trials include:

-- BNT111 in a phase 1 trial in advanced melanoma. Data from this trial is expected in the first half of this year.
-- BNT113 in a phase 1 trial in HPV+ head and neck cancers. A phase II trial of this compound is expected to be initiated by the second half of 2020.
-- BNT114 in a phase 1 trial in triple-negative breast cancer. Data update on this trial is anticipated in the first half of 2020.
-- RO7198457 (BNT122), which is being developed in collaboration with Genentech, is in phase I trial in multiple solid tumors and in phase II trial in patients with previously untreated advanced melanoma. Data update from the RO7198457 (BNT122) phase I trial in multiple solid tumors is expected in 2020 and topline interim data from the RO7198457 (BNT122) phase II trial in first-line melanoma is anticipated in the second half of 2020.
-- SAR441000 (BNT131), which is being developed in collaboration with Sanofi, is in phase I trial for solid tumors. Data update on this trial is expected in the second half of this year.
-- GEN1046 (BNT311) and GEN1042 (BNT312), which are being developed in collaboration with Genmab, in phase 1 trial for multiple solid tumors. Data update from the GEN1046 (BNT311) phase I trial is expected in the first half of 2021.
-- MVT-5873 (BNT321) is in phase 1 clinical development in pancreatic cancer.

The planned clinical trials for this year are:

-- A phase I/II trial of BNT112 in advanced prostate cancer. Last November, BioNTech signed a clinical trial supply agreement with Regeneron. The agreement allows Regeneron to supply Libtayo for use in combination with BNT112 in the phase I/II trial in advanced prostate cancer.
-- A phase I/II clinical trial for BNT211 in patients with advanced CLDN6 + solid tumors is expected to be initiated in the first half of 2020.
-- A phase I trial of BNT141 in multiple solid tumors is expected to start in the second half of 2020.
-- A phase I trial of BNT142 in multiple solid tumors is expected to start in the second half of 2020.
-- A phase I trial of BNT151 in multiple solid tumors is expected to start in the first half of 2020.
-- A phase I trial of BNT152 in multiple solid tumors is expected to start in the second half of 2020.
-- A phase I/IIa trial of BNT411 in multiple solid tumors is expected to start in the first half of 2020.

The Company's extensive pipeline is said to have a multi-blockbuster potential.

With the Company expecting a significant news flow in the upcoming next 18 months, there are numerous near-term catalysts to watch out for this year.

Balance sheet:

BioNTech's first earnings report as a public company was released last November, and it was for the third quarter ended September 30, 2019.

The net loss for the third quarter ended September 30, 2019, widened to €30.1 million from €23.5 million for the quarter ended September 30, 2018.

The Company generates revenue primarily from collaborative agreements.

Total revenue was €28.7 million for the third quarter of 2019 compared to €20.4 million for the year-ago quarter.

Cash and cash equivalents as of September 30, 2019, were €463.3 million.

BioNTech's lock-up period expires on April 7, 2020.

As mentioned above, BioNTech made its debut on the Nasdaq Global Select Market on October 10, 2019, offering its ADSs at a price of $15.00 each. The stock has thus far hit a low of $12.52 and a high of $45.00.

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