Citric Acid/Lactic Acid/Potassium Bitartrate

— Pharma 1 Targets Mid-2025 Regulatory Submission in UAE for SOLOSEC to Treat Bacterial Vaginosis and Trichomoniasis — SAN DIEGO, May 21, 2025 /PRNewswire/ -- Women's health innovator Evofem Biosciences, Inc. (OTCPK: EVFM) and private Emirati health care company Pharma 1 Drug Store LLC have signed a License and Supply Agreement for the Middle East rights to SOLOSEC® (secnidazole) 2 g oral granules, Evofem's FDA-approved single-dose oral treatment for two common sexual health conditions. Consideration to Evofem for the exclusive commercial rights to SOLSOEC in the Territory includes an upfront payment, payments on achievement of certain regulatory milestones, and sales-based milestone payments. Once approved, Evofem will supply SOLOSEC to Pharma 1 for sale in the Territory at cost-plus. "SOLOSEC offers a convenient 'one-and-done' oral treatment for two common sexual health conditions, bacterial vaginosis (BV) and trichomoniasis, which affect millions of people in the member states of the Gulf Cooperation Council (GCC)," said Abdulwahab Atfah, CEO of Pharma 1 Drug Store. "We are pleased to secure exclusive commercial rights to SOLOSEC in the Territory and eager to file for regulatory approval of SOLOSEC in the United Arab Emirates (UAE) this summer." "In addition to its strong brand identity, SOLOSEC is manufactured in the United States, which holds considerable value in markets where trust in quality, regulatory rigor, and prescriber confidence are key differentiators," added Mr. Atfah. "We applaud Pharma 1's focus on sexual health, particularly in women, and are excited to expand our strong relationship beyond PHEXXI to now include SOLOSEC," said Evofem CEO Saundra Pelletier. "We are confident that Pharma 1 is the right partner to effectively launch and commercialize SOLOSEC in the UAE and surrounding region." Studies in the Middle East and North Africa (MENA) region have reported BV prevalence ranging from 25% to 41%. A systematic review and meta-analysis of global BV prevalence among reproductive-aged women in the general population found that one in four women in MENA have BV1. In the UAE alone, this represents between 1.0 million and 1.7 million women. Despite the availability of anti-infectives approved to treat Trichomonas vaginalis, the parasite that causes trichomoniasis, in 2020 the WHO estimated 156.3 million new cases of trichomoniasis worldwide: 73.7 million in females and 82.6 million in males.3 Undiagnosed infections and lack of compliance with multi-day treatment regimens are critical contributing factors. A meta-analysis of evidence sourced from 263 international, regional, and national databases found that MENA has a substantial trichomoniasis prevalence, with approximately 4.7% of women in the general population affected by this sexually transmitted infection (STI).2 Trichomoniasis was more common in intermediate- and high-risk populations (17.2% and 10.3%, respectively) and among symptomatic women (13.9%). Under the terms of the agreement, Pharma 1 will have the exclusive commercialization rights for PHEXXI in the Middle East, including the UAE, Kuwait, Saudi Arabia, Qatar and certain other countries in the region. Pharma 1 will be responsible for obtaining and maintaining any regulatory approvals required to market and sell SOLOSEC, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. About Bacterial Vaginosis Bacterial vaginosis (BV), the most common cause of vaginal discharge in reproductive-age women1, is associated with multiple consequential adverse outcomes including an increased risk of adverse birth outcomes, acquisition of human immunodeficiency virus and other STIs, pelvic inflammatory disease, and a high incidence of symptomatic recurrence.4 A study published in the New England Journal of Medicine in 2025 provided evidence that BV is in fact an STI.5 About Trichomoniasis Trichomoniasis (or "Trich") is an STI caused by infection with Trichomonas vaginalis, a protozoan parasite. It is the most common nonviral STI globally, affecting an estimated 156 million men and women worldwide. 3 The CDC notes that up to 70% of people infected with Trich are unaware that they are infected and may unwittingly pass the parasite to sexual partners.6 Untreated infections might last from months to years. In women, Trich can cause a foul-smelling vaginal discharge, genital itching, and pain with urination or sex. Trich is also associated with an increased risk for cervical cancer, infertility, HIV acquisition, and, among women with HIV infection, pelvic inflammatory disease (PID). Pregnant women who have Trich might be at higher risk of delivering their babies prematurely. Men who have Trich typically have no symptoms, however when men do have symptoms these may include itching or irritation inside the penis, burning with urination or after ejaculation and discharge from the penis.2 About SOLOSEC SOLOSEC® (secnidazole) 2 g oral granules is a single dose oral 5-nitroimidazole drug. It is FDA-approved for the treatment of two sexual health diseases: Bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and Trichomonas vaginalis, 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. About Evofem Biosciences Evofem Biosciences, Inc. is commercializing two FDA-approved products to address unmet needs in women's sexual and reproductive health: PHEXXI and SOLOSEC. 2024 was its fourth consecutive year of net sales growth. PHEXXI® and SOLOSEC® are registered trademarks of Evofem Biosciences, Inc. About Pharma 1 Pharma 1 Drug Store is an Emirati company dedicated to providing practical solutions, backed by scientific studies and accurate surveys, that cater to the ever-evolving healthcare needs of people in the GCC and support development of a healthier community. Pharma 1 are agents to a growing number of pharmaceutical companies, with a variety of commercial products and medications in process with the Ministry of Health and Prevention. Learn more at https://pharma1ds.com/. Sources 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. Words such as, but not limited to, "anticipate," "aim," "believe," "contemplate," "continue," "could," "design," "estimate," "expect," "intend," "may," "might," "plan," "possible," "potential," "predict," "project," "seek," "should," "suggest," "strategy," "target," "will," "would," and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include but are not limited to expected timing of the planned filing for regulatory approval of SOLOSEC in the UAE. 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, 2024 filed with the SEC on March 24, 2025, amended on March 28, 2025, and any subsequent Form 10-Q 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. araskopf@evofem.com (917) 673-5775 SOURCE Evofem Biosciences, Inc.

WARRINGTON, Pa., May 16, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the first quarter ended March 31, 2025 and provided key business updates. “The first quarter of 2025 was marked with significant progress. We announced our new corporate strategy to become a revenue generating company by seeking to identify and acquire revenue-generating FDA-approved assets while advancing our cardiology and oncology pipeline,” said Jed Latkin, Chief Executive Officer of Windtree. Mr. Latkin continued, “We believe that this strategy has the potential to transform Windtree into both a commercial and development stage company that generates revenue, helps patients and enhances our attractiveness to shareholders. The Company entered into an initial strategic transaction for a right to buy a revenue-generating multifamily residential property. Leveraging off our firm partnership in China we are helping a rapidly growing biopharmaceutical company lower their costs of production by almost 65%. We anticipate the partnership should start generating revenues by the end of 2026. We continue to develop our pipeline, including the ongoing enrollment of subjects in the istaroxime cardiogenic shock SCAI Stage C study. We plan an interim analysis of the first 20 subjects in Q3 2025. This study, when completed, is intended to advance the program to Phase 3 in cardiogenic shock, a condition with significant mortality and morbidity. Drug innovation in cardiogenic shock is desired, and we believe that istaroxime has the potential to provide unique benefits over other currently available drugs. We look forward to continued communication with our shareholders on our progress on all our initiatives.” Key Business Updates Announced a late-breaking clinical science abstract presentation on istaroxime at the Technology and Heart Failure Therapeutics Conference. Entered into a license and supply agreement to become the sourcing partner for Evofem Biosciences, Inc. for PHEXXI® (lactic acid, citric acid and potassium bitartrate), a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. The Company intends to leverage its manufacturing contacts to reduce pharmaceutical product cost of goods for PHEXXI. Announced a strategic transaction to drive revenue generation in support of our ongoing therapeutic pipeline development. The initial transaction provides the right to buy the target asset which may provide consistent revenue to the Company while it continues to develop its biotech pipeline drug candidates. The transaction is an assignment and conditional assumption agreement with a seasoned real estate investment group pursuant to which the Company has gained the rights to purchase a 436 unit, multifamily residential property in Houston, Texas. Closed on a private placement transaction in April 2025 and May 2025 for aggregate gross proceeds of approximately $2.6 million related to the issuance of Series D convertible preferred stock. Regained Nasdaq compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. The Company will be subject to a mandatory panel monitor until March 20, 2026. Continued expansion of our patent estate for istaroxime with the granting of a notice of allowance in acute heart failure by the United States Patent and Trademark Office as well as a patent filing in India. For the preclinical oncology aPKCi inhibitor, a patent was issued for Japan. Select First Quarter 2025 Financial Results For the fiscal quarter ended March 31, 2025, the Company reported an operating loss of $4.1 million compared to an operating loss of $4.4 million in the first quarter of 2024. Research and development expenses were $2.3 million for the first quarter of 2025, compared to $2.3 million for the first quarter of 2024. Research and development expenses primarily relate to the continued development of istaroxime for the treatment of early cardiogenic shock, including costs related to the SEISMiC C trial during the first quarter of 2025 and costs related to the SEISMiC Extension trial during the first quarter of 2024. General and administrative expenses for the first quarter of 2025 were $1.8 million, compared to $2.1 million for the first quarter of 2024. The $0.3 million decrease in general and administrative expenses is due to a decrease of $0.2 million in professional fees, primarily related to reduced legal fees and a decrease of $0.1 million in non-cash stock-based compensation expense. The Company reported a net loss attributable to common stockholders of $5.0 million ($4.63 per basic share) on 1,088,564 weighted-average common shares outstanding for the quarter ended March 31, 2025, compared to net income of $10.2 million ($1,099.37 per basic share) on 9,295 weighted average common shares outstanding for the comparable period in 2024. As of March 31, 2025, the Company reported cash and cash equivalents of $1.2 million and current liabilities of $6.5 million. We believe that we have sufficient resources available to fund our business operations through May 2025. Readers are referred to, and encouraged to read in its entirety, the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which was filed with the Securities and Exchange Commission on May 15, 2025, and includes detailed discussions about the Company’s business plans and operations, financial condition, and results of operations. About Windtree Therapeutics, Inc.Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue-generating company and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include, among other things: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company's risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the Company's ability to maintain compliance with the continued listing requirements of Nasdaq; the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in the Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contact Information: Eric Curtisecurtis@windtreetx.com WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIESConsolidated Balance Sheets (in thousands, except share and per share data) March 31, 2025 December 31, 2024 (Unaudited) ASSETS Current assets: Cash and cash equivalents $1,173 $1,779 Prepaid expenses and other current assets 421 795 Total current assets 1,594 2,574 Property and equipment, net 94 111 Restricted cash 9 9 Operating lease right-of-use assets 939 1,051 Intangible assets 24,130 24,130 Total assets $26,766 $27,875 LIABILITIES, MEZZANINE EQUITY & STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $3,110 $1,879 Accrued expenses 1,785 1,706 Operating lease liabilities - current portion 519 508 ELOC commitment note payable - 328 Derivative liability - ELOC commitment note - 299 Senior secured notes payable 374 - Common stock warrant liability 162 305 Loans payable 167 333 Other current liabilities 359 359 Total current liabilities 6,476 5,717 Operating lease liabilities - non-current portion 519 653 Other liabilities 3,800 3,800 Deferred tax liabilities 4,643 4,528 Total liabilities 15,438 14,698 Mezzanine equity: Series C redeemable preferred stock, $0.001 par value; 18,820 shares authorized; 2,833 and 11,757 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively 1,038 3,181 Series B redeemable preferred stock, $0.001 par value; 5,500 shares authorized; 0 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively - - Total mezzanine equity 1,038 3,181 Stockholders’ equity: Preferred stock, $0.001 par value; 4,975,680 shares authorized; 0 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively - - Common stock, $0.001 par value; 120,000,000 shares authorized; 3,555,954 and 256,397 shares issued and 3,555,953 and 256,396 shares outstanding at March 31, 2025 and December 31, 2024, respectively 4 - Additional paid-in capital 863,995 859,660 Accumulated deficit (850,655) (846,610)Treasury stock (at cost); 1 share (3,054) (3,054)Total stockholders’ equity 10,290 9,996 Total liabilities, mezzanine equity & stockholders’ equity $26,766 $27,875 WINDTREE THERAPEUTICS, INC. AND SUBSIDIARIES Consolidated Statements of Operations (in thousands, except share and per share data) Three Months Ended March 31, 2025 2024 Expenses: Research and development $2,270 $2,253 General and administrative 1,820 2,152 Total operating expenses 4,090 4,405 Operating loss (4,090) (4,405) Other income (expense): (Loss) gain on debt extinguishment, net (22) 14,520 Change in fair value of common stock warrant liability 134 - Interest income 7 30 Interest expense (20) (13)Other (expense) income, net (54) 201 Total other income, net 45 14,738 (Loss) income before income taxes (4,045) 10,333 Income tax expense - (114)Net (loss) income $(4,045) $10,219 Dividends on Series C preferred stock (998) - Net (loss) income attributable to common stockholders $(5,043) $10,219 Net (loss) income per share attributable to common stockholders Basic and diluted $(4.63) $1,099.37 Weighted average number of common shares outstanding Basic and diluted 1,088,564 9,295