PMV Pharmaceuticals files $200,000,000 shelf with $113,792,846.40 ATM supplement

The shelf and the sales agreement

PMV Pharmaceuticals, Inc. filed a Form S-3 shelf registration statement with the Securities and Exchange Commission on November 20, 2024. The base prospectus covers up to $200,000,000 of common stock, preferred stock, debt securities, warrants, subscription rights, purchase contracts and units. The document is a preliminary prospectus that is subject to completion.

Inside that total sits a sales agreement prospectus supplement for up to $113,792,846.40 of common stock. The shares would be sold through Jefferies LLC as sales agent under an Open Market Sale Agreement dated October 4, 2021. The filing says the $113,792,846.40 is included in the $200,000,000.

Jefferies is the only sales agent the filing names. PMV pays Jefferies 3.0% of the gross proceeds of any shares sold, and the filing says Jefferies would be deemed an underwriter under the Securities Act for those sales. Jefferies is represented by Latham & Watkins LLP of Menlo Park, California. PMV's counsel is Wilson Sonsini Goodrich & Rosati, Professional Corporation, of New York. The filing names no other underwriter or placement agent for this supplement.

The earlier program and the share count

PMV first set up the Jefferies program with a prospectus supplement dated October 4, 2021, for up to $150.0 million of shares. The filing says PMV has since sold 5,149,446 shares under it at a weighted average exercise price of $6.97 per share, for net proceeds of approximately $35.1 million.

The new supplement uses the Nasdaq closing price of $1.59 per share on November 19, 2024 as its reference point. The filing says the number of shares issued will vary with the sales price, and it gives no share count for the full amount. PMV had 51,749,504 shares outstanding as of September 30, 2024. Options over 8,687,507 shares were outstanding at that date, at a weighted-average exercise price of $2.87 per share.

The filing does not give PMV's cash balance, net loss or operating cash use. It says proceeds would be used with existing cash, cash equivalents and short-term marketable securities.

The lead candidate and its trial

The lead product candidate, PC14586 (rezatapopt), is an oral small molecule designed to correct p53 misfolding caused by the Y220C mutation. PMV says that mutation is associated with about 1.0% of all cancers. FDA granted Fast Track designation in October 2020.

The Phase 1/2 PYNNACLE trial started in October 2020. After an End of Phase 1 meeting with FDA in July 2023, PMV says the parties agreed on a recommended Phase 2 dose and a single-arm registrational Phase 2 portion. The company says it is dosing patients in that pivotal monotherapy portion and has activated over 75% of sites.

The filing also reports a setback. In October 2024 PMV stopped enrolling in the Phase 1b arm that combined rezatapopt with KEYTRUDA (pembrolizumab), Merck and Co.'s anti-PD-1 therapy. The filing reports no response rates or other efficacy results from the trial.

What the company says comes next

PMV says an investigator-initiated Phase 1b study with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center will test rezatapopt with azacytidine in patients with a TP53 Y220C mutation. The company expects enrollment to begin in the first quarter of 2025. It also expects to provide interim data from the Phase 2 monotherapy portion by mid-2025.

Those are the company's own dates. PMV could sell up to $113,792,846.40 of stock at a reference price of $1.59 while the lead trial's efficacy data are still pending, and after the Jefferies program already sold shares at a weighted average of $6.97.

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