INFORMATION REGARDING FORWARD LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements involve a number of risks and uncertainties. We
caution readers that any forward-looking statement is not a guarantee of future
performance and that actual results could differ materially from those contained
in the forward-looking statement. These statements are based on current
expectations of future events. Such statements include, but are not limited to,
statements about future financial and operating results, plans, objectives,
expectations and intentions, costs and expenses, interest rates, outcome of
contingencies, financial condition, results of operations, liquidity, business
strategies, cost savings, objectives of management, the impact of the COVID-19
pandemic on our business and other statements that are not historical facts. You
can find many of these statements by looking for words like “believes,”
“expects,” “anticipates,” “estimates,” “may,” “should,” “will,” “could,” “plan,”
“intend” or similar expressions in this Quarterly Report on Form 10-Q or in
documents incorporated by reference into this Quarterly Report on Form 10-Q. We
intend that such forward-looking statements be subject to the safe harbors
created thereby. Examples of these forward-looking statements include, but are
not limited to:
• progress and preliminary and future results of any clinical trials;
• anticipated regulatory filings, requirements and future clinical trials;
• the effects of the COVID-19 pandemic on our business and financial results;
• timing and plans for the expansion of our focus to address other methods
of nicotine addiction;
• timing and amount of future contractual payments, product revenue and
operating expenses; and
• market acceptance of our products and the estimated potential size of
these markets.
These forward-looking statements are based on the current beliefs and
expectations of our management and are subject to significant risks and
uncertainties. If underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results may differ materially from current
expectations and projections. Factors that might cause such a difference include
those discussed in Item 1A “Risk Factors,” as well as those discussed elsewhere
in the Quarterly Report on Form 10-
reliance on these forward-looking statements, which speak only as of the date of
this Quarterly Report on Form 10-Q or, in the case of documents referred to or
incorporated by reference, the date of those documents.
All subsequent written or oral forward-looking statements attributable to us or
any person acting on our behalf are expressly qualified in their entirety by the
cautionary statements contained or referred to in this section. We do not
undertake any obligation to release publicly any revisions to these
forward-looking statements to reflect events or circumstances after the date of
this Quarterly Report on Form 10-Q or to reflect the occurrence of unanticipated
events, except as may be required under applicable
update one or more forward-looking statements, no inference should be drawn that
we will make additional updates with respect to those or other forward-looking
statements.
Overview
We are a clinical-stage pharmaceutical company committed to the global
development and commercialization of cytisinicline for smoking cessation and
nicotine addiction. Our primary focus is to address the global smoking and
nicotine addiction epidemic, which is a leading cause of preventable death and
is responsible for more than eight million deaths annually worldwide. We also
plan to expand our focus to address other methods of nicotine addiction such as
e-cigarettes/vaping.
Our management team has significant experience in growing emerging companies
focused on the development of under-utilized pharmaceutical compounds to meet
unmet medical needs. We intend to use this experience to develop and ultimately
commercialize cytisinicline either directly or via strategic collaborations.
Cytisinicline is an established smoking cessation treatment that has been
approved and marketed in Central and
years. We have an exclusive license and supply agreement with Sopharma for the
development and commercialization of cytisinicline outside of Sopharma’s
territories which are predominately located in Central and
estimated that over 20 million people have used cytisinicline to help treat
nicotine addiction, including over 2,700 smokers in investigator-conducted,
Phase 3 clinical trials in
in the
the journal Addiction in
Cytisinicline is a naturally occurring, plant-based alkaloid. Cytisinicline is
structurally similar to nicotine and has a well-defined, dual-acting mechanism
of action that is both agonistic and antagonistic. It is believed to aid in
smoking cessation and the treatment of
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nicotine addiction by interacting with nicotine receptors in the brain by
reducing the severity of nicotine withdrawal symptoms through agonistic effects
on nicotine receptors and by reducing the reward and satisfaction associated
with nicotine through antagonistic properties.
In 2018, the
non-proprietary, or generic, name for the substance also known as cytisine.
We have no products approved for commercial sale and have not generated any
revenue from product sales to date. We have never been profitable and have
incurred operating losses in each year since inception. Our net loss was
million
working capital balance of
30, 2021
Cytisinicline Ongoing and Recent Clinical Developments
Clinical Trials
Ongoing Company-Sponsored Clinical Trials
In
evaluating the efficacy and safety of 3 mg cytisinicline dosed three times daily
compared to placebo in adult smokers at 17 clinical sites in
ORCA-2 participants have been randomized to one of three study arms to determine
the smoking cessation efficacy and safety profile of cytisinicline administered
for either 6 or 12 weeks, compared to placebo. All subjects receive standard
behavioral support and have been assigned to one of the following groups:
• Arm A: 12 weeks of placebo • Arm B: 6 weeks of cytisinicline, followed by 6 weeks of placebo • Arm C: 12 weeks of cytisinicline
The primary outcome measure of success in the ORCA-2 trial is biochemically
verified continuous abstinence during the last 4 weeks of treatment in the 6 and
12-week cytisinicline treatment arms compared to placebo. Each treatment arm
will be compared independently to the placebo arm, and the trial will be
determined to be successful if either or both of the cytisinicline treatment
arms show a statistical benefit compared to placebo. Secondary outcome measures
will be conducted to assess continued abstinence rates through 6 months from the
start of study treatment. In
its enrollment target of 750 adult smokers. A total of 810 adult smokers were
randomized and the study is closed to further enrollment. Topline ORCA-2 data
results are expected to be reported within the first half of 2022.
Completed Company-Sponsored Clinical Trials
In
trial and defined the dose selection of 3 mg, three times daily, or TID, for our
Phase 3 development. ORCA-1 was the first trial in our
Cytisinicline for Addiction Program, or ORCA Program, that aims to evaluate the
effectiveness of cytisinicline for smoking cessation, nicotine addiction
therapy, and potential benefit in other indications.
ORCA-1 was initiated in
States
standard declining titration schedule as well as a more simplified TID dosing
schedule, both over 25 days. The trial was randomized and blinded to compare the
effectiveness of the cytisinicline doses and schedules to respective placebo
groups. Subjects were treated for 25 days, provided behavioral support, and
followed up for an additional four weeks to assess continued smoking abstinence
after the 25-day treatment.
The primary endpoint in the study was the reduction in daily smoking, a
self-reported measure. Three of the four cytisinicline treatment arms
demonstrated a statistically significant reduction, p<0.05, compared to placebo.
The fourth arm trended to significance (p= 0.052). Across all treatment arms,
over the 25-day treatment period, subjects on cytisinicline experienced a 74-80%
median reduction in the number of cigarettes smoked, compared to a 62% reduction
in the placebo arms.
The secondary endpoint of the trial was a 4-week continuous abstinence rate,
which is the relevant endpoint for regulatory approval. All cytisinicline
treatment arms showed significant improvements in abstinence rates compared to
the placebo arms. The most impressive results were observed in the 3 mg TID
cytisinicline arm which demonstrated a 50% abstinence rate at week 4, compared
to
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10% for placebo (p<0.0001) and a continuous abstinence rate, weeks 5 through 8,
of 30% for cytisinicline compared to 8% for placebo (p= 0.005). At week 4, all
four cytisinicline arms demonstrated statistically significant (p<0.05)
reductions in expired carbon monoxide, or CO, a biochemical measure of smoking
activity. Expired CO levels had declined by a median of 71-80% in the
cytisinicline treatment arms, compared to only 38% in the placebo arms. The
greater reductions in expired CO levels for the cytisinicline arms versus
placebo suggest that placebo-treated subjects may have over-reported their
reduction in cigarettes smoked or overcompensated with greater inhalation while
smoking fewer cigarettes.
Cytisinicline was well-tolerated with no serious adverse effects, or AEs,
reported. The most commonly reported (>5%) AEs across all cytisinicline
treatment arms versus placebo arms were abnormal dreams, insomnia, upper
respiratory tract infections, and nausea. In the 3 mg TID treatment arm versus
placebo arms, the most common AEs were abnormal dreams, insomnia, and
constipation (each 6% vs 2%), upper respiratory tract infections (6% vs 14%),
and nausea (6% vs 10%), respectively. Compliance with study treatment was
greater than 94% across all arms.
We presented the ORCA-1 results in
of the
Norway
Research
selected 3 mg TID for Phase 3 development. Overall, the 3 mg dose administered
TID demonstrated the best overall safety and efficacy when compared to other
doses and administrations studied in ORCA-1. At the SRNT European meeting held
in
treatment had an earlier onset of sustained abstinence compared to placebo and
that the cytisinicline TID schedule appeared more effective for achieving
sustained abstinence in smokers who had previously failed to quit on
varenicline compared to the titration schedule.
In
Administration
Phase 3 clinical program using the simplified 3 mg TID dosing schedule. The FDA
agreed that the 3 mg TID dosing schedule was acceptable. We also discussed with
the FDA timing for the submission of the 13-Week interim report from the second
ongoing chronic toxicology study to support the longer treatment durations of 6-
and 12-weeks in the Phase 3 clinical program. This interim chronic toxicology
report was submitted to the FDA in the second quarter of 2020.
Completed Investigator-Sponsored Clinical Trial
In
investigator-sponsored Phase 3 RAUORA trial. RAUORA was a non-inferiority study
comparing cytisinicline to Chantix® (varenicline) in M?ori (indigenous New
Zealanders) and wh?nau (family) of M?ori. The study was led by Dr.
Walker
subjects. In total, 1,105 M?ori or wh?nau expressed interest in participating in
the study and a total of 679 were randomized to receive either cytisinicline or
varenicline. The average age of participants in the trial was 43 years and
approximately 70% of the participants were women.
The study compared cytisinicline administered on a schedule of 25 days of
downward dosing titration followed by twice-daily dosing for a total of 12 weeks
with varenicline administered on a schedule of seven days of upward titration
followed by twice-daily dosing for a total of 12 weeks. The primary endpoint was
a comparison of biochemically confirmed continuous abstinence rates at 6 months,
and the trial was designed to assess if the two agents were non-inferior to each
other.
The primary endpoint of the non-inferiority trial was to demonstrate that
cytisinicline quit rates would be no less than 10% lower than the quit rates for
varenicline. Topline results indicated that the RAUORA trial achieved its
primary endpoint in showing that cytisinicline plus behavioral support was at
least as effective as varenicline plus behavioral support at 6 months.
Cytisinicline met the pre-specified non-inferiority endpoint and was trending
towards superiority with an Absolute Risk Difference of +4.29 in favor of
cytisinicline (95% CI -0.22 to 8.79), demonstrating a 4.29% improvement in quit
rates in favor of cytisinicline. Specifically, continuous abstinence rates at 6
months, verified by exhaled carbon monoxide, were 12.1% for cytisinicline
compared to 7.9% for varenicline. The Relative Risk was 1.55 on an
intent-to-treat basis, indicating that subjects in the cytisinicline arm were
approximately one and a half times more likely to have quit smoking at 6 months
compared to subjects who received varenicline.
Additionally, significantly fewer overall adverse events were reported in
cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65,
p<0.001). Notably, of the subjects who experienced adverse events, cytisinicline
subjects reported significantly less nausea, insomnia and vivid dreams (p<0.05).
The final RAUORA trial results and additional analyses were presented at the
SRNT European Annual Meeting in
Addiction in
of Cambridge Department of Biochemistry
in vitro binding characteristics of cytisinicline compared to varenicline at the
human 5-HT3 receptor. Using a radioligand antagonist displacement design, the
study reported an IC50 of 0.50 mM for cytisinicline and 0.25 µM for varenicline,
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representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor
for varenicline compared to cytisinicline. Agonist activation of 5-HT3 receptors
in the brain stem has been shown to induce nausea and vomiting. The data
demonstrating the difference in binding potency at the 5-HT3 receptor provide
potential rationale for the lower overall incidence of adverse events reported
for cytisinicline compared to varenicline.
Planned Company-Sponsored Clinical Trials
In early 2022, we plan to initiate the Phase 3 ORCA-3 clinical trial. ORCA-3
will mirror the ORCA-2 trial in study design, safety/efficacy evaluations, and
statistical criteria and will serve as the second required Phase 3 trial to
support licensure of cytisinicline in
participants will be similarly randomized to one of three study arms to
determine the smoking cessation efficacy and safety profile of cytisinicline
administered for either 6 or 12 weeks, compared to placebo. The primary outcome
measure of success in the ORCA-3 trial will also be biochemically verified
continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week
cytisinicline treatment arms compared to placebo. Each treatment arm will be
compared independently to the placebo arm, and the trial will be determined to
be successful if either or both of the cytisinicline treatment arms show a
statistical benefit compared to placebo. Secondary outcome measures will be
conducted to assess continued abstinence rates through 6 months from the start
of study treatment.
In
Institute on Drug Abuse
to evaluate the use of cytisinicline as a treatment for cessation of nicotine
e-cigarette use. This initial grant award, in the amount of
on
clinical operational activities, such as protocol finalization, clinical trial
site identification, and submission of a new IND to the FDA for investigating
cytisinicline in nicotine e-cigarette users. In
the FDA has completed their review and accepted the IND application to
investigate cytisinicline as a cessation treatment in this population. Following
expect to receive the next stage of the grant award of approximately
million
2022 to evaluate cytisinicline in approximately 150 adult nicotine e-cigarette
users in
cover approximately half of the ORCA-V1 clinical study costs. The Primary
Investigators for the grant are Achieve’s Chief Medical Officer, Dr.
Jacobs
and Director,
Hospital
The use of e-cigarettes continues to be widespread, with most recent reports
from the
adult users in
historically viewed as less harmful than combustible cigarettes, their long-term
safety remains controversial. In a recent study that we conducted surveying
approximately 500 users of nicotine vaping devices or e-cigarettes,
approximately 73% of participants responded that they intend to quit vaping
within the next three to 12 months. Of those who intended to quit even sooner,
within the next 3 months, more than half stated they would be extremely likely
to try a new prescription product to help them do so.
We believe that cytisinicline, if approved, could be the first prescription drug
indicated for vape and e-cigarette users who are ready to quit their nicotine
addiction.
Non-clinical
Non-clinical toxicology studies were sponsored by the
Complementary
Application, or IND. We filed our IND application for cytisinicline with the
FDA, which included the NCCIH sponsored non-clinical studies.
Non-clinical toxicology studies that will be required for a New Drug
Application, or NDA, include two longer-term chronic toxicology studies and two
carcinogenicity studies, which are in distinct stages of execution as
company-sponsored studies. Two chronic toxicology studies have been completed
and submitted to the FDA. Additionally, one of two carcinogenicity studies has
been completed, while the second carcinogenicity study is currently in
progress.
Impact of COVID-19 Pandemic
The extent of the impact of the COVID-19 pandemic on our operational and
financial performance will depend on certain developments, including the
duration of the outbreak, impact on our clinical studies, employee or industry
events, and effect on our suppliers, service providers and manufacturers, all of
which are uncertain and cannot be predicted. As a result of the Covid-19
pandemic, we may experience disruptions in our operations, liquidity, supply
chain, facilities, and clinical trials. We may in the future experience more
significant delays in enrollment, participant dosing, distribution of clinical
trial materials, study monitoring and data analysis that could materially
adversely impact our business, results of operations and overall financial
performance in future periods.
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Specifically, we may experience impact from changes in how we and companies
worldwide conduct business due to the COVID-19 pandemic, including but not
limited to restrictions on travel and in-person meetings, delays in site
activations and enrollment of clinical trials, prioritization of hospital
resources toward pandemic effort, delays in review by the FDA, and disruptions
in our supply chain for our product candidates. As of the filing date of this
Quarterly Report on Form 10-Q, the extent to which the COVID-19 pandemic has
impacted our financial condition, results of operations or guidance has been
minimal. The effect of any additional COVID-19 pandemic issues will not be fully
reflected in our results of operations and overall financial performance until
future periods. See the section titled “Risk Factors” for further discussion of
the possible impact of the COVID-19 pandemic on our business.
License & Supply Agreements
Sopharma License and Supply Agreements
We are party to a license agreement, or the Sopharma License Agreement, and a
supply agreement, or the Sopharma Supply Agreement, with Sopharma, AD, or
Sopharma. Pursuant to the Sopharma License Agreement, we were granted access to
all available manufacturing, efficacy and safety data related to cytisinicline,
as well as a granted patent in several European countries related to new oral
dosage forms of cytisinicline providing enhanced stability. Additional rights
granted under the Sopharma License Agreement include the exclusive use of, and
the right to sublicense, certain cytisincline trademarks in all territories
described in the Sopharma License Agreement. Under the Sopharma License
Agreement, we agreed to pay a nonrefundable license fee. In addition, we agreed
to make certain royalty payments equal to a mid-single digit percentage of all
net sales of cytisinicline products in our territory during the term of the
Sopharma License Agreement, including those sold by a third party pursuant to
any sublicense which may be granted by us. To date, any amounts paid to Sopharma
pursuant to the Sopharma License Agreement have been immaterial.
In
Bristol
Bristol License Agreement
the
research activities into cytisinicline and its derivatives, including a number
of patent applications related to novel approaches to cytisinicline binding at
the nicotinic receptor level.
In consideration of rights granted by the
nominal license fee and agreed to pay amounts of up to
aggregate, tied to a financing milestone and to specific clinical development
and commercialization milestones resulting from activities covered by the
commercialize any product candidates subject to the
License Agreement
digits and payments up to a percentage in the mid-teens of any sublicense
income, subject to specified exceptions, based upon net sales of such licensed
products.
On
to the
human medicinal uses of cytisinicline across all therapeutic categories from the
derivatives. In consideration of rights granted by the amended
Bristol License Agreement
the execution of the amended
additional amounts of up to
milestone and to specific clinical development and commercialization milestones
resulting from activities covered by the amended
Agreement
License Agreement
financing, development and commercialization milestones. Additionally, if we
successfully commercialize any product candidate subject to the amended
License Agreement
digits and payments up to a percentage in the mid-teens of any sublicense
income, subject to specified exceptions, based upon net sales of such licensed
products. Up to
Research and Development Expenses
Research and development, or R&D, expenses consist primarily of costs for
clinical trials, contract manufacturing, personnel costs, milestone payments to
third parties, facilities, regulatory activities, non-clinical studies and
allocations of other R&D-related costs. External expenses for clinical trials
include fees paid to clinical research organizations, clinical trial site costs
and patient treatment costs.
We manage our clinical trials through contract research organizations and
independent medical investigators at our sites and at hospitals and expect this
practice to continue. Due to our ability to utilize resources across several
projects, we do not record or
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maintain information regarding the indirect operating costs incurred for our R&D
programs on a program-specific basis. In addition, we believe that allocating
costs on the basis of time incurred by our employees does not accurately reflect
the actual costs of a project.
We expect our R&D expenses to increase for the foreseeable future as we continue
to conduct our ongoing non-clinical studies, and initiate new clinical trials
and registration-enabling activities. The process of conducting clinical trials
and non-clinical studies necessary to obtain regulatory approval is costly and
time consuming and we may never succeed in achieving marketing approval for
cytisinicline. (See “Item 1A. Risk Factors-Risks Related to the Development of
Our Product Candidate Cytisinicline.”)
Successful development of cytisinicline is highly uncertain and may not result
in an approved product. We cannot estimate completion dates for development
activities or when we might receive material net cash inflows from our R&D
projects, if ever. We anticipate we will make determinations as to which
markets, and therefore, which regulatory approvals, to pursue and how much
funding to direct toward achieving regulatory approval in each market on an
ongoing basis in response to our ability to enter into new strategic alliances
with respect to each program or potential product candidate, the scientific and
clinical success of each future product candidate, and ongoing assessments as to
each future product candidate’s commercial potential. We will need to raise
additional capital and may seek additional strategic alliances in the future in
order to advance our various programs.
Our projects or intended R&D activities may be subject to change from time to
time as we evaluate results from completed studies, our R&D priorities and
available resources.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries and related
costs for our personnel in executive, finance and accounting, corporate
communications and other administrative functions, as well as consulting costs,
including market research, business consulting, human resources and intellectual
property. Other costs include professional fees for legal and auditing services,
insurance and facility costs.
Results of Operations
For the three and nine months ended
Research and development expenses
Our R&D expenses for our clinical development program for the three and nine
months ended
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
Clinical development programs:
Cytisinicline $ 4,591 $ 1,891 $ 19,460 $ 4,535
Total research and development expenses
R&D expenses for the three and nine months ended
for the three and nine months ended
increase in the 2021 periods as compared to the 2020 periods was primarily due
to costs incurred as a result of enrollment and ramp up of activity in our Phase
3 ORCA-2 trial that was initiated in the fourth quarter of 2020 and was fully
enrolled by the middle of 2021.
General and administrative expenses
Our general and administrative expenses for the three and nine months ended
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
Total general and administrative expenses
General and administrative expenses for the three and nine months ended
from
30, 2020
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increase was primarily due to higher employee expenses associated with
stock-based compensation, increase in premiums for insurance and clinical trial
media and awareness expenses.
Liquidity and Capital Resources
We have incurred an accumulated deficit of
2021
operate our business and continue or expand our R&D activities and other
operations. We have not generated any revenue from product sales to date, and we
may not generate product sales revenue in the near future, if ever. As of
and a positive working capital balance of
existing cash, cash equivalents and restricted cash, will be sufficient for us
to fund our current operating expenses and capital expenditures into 2023. This
forecast includes our anticipated costs of the ORCA-2 and our portion of the
ORCA-V1 trials, but does not include the costs of other future clinical trials
such as ORCA-3.
We have historically financed our operations through equity financings. While we
believe that we will be able to settle our commitments and liabilities in the
normal course of business as they fall due during the next 12 months, as a
development-stage company with no current sources of revenue, we are dependent
on our ability to raise funds (through public or private securities offerings,
debt financings, government funding or grants, or other sources, which may
include licensing, collaborations or other strategic transactions or
arrangements) to support the ongoing advancement of our clinical trials and
corporate activities.
Lincoln Park Capital Equity Line
On
into a share and unit purchase agreement, which was amended on
or the Purchase Agreement, pursuant to which we have the right to sell to LPC up
to
subject to certain limitations and conditions set forth in the Purchase
Agreement. On
to sell shares of our common stock to LPC in excess of 20% of our outstanding
shares of common stock (as of the date we entered into the Purchase Agreement)
in order to be able to sell to LPC the full amount remaining under the Purchase
Agreement.
Pursuant to the Purchase Agreement, LPC initially purchased 1,644 of our units,
or the Units, at a purchase price of
of (a) one share of our common stock and (b) one warrant to purchase one-quarter
of a share of common stock at an exercise price of
Warrant. Each Warrant became exercisable six months following the issuance date
until the date that is five years and six months after the issuance date and is
subject to customary adjustments. The Warrants were issued only as part of the
Units in the initial purchase of
connection with any other purchases of common stock under the Purchase
Agreement.
After the initial purchase, if our stock price is above
other business day over the 54-month term of the Purchase Agreement, and up to
an aggregate amount of an additional
limitations) of shares of common stock, we have the right, from time to time, in
our sole discretion and subject to certain conditions to direct LPC to purchase
up to 7,500 shares of common stock. The purchase price of shares of common stock
pursuant to the Purchase Agreement will be based on prevailing market prices of
common stock at the time of sales without any fixed discount, and we will
control the timing and amount of any sales of common stock to LPC. As
consideration for entering into the Purchase Agreement, we issued to LPC 617
shares of common stock in
of the Purchase Agreement in
expense reimbursement. The consideration of 617 shares of our common stock were
fair valued based on the closing price of our common stock as at the transaction
date and recognized as part of offering expenses.
During the nine months ended
of our common stock pursuant to the Purchase Agreement with LPC. Since entry
into the Purchase Agreement, from
we offered and sold an aggregate of 27,868 shares of our common stock, including
the 1,644 shares that were part of the initial purchase of Units. These
aggregate sales resulted in gross proceeds to us of approximately
and offering expenses of
common stock having an aggregate value of approximately
available for sale under this offering program.
On
with certain accredited investors pursuant to which we sold to the purchasers in
a private placement approximately 280,782 units, or Units, each consisting of
(i) one share of common stock, and (ii) a warrant to purchase 0.75 shares of
common stock at an offering price of
proceeds of approximately
received a cash commission on the gross proceeds from the sale of the Units and
was issued a five year warrant upon substantially similar terms as the
investors’ warrants to purchase 25,270 shares of common stock at an initial
exercise price of
placement agent expenses and
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commissions and offering expenses was approximately
Each warrant became exercisable on
of the initial closing date of the offering, through
the five-year anniversary of the initial closing date of the offering. The
warrants issued pursuant to subscription agreements executed on
are exercisable at a price per share of common stock of
adjustment, and the warrants issued pursuant to subscription agreements executed
on
subject to adjustment. Additionally, subject to certain exceptions, if, after
the initial exercise date, (i) the volume weighted average price of the common
stock for each of 30 consecutive trading days, or the Measurement Period, which,
Measurement Period commences on the closing date, exceeds 300% of the exercise
price (subject to adjustments for stock splits, recapitalizations, stock
dividends and similar transactions), (ii) the average daily trading volume for
such Measurement Period exceeds
equity conditions are met, and subject to a beneficial ownership limitation,
then we may call for cancellation of all or any portion of the warrants then
outstanding.
On
sold 731,707 shares of our common stock at a price of
The registered direct offering raised total gross proceeds of approximately
million
and offering expenses, we received net proceeds of approximately
On
securities, pursuant to which we sold an aggregate of (a) 569,043 shares of our
common stock, including 92,856 shares subject to the underwriter’s option to
purchase additional shares, or the August Shares, and (b) pre-funded warrants to
purchase 142,857 shares of our common stock, or the Pre-Funded Warrants, to the
underwriter. The August Shares were sold at the public offering price of
per share. The Pre-Funded Warrants were sold at a public offering price of
price for the August Shares less a
Pre-Funded Warrant.
The Pre-Funded Warrants are exercisable at any time after the date of issuance.
A holder of Pre-Funded Warrants may not exercise the warrant if the holder,
together with its affiliates, would beneficially own more than 9.99% of the
number of shares of common stock outstanding immediately after giving effect to
such exercise. A holder of Pre-Funded Warrants may increase or decrease this
percentage, but not in excess of 19.99%, by providing at least 61 days’ prior
notice to us.
The underwritten public offering raised total gross proceeds of approximately
discounts and commissions and offering expenses, we received net proceeds of
approximately
offering expenses have been charged against the gross proceeds.
On
securities, pursuant to which we sold an aggregate of 2,472,500 shares of our
common stock, including 322,500 shares subject to the underwriter’s option to
purchase additional shares, or the December Shares. The December Shares were
sold at the public offering price of
We also issued a warrant to purchase 50,000 shares of common stock to the
representative of the underwriters, the Representative’s Warrant, as a portion
of the underwriting compensation payable in connection with this offering. The
Representative’s Warrant will be exercisable beginning on
exercise price of
fair value of the Representative’s Warrant of
The underwritten public offering raised total gross proceeds of approximately
discounts and commissions and offering expenses, we received net proceeds of
approximately
offering expenses have been charged against the gross proceeds.
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On
pursuant to which we sold an aggregate of 3,285,714 shares of our common stock,
including 428,571 shares subject to the underwriter’s option to purchase
additional shares, or the May Shares. The May Shares were sold at the public
offering price of
The underwritten public offering raised total gross proceeds of approximately
discounts and commissions and offering expenses, we received net proceeds of
approximately
offering expenses have been charged against the gross proceeds.
Cash Flows
Cash Used in Operating Activities
For the nine months ended
activities was
as compared to the 2020 period was primarily attributable to increase in
research and development expenses related to our ORCA-2 trial.
Cash Provided in Financing Activities
For the nine months ended
activities was
ended
offering and warrant exercises. Net cash provided by financing activities in the
nine months ended
2020
2020
Cash Used in Investing Activities
Net cash used in investing activities for the nine months ended
2021
Net cash used in investing activities in the nine months ended
2020
Off-Balance Sheet Arrangements
We did not have any off-balance sheet financing arrangements as of
2021
Commitments and Contingencies
We previously disclosed certain contractual obligations and contingencies and
commitments relevant to us within the financial statements and Management’s
Discussion and Analysis of Financial Condition and Results of Operations in our
Annual Report on Form 10-K for the year ended
the
“Contractual Obligations” table in Part II, Item 7, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” of our 2020 Form
10-K. For more information regarding our current contingencies and commitments,
see Note 7 to the financial statements included above.
Critical Accounting Policies and Estimates
The preparation of financial statements in accordance with
management to make estimates and assumptions that affect reported amounts and
related disclosures. We have discussed those estimates that we believe are
critical and require the use of complex judgment in their application in our
audited financial statements for the year ended
Report on Form 10-K filed with the
2020
government funded research grants, see Note 2, “Accounting Policies” of the
consolidated financial statements.
New Accounting Standards
See Note 2, “Accounting Policies,” of the consolidated financial statements for
information related to the adoption of new accounting standards in 2021, none of
which had a material impact on our financial statements, and the future adoption
of recently issued accounting standards, which we do not expect to have a
material impact on our financial statements.
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