Moderna Therapeutics, a developer of messenger RNA (mRNA) treatments, has disclosed plans to raise $500 million through the largest-ever initial public offering for a biotech, according to an S-1 registration statement filed with the U.S. Securities and Exchange Commission

Moderna has yet to spell out how much it would set aside toward any of several purposes outlined in its S-1 registration statement, filed late Friday. The company also did not specify how much in net proceeds it expected to generate, which would depend on how much money the company agrees to raise in the IPO.

“As we unlock the inherent advantages of mRNA, we aim to address as many diseases and impact as many patients as our technology, talent, and capital permit,” Moderna stated in the S-1 filing.

The proposed IPO surfaced nine months after Moderna raised an additional $500 million in a financing round the company said would help it fund further R&D into its pipeline of messenger RNA (mRNA) treatment candidates.

As of September 30, Moderna had raised more than $2.6 billion in total funding from its strategic collaborators and investors, and had cash, cash equivalents, and investments of $1.2 billion, the company stated in its prospectus.

Through September 30, Moderna added, it has incurred approximately $480 million in expenses to advance its platform technology and intellectual property.

Moderna’s IPO filing identified three purposes for the proceeds:

  • Funding drug discovery and clinical development, and further expanding its manufacturing platform, capabilities, and infrastructure to support its pipeline.
  • Funding further development of its mRNA technology platform and the creation of new modalities.
  • Funding working capital and other general corporate purposes.

“We may also use a portion of the net proceeds to in-license, acquire, or invest in complementary businesses or technologies to continue to build our pipeline, research, and development capabilities and our intellectual property position, although we currently have no agreements, commitments, or understandings with respect to any such transaction,” Moderna added.

Headquartered in Cambridge, MA, Moderna and its collaborators have advanced a development pipeline of 21 programs since the company’ inception in 2010—of which 10 have entered clinical studies and another three have open INDs. The company’s therapeutic and vaccine development programs span infectious diseases, oncology, cardiovascular diseases, and rare genetic diseases.

Furthest along in clinical development is AZD8601, a localized regenerative therapeutic for vascular endothelial growth factor VEGF-A that is being led through clinical development by AstraZeneca. VEGF-A advanced to a Phase II trial earlier this year. Moderna and AstraZeneca are co-developing mRNA therapeutics under an up-to-$420-million-plus collaboration launched in 2013.

Six Therapeutic Modalities

Localized regenerative therapeutics is one of Moderna’s six “modalities” or groups of programs with common product features and the associated combination of enabling mRNA technologies, delivery technologies, and manufacturing processes.

The modality with the largest number of candidates (nine) is prophylactic vaccines, of which seven have Phase I trials ongoing or completed, according to Moderna: RSV vaccine (mRNA-1777), CMV vaccine (mRNA-1647), hMPV+PIV3 vaccine (mRNA-1653), H10N8 vaccine (mRNA-1440), H7N9 vaccine (mRNA-1851), Zika vaccine (mRNA-1325), and Chikungunya vaccine (mRNA-1388). The other two programs in the modality are in preclinical phases: Zika vaccine (mRNA-1893) and VZV vaccine mRNA-1278.

Three other modalities have three candidates each.

The systemic secreted therapeutics modality consists of an open-IND antibody against Chikungunya virus (mRNA-1944), and two preclinical programs, Relaxin (AZD7970), and Fabry disease (mRNA-3630). The antibody against Chikungunya virus development candidate is in collaboration with the Defense Advanced Research Projects Agency (DARPA), while the Relaxin program is with AstraZeneca, and the Fabry program is wholly-owned.

The Intratumoral immuno-oncology modality includes a Phase I development candidate targeting OX40L (mRNA-2416), an open IND candidate targeting OX40L+IL23+IL36g (mRNA-2752), and a preclinical candidate targeting IL12 (MEDI1191) being developed with AstraZeneca.

The three candidates in the systemic intracellular therapeutics modality are all preclinical: MMA (mRNA-3704), PA (mRNA-3927), and PKU (mRNA-3283).

Moderna’s sixth modality is cancer vaccines, of which two candidates are in development by the company with Merck & Co.—the Phase I personalized cancer vaccine, or PCV, (mRNA-4157) and the open-IND KRAS vaccine (mRNA-5671).

Moderna bolstered its manufacturing capabilities in July when it opened a 200,000-square-foot cGMP clinical development manufacturing plant in Norwood, MA. The plant was intended to give the company the capacity to develop materials for preclinical toxicology studies as well as Phase I and II clinical development programs, as well as to manufacture, test, and run fill/finish operations for its portfolio of mRNA development candidates. The facility also houses the company’s PCV Unit for individualized supply batches of mRNA for potential personalized cancer vaccines.

“We built and continue to invest in a platform to advance the technological frontier of mRNA medicines,” Moderna added. “We made and continue to make forward investments in scalable infrastructure and capabilities to pursue a pipeline of potential medicines that reflect the breadth of the mRNA opportunity.

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