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Achieve Life Sciences(ACHV) - 2020 Q1 - Quarterly Report
ACHVAchieve Life Sciences(ACHV)2020-05-14 11:46

Smoking Cessation Treatment - Cytisinicline is an established smoking cessation treatment with over 20 million users globally, including over 2,000 patients in Phase 3 clinical trials[99] - In the Phase 2b ORCA-1 trial, subjects on cytisinicline experienced a 74-80% median reduction in the number of cigarettes smoked compared to a 62% reduction in placebo arms[110] - The 3 mg TID dosing schedule for cytisinicline demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p<0.0001)[111] - The FDA agreed on the 3 mg TID dosing schedule for Phase 3 development following the ORCA-1 trial results[114] - The planned Phase 3 trial will assess smoking abstinence over 6-week and 12-week treatment periods, with secondary endpoints extending to 24 weeks[115] - Cytisinicline has shown no clinically significant drug interactions, allowing for co-administration with other medications[103] - The Phase 1 clinical study indicated that cytisinicline was well tolerated, with no severe adverse events reported[112] - The company aims to address the global smoking and nicotine addiction epidemic, which causes over 8 million deaths annually[98] Financial Performance - The company reported a net loss of 3.3millionforthethreemonthsendedMarch31,2020,withanaccumulateddeficitof3.3 million for the three months ended March 31, 2020, with an accumulated deficit of 49.0 million[118] - Cash and cash equivalents as of March 31, 2020, were 12.2million,withapositiveworkingcapitalbalanceof12.2 million, with a positive working capital balance of 11.4 million[118] - Research and development expenses decreased to 1.5millionforthethreemonthsendedMarch31,2020,downfrom1.5 million for the three months ended March 31, 2020, down from 4.1 million in the same period of 2019[132] - General and administrative expenses for the three months ended March 31, 2020, were 1.8million,comparedto1.8 million, compared to 1.9 million for the same period in 2019[133] - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[118] - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development of cytisinicline[119] - The company is uncertain about its ability to continue as a going concern without obtaining additional financing[119] - The company anticipates that its operating losses will fluctuate significantly from quarter to quarter and year to year due to the timing of clinical development programs[119] Financing Activities - The company has entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC, allowing it to sell up to 11.0millioninsharesofcommonstock[139]−ThecompanyhasengagedFreeMindGrouptoassistinsecuringnon−dilutivefundingforevaluatingcytisiniclineinreducingorceasingvaping[117]−ThecompanyextendedthetermofthePurchaseAgreementwithLPCfrom30monthsto54monthsandincreasedthenumberofsharesforRegularPurchasesfrom80,000to150,000[142]−FromSeptember14,2017,toMay14,2020,thecompanysoldatotalof557,378shares,generatinggrossproceedsofapproximately11.0 million in shares of common stock[139] - The company has engaged FreeMind Group to assist in securing non-dilutive funding for evaluating cytisinicline in reducing or ceasing vaping[117] - The company extended the term of the Purchase Agreement with LPC from 30 months to 54 months and increased the number of shares for Regular Purchases from 80,000 to 150,000[142] - From September 14, 2017, to May 14, 2020, the company sold a total of 557,378 shares, generating gross proceeds of approximately 4.4 million with offering expenses of 0.5million[143]−ThepublicofferingcompletedonDecember17,2019,raisedtotalgrossproceedsof0.5 million[143] - The public offering completed on December 17, 2019, raised total gross proceeds of 13.8 million, with net proceeds of 12.3millionafterdeducting12.3 million after deducting 1.5 million in underwriting discounts and commissions[156] - The company entered into a private placement on April 27-28, 2020, issuing approximately 5,615,653 units for aggregate gross proceeds of approximately 1.9million[158]−ThecompanydidnotofferanysharesforsaleundertheAtTheMarketOfferingAgreementfromJune7,2019,toMay14,2020,withapproximately1.9 million[158] - The company did not offer any shares for sale under the At The Market Offering Agreement from June 7, 2019, to May 14, 2020, with approximately 6.0 million remaining available for sale[148] - The Warrant Exercise Agreement with Armistice resulted in aggregate exercise proceeds of approximately 4.2millionfromtheexerciseofwarrantsfor1,107,813shares[149]AssetandLiabilityManagement−AsofMarch31,2020,totalassetsdecreasedto4.2 million from the exercise of warrants for 1,107,813 shares[149] Asset and Liability Management - As of March 31, 2020, total assets decreased to 16.6 million from 21.1millionasofDecember31,2019,primarilyduetocashandshort−terminvestmentsusedforoperations[166]−Totalliabilitiesdecreasedto21.1 million as of December 31, 2019, primarily due to cash and short-term investments used for operations[166] - Total liabilities decreased to 1.7 million as of March 31, 2020, from 3.0millionasofDecember31,2019,mainlyduetoloweremployeebonusaccrualsandtradepayables[166]−ForthethreemonthsendedMarch31,2020,netcashusedinoperatingactivitieswas3.0 million as of December 31, 2019, mainly due to lower employee bonus accruals and trade payables[166] - For the three months ended March 31, 2020, net cash used in operating activities was 4.5 million, a decrease from $4.9 million for the same period in 2019, attributed to reduced research and development expenses[160] - The company had no off-balance sheet financing arrangements as of March 31, 2020[163]