Financial Report Evaluator - grade based

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3y ago

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genreport

string

"Achieve Life Sciences, Inc. Buy
(ACHV – $0.81 – intraday) Price Target: $1
Positive Trial Results and Strong Pipeline; Maintain Buy Rating
Quarter and Outlook – Achieve Life Sciences reported positive Phase 2 ORCA-V1 clinical trial results for cytisinicline, a treatment for vaping cessation. The trial showed statistically significant benefits for cytisinicline compared to placebo, with a vaping cessation rate of 31.8% for the treatment group compared to 15.1% for the placebo group. The results were consistent across different demographics and clinical trial sites. Achieve is on track to report topline results from the Phase 3 ORCA-3 trial in the second quarter. The company's cash, cash equivalents, and restricted cash were $16.6 million as of March 31, 2023.
Our Take – Achieve Life Sciences continues to make progress in the development of cytisinicline for smoking cessation and vaping cessation. The positive results from the ORCA-V1 trial demonstrate the potential of cytisinicline as a treatment for e-cigarette cessation, addressing a growing market with no available options. With the upcoming ORCA-3 trial results expected this quarter, Achieve is well-positioned to move forward with an NDA submission and potential commercialization. We maintain our Buy rating on Achieve Life Sciences.
HIGHLIGHTS
• Positive Trial Results – Achieve reported positive Phase 2 ORCA-V1 clinical trial results for cytisinicline, showing a statistically significant benefit for vaping cessation compared to placebo. The vaping cessation rate was 31.8% for the treatment group compared to 15.1% for the placebo group.
• Strong Pipeline – Achieve is on track to report topline results from the Phase 3 ORCA-3 trial in the second quarter. The trial is evaluating the efficacy and tolerability of cytisinicline for smoking cessation.
• Financial Position – As of March 31, 2023, Achieve had cash, cash equivalents, and restricted cash of $16.6 million, providing runway into late-2023.
INVESTMENT THESIS AND VALUATION
Achieve Life Sciences is making significant progress in the development of cytisinicline for smoking cessation and vaping cessation. The positive results from the ORCA-V1 trial demonstrate the potential of cytisinicline as a treatment for e-cigarette cessation, addressing a growing market with no available options. With the upcoming ORCA-3 trial results expected this quarter, Achieve is well-positioned to move forward with an NDA submission and potential commercialization. We maintain our Buy rating on Achieve Life Sciences.
Valuation – Our price target of $1 is based on a discounted cash flow analysis, taking into account the potential market opportunity for cytisinicline in smoking cessation and vaping cessation. We believe that Achieve's strong pipeline and positive trial results warrant a higher valuation."

report

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Achieve Life Sciences, Inc. Buy  (ACHV – $6.24) Price Target: $19   
ORCA-3 Delivers Catalyst For Regulatory And Partnership  Activity, Cash Runway Extended; Adjusting PT To $19  
Last week, ACHV reported ORCA-3 topline data supporting cytisinicline’s strong  profile and confirming ORCA-2 results. An equity raise extends the Company’s cash  runway into 3Q24. We view the clinical and regulatory pathways substantially de risked and expect partnership/acquisition discussions to accelerate. We affirm our  Buy rating and have adjusted our price target to $19 from $22. 
OUR OPINION 
Working under the assumption ORCA-3 data would confirm ORCA-2, the lead-up  to the data release brought with it two questions: 1) how quickly could a  partnership/acquisition transaction be completed and 2) how much additional  capital, if any, would the Company need in the interim? We now know ORCA-3  confirmed ORCA-2 and the raise, we estimate, will extend the cash runway into  3Q24 and should remove financing overhang. Given limited visibility into ongoing  discussions, predicting timing is challenging. That said, it would seem to us any  partner/acquirer would prefer to be engaged in the NDA submission (guided to  1H24), which would put a deal on a similar timeline, likely slightly ahead. In our  view, an acquisition or partnership is the optimal scenario for ACHV shareholders  to maximize the blockbuster potential of cytisinicline. We remain buyers of ACHV,  particularly with the stock having traded down following the ORCA-3 data. 
Price Target Change – We are adjusting our price target to reflect shares issued in  the recent capital raise. We derive our price target of $19 by applying a 5x EV  multiple to our FY27 revenue estimate of $147.4M and discounting back. 
ORCA-3 DATA 
• Primary Endpoints – In the 6- and 12-week arms, cytisinicline statistically  significantly improved the odds of quitting by 2.9 and 4.4 times, respectively.  • Secondary Endpoints – In the 6- and 12-week arms, cytisinicline statistically  
significantly improved the odds of quitting over a 6-month period by 6.3 and 5.8  times, respectively.  
6-Week 
Primary Endpoint Secondary Endpoint 
Cyt Placebo Odds p-value Cyt Placebo Odds p-value ORCA-2 25.3% 4.4% 8.0x <0.0001 8.9% 2.6% 3.7x =0.0016 
ORCA-3 14.8% 6.0% 2.9x =0.0008 6.8% 1.1% 6.3x =0.0006 
12-Week 
Primary Endpoint Secondary Endpoint 
Cyt Placebo Odds p-value Cyt Placebo Odds p-value ORCA-2 32.6% 7.0% 6.3x <0.0001 21.1% 4.8% 5.3x <0.0001 
ORCA-3 30.3% 9.4% 4.4x <0.0001 20.5% 4.2% 5.8x <0.0001

• Efficacy in Context – ORCA-3 primary endpoint data were impressive in isolation  and confirm its relative and comparative performance (below, we are using  primary endpoint data for ORCA-2 and ORCA-3).

ORCA-2 
ORCA-3

NRT 
Bup 
Var 
Cyt 
6-Wk 
12-Wk 
6-Wk 
12-Wk
Odds  
Ratio
1.84 
1.82 
2.88 
3.98 
8.0 
6.3 
2.9 
4.4

NRT – nicotine replacement therapy; Bup – bupropion (Zyban); Var – varenicline (Chantix);  Cyt – cytisine / cytisinicline; Source: Cochrane 2013, 2016 and Achieve Life Sciences 
• Adverse Events – ORCA-3 data reaffirmed cytisinicline’s adverse event profile with  no new safety signals. 
CASH RUNWAY 
On May 17, 2023, the Company announced the refinancing of its debt facility with  SVB, delaying maturity to December 2024 from December 2023. Last week, the  Company issued 3M shares at $5.50/share, netting approximately $15.2M. Together,  we estimate these actions extend the Company’s cash runway into 3Q24. We have  updated our model to reflect the transaction. 
INVESTMENT THESIS AND VALUATION  
Achieve Life Sciences is conducting pivotal clinical program for cytisinicline in smoking  cessation. Achieve hopes to leverage the compound’s efficacy and safety history,  along with recent clinical studies, into a commercial asset in the United States,  capable of taking on, and potentially beating, Chantix. With an immediately  addressable market of over 1.3 million patients in the US, we believe ACHV is well positioned to drive value for patients and shareholders alike over the long-term. We  derive our price target of $19 by applying a 5x EV multiple to our FY27 revenue  estimate of $147.4M and discounting back.

financereport

string

Achieve Life Sciences Reports Financial Results for First Quarter 2023 and Provides Corporate Update Tuesday, May 09, 2023 08:05:00 PM (GMT) 
Company to host conference call at 4:30 PM EDT today, May 9, 2023 
SEATTLE and VANCOUVER, British Columbia, May 09, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced first quarter 2023 financial results and provided an update on the cytisinicline development program. 
Recent Business Highlights 
Released positive Phase 2 ORCA-V1 clinical trial results showing statistically significant vaping cessation benefit for cytisinicline 
Announced accomplishment of key milestones, including last subject dosing and last subject visit, in the Phase 3 ORCA-3 trial evaluating cytisinicline for smoking cessation 
Presented additional analyses from the Phase 3 ORCA-2 trial at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting 
Appointed three new members to Achieve’s Board of Directors 
“We are excited about our start to 2023, announcing statistically significant trial results from ORCA-V1 in April, and on-track to report topline results from the Phase 3 ORCA-3 trial in the second quarter,” stated John Bencich, Chief Executive Officer of Achieve. “We continue to believe in the tremendous potential of cytisinicline to become the first new FDA-approved treatment for smoking cessation in nearly twenty years, and now with the results of ORCA-V1, the possibility of becoming the first treatment specifically indicated for e-cigarette cessation.” 
ORCA-V1 E-Cigarette Cessation Benefit for Cytisinicline 
Achieve announced successful results from the Phase 2 ORCA-V1 trial in April 2023. Trial participants who received 12 weeks of cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping during the last 4 weeks of treatment compared to subjects who received placebo (p=0.035). The vaping cessation rate during weeks 9 through 12 was 31.8% for those who received cytisinicline treatment compared to 15.1% for those who received placebo. A benefit in favor of cytisinicline was consistently observed across the secondary endpoints and was observed across clinical trial sites and demographics such as age, gender, race, or whether they had smoked cigarettes in the past. Cytisinicline was well tolerated and no serious adverse events were reported. 
Phase 3 ORCA-3 Last Subject Dosed/Last Subject Visit Completed 
In January 2023 and March 2023, the final subject was dosed, and the last subject last visit was completed, respectively, in the ongoing Phase 3 ORCA-3 trial. ORCA-3 enrolled 792 adults who smoke cigarettes across 20 clinical trial locations in the United States. Study participants were randomized to receive either 6 or 12 weeks of cytisinicline treatment or placebo, and all participants received standard behavioral support for the duration of the study. The primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment and the trial will be determined successful if either cytisinicline treatment arm shows a statistical benefit compared to placebo. Topline results are on track to be reported in the second quarter of 2023. 
Cytisinicline Data Presentation at SRNT Annual Meeting 
In April 2023, additional analyses from the Phase-3 ORCA-2 trial were reported at the SRNT Annual Meeting confirming that successful smoking cessation was observed in subgroups of people who smoke that received cytisinicline, regardless of age, gender, smoking history, or previous quit attempts. Subjects who received either 6 or 12 weeks of cytisinicline treatment experienced consistently higher rates of smoking cessation. The improvement was observed by the second week of treatment and maintained weekly throughout study treatment and during the 24-week follow-up period; such improvement was not observed in those who received placebo. Study compliance was high with 82% of subjects completing the 12 weeks of treatment. No treatment-related serious adverse events were reported and the majority of adverse events were mild in all subjects. 
Three New Members Appointed to Board of Directors 
In March 2023, the Company announced a refresh to the Board of Directors with the appointment of three new directors, Mr. Stuart Duty, Mr. Thomas King, and Mr. Tom Sellig. The new directors bring extensive capital markets, strategic transaction, sales, marketing, and manufacturing expertise in the pharmaceutical and life sciences industries. 
Financial Results 
As of March 31, 2023, the Company’s cash, cash equivalents, and restricted cash was $16.6 million. Total operating
expenses for the first quarter ended March 31, 2023 were $8.6 million. Total net loss for the first quarter ended March 31, 2023 was $9.0 million. As of May 9, 2023, Achieve had 18,040,760 shares outstanding. 
Conference Call Details 
Achieve will host a conference call at 4:30 PM EDT today, Tuesday, May 9, 2023. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (866) 682-6100 (U.S. & Canada) or (862) 298-0702 (International) and referencing conference ID 13738142. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days. 
About Achieve and Cytisinicline 
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2 
In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.3In 2022, approximately 2.5 million middle and high school students in the United States reported using e-cigarettes.4 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. 
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. 
Forward Looking Statements 
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic conditions, including inflation, rising interest rates, instability in the global banking sector, and public health crises, such as the COVID-19 pandemic and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. 
Investor Relations Contact 
Nicole Jones 
achv@cg.capital 
(404) 736-3838 
Media Contact 
Glenn Silver 
Glenn.Silver@Finnpartners.com 
(646) 871-8485 
References 
1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 
2 U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
3 Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 
4 Park Lee E, Ren C, Cooper M, Cornelius M, Jamal A, Cullen KA. Tobacco Product Use Among Middle and High School Students – United States, 2022. Morbidity and Mortality Weekly Report, 2022; 71:45. 
Consolidated Statements of Loss 
(In thousands, except per share and share data) 
Three months ended March 31, 
2023 2022 
Operating expenses: 
Research and development 5,534 4,388 General and administrative 3,044 2,838 Total operating expenses 8,578 7,226 
Loss from operations (8,578) (7,226) Other income (expense) (414) (347) Net loss $ (8,992) $ (7,573) 
Basic and diluted net loss per share $ (0.50) $ (0.80) Weighted average number of basic and diluted common shares 17,917,769 9,458,745 
Consolidated Balance Sheets 
(In thousands) 
March 31, December 31, 
2023 2022 
Assets: 
Cash and cash equivalents $ 16,514 $ 24,771 Prepaid expenses and other current assets 1,710 2,559 Other assets and restricted cash 68 123 Right-of-use assets 109 66 License agreement 1,363 1,418 Goodwill 1,034 1,034 Total assets $ 20,798 $ 29,971 
Liabilities and stockholders' equity: 
Accounts payable and accrued liabilities $ 3,872 $ 5,470 Current portion of long-term obligations 58 58 Convertible debt 16,371 16,071 Long-term obligations 54 69 Stockholders' equity 443 8,303 Total liabilities and stockholders' equity $ 20,798 $ 29,971 
Primary Identifiers: ACHV-US 
Related Identifiers: ACHV-US 
Subjects: Earnings Releases and Operating Results

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Financial Report Evaluator - grade based

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