As attitudes toward family planning and contraception have changed, and as the era of telehealth, such as medical services from Hims & Hers and Ro, has begun, the absence of a birth control “pill” for men has become obvious.
Charlottesville, Virginia’s Contraline is taking the bull by the horns by creating what it says is a first-in-class, topical product candidate that’s now generating excitement from a slew of large investors.
On Tuesday, Contraline closed a $92.5 million series B financing round, co-led by venture capital heavyweights BVF Partners and RA Capital Management. The company, established in 2015, received backing from GV (formerly Google Ventures), Lumira Ventures, and Invus as well as some new and existing investors during the fundraise, the company said in a June 2 release.
With the money, for one thing, Contraline intends further to advance its potential first-in-class male contraceptive candidate NES/T Gel. So far, male contraception is limited to condoms, vasectomy, and nothing of the kind, like the birth control pill or implant for women.
But that dearth of drug-based contraceptives for men isn’t for lack of trying, Kevin Eisenfrats, Contraline’s co-founder and CEO, said. They have been working on male contraceptives for almost 50 years, “nearly in parallel with the female contraceptives,” he said, but with challenges.
On its face, designing a product capable of stopping hundreds of millions of sperm as opposed to a single egg once a month, and at a safety benchmark necessary for use in healthy people, is a big challenge, Eisenfrats explained.
The CEO also mentioned “funding challenges over the years,” saying that contraception is “not a well-financed area versus some of the other areas of drug development.”
NES/T is a novel candidate for male birth control that is a gel containing both the synthetic progestin Segesterone acetate (also known as Nestorone) and testosterone. This NES/T cocktail has been specifically formulated to lower the production of sperm and not to lower the level of testosterone in the physiology of the man taking the contraceptive.
The program was developed by the research group the Population Council and NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), but has now been developed and commercialized by Contraline with global rights.
The segesterone acetate found in the gel of Contraline has also been approved as a component of a different approved contraceptive product, this time for women, in the vaginal ring contraceptive Annovera, which was approved in the U.S. back in 2018, and is sold by Mayne Pharma.
The overall goal behind wedding testosterone with segesterone acetate was to “minimize side effects, basically of having low or high T,” Eisenfrats said, referring to serum testosterone levels. A progestin alone might regulate hormone levels in men to prevent the formation of sperm (as it does for women who take contraceptive pills, for example), but it may also bring down testosterone if there is no balance.
The new Series B cash infusion from Contraline comes on the heels of NES/T completing a phase 2b trial that involved 462 couples across the globe, which the company has stated is “encouraging efficacy, tolerability, reversibility and user acceptability.” Now, Contraline anticipates kicking off phase 3 development for the program in 2027.
While encouraged by the phase 2b data on its NES/T gel, the question of how to fund a phase 3 for the experimental male contraceptive persisted before the fundraising round, Eisenfrats said, noting that “Big Pharma really has kind of sidestepped this field.”
Now, with big investors such as BVF and RA Capital on board, Contraline will have the cash to complete its phase 3 trial through to a submission to the FDA, he said.
Contraline is also working on an investigational non-hormonal, long-acting male contraceptive called ADAM, aside from NES/T.
Though NES/T is the primary focus for the company right now, Eisenfrats said that the company will be “the male contraception company,” with the proceeds from the series B funding also going toward the midstage testing of ADAM.
Eisenfrats’ vision for ADAM, which he called his “brainchild,” is to create an implantable contraceptive for men that lasts for several years and is easily reversible. “It’s not a competitor or replacement of vasectomy,” Eisenfrats pointed out. But Contraline expects to begin a phase 2 program from that asset next year, too.
Over the past few years, a change in society has taken place that has paved the way for a male birth control pill, like NES/T, to become available, Eisenfrats says.
From the 2000s to the 2010s and “especially” now in the current decade, “we’ve seen a massive peak in demand in terms of men stepping forward and saying, ‘Enough; Why is this only falling on women, and how can I play a role when it comes to family planning?’” the CEO explained.
“Twenty, 30 years ago I don’t think people were ready for this,” he continued.
“In general, I think we’re in a huge white space right now in the male health space,” Eisenfrats said. Meanwhile, companies such as Hims and Hers and Ro have proven that “men are willing to engage in healthcare, they are willing to buy drugs—you just have to make it convenient and accessible for them,” he continued.
It would have been too soon to think about a company like Contraline introducing their own drug even ten years ago; the reality now is that it’s “definitely a possibility,” Eisenfrats said.
“We’re not closing that door,” he said when asked about the company’s potential marketing strategy, should an approval for NES/T eventually come through.
Contraline has secured $92.5 million in new funding to advance its promising male birth control candidate, highlighting growing investor interest in the largely underserved men’s health market. The latest financing round positions Contraline to continue clinical development and expand research efforts aimed at providing men with new contraceptive options.
As demand for reproductive health innovation increases, Contraline is emerging as a key player in a field that has historically seen limited advancement compared to female contraception.
Contraline Targets a Major Gap in Men’s Health
The recent investment reflects confidence in the vision of Contraline and its approach to male contraception. Many healthcare experts describe men’s reproductive health as a significant area of opportunity, and Contraline is working to address this unmet need through innovative medical technology.
By focusing on long-lasting and potentially reversible contraceptive solutions, Contraline seeks to offer men greater participation in family planning decisions.
