Financial Performance and Losses - Net loss for the three and nine months ended September 30, 2024 was $2.7 million and $4.6 million, respectively, with a $7.5 million non-cash R&D expense related to the Varian asset acquisition and a $14.6 million gain on debt extinguishment[236] - The company reported a net loss of $4.55 million for the nine months ended September 30, 2024, compared to a net loss of $15.14 million in the same period in 2023[268] - A gain on debt extinguishment of $14.59 million was recorded for the nine months ended September 30, 2024[268] - The company recognized a $14.5 million non-cash gain on debt extinguishment related to the Exchange and Termination Agreement with Deerfield Management Company L.P.[284] - The company recognized a $14.5 million non-cash gain on debt extinguishment during the three months ended September 30, 2024, related to the Exchange and Termination Agreement with Deerfield[320] Accumulated Deficit and Financing - Accumulated deficit as of September 30, 2024 was $848.8 million, with financing primarily through private placements, public offerings, and borrowings[236] - The company expects to continue to incur operating losses for at least the next several years and had an accumulated deficit of $848.8 million as of September 30, 2024[293] - Management has concluded substantial doubt exists about the company's ability to continue as a going concern for at least 12 months, with plans to secure additional capital through public or private securities offerings, convertible debt financings, and strategic transactions[296] Research and Development Expenses - Research and development expenses for the nine months ended September 30, 2024, increased by $8.8 million compared to the same period in 2023[268] - Research and development expenses for the nine months ended September 30, 2024 increased by $8.8 million to $14.1 million, primarily due to a $7.5 million non-cash charge related to the acquired IPR&D from the Varian asset purchase[270] - The istaroxime – cardiogenic shock program costs increased by $2.1 million for the nine months ended September 30, 2024 compared to the same period in 2023, driven by trial execution costs for the SEISMiC Extension study and start-up procedures for the SEISMiC C study[273] - Total direct clinical and preclinical programs expenses increased by $2.2 million for the nine months ended September 30, 2024 compared to the same period in 2023, primarily due to the istaroxime – cardiogenic shock program[272] Clinical Trials and Studies - Istaroxime demonstrated significant improvement in systolic blood pressure and cardiac function in the SEISMiC Extension study, with enrollment for the SEISMiC C study expected to complete by late 2025[230][241][242] - The SEISMiC C study is expected to enroll up to 100 subjects with SCAI Stage C cardiogenic shock, with an unblinded review of data from the first 20 subjects planned for early Q2 2025[230][242] - Rostafuroxin demonstrated efficacy in Caucasian patients in a Phase 2b trial for treatment-naïve hypertension, but an additional Phase 2 trial is needed for African American patients with treatment-resistant hypertension[246] Strategic Partnerships and Licensing - The company is pursuing licensing arrangements and strategic partnerships for rostafuroxin, a novel product candidate for hypertension treatment in patients with a specific genetic profile[232] - The company has regional licensed partnerships with Lee's Pharmaceutical (HK) Ltd. for the development and commercialization of istaroxime and other cardiovascular assets in Greater China[233] - The company is actively exploring licensing transactions, research partnerships, or other strategic opportunities to advance SERCA2a activator candidates[245] Intellectual Property and Patents - The company holds patents for dual mechanism and pure SERCA2a activators, with protection extending until 2038 and 2039, respectively[245] - Intangible assets as of September 30, 2024, included $22.34 million for istaroxime and $2.91 million for rostafuroxin[259] Preclinical and Oncology Research - The topical formulation of aPKCi inhibitor (VAR-101) showed dose-dependent anti-tumor activity in murine and human basal cell carcinoma (BCC) cell lines, supported by preclinical data from Cancer Research UK[247] - The oral formulation of aPKCi inhibitor (VAR-102) demonstrated dose-dependent anti-tumor activity in a mouse model of non-small cell lung cancer (NSCLC)[248] - The company plans to advance investigational new drug enabling activities for the aPKCi inhibitor platform acquired from Varian, with potential applications in oncology and rare malignant diseases[235] Stock and Financing Activities - The company implemented a 1-for-18 reverse stock split on April 19, 2024, to regain compliance with Nasdaq's minimum bid price requirement[249][252] - The company regained compliance with Nasdaq's Rule 5550(a)(2) on May 6, 2024, following the reverse stock split[252] - The company sold 1.4 million shares of Common Stock under the ELOC Purchase Agreement for net proceeds of $3.1 million during the three months ended September 30, 2024[294] - The company completed two private placement transactions in July 2024 for aggregate gross proceeds of approximately $13.9 million, with net proceeds of $2.3 million[294] - The company entered into the ELOC Purchase Agreement in June 2024, allowing it to sell up to $35 million of newly issued shares of common stock over a 36-month period[306] - For the three months ended September 30, 2024, the company sold 1.4 million shares of common stock under the ELOC Purchase Agreement for gross proceeds of $4.4 million[307] - The company's April 2023 public offering resulted in gross proceeds of approximately $12.4 million, with net proceeds of $10.8 million after deducting underwriting discounts and commissions[311][312] - During the nine months ended September 30, 2024, the company sold 143,120 shares of common stock under the 2023 ATM Program, resulting in aggregate gross and net proceeds of approximately $1.4 million[317] Cash Flow and Liabilities - Net cash used in operating activities for the nine months ended September 30, 2024 was $11.7 million, primarily driven by a net loss of $4.6 million and a $14.6 million gain on debt extinguishment[299] - Net cash provided by financing activities for the nine months ended September 30, 2024 was $9.6 million, including $4.4 million from the ELOC Purchase Agreement and $3.9 million from private placements[302] - As of September 30, 2024, the company had cash and cash equivalents of $2.3 million and current liabilities of $14.4 million, including an $8.6 million warrant liability[295] - The company financed $0.5 million of insurance premiums in August 2024 at a 7.94% fixed annual interest rate, with monthly payments of approximately $56,000 due through May 2025[318] Goodwill and Intangible Assets - Goodwill impairment losses totaled $3.1 million for the nine months ended September 30, 2023, with goodwill written down to zero as of June 30, 2023[258] - Intangible assets as of September 30, 2024, included $22.34 million for istaroxime and $2.91 million for rostafuroxin[259] General and Administrative Expenses - Clinical, medical, and regulatory operations expenses decreased by $0.8 million for the nine months ended September 30, 2024 compared to the same period in 2023, due to a $0.7 million decrease in personnel costs and a $0.1 million decrease in non-cash stock-based compensation[280] - General and administrative expenses decreased by $0.8 million for the nine months ended September 30, 2024 compared to the same period in 2023, driven by reductions in personnel costs, severance costs, non-cash stock-based compensation, and insurance costs[283] Off-Balance Sheet Arrangements - The company did not have any material off-balance sheet arrangements as of September 30, 2024 or 2023[322]
Windtree Therapeutics(WINT) - 2024 Q3 - Quarterly Report