Achieve Life Sciences(US:ACHV)2019-08-08 20:53Financial Performance - The company reported a net loss of $9.5 million for the six months ended June 30, 2019, compared to a net loss of $5.8 million for the same period in 2018, with an accumulated deficit of $38.8 million as of June 30, 2019[124]. - The company has not generated any revenue from product sales to date and has incurred operating losses each year since inception[124]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for cytisinicline[125]. - The company has incurred an accumulated deficit of $38.8 million through June 30, 2019, and expects to incur substantial additional losses in the future[142]. - The company has not generated any revenue from product sales to date and may not do so in the near future[142]. Clinical Trials and Development - The Phase 2b ORCA-1 trial demonstrated a 74-80% median reduction in the number of cigarettes smoked among subjects on cytisinicline, compared to a 62% reduction in the placebo arms[120]. - The 3.0 mg TID cytisinicline treatment arm showed a 54% continuous abstinence rate starting at week 4, compared to 16% for placebo (p < 0.0001)[121]. - The FDA agreed to the company's Initial Pediatric Study Plan, providing a full waiver for evaluating cytisinicline in a pediatric population due to low numbers of children smoking under the age of 12[115]. - The company initiated a clinical study in June 2017 to evaluate the effect of food on the bioavailability of cytisinicline, which demonstrated similar bioavailability in fed and fasted subjects[113]. - The company has met with the FDA to discuss the steps required for the approval of cytisinicline, including plans for chronic toxicology and additional human studies[113]. Financial Position and Capital Needs - The company has a cash and cash equivalents balance of $10.4 million and a positive working capital balance of $7.8 million as of June 30, 2019[124]. - The company anticipates needing to raise substantial additional capital to fund its operations and clinical development activities[126]. - The company entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC, allowing it to sell up to $11.0 million in shares of common stock[147]. - During the three and six months ended June 30, 2019, the company sold 124,000 shares of common stock for gross proceeds of approximately $0.4 million[150]. - As of August 8, 2019, shares of common stock with an aggregate value of approximately $6.9 million remained available for sale under the offering program[150]. Expenses and Cash Flow - Research and development expenses for the three months ended June 30, 2019, increased to $2.0 million from $1.0 million in 2018, representing a 94% increase[139]. - For the six months ended June 30, 2019, research and development expenses rose to $6.1 million from $2.2 million in 2018, marking a 177% increase[139]. - General and administrative expenses for the three months ended June 30, 2019, decreased to $1.6 million from $1.8 million in 2018, a decline of 7%[141]. - For the six months ended June 30, 2019, general and administrative expenses decreased to $3.5 million from $3.6 million in 2018, a reduction of 1%[141]. - For the six months ended June 30, 2019, net cash used in operating activities was $8.7 million, an increase from $4.1 million in the same period of 2018, primarily due to higher R&D expenses[162]. - Net cash provided by financing activities for the same period in 2019 was $4.6 million, down from $13.9 million in 2018, reflecting proceeds from warrant exercises[163]. - Net cash provided by investing activities for the six months ended June 30, 2019, was $5.0 million, compared to net cash used of $26,000 in 2018[164]. Shareholder Activities - The company completed a public offering on June 19, 2018, selling 710,500 Class A Units at $4.00 each and 9,158 Class B Units at $1,000 each, raising approximately $12.2 million in net proceeds[151][152]. - From June 19, 2018, to August 8, 2019, all 9,158 shares of Series A Convertible Preferred Stock were converted into 2,289,500 shares of common stock, with no shares remaining outstanding[152]. - During the same period, 1,168,000 warrants were exercised at $4.00 each, generating approximately $4.7 million, leaving 2,282,000 warrants outstanding[153]. - The October 3, 2018 registered direct offering raised total gross proceeds of $5.6 million, with net proceeds of $5.0 million after expenses[154]. - The company entered into an At The Market Offering Agreement on June 7, 2019, allowing for the sale of up to $6.0 million in common stock[155][158]. Asset Management - As of June 30, 2019, the company reported a decrease in assets compared to December 31, 2018, primarily due to reduced cash and short-term investments used for operations[168]. - The fair value of new warrants issued in connection with a Warrant Exercise Agreement was recognized as $3.9 million in accumulated deficit as of June 30, 2019[161].