Braintree Laboratories, Inc.

Sub-analyses of the pivotal phase 3 data demonstrated that within three years following insertion of the novel, low-dose copper IUD: Bleeding and pain dramatically decreased after the first three months. IUD discontinuation rates due to AEs of bleeding and pain were infrequent and decreased over three years of use. Risk of pelvic infection was low regardless of past medical history or baseline infection. ROSWELL, Ga., Oct. 30, 2023 /PRNewswire/ -- Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, today announced additional positive data from the pivotal Phase 3 open-label study of the investigational Copper 175 mm2 intra-uterine device (IUD). The data presented at three recent women's health scientific congresses provide further support for the investigational, next-generation, hormone-free IUD as exhibited in its pivotal phase 3 trial. Continue Reading "Sebela Women's Health remains encouraged by the additional analysis of the pivotal Phase 3 trial for what would be the first hormone-free IUD coming to market in almost 40 years." said Kelly Culwell, MD, Head of Research and Development at Sebela Women's Health. "In a study conducted by the non-profit group, HealthyWomen, 60% of the more than 5,000 respondents indicated they preferred a birth control without hormones, and effectiveness was the most important factor to both patients and their practitioners. This innovative investigational low-dose copper IUD clearly helps to fill a gap in the need for more than one hormone-free, long-acting, highly effective contraceptive option for women."1 Bleeding and pain dramatically decreased after the first three months. Post this About the Investigational Copper 175 mm 2 IUD The hormone-free Copper 175 mm2 IUD has a flexible frame made of nitinol, a material that has superelastic properties and allows for the copper to be strategically placed near the ostia of the fallopian tubes and the internal os of the cervix for proximal effect. 2-3 In the United States, the Copper 175 mm2 IUD utilizes the smallest hormone-free frame measuring 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. The sterile IUD does not require loading; it comes fully preloaded within a tapered, rounded tip inserter with a small insertion tube diameter of 3.7 mm. According to guidelines from the American College of Obstetrics and Gynecology, long-acting reversible contraceptives (LARC), or intrauterine devices and contraceptive implants, are among the most effective contraceptive methods, have few contraindications, and almost all patients are appropriate candidates for them.4 While there are a variety of contraceptive methods available to women in the U.S., 45% of pregnancies are unplanned.5 "As both a researcher and practitioner in the field of women's health, analysis of these additional data from the pivotal Phase 3 study of the investigational low-dose copper IUD is not only encouraging, but also important," said Principal Investigator David K. Turok, MD, MPH, Associate Professor, Department of Obstetrics and Gynecology, University of Utah. "Clinicians tend to believe that IUDs increase the risk of pelvic infection, and that the bleeding and pain experienced with hormone-free IUDs is long-lasting and leads to discontinuation of use. These data suggest we may need to re-visit some of our common beliefs about IUDs with this product, as well as expand our thinking to the many women who may actually be appropriate hormone-free IUD candidates based on this new data." Bleeding and Pain Dramatically Decreased After First Three Months "Bleeding and pain over time with a novel low-dose copper intrauterine device with a flexible nitinol frame" Society of Family Planning (SFP) Annual Meeting in Seattle, WA Oral Presentation by Dr. David Turok, Associate Professor of Obstetrics and Gynecology, Chief of the Division of Family Planning, University of Utah, Saturday, Oct. 28, 1:15 pm This post-hoc analysis of the Phase 3 study assessed participant bleeding and pain with use of the investigational hormone-free, low-dose copper (175mm2) IUD with a flexible nitinol frame. Treatment-emergent adverse events (TEAEs) related to bleeding or pain, their frequency over time, and the number resulting in study discontinuation at three years were assessed. In total, 1601 of 1620 (98.8%) enrolled participants had a successful IUD insertion. Heavy menstrual bleeding among participants decreased over time and was reported at months 0-3; 69.0%, >3-6; 25.0%, >6-12; 23.1%, >12-24; 8.9%, and >24-36; 4.7%. During this same timeframe, dysmenorrhea reports decreased similarly from 63.8% to 5.2%. Over three years of observation, bleeding or pain-related TEAEs (>1.0%) reported as the primary reason for study discontinuation were heavy menstrual bleeding (6.1%), dysmenorrhea (3.9%), pelvic discomfort (1.7%), and pelvic pain (1.3%). Similarly, IUD discontinuations due to bleeding and pain decreased over time. Phase 3 Pivotal Data "A Novel Low-Dose Copper Intrauterine Contraceptive with a Flexible Nitinol Frame (Copper 175mm2): Clinical Trials Overview" (Encore Data) Nurse Practitioners in Women's Health (NPWH) Annual Meeting in San Diego, CA Poster presentation by Dr. Anita Nelson, Essential Access Health, Monday, Oct. 30, 11:45 am This encore presentation reaffirmed the positive results of the pivotal Phase 3 study demonstrating the efficacy of the investigational Copper 175 mm2 IUD with a cumulative 3-year Pearl Index (number of pregnancies per 100 women over 1 year) of 0.96 (95% CI, 0.59-1.48) or 99% efficacy. This prospective study, which enrolled women of child-bearing potential from 42 centers across the United States, following the U.S. Food and Drug Administration's rigorous clinical trial standards of Good Clinical Practice, demonstrated the Copper 175 mm2 IUD was well tolerated. Both clinicians and study participants also reported positive experiences with placement of the IUD, with an overall placement success rate 98.8%. The intent-to-treat population included 1,620 women aged 17-45, 60.1 % nulliparous and 39.9% parous. The primary outcome for the study was contraceptive efficacy through 3 years of use, as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year). The study remains ongoing to assess use beyond 3 years. In the efficacy cohort (n=1397) representing subjects 35 years and younger, the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 0.96 (95% CI, 0.59-1.48). The most common adverse events were similar to those seen with use of IUDs – heavy menstrual bleeding, dysmenorrhea, and intermenstrual bleeding, with rates decreasing over time. Over three years, 15.4% discontinued for bleeding or pain adverse events (8.6% in the first year). Expulsion rates were low throughout the study, ranging from 2.4% in year 1 to 1.1% in year 3. Risk of Pelvic Infection Low Regardless of Past Medical History or Baseline Infection "Pelvic infection risk after insertion of a novel low-dose copper IUD with a flexible nitinol frame in participants with a history of chlamydia trachomatis (CT) or Neisseria Gonorrhoeae (NG)" American Society of Reproductive Medicine (ASRM) Scientific Congress in New Orleans, LA Oral presentation by David Turok, MD on Monday, Oct. 16, 1:30 pm CST This post-hoc analysis of the Phase 3 study assessed the risk for pelvic infection over three years after insertion of investigational Copper 175 mm2 IUD with a flexible nitinol frame. Data demonstrated that of the 1601 total study participants, only 1.2% developed an on-study pelvic infection overall. Of the 131 study participants with a past medical history or positive for CT/NG at screening, only 2.3% developed an on study pelvic infection. The majority of infections occurred more than a year into the study, most infections were treated as outpatient, and no infections resulted in IUD removal. About Sebela Pharmaceuticals® Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Sebela Women's Health has two next-generation intrauterine devices (IUDs) for contraception in the final stages of clinical development. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development including Tegoprazan which is in phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 300 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 844-732-3521. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, as amended, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, are based on current expectations, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. References 1. Jacquelyne Froeber. HealthyWomen. Taking Control: Our Recent Survey Says Women Want Regular Periods, No Hormones and More Communication About Contraceptives. Issued May10, 2023. Accessed October 11, 2023. 2. ClinicalTrials.gov. Evaluation of the Efficacy, Safety and Tolerability of VeraCept IUD. Updated June 23, 2022. Accessed September 23, 2022. 3. Turok DK, Nelson AL, Dart C, et al. Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: phase 2 data to 36 months. Obstet Gynecol. 2020;135(4):840-847. doi:10.1097/AOG.0000000000003756 4. ACOG, Clinical Practice Bulletin #186, Nov. 2017 reaffirmed 2021; Committee Statement #5, April 2023. Accessed on April 18, 2023: and 5. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med 2016;374(9):843-52, doi:10.1056/NEJMsa1506575 SOURCE Sebela Pharmaceuticals Inc

SUFLAVE™ offers the same efficacy as SUPREP® Bowel Prep Kit BRAINTREE, Mass., June 22, 2023 /PRNewswire/ -- Sebela Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) granted approval of SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution), for colonoscopy preparation in adults. SUFLAVE, a low-volume, safe and effective colonoscopy preparation – with a taste similar to a lemon-lime sports drink – was developed and will be marketed by Braintree Laboratories, a leader in gastroenterology and part of Sebela Pharmaceuticals. The current active screening rate in the United States for colorectal cancer (CRC) is 72%, leaving 28% unscreened, which contributes to 153,000 CRC diagnoses and more than 52,000 deaths annually.i,ii Colonoscopy is the most common detection method for colorectal cancer, a leading cause of cancer-related deaths that can be managed more effectively through screening and early detection.iii Successful colonoscopy screening is dependent upon adequate cleansing of the colon.iv Despite this, available methods of liquid preparation are not widely accepted by patients due to large volumes of poor-tasting solutions, resulting in low patient compliance and the need for repeat screenings. Additionally, colonoscopy preparation products and processes are commonly cited as a significant patient barrier to colon cancer screening,v reinforcing an unmet need among patients for better bowel preparation options. Tolerance of bowel preparation remains the largest deterrent for patients considering screening colonoscopy with 71% of patients saying it's the worst part of colonoscopy and 55% indicating it was the greatest deterrent to a future colonoscopy.vi Prep volume, palatability and patient education are three key factors in reducing prep hesitancy. "Patients frequently struggle with the taste and volume of traditional bowel preparations – and fear related to the preparation can also negatively impact patient willingness to undergo follow-up colonoscopy if it is indicated," said Douglas K. Rex, M.D., Distinguished Professor Emeritus at Indiana University School of Medicine and a full time practicing clinical gastroenterologist. "I believe the palatable lemon-lime flavor of SUFLAVE will be a welcomed option for patients – reducing preparation hesitancy and giving more people the chance to feel comfortable during preparation and getting a successful and effective procedure." In a head-to-head pivotal study versus SUPREP® Bowel Prep Kit, (sodium sulfate, potassium sulfate, and magnesium sulfate) Oral Solution, 94% of patients achieved successful bowel cleansing with SUFLAVE. The majority of patients reported that SUFLAVE tastes like a sports drink, and 79% of patients found the taste neutral to very pleasant compared to SUPREP (54%). Additionally, 87% of patients found SUFLAVE tolerable to very easy to consume, and 80% of patients reported that they would ask for SUFLAVE for a subsequent colonoscopy. Rates of gastrointestinal adverse events with SUFLAVE were low (<8%).vii "We believe in patient choice and are committed to improving the colon preparation process for patients. We are delighted with the FDA's approval of SUFLAVE – which has efficacy equivalent to SUPREP, but with taste similar to a sports drink," said Alan Cooke, President and CEO of Sebela Pharmaceuticals. "We are proud of the hard work and dedication of the Braintree team and the phase 3 trials investigator group who continue to bring new, better choices to people undergoing colonoscopy screening." SUFLAVE is the latest innovation in colonoscopy preparation from Braintree Laboratories. In November 2020, the FDA approved the company's tablet preparation, SUTAB®, which has had an excellent adoption record with use by over 2 million patients. SUFLAVE will be available by prescription to patients in the U.S. in early August. IMPORTANT SAFETY INFORMATION SUFLAVE™ (polyethylene glycol, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride for oral solution) is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. DOSAGE AND ADMINISTRATION: A low residue breakfast may be consumed on the day before colonoscopy, followed by clear liquids up to 2 hours prior to colonoscopy. Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion. Each bottle and one flavor-enhancing packet are equivalent to one dose. An additional 16 ounces of water must be consumed after each dose. Stop consumption of all fluids at least 2 hours before the colonoscopy. CONTRAINDICATIONS: Use is contraindicated in the following conditions: Gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUFLAVE. WARNINGS AND PRECAUTIONS: Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Suspected GI obstruction or perforation: Rule out the diagnosis before administration; Patients at risk for aspiration: Observe during administration; Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur. ADVERSE REACTIONS: Most common adverse reactions (> 2%) are: nausea, abdominal distension, vomiting, abdominal pain, and headache. DRUG INTERACTIONS: Drugs that increase risk of fluid and electrolyte imbalance. See Full Prescribing Information and Medication Guide About Sebela Pharmaceuticals Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Braintree, a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has multiple gastroenterology programs in late-stage clinical development including Tegoprazan which is in phase 3 trials for gastro-esophageal reflux disease (GERD), specifically, erosive esophagitis (EE) and non-erosive reflux disease (NERD). In addition, Sebela Women's Health has two next generation intra-uterine devices (IUDs) for contraception in the final stages of clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 800-874-6756. Forward-looking Statements This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of SUFLAVE™; growth and opportunity, including peak sales and the potential demand for SUFLAVE™, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Sebela Pharmaceuticals does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. For further information, contact: Logan Campbell, Red Havas [email protected] 1-724-987-2781 ______________ i Centers for Disease Control and Prevention. (2023, March 22). Colorectal (colon) cancer statistics. Center for Disease Control and Prevention. Retrieved June 12, 2023, from ii Colorectal cancer – statistics. Cancer.net (2023, February). Retrieved June 12, 2023, from iii Doubeni CA, Corley DA, Quinn VP, et al. Effectiveness of screening colonoscopy in reducing the risk of death from right and left colon cancer: a large community-based study. Gut. 2018;67(2):291-298 iv Harrison, N. M., & Hjelkrem, M. C. (2016). Bowel cleansing before colonoscopy: Balancing efficacy, safety, cost and patient tolerance. World journal of gastrointestinal endoscopy, 8(1), 4–12. v Romero, R. V., & Mahadeva, S. (2013). Factors influencing quality of bowel preparation for colonoscopy. World journal of gastrointestinal endoscopy, 5(2), 39–46. vi emulapalli KC, Lahr RE, Rex DK. 2021 Patient Perceptions Regarding Colonoscopy Experience. J Clin Gastroenterol. 2023 Apr 1;57(4):400-403. doi: 10.1097/MCG.0000000000001689. PMID: 35324481. vii Data on File, Braintree, MA: Braintree Laboratories, Inc. SOURCE Sebela Pharmaceuticals

If approved by the U.S. Food and Drug Administration, this newly designed, low-dose copper IUD could be the first hormone-free IUD in almost 40 years ROSWELL, Ga., May 18, 2023 /PRNewswire/ -- Sebela Women's Health Inc., a part of Sebela Pharmaceuticals, today announced positive results of a Phase 3 study demonstrating that investigational Copper 175 mm2 IUD — a next-generation, hormone-free, low-dose copper intrauterine device — met the primary efficacy outcome measurement of prevention of pregnancy through 3 years of use, with a cumulative 3-year Pearl Index (number of pregnancies per 100 women over 1 year) of 0.96 (95% CI, 0.59-1.48) or 99% efficacy. The study, which enrolled women of child-bearing potential from 42 centers across the United States, demonstrated the Copper 175 mm2 IUD was well tolerated. Both clinicians and study participants also reported positive experiences with placement of the IUD, with an overall placement success rate 98.8%. If approved by the FDA, this newly designed, low-dose copper IUD could be the first hormone-free IUD in almost 40 years. "We're excited to present positive data from our Phase 3 study of this innovative hormone-free intrauterine device," said Kelly Culwell, MD, Head of Research and Development at Sebela Women's Health. "It has been nearly 40 years since there has been a newly designed hormone-free IUD in the United States and we believe this will be a significant advancement not only in long-acting reversible birth control, but also in hormone-free contraception." Phase 3 Study Details The Copper 175 mm2 IUD was investigated in a Phase 3 prospective, multicenter, single-arm, open-label study. The study assessed 3-year outcomes of women aged 17-45 years at 42 centers across the United States. The intent-to-treat population included 1,620 women aged 17-45, 60.1 % nulliparous and 39.9% parous. The primary outcome for the study was contraceptive efficacy through 3 years of use, as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year). The study remains ongoing to assess use beyond 3 years. In the efficacy cohort (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 0.96 (95% CI, 0.59-1.48). The most common adverse events were similar to those seen with use of IUDs – heavy menstrual bleeding, dysmenorrhea, and intermenstrual bleeding. However, the Copper 175 mm2 IUD adverse events rates trended down over time. Over three years, 15.4% discontinued for bleeding or pain adverse events (8.6% in the first year). Expulsion rates were low throughout the study, ranging from 1.9% in year 1 to 0.9% in year 3. "This newly designed, flexible frame allows the Copper 175 mm2 IUD to prevent pregnancies using less than half the amount of copper used in the only other copper IUD on the market," said Principal Investigator David K. Turok, MD, MPH, Associate Professor, Department of Obstetrics and Gynecology, University of Utah. "The possibility of having another hormone-free IUD with low discontinuation rates due to pain and bleeding, as well as low expulsion rates, is exciting." Dr. Turok will be presenting a subset of the Copper 175 mm2 IUD Phase 3 data on May 21, 2023, at the ACOG Annual Clinical & Scientific Meeting in Baltimore, MD. The Copper 175 mm2 IUD has a flexible frame made of nitinol, a material which has superelastic properties and allows for the copper to be strategically placed near the ostia of the fallopian tubes and the internal os of the cervix for proximal effect. 1-3 The Copper 175 mm2 IUD frame measures 32 mm horizontally and 30 mm vertically with pre-cut retrieval strings. The sterile IUD does not require loading; it comes fully preloaded within a tapered rounded tip inserter with the small insertion tube diameter of 3.7 mm. According to guidelines from the American College of Obstetrics and Gynecology, long-acting reversible contraceptives (LARC), or intrauterine devices and contraceptive implants, are among the most effective contraceptive methods, they have few contraindications, and almost all patients are appropriate candidates for them.4 While there are a variety of contraceptive methods available to women in the U.S., 45% of pregnancies are unplanned.5 About Sebela Pharmaceuticals® Sebela Pharmaceuticals is a US pharmaceutical company with a market leading position in gastroenterology and a focus on innovation in women's health. Sebela Women's Health has two next-generation intrauterine devices (IUDs) for contraception in the final stages of clinical development. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, is the market leader in colonoscopy screening preparations for over 35 years, having invented, developed and commercialized a broad portfolio of innovative prescription colonoscopy preparations and multiple gastroenterology products. Braintree also has several gastroenterology programs in late-stage clinical development. Sebela Pharmaceuticals has offices/operations in Roswell, GA; Braintree, MA; and Dublin, Ireland; has annual net sales of approximately $200 million; and has grown to over 320 employees through strategic acquisitions and organic growth. Please visit sebelapharma.com for more information or call 844-732-3521. Forward Looking Statements This press release and any statements made for and during any presentation or meeting contain forward- looking statements related to Sebela Women's Health Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995, as amended, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of IUDs as described herein; growth and opportunity, including peak sales and the potential demand for these IUDs, as well as their potential impact on applicable markets; market size; substantial competition; our ability to continue as a growing concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties supply and manufacturing uncertainties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, are based on current expectations, and Sebela Women's Health Inc. does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. References 1. ClinicalTrials.gov. Evaluation of the Efficacy, Safety and Tolerability of VeraCept IUD. Updated June 23, 2022. Accessed September 23, 2022. 2. Turok DK, Nelson AL, Dart C, et al. Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: phase 2 data to 36 months. Obstet Gynecol. 2020;135(4):840-847. doi:10.1097/AOG.0000000000003756 3. U.S. Food & Drug Administration. Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol Guidance for Industry and Food and Drug Administration Staff. Issued on July 9, 2021. Accessed on October 8, 2022. 4. ACOG, Clinical Practice Bulletin #186, Nov. 2017 reaffirmed 2021; Committee Statement #5, April 2023. Accessed on April 18, 2023: and 5. Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008-2011. N Engl J Med 2016;374(9):843-52, doi:10.1056/NEJMsa1506575