BioNTech, the German developer of individualized treatments for cancer and other diseases that has raised more than $1 billion in capital as a privately-held company, has disclosed plans to go public by raising $100 million through an initial public offering.
Without spelling out specific amounts, BioNTech said net proceeds from the IPO would fund development of several of its pipeline candidates, starting with completing ongoing and planned trials for three Phase I candidates developed through its FixVac? platform, which stands for fixed vaccine combination of shared tumor-associated antigens against cancer: BNT111 is indicated for advanced melanoma (adjuvant and metastatic), BNT113 for HPV-positive head and neck cancers, and BNT114 for triple-negative breast cancer.
The FixVac candidates consist of selected combinations of pharmacologically optimized uridine mRNA encoding known cancer-specific shared antigens. They feature BioNTech’s immunogenic mRNA backbone and RNA-lipoplex, or RNA-LPX, delivery formulation, which according to the company is designed to enhance stability and translation, target dendritic cells, and trigger both innate and adaptive immune responses.
The FixVac treatments are among more than 20 candidates within BioNTech’s pipeline, most of which consists of cancer treatments. Eight of those candidates have advanced into clinical phases, where they are now being assessed in nine trials.
Twelve candidates are mRNA-based; the company was the top-ranked privately-held company in GEN’s A-List of Top 10 RNA-Based Biopharmas of 2018, published December 17, 2018.
“Next generation of immunotherapies”
“We believe we are uniquely positioned to develop and commercialize the next generation of immunotherapies with the potential to significantly improve clinical outcomes for patients and usher in a new era of individualized medicine,” BioNTech stated in its F-1 registration statement, filed September 9.
In it, the company disclosed plans to sell American Depositary Shares on the NASDAQ Global Select market, under the symbol BNTX.
BioNTech also plans to fund R&D expenses for several clinical-phase candidates being developed through collaborations with biopharma partners:
- GEN1046 (BNT311) and GEN1042 (BNT312), two Phase I/II next-generation checkpoint immunomodulators being developed with Genmab, which completed a U.S. IPO this year, raising an estimated $546.5 million in net proceeds. GEN1046 targets PD-L1 in conjunction with 4-1BB (NCT03917381), while GEN1042 targets CD40 in conjunction with 4-1BB (NCT04083599).
- RO7198457 (BNT122), the company’s lead Individualized Neoantigen Specific Immunotherapy (iNeST) candidate, an advanced melanoma treatment being developed with Genentech, a member of the Roche Group. RO7198457 is being assessed in combinations with Merck & Co.’s Keytruda? (pembrolizumab) (Phase II; NCT03815058) and Genentech/Roche’s Tecentriq? (atezolizumab) (Phase I; NCT03289962)
- SAR441000 (BNT131), being developed with Sanofi. SAR441000 is an intratumoral immunotherapy that has begun a Phase I trial (NCT03871348) in multiple undisclosed solid tumors, alone and in combination with Regeneron Pharmaceuticals’ Libtayo? (cemiplimab).
Sanofi in January made an €80 million (approximately $90 million) equity investment in BioNTech, in an extension of a collaboration launched in 2015 that included an agreement to co-develop the first cancer immunotherapy candidate from the collaboration.
In addition, BioNTech plans to use IPO proceeds to advance through Phase I trials additional unspecified early clinical candidates. The company said they would include oncology candidates developed through its chimeric antigen receptor T-cell (CAR T), RiboMabs, RiboCytokines, and TCR platforms; as well as infectious disease candidates developed through its immunotherapy and rare disease protein replacement therapy platforms.
Infectious disease expansion
In infectious disease, BioNTech has a preclinical influenza vaccine being developed with Pfizer and set to begin its first study next year, plus mRNA-based vaccines for up to 10 indications being developed through a collaboration with the University of Pennsylvania.
On September 4, BioNTech said it would expand its infectious disease portfolio by developing HIV and tuberculosis programs with the Bill & Melinda Gates Foundation. The Foundation made an initial equity investment of $55 million, with the potential to rise to $100 million through future grants toward candidate development.
BioNTech identified two other priorities for its net proceeds. One portion would be used for advancing preclinical candidates, developing additional product candidates through its therapeutic platforms, and funding further development of its core technologies. Another portion is envisioned to fund further expansion of the company’s manufacturing and lab capacity, as well as continued development of its infrastructure.
In its IPO, BioNTech has yet to spell out how much in net proceeds it expected to generate—which would depend on how much money the company agrees to raise—or how much it would set aside toward the purposes outlined in its registration statement.
BioNTech has raised $1.3 billion since its establishment in 2008, including most of a $325 million Series B financing completed in July. In its F-1 registration statement, filed September 9, BioNTech disclosed that an unnamed Hong Kong investor that was part of the Series B investor syndicate had yet to buy 5,524,506 shares in the company valued at €87.7 million ($97 million).
“Based on ongoing discussions with the investor, BioNTech management believes the payment may have been delayed in part due to ongoing geopolitical disruptions in Hong Kong and the ongoing trade dispute between the U.S. and China,” the company stated.
While the investor has stated its continued commitment to delivering the full investment amount, BioNTech added, the payment may be indefinitely delayed, or potentially not received at all: “In the event that this investor is not able to fund the purchase of the shares and we do not make alternative arrangements for the purchase of the shares, we may demand that the shares be transferred back to us for no consideration.”
The Series B financing was intended not only to help BioNTech advance its pipeline, but to increase its manufacturing capacity and explore an expanded global footprint, Sean Marett, chief business officer and chief commercial officer told GEN in July.