Following a record-shattering year, terms were set for the first two biotech IPOs of 2021 in deals that could generate up to $300 million.

Cullinan Oncology LLC, of Cambridge, Mass., set terms Jan. 4 for raising about $150 million by pricing 8.3 million shares in the $17 to $19 range. The company is building a pipeline that includes a candidate in a phase I/IIa study and six preclinical immuno-oncology therapeutic candidates and programs. Renaissance Capital estimated that Cullinan would have, at the range’s midpoint, a $750 million fully diluted market value.

The company’s lead asset is CLN-081, an oral small molecule designed as an irreversible EGFR inhibitor for selectively targeting cells expressing mutant EGFR variants, including EGFR exon 20 insertion, or EGFRex20ins, mutations, with relative sparing of cells expressing wild-type EGFR. CLN-081 is in a phase I/IIa dose-escalation and expansion trial evaluating oral, twice-daily administration of various doses in patients with non-small-cell lung cancer harboring EGFRex20ins mutations who have had at least one prior treatment with platinum-based chemotherapy or another approved standard therapy.

It is also developing CLN-049, a bispecific antibody targeting FLT3 and CD3, and CLN-619, a monoclonal antibody designed to stimulate natural killer, or NK, and T-cell responses by engaging MICA/B.

Cullinan has created subsidiaries across the world to focus on specific therapeutics and disease indications. In September, Cullinan, along with the German Cancer Research Center and the Eberhard Karls University of Tübingen, Faculty of Medicine at the University of Tübingen, Germany, formed Cullinan Florentine to develop a novel FLT3 x CD3 bispecific antibody for treating patients with acute myeloid leukemia (AML). FLT3 is a commercially validated target in AML; yet, unlike small-molecule inhibitors targeting FLT3, a T-cell-engaging antibody like CLN-049, which binds to the extracellular domain of FLT3, is agnostic to mutations in the intracellular signaling domain, opening up a broader patient population and avoiding resistance mechanisms, the company said.

Cullinan Amber launched in July to develop a next-generation immuno-oncology platform to enhance the therapeutic window of immune-stimulatory cytokine combinations to treat cancer. Cullinan Amber acquired an exclusive license from the Massachusetts Institute of Technology for technology to develop multifunctional constructs retained in the tumor microenvironment via collagen binding. Its lead program is a single agent comprising interleukin-12 and IL-2, along with a collagen-binding domain.

Zai Lab Ltd., of Shanghai, and Cullinan struck a license agreement in late December for the development, manufacturing and commercialization of CLN-081 in greater China. Cullinan Pearl, a Cullinan subsidiary, will receive a $20 million up-front payment, with the potential to receive up to an additional $211 million in development, regulatory and sales-based milestone payments.

Cullinan closed an oversubscribed $131.2 million series C financing on Dec. 17 led by Foresite Capital with participation from additional new investors that included Boxer Capital of Tavistock Group, Eventide Asset Management, Nextech Invest and Orbimed.

Gracell sets its terms

Gracell Biotechnology Ltd., of Shanghai, also set the terms for its U.S. IPO Jan. 4. The CAR T-cell developer looks to raise $150 million by offering 8.8 million American depositary shares in a range of $16 to $18 each. But what a difference not even a week makes: On Dec. 29, Gracell filed with the SEC to raise up to $100 million.

Gracell would have a $1.1 billion fully diluted market value at the range’s midpoint, according to Renaissance Capital.

The company, established in 2017, said the proceeds will be used to fund its R&D, including work on lead FasTCAR-enabled candidate GC-012F for treating relapsed/refractory multiple myeloma, and allogeneic product candidate GC-027. Both are in investigator-initiated phase I trials in China.

Results from in vitro studies showed GC-012F provided a higher portion of central memory T cells with less exhaustion, higher proliferation capacity and killing ability similar to conventional CAR T cells at the same cell basis.

In late 2020, Gracell closed on a $100 million series C financing. The startup closed an $85 million series B funding in 2019.

The FasTCAR platform enables Gracell to deliver younger, less exhausted T cells for autologous cell therapies that show greater potency and can be manufactured within 22 to 36 hours. The conventional approach to cell culturing usually takes two to three weeks, the company said.

Neonmind lights up its IPO

Neonmind Biosciences Inc., of Vancouver, British Columbia, began trading its shares Jan. 4 on the Canadian Securities Exchange under the ticker symbol NEON after completing its oversubscribed IPO Dec. 30. Shares closed the day up 2,100% at CA21 cents each.

Neonmind said it anticipates gross proceeds of CA$4.6 million (US$3.61 million). The company is a subsidiary of Vancouver, British Columbia-based Better Plant Sciences Inc., and has a preclinical trial underway evaluating psilocybin as a potential treatment to promote and cause weight loss and to reduce food cravings. The study is being conducted by the University of British Columbia.

Looking back

IPOs in 2020 raised $22.6 billion, obliterating the 2018 record of $10.7 billion from 80 new issues. More than $17 billion was raised by 86 biopharma companies completing IPOs on U.S. exchanges. Thirty-two percent of the companies priced offerings above their pricing range. As a group, the post-listing market performance averaged 101%.