Diclofenac Epolamine

BERWYN, Pa.--( BUSINESS WIRE )-- Virpax ® Pharmaceuticals, Inc. (“Virpax” or the “Company”) (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, today announced its financial results for the three months ended June 30, 2024, and other recent developments. “ After successful meetings at BIO in San Diego, we remain encouraged by the progress we have made in advancing our product candidates, identifying and applying for additional grants, and engaging in discussions for licensing and other opportunities with a steady stream of potential new partners,” stated Gerald W. Bruce, CEO of Virpax Pharmaceuticals. “ Last month we reported positive results from a pharmacokinetics and safety study in a Swine Model pilot study for our lead asset, Probudur™, our long-acting liposomal bupivacaine formulation for immediate and extended pain relief. This followed encouraging results from our Maximum Tolerated Dose study in Sprague-Dawley Rats that we announced at the end of April,” continued Mr. Bruce. “ We expect to announce additional results from our remaining studies in anticipation of our first-in-human trials.” “ Additionally, we were able to secure financing and pay off the remaining balance of our litigation settlement, removing the overhang on our stock and finally putting this issue firmly behind us. We also regained compliance with the minimum bid price requirement for continued listing on Nasdaq,” concluded Mr. Bruce. RECENT DEVELOPMENTS During July 2024, Virpax received proceeds of approximately $2.8 million from the issuance of approximately two million shares of common stock received from investors who exercised warrants received in the May 15 th public offering. On July 24, Virpax announced that it had received formal notice from the Listing Qualifications staff of The Nasdaq Stock Market indicating that Virpax had regained compliance with the minimum bid price requirement, one of the two Nasdaq citations received, for continued listing on the exchange. On July 10, Virpax announced results for a pharmacokinetics (PK) and safety study in a Swine Model pilot study for Probudur, Virpax’s long-acting liposomal bupivacaine formulation injected at a wound site to provide both immediate and extended pain relief. Probudur was subcutaneously injected into 4 juvenile domestic pigs at a dose of 30 mg/kg and was well-tolerated by all of the pigs and demonstrated a long-term, slow-release profile. Histopathology was also conducted at the injection site and Probudur was well-tolerated by all pigs in this study. On July 8, Virpax announced that it closed a $2.5 million secured loan financing from an institutional investor which enabled the final payment of its litigation settlement. As a condition of the financing, the Company’s Board of Directors has been reorganized, and has been reduced to seven members from eight. Four new board members were selected by the institutional investor and appointed to the Board, and five former Board members resigned. The loan was subsequently repaid in full on July 25 th from proceeds of warrants exercised by investors who participated in the Company’s May 15 th public offering. On June 3, 2024, Gerald W. Bruce, CEO of Virpax, delivered the corporate presentation at the Bio International Convention in San Diego and hosted numerous meetings with interested parties. On May 15, 2024, Virpax announced a public offering of 1,666,667 shares of common stock (or common stock equivalents in lieu thereof), Series A-1 common warrants to purchase up to 1,666,667 shares of common stock, and Series A-2 common warrants to purchase up to 1,666,667 shares of common stock, at a combined public offering price of $1.35 per share and associated Series A-1 common warrant to purchase one share of common stock and Series A-2 common warrant to purchase one share of common stock, for aggregate gross proceeds of approximately $2.25 million, before deducting placement agent fees and other offering expenses. The Series A-1 and A-2 warrants have an exercise price of $1.35 per share, will be exercisable immediately, and will expire five years and eighteen months from the initial issuance date, respectively. On April 30, 2024, Virpax announced the results of Maximum Tolerated Dose Study for Probudur. The dosing ranges were selected based on a prior preliminary study. All doses of Probudur were well-tolerated. There were no noteworthy effects on body weight, clinical chemistry, hematology, or coagulation. It was also observed that bupivacaine appears to be less toxic in the presence of liposomes than when administrated as a free drug. FINANCIAL RESULTS FOR THE THREE MONTHS ENDED JUNE 30, 2024 General and administrative expenses were $1.5 million for the three months ended June 30, 2024, compared to $1.9 million for the same period in 2023. The primary reason for the decrease in general and administrative costs was due to severance expense recorded for the three months ended June 30, 2023, related to our former CFO, which was not incurred in 2024, along with reduced stock option and Directors and Officers insurance expense. Research and development expenses were $2.0 million for the three months ended June 30, 2024, compared to $1.3 million for the same period in 2023. The increase was primarily attributable to $1.1 million related to preclinical activities for Probudur, the Company’s lead asset. This was partially offset by a decrease in AnQlar and Epoladerm preclinical activities, including credit for cancellation of a prior AnQlar contract. The operating loss for the three months ended June 30, 2024, was $3.5 million, compared to $3.1 million for the same period in 2023. On June 30, 2024, Virpax had cash of approximately $1.9 million. About Virpax Pharmaceuticals Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™ , which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking approval of two nonprescription product candidates: AnQlar , which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™ , which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit virpaxpharma.com and follow us on Twitter , LinkedIn and YouTube . Forward-Looking Statement This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms and include statement regarding announcing additional results from our remaining studies in anticipation of our first-in-human trials . These statements relate to future events and involve known and unknown risks, uncertainties, and other factors, including the Company’s ability to successfully complete research and further development and commercialization of Company drug candidates in current or future indications; the Company’s ability to obtain additional grants to help fund upcoming clinical trials; the Company’s ability to manage and successfully complete clinical trials and the research and development efforts for multiple product candidates at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals for the Company’s product candidates; the Company’s ability to protect its intellectual property; the Company’s ability to maintain its Nasdaq listing and cure the stockholder’s equity deficiency; the Company’s ability to obtain capital to meet its current and long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) June 30, 2024 December 31, 2023 ASSETS Current assets Cash $ 1,870,729 $ 9,141,512 Prepaid expenses and other current assets 719,880 486,833 Total current assets 2,590,609 9,628,345 Total assets $ 2,590,609 $ 9,628,345 LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY Current liabilities Accounts payable and accrued expenses $ 2,885,107 $ 1,694,024 Litigation liability 2,500,000 6,000,000 Total current liabilities 5,385,107 7,694,024 Total liabilities 5,385,107 7,694,024 Commitments and contingencies Stockholders’ (deficit) equity Preferred stock, par value $0.00001, 10,000,000 shares authorized; no shares issued and outstanding as of June 30, 2024, and December 31, 2023 — — Common stock, $0.00001 par value; 100,000,000 shares authorized, 2,837,898 shares issued and outstanding as of June 30, 2024; and 1,171,233 shares issued and outstanding as of December 31, 2023 28 12 Additional paid-in capital 63,420,289 61,478,444 Accumulated deficit (66,214,815 ) (59,544,135 ) Total stockholders’ (deficit) equity (2,794,498 ) 1,934,321 Total liabilities and stockholders’ (deficit) equity $ 2,590,609 $ 9,628,345 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) For the Three Months Ended June 30, For the Six Months Ended June 30, 2024 2023 2024 2023 OPERATING EXPENSES General and administrative (net of insurance reimbursement of $0 and $1,250,000 during the three and six months ended June 30, 2023 - See Note 5) $ 1,502,288 $ 1,948,700 $ 3,191,470 $ 2,364,151 Research and development 1,956,094 1,290,787 3,569,369 2,526,401 Total operating expenses 3,458,382 3,239,487 6,760,839 4,890,552 Loss from operations (3,458,382 ) (3,239,487 ) (6,760,839 ) (4,890,552 ) OTHER INCOME (EXPENSE) Interest expense (11,002 ) — (11,002 ) — Other income 19,128 126,720 101,161 257,251 Total other income 8,126 126,720 90,159 257,251 Net loss $ (3,450,256 ) $ (3,112,767 ) $ (6,670,680 ) $ (4,633,301 ) Basic and diluted net loss per share $ (1.75 ) $ (2.66 ) $ (4.24 ) $ (3.96 ) Basic and diluted weighted average common stock outstanding 1,977,093 1,171,233 1,574,163 1,171,233 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) For the Six Months Ended June 30, 2024 2023 CASH FLOWS FROM OPERATING ACTIVITIES Net loss $ (6,670,680 ) $ (4,633,301 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 145,229 358,840 Change in operating assets and liabilities: Prepaid expenses and other current assets (233,047 ) (469,003 ) Accounts payable and accrued expenses 885,559 552,180 Litigation liability (3,500,000 ) — Net cash used in operating activities (9,372,939 ) (4,191,284 ) CASH FLOWS FROM FINANCING ACTIVITIES Proceeds from public offering 2,249,993 — Payments for issuance costs (453,368 ) — Issuance of common stock upon exercise of pre-funded warrants 7 — Proceeds from insurance financing agreement 502,798 — Payments to insurance financing agreement (197,274 ) — Net cash provided by financing activities 2,102,156 — Net change in cash (7,270,783 ) (4,191,284 ) Cash, beginning of period 9,141,512 18,995,284 Cash, end of period $ 1,870,729 $ 14,804,000

公司介绍 苏州高迈药业有限公司成立于2018年，位于苏州工业园区纳米园；专注于外用药的药学研发（乳膏，软膏，凝胶，外用溶液，贴剂）； 团队由日本的技术、生产人员领衔，国内知名高校教授为顾问团队；核心管理人员均具有多年的研发管理经验；目前已有1个外用药项目获批；4个已经申报受理项目；2024年计划申报12个项目。 公司致力于“高端仿制”“改良型新药”“自主创新药”三步走战略，打造专业外用药“第一股”。 项目清单乳膏/软膏/凝胶类1、利丙双卡因乳膏(已获批)11、维氟醌乳膏(氟轻松氢醌维A酸乳膏)21、 磷酸芦可替尼乳膏31、复方多粘菌素B软膏2、阿达帕林凝胶(已注册申报)12、尿素乳膏22、复方倍他米松樟脑乳膏32、盐酸丁卡因凝胶3、夫西地酸乳膏(已注册申报)13、盐酸特比萘芬乳膏23、曲咪新乳膏33、壬二酸凝胶4、过氧苯甲酰凝胶(已注册申报)14、卢立康唑乳膏24、多磺酸粘多糖乳膏34、酮洛芬凝胶5、阿达帕林过氧苯甲凝胶(已注册申报)15、曲安奈德益康唑乳膏25、氟维司群乳膏35、雌二醇凝胶6、盐酸阿莫罗芬乳膏16、布洛芬乳膏26、克霉唑阴道乳膏36、黄体酮阴道缓释凝胶7、硝酸咪康唑乳膏17、阿昔洛韦氢化可的松乳膏27、莫匹罗星软膏37、盐酸利多卡因凝胶8、利多卡因丁卡因乳膏18、氢醌乳膏28、克立硼罗软膏38、硝呋太尔制霉菌素阴道软膏9、克拉司酮乳膏19、糠酸莫米松乳膏29、双唑泰乳膏10、伊维菌素乳膏20、丙酸氟替卡松乳膏30、卡泊三醇软膏贴剂1、利多卡因凝胶贴膏4、双氯芬酸依泊胺贴7、双氯芬酸二乙胺乳胶剂10、美沙拉嗪栓2、双氯芬酸钠贴剂5、洛索洛芬钠凝胶贴膏8、妥洛特罗贴剂11、奥昔布宁透皮贴剂3、氟比洛芬凝胶贴膏6、洛索洛芬钠贴剂9、雌二醇贴片 // 其他 1、非那雄胺喷雾剂 2、盐酸阿莫罗芬搽剂 3、联苯苄唑溶液 4、盐酸特比萘芬喷雾剂 5、盐酸特比萘芬涂膜剂 6、硝酸益康唑气雾剂 7、西甲硅油乳剂 8、利多卡因丙胺卡因气雾剂 9、艾氟康唑外用溶液 10、利多卡因喷雾剂 11、盐酸氨酮戊酸外用散 *绿色标色已经获批 *浅绿色表示已经申报 设备及资质 联系我们 联系人 ：曹总13861331380 ↓↓扫描下方二维码免费报名