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.

开始日期2023-12-15

申办/合作机构

Queens Medical Center初创企业

NCT04553068 / Completed临床3期

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

开始日期2020-10-15

申办/合作机构

Evofem, Inc.

NCT03107377 / Completed临床2/3期

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

开始日期2017-11-03

申办/合作机构

Evofem, Inc.

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100 项与 L-乳酸/柠檬酸/酒石酸氢钾相关的专利（医药）

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项与 L-乳酸/柠檬酸/酒石酸氢钾相关的文献（医药）

2024-02-01·Human reproduction (Oxford, England)

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

Article

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

Abstract:

STUDY QUESTION:

How 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 ANSWER:

Although 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 ALREADY:

O-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, DURATION:

Thirty 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, METHODS:

All 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 CHANCE:

A 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 CAUTION:

The 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 FINDINGS:

This 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 NUMBER:

EUDRACT 2018-000105-23

2024-01-01·Reproductive biomedicine online

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

Article

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

RESEARCH QUESTION:

What 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?

DESIGN:

A 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.

RESULTS:

The 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.

CONCLUSION:

A 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.

2023-08-15·Neurology

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

Article

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

BACKGROUND AND OBJECTIVES:

Primary 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.

METHODS:

In 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.

RESULTS:

26 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]).

DISCUSSION:

Long-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.

项与 L-乳酸/柠檬酸/酒石酸氢钾相关的新闻（医药）

2024-11-14

·PRNewswire

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

并购上市批准财报引进/卖出

2024-10-28

·evofem.investorroom.com

Aditxt Completes Final Equity Investment and Key Milestone Under the Amended and Restated Merger Agreement with Evofem

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), a social innovation platform dedicated to accelerating promising health innovations, today announced the achievement of a key milestone under the Amended and Restated Merger Agreement, as amended (the “A&R Merger Agreement”) toward completion of its intended acquisition of women’s health innovator Evofem Biosciences, Inc. (“Evofem”) (OTCQB: EVFM). Today, Aditxt purchased $2.28 million of Evofem Series F-1 convertible preferred stock. This is the final investment in Evofem stipulated under the A&R Merger Agreement. Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, said, “We believe that this is a critical milestone towards the completion of the proposed acquisition and positioning Evofem as a global women’s health enterprise focusing on advancing treatment, prevention, and diagnostic innovations.” Under the A&R Merger Agreement, assuming the related proposal is approved by Evofem stockholders and other closing conditions are met, Aditxt’s subsidiary Adifem, Inc. will merge with and into Evofem. Evofem will be the surviving company and a wholly-owned subsidiary of Aditxt. The closing of the transactions with Evofem is subject to several conditions, including but not limited to approval of the transaction by shareholders of Evofem and Aditxt raising sufficient capital to fund its obligations prior to and at closing. The Company estimates it will require approximately $17 million in additional cash to fund its proposed acquisition of Evofem, inclusive of the repayment needed to satisfy Evofem’s Senior Secured Note in conjunction with the closing. Evofem recently received a notice of default with respect to such Senior Secured Note, which it disputes. No assurance can be provided that all of the conditions to closing will be obtained or satisfied and that the transactions will ultimately close. Albanna and Evofem CEO Saundra Pelletier will discuss the proposed transaction and post-acquisition plans, among other topics, on a Virtual Fireside Chat as follows: Date: Monday, October 28, 2024 Time: 11:30 AM Eastern Time Access: https://us06web.zoom.us/webinar/register/WN_wMfjOmRqTc-e6jy4b9MRjw#/registration The Virtual Fireside Chat will be moderated by Dr. Drew Pinsky, a media personality and board-certified physician. Interested parties are encouraged to register for the event and to log in five minutes early. About Evofem Biosciences, Inc. Evofem 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. Phexxi® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc. Follow us on: LinkedIn: https://www.linkedin.com/company/evofem Facebook: http://www.facebook.com/Evofem X (f/k/a Twitter): https://x.com/Evofem About Aditxt, Inc. Aditxt, Inc.® is a social innovation platform dedicated to accelerating promising health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The 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 that democratizes innovation, ensures every stakeholder’s voice is heard and valued, and empowers collective progress. Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For these, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and a Merger Agreement with Evofem. 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. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations at closing. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close. For more information, www.aditxt.com. Follow us on: LinkedIn: https://www.linkedin.com/company/aditxt Facebook: https://www.facebook.com/aditxtplatform/ 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 its strategic M&A initiatives; the Company’s ability to 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 Aditxt’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. Contacts Corporate, Investor, and Media Relations: Engagement@Aditxt.com

并购上市批准

2024-09-09

·evofem.investorroom.com

Aditxt and Evofem Sign Second Amendment to Amended and Restated Merger Agreement, Target Closing of Acquisition in Fourth Quarter of 2024

Aditxt, Inc. (NASDAQ: ADTX) (“Aditxt” or the “Company”), an innovation platform dedicated to accelerating health innovations, and women’s health pioneer, Evofem Biosciences, Inc. (OTCQB: EVFM) (“Evofem”) today announced they have entered into the Second Amendment to the Amended and Restated Agreement and Plan of Merger (the “Second Amendment”), under which Aditxt intends to acquire Evofem. Under the Second Amendment, the parties have extended the dates by which Aditxt shall complete the remaining $3 million in funding to Evofem through the purchase of 3,000 shares of Evofem’s F-1 Preferred Stock. Aditxt will provide $1.5 million of financing by September 30, 2024, and an additional $1.5 million by October 31, 2024. Both companies continue to work collaboratively to align strategic priorities and expect to close the transaction in the fourth quarter of 2024. Evofem intends to achieve and accelerate year-over-year revenue growth through continued execution of its three-pronged growth strategy: to increase net sales of its differentiated women’s health products in the U.S., the hormone-free contraceptive Phexxi® (lactic acid, citric acid and potassium bitartrate) and SOLOSEC® (secnidazole) 2g oral granules to treat two common sexual health infections; to expand its commercial portfolio through acquisitions of complementary late-stage or in-market women’s health assets; and to partner or license its products for international markets as part of a broader initiative to expand its global footprint in women’s health. Amro Albanna, Co-Founder, Chairman, and CEO of Aditxt, said, “Women’s health presents unique challenges that call for innovative solutions designed to meet the evolving needs of women at every stage of life. Evofem has shown the strategic vision and adaptability needed to take the lead in this field, building on a solid foundation of progress. However, the impact of these advancements extends beyond the science itself—it’s about ensuring women everywhere can benefit from these innovations. Global support is essential to drive Evofem’s mission forward, ensuring access to transformative healthcare that can truly improve the lives of women around the world.” “The alliance between Evofem and Aditxt is underpinned by a shared belief in the need for innovation in women’s healthcare,” said Saundra Pelletier, CEO of Evofem Biosciences. “For too long, big Pharma has invested in ‘me too’ products in already crowded categories that offer no new benefits for women. With the support and vision of Aditxt, Evofem will continue to elevate the quality of life for women by offering products that are better and positively impact the daily lives of women who must care for so many.” Aditxt currently operates two programs focused on immune health and precision health. The Company plans to introduce two additional programs dedicated to public health and women’s health. For the latter two programs, Aditxt has entered into an Arrangement Agreement with Appili Therapeutics, Inc. (“Appili”) (TSX: APLI; OTCPink: APLIF), which focuses on infectious diseases, and the aforementioned Merger Agreement with Evofem. 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. The closing of each of the transactions with Appili and Evofem is subject to several conditions, including but not limited to approval of the transactions by the respective target shareholders and Aditxt raising sufficient capital to fund its obligations prior to and at closing. No assurance can be provided that all of the conditions to closing will be obtained or satisfied or that either of the transactions will ultimately close. About Evofem Biosciences, Inc. Evofem 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. Follow us on: LinkedIn: https://www.linkedin.com/company/evofem Facebook: http://www.facebook.com/Evofem X (f/k/a Twitter): https://x.com/Evofem Phexxi ® and SOLOSEC ® are registered trademarks of Evofem Biosciences, Inc. About Aditxt, Inc. Aditxt, Inc.® is an innovation platform dedicated to accelerating health innovations. Aditxt’s ecosystem of research institutions, industry partners, and shareholders collaboratively drives their mission to "Make Promising Innovations Possible Together." The 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 that democratizes innovation, ensures every stakeholder’s voice is heard and valued and empowers collective progress. For more information, www.aditxt.com. Follow us on: LinkedIn: https://www.linkedin.com/company/aditxt Facebook: https://www.facebook.com/aditxtplatform/ Forward-Looking Statements for Evofem 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 anticipated timing to close the contemplated transaction between Aditxt and Evofem and Evofem’s ability to achieve its strategic goals. 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 July 30, 2024 filed with the SEC on August 15, 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. Forward-Looking Statements for Aditxt 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 its strategic M&A initiatives; the Company’s ability to 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 Aditxt’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. View source version on businesswire.com: https://www.businesswire.com/news/home/20240909413916/en/ Evofem Biosciences, Inc. Amy Raskopf araskopf@evofem.com (917) 673-5775 Aditxt, Inc. Mary O’ Brien mobrien@aditxt.com (516) 753-9933

并购上市批准

100 项与 L-乳酸/柠檬酸/酒石酸氢钾相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	G02BB	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
避孕	美国	Evofem, Inc.	2020-05-22

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适应症	最高研发状态	国家/地区	公司	日期
沙眼衣原体感染	临床3期	美国	Evofem, Inc.	2020-10-15
淋病	临床3期	美国	Evofem, Inc.	2020-10-15

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临床结果

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分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04553068 (EVOGUARD, CTgov)	临床3期	淋病 \| 沙眼衣原体感染	1,892	EVO100 (EVO100 Gel)	構艱繭遞夢壓選簾廠糧(構顧願觸餘窪夢糧獵鹽) = 選遞鑰淵餘築淵夢獵選鹽餘艱鹽醖鹹淵遞壓艱 (遞糧選壓夢淵鏇鏇蓋壓, 糧淵憲餘壓選積選襯構 ~ 鑰醖鏇積選願積願醖繭) 更多	-	2024-01-30
				Placebo (Placebo Gel)	構艱繭遞夢壓選簾廠糧(構顧願觸餘窪夢糧獵鹽) = 積廠積製廠獵鏇艱窪淵鹽餘艱鹽醖鹹淵遞壓艱 (遞糧選壓夢淵鏇鏇蓋壓, 艱範鏇網鏇鑰鬱衊艱構 ~ 獵繭襯糧襯願鬱憲獵選) 更多
NCT04553068 (EVOGUARD, PRNewswire) 人工标引	临床3期	衣原体感染 \| 淋病	1,903	EVO100	網蓋鏇範醖壓蓋淵衊憲(繭繭積鬱壓鹹壓鏇顧膚) = Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women did not achieve its endpoints. 夢餘鬱網蓋製夢鹽夢鹽 (選鬱壓鏇襯繭鏇窪鏇範 )	不佳	2022-10-11
				Placebo
NCT03107377 (AMPREVENCE, Pubmed \| Am J Obstet Gynecol)	临床2/3期	感染	860	EVO100	窪齋遞艱願構築願構壓(膚構窪築鏇網齋鬱淵鹽) = 4.6% [18/388] 艱憲鹹餘餘夢鹹鏇鏇鑰 (壓艱齋廠願蓋淵製獵衊 ) 更多	积极	2021-03-08
				Placebo
NCT03107377 (AMPREVENCE, CTgov)	临床2/3期	沙眼衣原体感染	860	EVO100 (EVO100)	網鬱艱網齋餘積壓窪鬱(憲鑰鹽蓋顧願繭鹽鏇膚) = 糧蓋醖願窪夢鬱鏇餘範襯齋積獵觸艱構鬱餘壓 (艱積鏇願衊繭廠鑰壓遞, 築醖壓夢鹹構壓構鬱膚 ~ 鑰積範選網壓襯願衊蓋) 更多	-	2020-08-12
				Placebo (Placebo)	網鬱艱網齋餘積壓窪鬱(憲鑰鹽蓋顧願繭鹽鏇膚) = 築簾醖鏇廠夢簾艱憲蓋襯齋積獵觸艱構鬱餘壓 (艱積鏇願衊繭廠鑰壓遞, 遞構鏇糧顧繭憲衊顧鑰 ~ 網蓋廠糧繭簾築廠憲壓) 更多
EHA2019	N/A	肿瘤 \| 复发难治性急性淋巴细胞白血病	16	MVP (CD19 CAR-T)	壓鹹遞鏇獵艱窪製網選(獵淵廠鑰齋窪構艱製網) = 鏇夢積鹹壓製齋憲獵餘窪觸獵範鑰廠鹹糧製鑰 (顧製繭願網鑰顧餘網顧 ) 更多	-	2019-06-15
				MVP (CD22 CAR-T)	壓鹹遞鏇獵艱窪製網選(獵淵廠鑰齋窪構艱製網) = 製醖鑰膚艱製選衊齋簾窪觸獵範鑰廠鹹糧製鑰 (顧製繭願網鑰顧餘網顧 ) 更多