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OYST - Oyster Point Pharma Inc News Story

$21 0.4  2.0%

Last Trade - 13/04/21

Sector
Healthcare
Size
Mid Cap
Market Cap £388.1m
Enterprise Value £247.9m
Revenue £n/a
Position in Universe 3448th / 6841

Oyster Point Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Business Highlights

Thu 18th February, 2021 9:01pm
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* OC-01 (Varenicline) Nasal Spray New Drug Application (NDA) Submitted to the
U.S. Food and Drug Administration (FDA) for the Treatment of Signs and
Symptoms of Dry Eye Disease on December 17, 2020
* Phase 2 Clinical Trial Protocol of OC-01 (Varenicline) Nasal Spray in
Patients with Neurotrophic Keratopathy (NK) Submitted to the FDA on November
30, 2020
* OLYMPIA Phase 2 Study of OC-01 (Varenicline) Nasal Spray in NK on Track for
Enrollment of the First Patient in the First Half of 2021
* Announced Positive IMPERIAL Phase 2 Study Results
* Advancement of Commercialization Preparations and Strengthening of the
Executive Leadership Team
* Cash Position of $192.6 million as of December 31, 2020
PRINCETON, N.J., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc.
(Nasdaq: OYST), ("Oyster Point Pharma", or "the Company"), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of first-in-class pharmaceutical therapies to treat ocular
surface diseases, announced its financial results for the fourth quarter of
2020, and provided an overview of recent business highlights.

“The submission of our NDA to the FDA for OC-01 (varenicline) nasal spray
represents an important milestone for Oyster Point Pharma and progresses the
development of what we believe will be an important first in class nasal spray
for the treatment of the signs and symptoms of dry eye disease." said Jeffrey
Nau, Ph.D., MMS president and chief executive officer of Oyster Point Pharma.
Dr. Nau continued, "We believe that the strength of our clinical data in mild,
moderate and severe dry eye patients, and OC-01's novel mechanism of action as
shown in pre-clinical and clinical studies to stimulate natural tear film
production and re-establish tear film homeostasis, will support eye care
practitioners’ use of a new tool in their dry eye disease treatment
armamentarium, if approved by the FDA.”

Recent Business Highlights
* Submission of the NDA for OC-01 for Signs and Symptoms of Dry Eye Disease to
the FDA: On December 17, 2020, the Company submitted a 505(b)(2) NDA to the
FDA for OC-01 (varenicline) nasal spray for the treatment of signs and
symptoms of dry eye disease. 


* Phase 2 Clinical Trial Protocol Submission to the FDA: On November 30, 2020,
the Company submitted to the FDA a protocol to initiate a clinical study in
adult patients with NK. The submission was made to the Company’s IND
application for OC-01 (varenicline) nasal spray in dry eye disease. NK is the
second of a number of important potential indications the Company is
evaluating for studying OC-01 (varenicline) nasal spray, illustrating the
Company's commitment to treating unmet needs related to ocular surface
diseases. 


* OLYMPIA Phase 2 Study on Track: Enrollment of the first patient in the
OLYMPIA Phase 2 study of OC-01 (varenicline) nasal spray in NK remains on
track, planned for the first half of 2021.


* Announced IMPERIAL Phase 2 Study Results: Results from the Phase 2 IMPERIAL
study illustrated OC-01 (varenicline) nasal spray caused a statistically
significant decrease in goblet cell size, indicating goblet cell degranulation
and release of mucin, as compared to placebo after a single administration.
Topline data was presented at the American Academy of Ophthalmology 2020 (AAO
2020) virtual meeting and judged to be one of the top 10% best papers at AAO
2020.


* Advancement of Commercialization Preparations: The Company has made
meaningful progression toward its planned U.S. launch of OC-01 (varenicline)
nasal spray in the fourth quarter of 2021, if approved by the FDA, including
the addition of key talent in the areas of commercial operations, medical
affairs, and manufacturing. 


* Strengthened Executive Leadership Team: On December 7, 2020, the Company
announced the appointment of Marian Macsai, M.D., as chief medical officer,
and Eric Carlson, Ph.D., as chief scientific officer, both of whom joined the
executive leadership team.
Overview of Financial and Operating Results

Fourth Quarter 2020 Financial Results
* Cash Position: As of December 31, 2020, cash and cash equivalents were
$192.6 million, compared to $139.1 million as of December 31, 2019. The
increase in cash and cash equivalents in the amount of $53.4 million was
primarily due to proceeds from a follow-on equity offering in the amount of
$112.6 million, partially offset by cash used in operations in the amount of
$58.4 million and capital expenditures in the amount of $0.7 million.


* R&D Expenses: Total research and development expenses for the fourth quarter
of 2020 were $11.7 million compared to $15.0 million for the same period in
2019. The Company's expenditures for preclinical and clinical programs were
$4.6 million lower during the fourth quarter of 2020 compared to the same
period in 2019 primarily due to the completion of the ONSET-2 Phase 3 clinical
trial in May 2020. The Company incurred a higher chemistry, manufacturing, and
controls (CMC) expense of $2.9 million primarily due to the continued
advancement of OC-01 (varenicline) nasal spray. The Company's expenditures in
other research and development expense were $1.6 million lower during the
fourth quarter of 2020 compared to the same period in 2019. The decrease in
other research and development costs was primarily a result of the NDA
submission fee to the FDA in the amount of $2.9 million made in December
2020, as compared to the $5.0 million license payment to Pfizer in December
2019. This decrease was partially offset by higher costs in the amount of
$0.5 million primarily related to data management and regulatory costs in
connection with the advancement of the OC-01 (varenicline) nasal spray and NDA
submission. 


* SG&A Expenses: Total selling, general and administrative expenses for the
fourth quarter of 2020 were $10.5 million compared to $5.1 million for the
same period in 2019. The increase was due to higher employee headcount and
reflects an increase in payroll-related expense, including stock-based
compensation, of $3.0 million. The Company incurred higher commercialization
planning expenses of $1.5 million in anticipation of an expected U.S. launch
of OC-01 (varenicline) nasal spray, if approved by the FDA, in the fourth
quarter of 2021. Additionally, there was an increase in other general and
administrative expenses of $0.9 million due to expansion of the Company's
organization and operating as a publicly traded company. 


* Net Loss: For the fourth quarter of 2020, the Company had a net loss of
$22.2 million, or $(0.86) per share, compared to a net loss of
$19.7 million, or $(1.41) per share, for the same period in 2019.
Conference Call Details and Webcast

Oyster Point Pharma will host a live conference call and webcast today at 4:30
pm Eastern Time to discuss the fourth quarter 2020 financial results and
provide a business update. To access the live call by phone, please dial (855)
548-1220 (US/Canada) or (602) 563-8619 (International). The conference ID
number is 2066335. The webcast will be made available on the company’s
website at www.oysterpointrx.com under the “Events & Presentations”
section of the company’s website at
https://edge.media-server.com/mmc/p/7mdvsfdb.

A telephone replay will be available for approximately 7 days following the
live conference call. To access the telephone replay, please dial (855)
859-2056 (US/Canada) or (404) 537-3406 (International). The conference ID
number is 2066335. A replay of the webcast will be available for approximately
30 days following the live audio webcast.

About Oyster Point Pharma

Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of first-in-class
pharmaceutical therapies to treat ocular surface diseases. Oyster Point
Pharma’s lead product candidate, OC-01 (varenicline) nasal spray, a highly
selective cholinergic agonist, is being developed as a nasal spray to treat
the signs and symptoms of dry eye disease. In preclinical and clinical
studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism
of action via activation of the trigeminal parasympathetic pathway to
stimulate the glands and cells responsible for natural tear film production,
known as the lacrimal functional unit. OC-01 (varenicline) nasal spray is an
investigational new drug and has not been approved for any use in any country.
The safety and efficacy of OC-01 (varenicline) nasal spray have not previously
been established.

About Dry Eye Disease

Dry eye disease is a chronic, progressive condition that impacts more than 30
million people in the United States (U.S.) and is growing in prevalence. An
estimated 16 million adults in the U.S. have been diagnosed with dry eye
disease, a multifactorial condition of the ocular surface characterized by
disruption of the tear film. A healthy tear film protects and lubricates the
eyes, washes away foreign particles, contains growth factors and antimicrobial
components to reduce the risk of infection, and creates a smooth surface that
contributes refractive power for clear vision. Dry eye disease can have a
significant impact on a person’s day-to-day quality of life, as it can cause
persistent stinging, scratching, burning sensations, sensitivity to light,
blurred vision, and eye fatigue. Despite the large prevalence of dry eye and
the burden of the disease, there remains a significant unmet need for
effective therapies.

About Neurotrophic Keratopathy

Neurotrophic keratopathy (NK), is a disease characterized by decreased corneal
sensitivity and poor corneal healing. The most common causes of loss of
corneal sensation are viral infection (herpes simplex and herpes zoster
keratoconjunctivitis) followed by chemical burns, physical injuries, and
corneal surgery. In addition, systemic diseases such as diabetes and multiple
sclerosis may decrease sensory nerve function or damage sensory fibers. NK can
be classified broadly into three stages: Stage 1 (mild) consists of ocular
surface irregularities and reduced vision, Stage 2 (moderate) exhibits a
non-healing persistent defect of the corneal epithelium, and Stage 3 (severe)
exhibits corneal ulceration, which may progress to corneal melting and
perforation. If not adequately addressed, the progression of NK can lead to
the loss of the cornea and the need for transplantation.

Forward-Looking Statements

This press release contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995 that reflect
the current beliefs, expectations and assumptions of the “Company regarding
the future of the Company’s business, our future plans and strategies,
regulatory approvals, clinical results, future financial condition and other
future conditions. All statements other than statements of historical facts
contained in this press release, including express or implied statements
regarding future results of operations and financial position, business
strategy, product candidates, regulatory approvals, expected research and
development costs, planned preclinical studies and clinical trials, expected
results of clinical trials, and their timing and likelihood of success, as
well as plans and objectives of management for future operations, are
forward-looking statements. The words “may,” “will,” “should,”
“would,” “expect,” “plan,” “anticipate,” “could,”
“intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the
negative of these terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. These forward-looking statements are subject
to a number of risks, uncertainties and assumptions, including, among other
things: the timing or likelihood of regulatory filings and approvals for our
product candidates; our ability to obtain and maintain regulatory approvals of
our product candidates; our plans relating to commercializing our product
candidates, if approved, including the geographic areas of focus and sales
strategy; the success of competing therapies that are or may become available;
the beneficial characteristics, safety, efficacy and therapeutic effects of
our product candidates; our plans relating to the further development and
manufacturing of our product candidates, including the size, number and
additional indications or disease areas to be evaluated and pursued; the
impact of the COVID-19 pandemic on our business, operations, and regulatory
and clinical development timelines, plans and expectations; the size of the
market opportunities and prevalence of dry eye disease and Neurotrophic
Keratopathy (NK) for our product candidates, the likelihood of our clinical
trials demonstrating safety and efficacy of our product candidates, and other
positive results; the timing of initiation of our future clinical trials, and
the reporting of data from our current and future trials; the expected
potential benefits of strategic collaborations with third parties and our
ability to attract collaborators with development, regulatory and
commercialization expertise; existing regulations and regulatory developments
in the United States and other jurisdictions; our plans and ability to obtain
or protect intellectual property rights, including extensions of existing
patent terms where available; our continued reliance on third parties to
conduct additional clinical trials of our product candidates, and for the
manufacture of our product candidates for preclinical studies and clinical
trials, and potentially for commercial supply; the accuracy of our estimates
regarding expenses, future revenue, capital requirements and needs for
additional financing; our financial performance; market conditions; the
sufficiency of our existing capital resources to fund our future operating
expenses and capital expenditure requirements; our expectations regarding the
period during which we will qualify as an emerging growth company under the
JOBS Act; and other risks described in the “Risk Factors” section included
in our public filings that we have made and will make with the Securities and
Exchange Commission (SEC). The Company is providing the information in this
press release as of this date and does not undertake any obligation to update
any forward-looking statements contained in this press release as a result of
new information, future events or otherwise.

Investor Contact
Tim McCarthy 
LifeSci Advisors, LLC 
(212) 915-2564 
investors@oysterpointrx.com

Media Contact
Sheryl Seapy, W2O Group
(213) 262-9390
sseapy@w2ogroup.com



Oyster Point Pharma, Inc.
Select Balance Sheet Data
(in thousands)

                            December 31, 2020       December 31, 2019     
                                                                          
 Cash and cash equivalents  $          192,585      $          139,147    
 Working capital*           $          185,385      $          136,781    
 Total assets               $          197,910      $          143,209    
 Stockholders’ equity       $          186,659      $          137,298    

_____________________________
* Working capital is defined as current assets less current liabilities.



Oyster Point Pharma, Inc.
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)

                                                         Three months ended December 31,                          Year ended December 31,                            
                                                         2020                           2019                      2020                         2019                  
                                                                                                                                                                     
 Research and development:                               (unaudited)                                                                                                 
 Clinical, preclinical                                   $       2,124                  $       6,712             $       12,265               $      13,550         
 Chemistry, manufacturing and controls                   5,240                          2,376                     19,476                       13,145                
 Other                                                   4,343                          5,946                     8,070                        6,933                 
 Total research and development                          11,707                         15,034                    39,811                       33,628                
 Selling, general and administrative                     10,537                         5,127                     31,178                       13,673                
 Loss from operations                                    (22,244          )             (20,161          )        (70,989          )           (47,301         )     
 Other income, net                                       12                             437                       469                          1,590                 
 Net loss and comprehensive loss                         $       (22,232  )             $       (19,724  )        $       (70,520  )           $      (45,711  )     
 Net loss per share basic and diluted                    $       (0.86    )             $       (1.41    )        $       (2.92    )           $      (9.97    )     
 Weighted average shares outstanding, basic and diluted  25,869,601                     13,993,730                24,128,603                   4,585,146             

 

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GlobeNewswire, Inc. 2021
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