This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.

Start Date15 Dec 2023

Sponsor / Collaborator

Queens Medical CenterStartup

NCT04553068 / CompletedPhase 3

Phase 3 Double-blind Placebo-controlled Efficacy Trial of EVO100 Vaginal Gel for the Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection

This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of CT and GC infection

Start Date15 Oct 2020

Sponsor / Collaborator

Evofem, Inc.

NCT03107377 / CompletedPhase 2/3

Phase 2B Double-blind Placebo-controlled Efficacy Trial of EVO100 (Previously Known as Amphora ® Gel) for the Prevention of Acquisition of Urogenital Chlamydia Trachomatis Infection

Phase 2B double-blind placebo-controlled efficacy trial of EVO100 (previously known as Amphora ® Gel) for the prevention of acquisition of urogenital Chlamydia trachomatis infection

Start Date03 Nov 2017

Sponsor / Collaborator

Evofem, Inc.

[+1]

100 Clinical Results associated with Citric Acid/Lactic Acid/Potassium Bitartrate

100 Translational Medicine associated with Citric Acid/Lactic Acid/Potassium Bitartrate

100 Patents (Medical) associated with Citric Acid/Lactic Acid/Potassium Bitartrate

Literatures (Medical) associated with Citric Acid/Lactic Acid/Potassium Bitartrate

01 Feb 2024·Human Reproduction

Oral dydrogesterone versus micronized vaginal progesterone for luteal phase support: a double-blind crossover study investigating pharmacokinetics and impact on the endometrium

Article

Author: Arck, P ; Bourgain, C ; Tournaye, H ; Centelles-Lodeiro, J ; Raes, J ; Mackens, S ; Griesinger, G ; Olsen, C ; Thiele, K ; Loreti, S ; Vieira-Silva, S ; Waelput, W ; De Brucker, M ; Blockeel, C

AbstractSTUDY QUESTIONHow do plasma progesterone (P) and dydrogesterone (D) concentrations together with endometrial histology, transcriptomic signatures, and immune cell composition differ when oral dydrogesterone (O-DYD) or micronized vaginal progesterone (MVP) is used for luteal phase support (LPS)?SUMMARY ANSWERAlthough after O-DYD intake, even at steady-state, plasma D and 20αdihydrodydrogesterone (DHD) concentrations spiked in comparison to P concentrations, a similar endometrial signature was observed by histological and transcriptomic analysis of the endometrium.WHAT IS KNOWN ALREADYO-DYD for LPS has been proven to be noninferior compared to MVP in two phase III randomized controlled trials. Additionally, a combined individual participant data and aggregate data meta-analysis indicated that a higher pregnancy rate and live birth rate may be obtained in women receiving O-DYD versus MVP for LPS in fresh IVF/ICSI cycles. Little data are available on the pharmacokinetic (PK) profiles of O-DYD versus MVP and their potential molecular differences at the level of the reproductive organs, particularly at the endometrial level.STUDY DESIGN, SIZE, DURATIONThirty oocyte donors were planned to undergo two ovarian stimulation (OS) cycles with dual triggering (1.000 IU hCG + 0.2 mg triptorelin), each followed by 1 week of LPS: O-DYD or MVP, in a randomized, cross-over, double-blind, double-dummy fashion. On both the first and eighth days of LPS, serial blood samples upon first dosing were harvested for plasma D, DHD, and P concentration analyses. On Day 8 of LPS, an endometrial biopsy was collected for histologic examination, transcriptomics, and immune cell analysis.PARTICIPANTS/MATERIALS, SETTING, METHODSAll oocyte donors were <35 years old, had regular menstrual cycles, no intrauterine contraceptive device, anti-Müllerian hormone within normal range and a BMI ≤29 kg/m2. OS was performed on a GnRH antagonist protocol followed by dual triggering (1.000 IU hCG + 0.2 mg triptorelin) as soon as ≥3 follicles of 20 mm were present. Following oocyte retrieval, subjects initiated LPS consisting of MVP 200 mg or O-DYD 10 mg, both three times daily. D, DHD, and P plasma levels were measured using liquid chromatography–tandem mass spectrometry. Histological assessment was carried out using the Noyes criteria. Endometrial RNA-sequencing was performed for individual biopsies and differential gene expression was analyzed. Endometrial single-cell suspensions were created followed by flow cytometry for immune cell typing.MAIN RESULTS AND THE ROLE OF CHANCEA total of 21 women completed the entire study protocol. Subjects and stimulation characteristics were found to be similar between groups. Following the first dose of O-DYD, the average observed maximal plasma concentrations (Cmax) for D and DHD were 2.9 and 77 ng/ml, respectively. The Cmax for D and DHD was reached after 1.5 and 1.6 h (=Tmax), respectively. On the eighth day of LPS, the first administration of that day gave rise to a Cmax of 3.6 and 88 ng/ml for D and DHD, respectively. For both, the observed Tmax was 1.5 h. Following the first dose of MVP, the Cmax for P was 16 ng/ml with a Tmax of 4.2 h. On the eighth day of LPS, the first administration of that day showed a Cmax for P of 21 ng/ml with a Tmax of 7.3 h. All 42 biopsies showed endometrium in the secretory phase. The mean cycle day was 23.9 (±1.2) in the O-DYD group versus 24.0 (±1.3) in the MVP group. RNA-sequencing did not reveal significantly differentially expressed genes between samples of both study groups. The average Euclidean distance between samples following O-DYD was significantly lower than following MVP (respectively 12.1 versus 18.8, Mann–Whitney P = 6.98e−14). Immune cell profiling showed a decrease of CD3 T-cell, γδ T-cell, and B-cell frequencies after MVP treatment compared to O-DYD, while the frequency of natural killer (NK) cells was significantly increased.LIMITATIONS, REASONS FOR CAUTIONThe main reason for caution is the small sample size, given the basic research nature of the project. The plasma concentrations are best estimates as this was not a formal PK study. Whole tissue bulk RNA-sequencing has been performed not correcting for bias caused by different tissue compositions across biopsies.WIDER IMPLICATIONS OF THE FINDINGSThis is the first study comparing O-DYD/MVP, head-to-head, in a randomized design on a molecular level in IVF/ICSI. Plasma serum concentrations suggest that administration frequency is important, in addition to dose, specifically for O-DYD showing a rapid clearance. The molecular endometrial data are overall comparable and thus support the previously reported noninferior reproductive outcomes for O-DYD as compared to MVP. Further research is needed to explore the smaller intersample distance following O-DYD and the subtle changes detected in endometrial immune cells.STUDY FUNDING/COMPETING INTEREST(S)Not related to this work, C.Bl. has received honoraria for lectures, presentations, manuscript writing, educational events, or scientific advice from Abbott, Ferring, Organon, Cooper Surgical, Gedeon-Richter, IBSA, and Merck. H.T. has received honoraria for lectures, presentations, manuscript writing, educational events, or scientific advice from Abbott, Ferring, Cooper Surgical, Gedeon-Richter, Cook, and Goodlife. S.M. has received honoraria for lectures, presentations, educational events, or scientific advice from Abbott, Cooper Surgical, Gedeon-Richter, IBSA, and Merck and Oxolife. G.G. has received honoraria for lectures, presentations, educational events, or scientific advice from Merck, MSD, Organon, Ferring, Theramex, Gedeon-Richter, Abbott, Biosilu, ReprodWissen, Obseva, PregLem, Guerbet, Cooper, Igyxos, and OxoLife. S.V.-S. is listed as inventor on two patents (WO2019115755A1 and WO2022073973A1), which are not related to this work.TRIAL REGISTRATION NUMBEREUDRACT 2018-000105-23

01 Jan 2024·Reproductive BioMedicine Online

Circadian serum progesterone variations on the day of frozen embryo transfer in artificially prepared cycles

Article

Author: Roelens, Caroline ; De Munck, Neelke ; Drakopoulos, Panagiotis ; Tournaye, Herman ; Blockeel, Christophe ; Mackens, Shari ; Loreti, Sara

RESEARCH QUESTIONWhat is the intra-day variation of serum progesterone related to vaginal progesterone administration on the day of frozen embryo transfer (FET) in an artificial cycle?DESIGNA prospective cohort study was conducted including 22 patients undergoing a single blastocyst artificial cycle (AC)-FET from August to December 2022. Endometrial preparation was achieved by administering oestradiol valerate (2 mg three times daily) and consecutively micronized vaginal progesterone (MVP; 400 mg twice daily). A blastocyst FET was performed on the 6th day of MVP administration. Serum progesterone concentrations were measured on the day of transfer at 08:00, 12:00, 16:00 and 20:00 hours. The first and last blood samples were collected just before MVP was administered.RESULTSThe mean age and body mass index of the study population were 33.95 ± 3.98 years and 23.10 ± 1.95 kg/m². The mean P-values at 08:00, 12:00, 16:00 and 20:00 hours were 11.72 ± 4.99, 13.59 ± 6.33, 10.23 ± 3.81 and 9.28 ± 3.09 ng/ml, respectively. A significant decline, of 2.41 ng/ml (95% confidence interval 0.81-4.00), was found between the first and last progesterone measurements.CONCLUSIONA statistically significant intra-day variation of serum progesterone concentrations on the day of FET in artificially prepared cycles was observed. This highlights the importance of a standardized procedure for the timing of progesterone measurement on the day of AC-FET. Of note, the study results are applicable only to women using MVP for luteal phase support; therefore it is necessary to confirm its validity in comparison with the different existing administration routes of progesterone.

15 Aug 2023·Neurology

Long-term Outcomes in Primary CNS Lymphoma After R-MVP and High-Dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplant

Article

Author: Omuro, Antonio M.P. ; DeAngelis, Lisa M. ; Nandakumar, Subhiksha ; Grommes, Christian ; Therkelsen, Kate Elizabeth ; Schaff, Lauren R.

BACKGROUND AND OBJECTIVESPrimary CNS lymphoma (PCNSL), a rare CNS malignancy, is usually treated with high-dose methotrexate in the first-line setting, typically followed by consolidation therapy. Due to the broad range of currently available treatments for PCNSL, comparability in long-term follow-up studies is limited, and data are scattered across small studies.METHODSIn this study, we report the long-term survival of patients with newly diagnosed immunocompetent PCNSL, enrolled in a phase II trial from June 2005 to September 2011. Patients were treated using rituximab, methotrexate, vincristine, and procarbazine (R-MVP) chemotherapy followed by high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT) in those with partial or complete response to R-MVP. In a post hoc analysis, clinical and imaging features were evaluated in those still alive.RESULTS26 of 32 patients underwent HDC-ASCT consolidation. Of them, 3 patients died of treatment-related toxicity and 2 due to disease progression within 1 year of ASCT. None of the remaining 21 patients had disease progression with a median follow-up of 12.1 years and were included in the analysis. Compared with the post-HDC-ASCT assessment, at the last follow-up, there was no significant difference in the median Karnofsky Performance Status (80 [range: 60-100] vs 90 [range: 70-100]), the median Neurologic Assessment in Neuro-Oncology score (1 [range: 0-4] vs 1 [range: 0-5]), and leukoencephalopathy score (1 [range: 0-3] vs 1 [range: 1-4]).DISCUSSIONLong-term follow-up demonstrated that treatment was well tolerated in most patients enrolled in this study, with stable leukoencephalopathy on imaging and stable clinical performance status. Disease recurrence was not observed beyond 2 years after HDC-ASCT consolidation.

News (Medical) associated with Citric Acid/Lactic Acid/Potassium Bitartrate

14 Nov 2024

·www.prnewswire.com

Evofem Biosciences Announces Financial Results for the Third Quarter of 2024

— Improved loss from operations by 31% — — Acquired SOLOSEC, a commercially attractive, single-dose oral antibiotic FDA-approved to treat two pervasive sexual health infections — — Forged commercial agreement for Phexxi in Middle East — SAN DIEGO, Nov. 14, 2024 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. ("Evofem" or "the Company") (OTCQB: EVFM) today announced financial results for the third quarter and nine-month period ended September 30, 2024. Highlights include: Acquired global rights to SOLOSEC® (secnidazole) 2g oral granules, a single-dose oral antibiotic FDA approved to treat bacterial vaginosis and trichomoniasis, two common sexual health infections. Licensed Phexxi® (lactic acid, citric acid and potassium bitartrate) commercial rights in the Middle East to Emirati pharmaceutical company Pharma 1 Drug Store. The regulatory submission for the hormone-free contraceptive is on track for submission to the UAE Ministry of Health by year-end 2024. Launched a Market Development Collaboration with Pearsanta focused on its blood-based diagnostic test for endometriosis, a chronic disease associated with severe, life-impacting pain that affects approximately one in ten women of reproductive age. Improved loss from operations to $2.4 million for the third quarter of 2024, versus a loss from operations of $3.6 million in the prior year quarter. Aditxt, Inc. (Nasdaq: ADTX) has invested $5.0 million in Evofem since May 2024, including $1.3 million from the sale of Series F-1 Preferred Stock to Aditxt in the third quarter of 2024 and $2.7 million in October 2024. These investments were stipulated in the Amended and Restated Merger Agreement, as amended (the "A&R Merger Agreement"), between the companies. On November 8, 2024, Evofem remedied its prior bid price deficiency and regained compliance with the OTCQB Standards for Continued Eligibility. "We continue to advance Evofem's strategy to grow revenues organically and through strategic acquisitions and alliances," said Saundra Pelletier, CEO of Evofem Biosciences. "In the third quarter we closed several business development transactions that we expect will diversify and strengthen our revenue streams. We acquired and recently relaunched SOLOSEC as the only single-dose oral treatment FDA-approved for both bacterial vaginosis and trichomoniasis. We also forged an agreement that paves the way for the commercialization of Phexxi in the GCC, starting with the UAE. In addition, we launched a market development collaboration with Pearsanta, a subsidiary of Aditxt, for its endometriosis diagnostic. Further post-merger support from Aditxt and its ecosystem should help catalyze our growth trajectory and our ability to execute our mission to improve women's lives through diversified and differentiated diagnostic, preventive, and therapeutic offerings." Financial Results For the three months ended September 30, 2024, net product sales were $4.5 million compared to $5.1 million in the prior year period. The 12% decrease primarily reflects lower unit sales in the current period due to the impact of the continued absence of marketing, partially offset by the Phexxi WAC increase in January 2024 and a slight decrease in variable consideration. Total operating expenses were $6.9 million, a decrease of 20% compared to the prior year period. Selling and marketing costs were $2.4 million, a decrease of 20% compared to the prior year quarter. General and administrative costs were $3.1 million, a decrease of 4% compared to the prior year quarter. Research and development costs were $0.3 million, a decrease of 46% compared to the prior year quarter. Cost of goods sold (COGS) were $0.9 million, a 54% decrease compared to the prior year period primarily due to the lower product sales and the absence of re-packaging costs in the current year quarter. As a result, operating loss improved to $2.4 million for the third quarter of 2024 as compared to an operating loss of $3.6 million in the third quarter of 2023. Factoring in a $0.1 million gain in other income, net loss attributable to common stockholders was $2.4 million, or a loss of $0.02 per share, for the three months ended September 30, 2024. This compares to net income attributable to common shareholders of $66.0 million, or $15.34 per share, for the prior year quarter, which reflects a $75.3 million gain related to the Baker Fourth Amendment, which was treated as a debt extinguishment, offset in part by a $5.3 million loss on the quarterly valuation of the senior subordinated convertible notes and purchase rights and warrant modifications, and $0.5 million of interest expense related to the Adjuvant Note. Liquidity In the third quarter of 2024, Evofem raised $1.3 million in aggregate net proceeds through the sale and issuance of 1,260 shares of Series F-1 Convertible Preferred Stock to Aditxt pursuant to the A&R Merger Agreement. At September 30, 2024, the Company had $0.7 million of restricted cash, as compared to $0.6 million of restricted cash at December 31, 2023. In October 2024, Evofem raised $2.7 million in aggregate net proceeds through the sale and issuance of 2,740 shares of Series F-1 Convertible Preferred Stock to Aditxt pursuant to the A&R Merger Agreement. Evofem used a portion of this funding to pay in full its obligations to the U.S. Food and Drug Administration. About Evofem Biosciences Evofem Biosciences, Inc., is commercializing innovative products to address unmet needs in women's sexual and reproductive health. 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. In July 2024 Evofem broadened its commercial offering with the acquisition of SOLOSEC® (secnidazole) 2g oral granules, an FDA-approved oral antibiotic for the treatment of two sexual health diseases: bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. SOLOSEC provides a complete course of therapy in just one dose. In December 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt's subsidiary Adifem, Inc. is expected to merge with and into Evofem, with Evofem remaining as the surviving entity and a wholly owned subsidiary of Aditxt. The companies amended and restated the Merger Agreement, as amended (the "A&R Merger Agreement"), in its entirety in July 2024. The A&R Merger Agreement was subsequently amended in August, September, and October 2024, primarily to adjust investment dates. The closing of the transactions is subject to several conditions, including approval of the transactions by a majority of the combined voting power of Evofem's E-1 and Common Stock, voting together as a single class, at a meeting where quorum is present, and Aditxt raising sufficient capital to fund its obligations prior to and at closing. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): Phexxi® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc. Forward-Looking Statements This press release includes "forward-looking statements" within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to the Company's anticipated financial performance, expected timing of the regulatory submission to the UAE Ministry of Health, and the likelihood of success and anticipated timing to close the contemplated Aditxt transaction. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 12, 2024, Quarterly Report on Form 10-Q for the three and six months ended June 30, 2024 filed with the SEC on August 14, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law. Contact Amy Raskopf Evofem Biosciences, Inc. [email protected] (917) 673-5775 [email protected] -- Financial Tables Follow – SOURCE Evofem Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionDrug ApprovalFinancial StatementLicense out/in

17 Jul 2024

·www.businesswire.com

Aditxt and Evofem Amend and Restate Merger Agreement, Targeting September 30 Closing

MOUNTAIN VIEW, Calif.--( BUSINESS WIRE )--Aditxt, Inc. (“Aditxt”) (NASDAQ: ADTX), a company dedicated to discovering, developing, and deploying promising health innovations, announces this past Friday, July 12 th , Aditxt, its wholly owned subsidiary Adifem, Inc., and Evofem Biosciences, Inc.’s (“Evofem”) (OTCQB: EVFM) amended and restated their Merger Agreement. This amended and restated Merger Agreement, among others, addresses pre-closing issues critical for Evofem’s future success, including interim financing needs. The other revisions to the Merger Agreement, alongside additional interim financing for Evofem, include substituting cash for Aditxt’s common stock as the consideration for Evofem’s common stock in the merger and additional changes relating to it. Aditxt and Evofem are diligently working to close the contemplated transaction in the second half of 2024. The closing of the transaction between Aditxt and Evofem remains subject to the successful satisfaction of a number of closing conditions, including, but not limited to, Aditxt securing sufficient financing to fund its obligations at closing. No assurance can be given that all of the conditions to closing will be obtained or satisfied or that the transaction will ultimately close. Evofem recently announced the acquisition of SOLOSEC ® (secnidazole) 2g oral granules from Lupin Limited. Under the transaction terms, Lupin can receive a potential total consideration of up to $84 million based on future contingent milestones. “Aditxt and Evofem share a common vision in recognizing and valuing innovations like SOLOSEC that need additional support to reach their full potential,” said Saundra Pelletier, Chief Executive Officer of Evofem. “The expertise, focus, and tenacity of Evofem's U.S. commercial organization have enabled us to deliver consistent annual net sales growth for Phexxi since its launch. With the addition of Aditxt's platform, we believe can accelerate our growth trajectory and expand into a multi-product women's health franchise. We are excited to harness these strengths and leverage our physician relationships to re-launch and grow SOLOSEC, which offers an attractive ‘one-and-done’ oral dosing regimen for women with bacterial vaginosis and trichomoniasis.” Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, commented on this announcement, “The acquisition of SOLOSEC marks an important milestone in Evofem’s evolution. We believe that SOLOSEC is a valuable asset that diversifies Evofem’s portfolio and has the potential to accelerate its evolution into a dynamic global women’s health business that addresses significant health challenges. Our commitment to supporting the expansion of Evofem’s portfolio with additional products and broadening its market reach domestically and internationally exemplifies how the Aditxt model operates. Our confidence in Evofem’s potential has only strengthened, and we firmly believe that, if supported by the right resources, they will drive significant advancements in women’s health.” About Aditxt, Inc. Aditxt, Inc.® (“Aditxt”) (NASDAQ: ADTX) is a social innovation platform dedicated to discovering, developing, and deploying promising innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to “Make Promising Innovations Possible Together.” The social innovation platform is the cornerstone of Aditxt’s strategy, where multiple disciplines drive disruptive growth and address significant societal challenges. Aditxt operates a unique model democratizing innovation, ensuring every stakeholder’s voice is heard and valued, empowering collective progress. Aditxt has a diverse innovation portfolio, including Adimune™, Inc., which is leading the charge in developing a novel class of therapeutics for retraining the immune system to combat organ rejection, autoimmunity, and allergies. Adivir™, Inc. focuses on enhancing population health, impacting public health globally, and Pearsanta™, Inc. delivers rapid, personalized, and high-quality lab testing accessible anytime, anywhere, at their CLIA-certified and CAP-accredited clinical laboratory based in Richmond, VA. For more information see: www.aditxt.com About SOLOSEC ® SOLOSEC ® (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age, and trichomoniasis, a sexually transmitted infection, in people 12 years of age and older. Since trichomoniasis is a sexually transmitted infection, sexual partners of infected patients should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC is designed to be easy to take, and one oral dose contains a complete course of treatment. 1 Additional information about SOLOSEC® can be found at www.SOLOSEC.com . 1 SOLOSEC Package Insert Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of federal securities laws. Forward-looking statements include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the Company’s ongoing and planned product and business development; the Company’s ability to finance and execute on its strategic M&A initiatives; the Company’s ability obtain the necessary funding and partner to commence clinical trials; the Company’s intellectual property position; the Company’s ability to develop commercial functions; expectations regarding product launch and revenue; the Company’s results of operations, cash needs, spending, financial condition, liquidity, prospects, growth and strategies; the Company’s ability to raise additional capital; the industry in which the Company operates; and the trends that may affect the industry or the Company. Forward-looking statements are not guarantees of future performance and actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, as well as market and other conditions and those risks more fully discussed in the section titled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s other filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

AcquisitionDrug Approval

15 Jul 2024

·www.prnewswire.com

Lupin Divests U.S. Commercial Women's Health Specialty Business to Evofem, including SOLOSEC

MUMBAI, India and NAPLES, Fla. and SAN DIEGO, July 15, 2024 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) announced today that it has divested its U.S. Commercial Women's Health Specialty Business to Evofem Biosciences, Inc. (OTCQB: EVFM) (Evofem), a U.S. biopharmaceutical company focused exclusively on Women's Health. Lupin's U.S. Commercial Women's Health Specialty Business is primarily focused on commercializing SOLOSEC® (secnidazole) 2g oral granules. This FDA-approved single-dose antimicrobial agent provides a complete course of therapy for the treatment of bacterial vaginosis (BV) and trichomoniasis, two common sexual health infections. Continue Reading Lupin Divests U.S. Commercial Women's Health Specialty Business to Evofem, including SOLOSEC Under the terms of the deal, Lupin can receive a potential total consideration of up to USD 84 million based on future contingent milestones. Dr. Fabrice Egros, President - Global Corporate Development, Lupin, said, "We are very pleased to divest our U.S. Commercial Women's Health Specialty business, including SOLOSEC®, to Evofem. This divestment is another step in aligning our U.S. specialty business with our strategic plan to build our specialty business in therapeutic areas where we have building blocks of synergy. These include respiratory and neurological diseases." "The acquisition of this commercial business aligns with and advances our mission to improve access to innovative and differentiated options that impact women's daily lives. SOLOSEC is a commercially attractive, single-dose oral antibiotic that addresses two pervasive sexual health infections. We can now fully leverage our commercial infrastructure, maximize our strong physician relationships, and re-launch an asset with tremendous growth potential," said Saundra Pelletier, Chief Executive Officer, Evofem. About Lupin Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector. Please visit for more information. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): About Evofem Biosciences Evofem Biosciences is focused on commercializing innovative products to address unmet needs in women's sexual and reproductive health. 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. Learn more at phexxi.com and evofem.com. In December 2023, Evofem entered into a Merger Agreement with Aditxt, Inc. (Nasdaq: ADTX) under which Aditxt intends to acquire Evofem. The parties reinstated and amended the Merger Agreement, as amended, in May 2024 and are working to close the contemplated transaction in the second half of 2024. Follow us on: LinkedIn: Facebook: X (f/k/a Twitter): About SOLOSEC® SOLOSEC® (secnidazole) 2 g oral granules is the first and only single-dose oral prescription approved to treat both bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and trichomoniasis, a sexually transmitted infection, in people 12 years of age and older.1-4 Since trichomoniasis is a sexually transmitted infection, sexual partners of infected patients should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC® is designed to be easy to take and one oral dose contains a complete course of treatment.[1] Additional information about SOLOSEC® can be found at . References: 1 SOLOSEC Package Insert 2 Workowski KA, Bachmann LH, Chan PA, et al. CDC Sexually Transmitted Diseases Treatment Guidelines, 2001. MMWR Recomm Rep 2021; 70(RR-04):1-192. 3 Onderdonk AB, Delaney ML, Fichorova RN. The Human Microbiome During Bacterial Vaginosis. Clin Microbiol Rev. 2016;29(2):223-238. 4 Koumans EH, Sternberg M, Bruce C, et al. The prevalence of bacterial vaginosis in the United States, 2001-2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis. 2007;34(11):864-869. Forward-Looking Statements This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements regarding the anticipated timing to close the contemplated Aditxt transaction. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in Evofem's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 27, 2024, Quarterly Report on Form 10-Q for the three months ended March 31, 2024 filed with the SEC on May 12, 2024, and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. Evofem does not undertake any duty to update any forward-looking statement except as required by law. Photo: Logo: SOURCE Lupin Limited

Drug ApprovalAcquisition

100 Deals associated with Citric Acid/Lactic Acid/Potassium Bitartrate

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Indication	Country/Location	Organization	Date
Contraception	US	Evofem, Inc.	22 May 2020

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10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chlamydia trachomatis infection	Preclinical	US	Evofem, Inc.	15 Oct 2020
Gonorrhea	Preclinical	US	Evofem, Inc.	15 Oct 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04553068 (EVOGUARD, CTgov)	Phase 3	Gonorrhea \| Chlamydia trachomatis infection	1,892	EVO100 (EVO100 Gel)	gcsjaedonq(ioudmikfcp) = flkfixfppu zpowdlzxgu (debavphnsq, kkdzcjzern - qkmqjajgdi) View more	-	30 Jan 2024
				Placebo (Placebo Gel)	gcsjaedonq(ioudmikfcp) = jmewccdrlk zpowdlzxgu (debavphnsq, ogngmmoykp - xygrejtiux) View more
NCT04553068 (EVOGUARD, PRNewswire) Manual	Phase 3	Chlamydia Infections \| Gonorrhea	1,903	EVO100	(srjnvyrzhd) = Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints. wstgsxtcoc (qyyxjnphjt )	Negative	11 Oct 2022
				Placebo
NCT03107377 (AMPREVENCE, Pubmed \| Am J Obstet Gynecol)	Phase 2/3	Infectious Diseases	860	EVO100	(teiomctdgu) = 4.6% [18/388] dylirprhnx (yaxviokjjh ) View more	Positive	08 Mar 2021
				Placebo
NCT03107377 (AMPREVENCE, CTgov)	Phase 2/3	Chlamydia trachomatis infection	860	EVO100 (EVO100)	yigmxxslqz(viiqcmdkcf) = kubirlyvpj nkzxjgnvdy (ndarymosxy, aksoagpiws - xedlksitfj) View more	-	12 Aug 2020
				Placebo (Placebo)	yigmxxslqz(viiqcmdkcf) = lgolkdpyul nkzxjgnvdy (ndarymosxy, bwspwzuymp - gazcvvpupu) View more
EHA2019	Not Applicable	Neoplasms \| refractory acute lymphoid leukemia in relapse	16	MVP (CD19 CAR-T)	rtgekngrnk(eofzrkbqjz) = uiqawugxmv stbbrfbwpo (yluihmgkul ) View more	-	15 Jun 2019
				MVP (CD22 CAR-T)	rtgekngrnk(eofzrkbqjz) = tcbpxurgdl stbbrfbwpo (yluihmgkul ) View more
OLCSG 0007 (Pubmed \| J Urol)	Phase 3	Locally Advanced Lung Non-Small Cell Carcinoma	200	Docetaxel and cisplatin (DP) chemotherapy with concurrent thoracic radiotherapy (TRT)	rbujkfohee(zznrpddfut) = mijzajqabg okqyprqawu (bfcudetvbh ) View more	Positive	10 Jul 2010
				Mitomycin, vindesine,Mitomycin, vindesine, and cisplatin (MVP) chemotherapy with concurrent TRT	rbujkfohee(zznrpddfut) = exvbekhqkc okqyprqawu (bfcudetvbh ) View more
WJTOG0105 (ASCO2009)	Phase 3	Non-small cell lung cancer stage III	456	MVP	(fvueikumhc) = xlzjmnutgj atflabdium (oamstqnfrg ) View more	-	20 May 2009
				IC	(fvueikumhc) = hmrafjcxjl atflabdium (oamstqnfrg ) View more
ASCO2007	Phase 3	Non-small cell lung cancer stage III	456	MVP	(vbceockrgj) = ipukhilslp hbzykpsudb (zkhpwrwhiu ) View more	Negative	20 Jun 2007
				IC	(vbceockrgj) = nagwmisbio hbzykpsudb (zkhpwrwhiu ) View more
ASCO2004	Phase 3	Non-Small Cell Lung Cancer	432	Docetaxel/carboplatin	xmzzgvcfwj(qjjccwelvr) = srejhtospt ncqgwvhhnj (spwxvahrcn ) View more	-	15 Jul 2004
				MIC/MVP	xmzzgvcfwj(qjjccwelvr) = vqmpubhuos ncqgwvhhnj (spwxvahrcn ) View more

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