SAN DIEGO—Lenz Therapeutics, Inc. (Nasdaq: LENZ), a late clinical-stage biopharmaceutical company focused on developing the first aceclidine-based eye drop that has been shown to improve near vision in people with presbyopia, today announced the completion of its previously announced merger with Graphite Bio, Inc., a clinical-stage, next-generation gene editing company. The new combined company will operate under the name Lenz Therapeutics, Inc.  “Following the close of this transaction, we believe we are well-positioned to bring the opportunity of a once-daily pharmacological eye drop intended to improve near vision throughout the full workday closer to the 128 million people in the United States who are impacted by presbyopia,” said Eef Schimmelpennink, president and CEO of Lenz Therapeutics.

“With clinical activities completed in each of the three Phase 3 CLARITY trials evaluating LNZ100 and LNZ101, we look forward to reporting topline results from these trials in April 2024 and, subject to successful completion of such trials, submitting an NDA to the FDA by mid-year. Backed by a strong balance sheet and supported by a proven management team and top-tier investors, we believe it is an exciting time for Lenz as we prepare to execute in a catalyst-rich year and, if approved by the FDA, potentially deliver the first aceclidine-based therapy intended to treat presbyopia,” Schimmelpennink said.

Lenz intends to launch either LNZ100 or LNZ101 in the U.S. with its own commercial organization. To support the projected launch following potential FDA approval, Lenz is actively building out its U.S. commercial capabilities and plans to share additional updates related to its commercialization planning in due course. In addition, Lenz is developing regulatory strategies and intends to opportunistically seek partnerships in Europe, Canada, and other markets to maximize the value of its product candidates. Lenz has already entered into a license and collaboration agreement with Ji Xing for the development and commercialization of LNZ100 and LNZ101 for the treatment of presbyopia in Greater China.

Concurrent with the closing of the merger, Graphite Bio completed a private placement of $53.5 million from a syndicate of health care investors led by Lenz’s existing investors, including participation from new investors. Following the merger, key health care investors in Lenz will include Versant Ventures, RA Capital Management, Alpha Wave Global, Point72, Samsara BioCapital, Sectoral Asset Management, RTW Investments and others.

The projected cash and cash equivalents as of the close of the business combination are expected to be approximately $210 million, which Lenz believes will be sufficient funds to build infrastructure and commercialize Lenz’s selected product candidate, subject to successful completion of the Phase 3 trials, NDA submission and subsequent FDA approval.

The combined company will be led by Schimmelpennink as president and chief executive officer of Lenz. In addition to Schimmelpennink, the Lenz leadership team includes current members of management Marc Odrich, MD, as chief medical officer, and Shawn Olsson, as chief commercial officer. In addition, Lenz appointed Dan Chevallard as chief financial officer, effective March 21, 2024; the board of directors of Lenz will include Schimmelpennink, Fred Guerard, Jim McCollum, Zach Scheiner, and Shelley Thunen, who joins from Lenz’s board of directors, Kim Drapkin, who continues from Graphite Bio’s board of directors, and Jeff George, who joined as the chair of the board of directors at the closing of the merger.