LENZ Therapeutics and Graphite Bio, Inc. are entering into a definitive merger agreement in which both companies will combine under the LENZ name to advance two investigational presbyopia therapeutic candidates to commercialization.
Let’s start with these companies.
Headquartered in San Diego, California, LENZ is a late-stage biopharmaceutical company focused on developing and potentially commercializing innovative therapies to improve vision.
Of interest: In March 2023, the company raised $83.5 million in oversubscribed Series B financing to support its ongoing phase 3 CLARITY trials for two potential presbyopia therapies (more on that in a moment).
Switching gears, Graphic Bio is a clinical-stage, next-generation gene editing company with a lead product candidate for sickle cell disease.
Gotcha. Now talk about these presbyopia therapies.
LENZ’s lead candidates include: LNZ100 (1.75% aceclidine) and LNZ101 (1.75% aceclidine and brimonidine).
To note: Aceclidine is a small-molecule acetylcholine receptor agonist that can cause miosis, which might result in a “pinhole” effect to improve near vision and prevent a myopic shift.
Any previous clinical data on them?
Yes! Data from the phase 2 INSIGHT trial (NCT05294328) evaluating LNZ100 and LNZ101 (1.75% aceclidine and brimonidine) reported positive topline results, with both therapies meeting the primary endpoints of a 3-line or greater improvement in visual acuity (VA) without losing 1-line or more in distance VA at 1 hour.
Each formulation also maintained an average pupil size of 1.5-2 mm for 10 hours, which was a biomarker of efficacy.
Now talk about this merger.
Well, as part of the deal, Graphite Bio is also entering into a subscription agreement for a private investment in public equity (PIPE) financing that’s slated to close alongside this merger.
Per the companies, this financing will include a syndicate of health investors (including LENZ’s existing ones)
And before you ask: $53.5 million is the magic number (for this PIPE financing, at least).
A few, including stockholder approval from both companies … see here for details.
So how much is this deal worth?
Adding the PIPE financing proceeds and cash expected from both companies at closing: an estimated $225 million of cash or cash equivalents.
Additionally, $115 million is expected from Graphite Bio; the company will also pay a dividend to its shareholders ($60 million, approximately) when the transaction closes, according to the agreement.
And who are these investors?
Per the companies, key investors include (but aren’t limited to):
- Versant Ventures
- RA Capital Management
- Alpha Wave Global
- Samsara BioCapital
- Sectoral Asset Management
- RTW Investments
What’s the plan for this merger?
With these net proceeds and concurrent financing, the companies (as one) are planning to advance LENZ’s LNZ100 and LNZ101 therapeutic candidates—pending positive data from the currently ongoing phase 3 trials (see below), a successful new drug application (NDA) submission, and subsequent FDA approval.
Give me a quick rundown on these phase 3 trials.
LENZ originally launched its phase 3 CLARITY program in December 2022 as a sequence of three double-masked, randomized, US-based, multi-center, safety/efficacy trials for the treatment of presbyopia.
All three trials are being run in parallel to further evaluate the safety and efficacy of LNZ100 and LNZ101 as once-daily eye drops to correct vision loss.
Proceeds from the company’s latest financing are directly enabling LENZ to complete the development, registration, and—pending a potential FDA approval in the future—the commercial launch of LNZ100 and LNZ101 in the United States.
When can we expect results?
According to Clinical Trials, the studies are estimated to be completed on the following dates: