Financial Performance - Total revenue for the three months ended September 30, 2024, was $2,257,000, compared to $2,217,000 for the same period in 2023, representing a 1.8% increase[15] - Gross profit for the nine months ended September 30, 2024, was $3,990,000, down from $4,043,000 in the same period of 2023, a decrease of 1.3%[15] - Net loss for the three months ended September 30, 2024, was $3,547,000, compared to a net loss of $4,706,000 for the same period in 2023, a reduction of 24.6%[15] - For the nine months ended September 30, 2024, the company incurred a net loss of $11,706,000 and used cash in operations of $11,092,000[26] - Operating expenses decreased by $1.9 million for the nine months ended September 30, 2024, compared to the same period in 2023[163] Assets and Liabilities - Total current assets decreased to $4,113,000 as of September 30, 2024, from $5,280,000 as of December 31, 2023, a decline of 22.1%[12] - Current liabilities increased to $5,466,000 as of September 30, 2024, compared to $5,119,000 as of December 31, 2023, an increase of 6.8%[12] - Total liabilities decreased to $7,279,000 as of September 30, 2024, from $8,627,000 as of December 31, 2023, a decrease of 15.6%[12] - As of September 30, 2024, the company had an accumulated deficit of approximately $530,009,000 and a working capital deficit of approximately $1,353,000[26] Capital Raising and Stock Activity - The company issued 1,248,527 common shares under 2024 Securities Purchase Agreements, raising additional capital[16] - The Company entered into a 2024 At-the-Market Offering agreement to sell shares of common stock with an aggregate sales price of up to $4,450,000, with a commission rate of 3.0% on gross proceeds[81] - The Company sold 1,650,473 shares in the 2023 Direct Offering, resulting in gross proceeds of approximately $4,716,000 before deducting expenses of $597,000[106] - The Company has the right to sell up to $10,000,000 of common stock under the 2023 Equity Line of Credit Agreement with Lincoln Park[113] - The Company sold 1,310,517 shares under the 2023 Equity Line of Credit Agreement for gross proceeds of approximately $3,078,000 as of September 30, 2024[118] Compliance and Regulatory Issues - The Company received a deficiency letter from Nasdaq on July 1, 2024, indicating that its Market Value of Listed Securities was below the minimum requirement of $35 million for continued inclusion on the Nasdaq Capital Market[30] - On October 17, 2024, Nasdaq notified the Company that the bid price for its common stock had closed below the minimum $1.00 per share for the last 30 consecutive business days, resulting in non-compliance with the listing requirement[31] - The Company has a 180-day period until April 15, 2025, to regain compliance with the minimum bid price requirement, which necessitates the closing bid price to meet or exceed $1.00 per share for at least ten consecutive business days[31] - The company received another deficiency letter from Nasdaq on October 17, 2024, for its common stock bid price falling below $1.00, with a compliance deadline of April 15, 2025[192] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $2,766,000, down from $2,958,000 in the same period of 2023, a decrease of 6.5%[15] - The company is developing a new non-invasive test for endometriosis, targeting a market that affects over 6.5 million women in the U.S.[162] - The company was awarded up to $10 million in milestone-based funding from ARPA-H to develop a multi-marker blood test for endometriosis[193] Product and Market Expansion - The company commercializes blood test products including Ova1Plus and OvaWatch, with Ova1 intended to assess malignancy likelihood in women with ovarian masses[165] - The addressable market for the company's tests increased to between 2 and 4 million tests per year following the expansion of the OvaWatch test features[158] - The company plans to broaden its commercial focus to include differential diagnosis of various gynecological diseases beyond ovarian cancer[145] - In November 2024, the company expanded its distribution agreement with BioReference to include OvaWatch, enhancing its market presence in New York[166] Shareholder and Stock Option Information - The weighted average common shares used to compute basic and diluted net loss per common share increased to 15,405,672 for the three months ended September 30, 2024, from 9,776,436 for the same period in 2023[15] - The weighted average exercise price of outstanding options under the 2010 Plan as of September 30, 2024, was $28.11[125] - The weighted average exercise price of outstanding options under the 2019 Plan as of September 30, 2024, was $7.15[129] - Total unrecognized compensation cost related to unvested stock option awards was approximately $551,000 as of September 30, 2024[135] Sales and Revenue Growth - Product revenue for Q3 2024 was $2,257,000, a 2% increase from $2,217,000 in Q3 2023, driven by a 4% increase in OvaSuite test volume[206][207] - The number of OvaSuite tests performed increased to 6,001 in Q3 2024 from 5,783 in Q3 2023[207] - Gross profit margin for product revenue improved to 60.0% in Q3 2024, up from 59.0% in Q3 2023, due to increased revenue and decreased costs[210]
Aspira Women’s Health (AWH) - 2024 Q3 - Quarterly Report