Evofem Biosciences Inc (OTCMKTS: EVFM) has been on the move northbound in recent trading since reversing off $0.071 new 52-week lows. The Company was delisted by the Nasdaq in August for failing to meet the minimum bid requirements and at $0.26 is trading at a fraction of the $8 it commanded in March or the $100 per share EVFM was trading at just 2 years go. Everyone knows how explosive ex Nasdaq can be once on the OTC and EVFM has big potential; the Company recently launched its first FDA-approved product, Phexxi® a hormone-free, on-demand prescription contraceptive vaginal gel.  

Sales of Phexxi have been picking up rapidly with EVFM reporting $10.25 million in revenues in the first 6 months of 2022. Revenues are expected to continue to grow at a brisk rate, recently another highly respected national-level payer began covering Phexxi. The Phexxi claim approval rate reached a new high for 2022 at more than 72% for the month of July. EVFM has been busy this month; they uplisted to the OTCQB Venture Market from the OTC Pink Open Market. Phexxi has also been approved by the Nigerian Regulatory Agency NAFDAC (National Agency for Food and Drug Administration and Control). This marks the Company’s first approval outside the United States. Regulatory dossiers have also been submitted in Ghana, Ethiopia and Mexico. The product will be potentially marketed under the brand name Femidence™.    

Evofem Biosciences Inc (OTCMKTS: EVFM) is developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from chlamydia and gonorrhea. The Company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Last week the Company completed Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints. 

Phexxi was approved by the FDA on May 22, 2020 and is the first and only FDA-approved, hormone-free, woman-controlled, on-demand prescription contraceptive gel for women. Evofem commercially launched Phexxi in September 2020 in the United States. The Company intends to commercialize Phexxi in all other global markets through partnerships or licensing agreements. 

EVO200 vaginal gel (EVO200), Evofem’s investigational candidate for the reduction of recurrent bacterial vaginosis (BV), uses the same proprietary vaginal pH modulator platform as Phexxi. EVO200 has been designated a QIDP by the FDA for this indication. In a Phase 1 dose-finding trial for this indication, the highest dose formulation of the study drug demonstrated reduced vaginal pH for up to seven days following a single administration. We may decide to pursue further development of EVO200 in the future. 

Phexxi, EVO200, and other product candidates in development share similar non-hormonal, acid-buffering, bioadhesive properties. However, they are designed differently to target viral and bacterial pathogens while playing an integral role to the survival of healthy bacteria in the vagina, enabling women to achieve better sexual and reproductive health. 

$EVFM getting ready for a bounce back? @rarakoko3 check out this OTC stock. pic.twitter.com/RmnWQ621Y8

— WallStreetFools (@wall_fools) October 27, 2022

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EVFM has been busy this month; they uplisted to the OTCQB Venture Market from the OTC Pink Open Market. The women’s health focused biotech company developed and commercializes Phexxi® (lactic acid, citric acid, potassium bitartrate), the first and only FDA-approved hormone-free, contraceptive vaginal gel. Phexxi net sales have increased for three consecutive quarters; the Company expects that third quarter results, due in mid-November, will continue this trend. Net product sales of the hormone-free contraceptive had already surpassed 2021 levels in the first half of 2022.    

Evofem is on track to report top-line data in mid-October 2022 from its registrational Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women. Positive study outcomes would enable regulatory submissions and potential approval for these potential new indications in 2023.  If approved by the FDA, Phexxi will be the first woman-controlled prescription prophylactic against chlamydia and gonorrhea, which are a significant and growing public health concern. Preliminary CDC data for 2021 show that infections with chlamydia and gonorrhea continued to increase during the second year of the COVID-19 pandemic, with no signs of slowing. 

Phexxi has also been approved by the Nigerian Regulatory Agency NAFDAC (National Agency for Food and Drug Administration and Control). This marks the Company’s first approval outside the United States. Regulatory dossiers have also been submitted in Ghana, Ethiopia and Mexico. The product will be potentially marketed under the brand name Femidence™.    

In October 2020, Adjuvant Capital made a $25 million strategic investment to expand global market access for Phexxi® (lactic acid, citric acid, potassium bitartrate) vaginal contraceptive gel and to support EVOGUARD, Evofem’s registrational Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women. Evofem is on track to report top-line data from this landmark trial in mid-October 2022. Positive study outcomes would enable regulatory submissions and potential U.S. approval for prevention of these sexually transmitted infections in 2023. As previously reported, Evofem has experienced strong growth in net sales of Phexxi® (lactic acid, citric acid and potassium bitartrate), as well as market access expansion, as payers and pharmacy benefit managers (PBMs) continue to add Phexxi to their formularies, allowing women to fill their prescriptions immediately. 

$EVFM

Signaled this push at the open today over .11, looking for .16 very quickly, saw .14 today already, chat banking on this https://t.co/khWEx6kZII pic.twitter.com/bxx6jpXAvB

— DB Daytrades (@DB_Daytrades) October 27, 2022

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Currently trading at a $14 million market valuation EVFM OS is 25,877,050 shares with authorized at 500 million. With $20 million in cash in the treasury EVFM was recently able to restructure its debt, providing forbearance from its debtholders related to all existing events of default. EVFM is an exciting situation in small caps; the Company was delisted by the Nasdaq in August for failing to meet the minimum bid requirements and at $0.26 is trading at a fraction of the $8 it commanded in March or the $100 per share EVFM was trading at just 2 years go. Everyone knows how explosive ex Nasdaq can be once on the OTC and EVFM has big potential; the Company recently launched its first FDA-approved product, Phexxi® a hormone-free, on-demand prescription contraceptive vaginal gel. Sales of Phexxi hormone-free, on-demand prescription contraceptive vaginal gel sales have been picking up rapidly with EVFM reporting $10.25 million in revenues in the first 6 months of 2022. EVFM has a lot of potential from current levels; some of the biggest runners in small history over the past 10 years have been ex big bord biotech’s, EVFM should be at the top of penny stock speculators watch lists here. We will be updating on EVFM when more details emerge so make sure you are subscribed to Microcapdaily.

Disclosure: we hold no position in EVFM either long or short and we have not been compensated for this article.