Full Press Release Details
Dr. Drew Pinsky (00:26):
Alright, welcome everyone. Thank you so much for being here. I am truly
excited. This is a pleasure to be a part of this project. First, I want to tell you about the players. Aditxt is a social innovation platform
that has to say socially owned, dedicated to accelerating promising health innovations, Aditxt ecosystem of research institutions, industry
partners and shareholders collaboratively drive the mission to make promising innovations possible together. Understand innovations don't
always get to the public and to the patients the way they should. That's the Aditxt intention to get them there. The innovation platform
is the cornerstone of the Aditxt strategy, where multiple disciplines drive disruptive growth and address significant societal changes.
Aditxt operates a unique model that democratizes innovation and ensures every stakeholder's voice is heard and valued and empowers collective
progress. Aditxt currently operates two programs, operated and focused on immune health and precision health.
The company will introduce two additional programs dedicated to public
health and women's health. For these Aditxt has entered into an arrangement agreement with Appili Therapeutics, which focuses on infectious
diseases. That is APLIF on the OTC Pink and a merger agreement with Evofem Biosciences Inc. That is EVFM. Each program will be designed
to function autonomously while collectively advancing Aditxt's mission of discovering, developing and deploying innovative health
solutions. To tackle some of the most urgent health challenges, I want to emphasize that getting innovative products that patients need,
doctors need, the public should have. That is what Aditxt is going to help us do. Evofem Inc is a commercializing innovative products
organization to address unmet needs in women's health and reproductive health. It was launched in September, 2020. They launched Phexxi
the first and only FDA approved hormone free birth control. I was very excited to see when this product came around and when Aditxt
got involved in the world of Phexxi.
I was extremely excited. In July, 2024, they
broadened their commercial offering with the acquisition of SOLOSEC an FDA approved single dose oral agent for the
treatment of two common sexual health infections, trichomoniasis, and bacterial vaginosis. Those of you that are clinicians know these
are very common problems and can be a frustrating issue for many patients. Saundra Pelletier is the CEO. She's the force behind driving
true innovations to market for women's health. She's here with me. She's the heart of the Evofem organization, having spent her entire
career defending women's rights and advocating for every woman to have access to game changing, project changing products that positively
impact their daily lives. I cannot tell you what a privilege it is to be a part of this, to have these two here with me. Today. We're
going to enter into a little conversation about what the goals are, what is available, what we're going to do. I'm going to just open
it with Amro to give him to kick off the conversation.
Amro Albanna (03:38):
Thank you Dr. Drew, and I appreciate the fact that you joined us today.
You and I have had discussions over the years, and today really is more of a conversation. It's more of a discussion. Look, we want to
make sure that we talk about women's health, the stage of women's health, and how desperately this field requires new innovations. We
want to talk about Evofem as a foundation for and how we see it as a foundation for accelerating women's health in the field of diagnostics,
treatment, and prevention. And finally, to really touch on the point that you just brought up, which is how do we bring these promising
innovations to the world? I mean, we all need health innovations. We all need to address some of the most challenging health needs that
Dr. Drew Pinsky (04:29):
I want to interrupt and just say, let's shine a hang lantern on that,
so to speak. People think that magically good things are invented and then we get them is not how it works. And Aditxt wants to make sure
you do get them. And this is why I'm so excited this morning.
Amro Albanna (04:46):
Yeah, absolutely. I mean, look, that's really the key. I mean, unless
you're involved in the industry, you really don't realize that just because it's a good idea does not mean it's going to make it to the
market. And there are all kinds of challenges that I know Saundra and I can talk for days about. But reality is promising innovations,
in fact, the vast number of promising innovations, we'll never see the light of day.
Dr. Drew Pinsky (05:09):
Fantastic, so hang on. That is nuts. That's crazy when you say things
like that. I think about the electric car a hundred years ago and like, oh, okay. Well, people kind of know that story, but they imagine
that in healthcare ethics would dictate that good things would get to patients, but it's just not how it works. So maybe we had to let
Saundra kind of kick in here. I see her chomping at the bit.
Saundra Pelletier (05:32):
I'm well, thank you, by the way. And so look, as it relates to women's
health, birth control was introduced in 1960. Okay? So imagine this. Since that time, women have been told all they get is synthetic hormones,
but they could just have them delivered in different ways. You could have them in a pill, in a patch, in an IUD, in a ring. But no one
has really said, what do women want? What's good for women are women suffering from side effects. And by the way, women don't have sex
every day. I realize that that might be a big statement, but to take a drug every day that you don't need if you're having side effects,
Dr. Drew Pinsky (06:13):
Well, but not only that, hang on, Saundra. I mean, any physician, any
healthcare provider, any woman that takes hormonal contraceptives knows that not having side effects is sort of unusual.
Saundra Pelletier (06:25):
A hundred percent. A hundred percent,
Saundra Pelletier (06:28):
Yes. And by the way, there's so many women right now in the United
States, 23 million women will tell you, Dr. Drew, that they will not use hormones. That they have tried all of these different choices,
that the headaches and the bleeding and the weight gain and the emotional highs and lows, they're not doing it anymore.
Dr. Drew Pinsky (06:45):
Well, not only that, doctors don't sit down. This is the part that
drives me crazy. I did a radio show for 30 years where I was having to explain to young people like, no, this is the hormonal contraceptive
that your doctor didn't sit down and explain to you that vaginal dryness, that lack of libido, that sleep, they just don't. And these
are routine, particularly with high progestational agents. It's routine now to see those side effects. So again, that's why I spotted
your product. It's like, oh, why did it take so long? Right?
Saundra Pelletier (07:18):
Yes. Well, and by the way, when Amro said, some of these innovations
never see the light of day. Only 30 to 40% of drugs get approved after they do phase one, phase two, phase three. So I'd love to show
you the product. I mean, I know you know it, but okay. So this innovation that I think we all agree is pretty game changing. It's called
Phexxi it is the first and the only non-hormonal birth control that women use on demand only when they have sex, only
when they need it, never when they don't. Men have had condoms for 150 years, right? A man can go out with a condom in his pocket, he
can protect himself, but now women are going to be empowered with the same thing. And a prescription is a box of 12. So a woman will get
12 of these prefilled applicators.
When you open this up, which you can put in your purse or your pocket,
this is the applicator. Any woman who's used a tampon or any kind of applicator, it's very, very easy. But here's why I like to show,
like to show everybody. By the way, sometimes I get invited extra to dinner parties because I bring this with me. But if you can see it,
this gel, it's five milliliters in each applicator. But here's what matters. Women are not going to use something that leaks out. But
what women is that it's lubricating, it's viscous. It stays inside the vaginal cavity. It creates lubrication if you want it and you need
it. And even young women today say to me, they're using lubrication as part of intimacy. So it's sort of a no brainer.
Dr. Drew Pinsky (08:47):
That's because they're having side effects from the hormonal contraceptive
difficulties, which is so, so common. But let's dig in a little bit. So I'd like to hear the mechanism of action and how it's different.
Saundra Pelletier (09:01):
Okay. So Rush University developed this, and they developed it in the
early nineties. They were looking for something for HIV prevention, and here's what they recognized. They recognized that a normal vaginal
pH for all women is 3.5 to 4.5. That's it. When semen enters, pH rises up to seven or eight and women get pregnant. Same thing that happens
when pathogens like chlamydia and gonorrhea enter. But what Rush realized is that this product, it helps a woman's body maintain her natural
pH making it inhospitable to semen. So it's pretty amazing that the ingredients are simple. Food grade, lactic acid, citric acid, potassium
by tartrate. But when combined together, they create this mechanism of action that prevents pregnancy, and it's really
Dr. Drew Pinsky (09:48):
Efficacy, efficacy rates.
Saundra Pelletier (09:49):
So two different things. So in our clinical study, there were 25,000
acts of sex. We had less than 1% of pregnancies. But when we did our clinical study, this is the other thing that I think is always challenging.
The FDA insisted that we count failures of women who didn't use the drug at all, or women who used it after sex. So in the label it says
93% and 86%. But what we've seen is being on the market for almost over two years, we've had less than 1% of pregnancies, to be honest.