OYST Oyster Point Pharma Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
|
OC-01 (The ONSET-2 Study)
Dry eye disease
|
NDA Filing
NDA Filing
|
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
OC-01
Dry eye disease
|
Phase 2
Phase 2
|
Phase 2 top-line data met primary endpoint - January 12, 2020.
|
Latest News
-
View Full Article Hide Full Article
PRINCETON, N.J., Nov. 13, 2020 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced new data from its Phase 2 IMPERIAL clinical trial evaluating OC-01 (varenicline) nasal spray in the treatment of the signs and symptoms of dry eye disease in adults at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting, being held on November 13-15.
A single administration of OC-01 nasal spray significantly reduced goblet cell area and perimeter as measured by in vivo confocal microscopy as compared to placebo in subjects with dry eye disease. Goblet cells in the conjunctiva are responsible for releasing mucus and, based on clinical data, may help re-establish tear film homeostasis. OC-01 nasal spray was found to be safe and well-tolerated in the study, with the most commonly reported treatment-related event being sneeze.
"The positive results from IMPERIAL add to the growing body of evidence around the safety and efficacy of OC-01 in addressing the signs and symptoms of dry eye disease, a condition that impacts the day-to-day lives of millions of adults in the United States despite current treatments," said Pedram Hamrah, M.D., principal investigator for the IMPERIAL study and an ophthalmologist and cornea specialist at Tufts Medical Center, and professor of ophthalmology at Tufts University School of Medicine. "The data from this clinical study show how parasympathetic activation may stimulate mucin production at the ocular surface."
The single-center, randomized, double-masked, placebo-controlled trial included 18 patients with dry eye disease. The objective of the study was to assess the effect of OC-01 nasal spray on goblet cell alterations by in vivo confocal microscopy (IVCM). IVCM images of the bulbar conjunctiva, the membrane covering the outer surface of the eye, taken prior to and 10 minutes after administration showed that OC-01 significantly reduced goblet cell area and perimeter in dry eye disease, indicating goblet cell degranulation, which releases lubricating mucus.
Details of the Poster Presentation
Title: OC-01 (Varenicline) Nasal Spray Induces Goblet Cell Alterations in Patients with Dry Eye Disease
Authors: Gabriela Dieckmann, M.D.; Stephanie M. Cox, O.D.; Maria J. Lopez, M.D.; M. Cunyet Ozmen, M.D.; Leyla Yavouz-Saricay, M.D.; Betul N. Bayraktutar, M.D.; William W. Binotti, M.D.; Jeffrey Nau, Ph.D., M.M.S.; Pedram Hamrah, M.D.
Abstract #: PO092
In addition to the poster presentation, Oyster Point Pharma president and CEO, Jeffrey Nau Ph.D., M.M.S., will present at the AAO Industry Showcase on Friday, Nov. 13 from 12:50 to 1:20 p.m. EST.
Presentations will be available to view during the event for those registered through the following link: https://www.aao.org/annual-meeting.
About OC-01 Nasal Spray
OC-01 is a highly selective nicotinic cholinergic agonist, being developed as a preservative free nasal spray to treat the signs and symptoms of dry eye disease. The parasympathetic nervous system, the "rest and digest" system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, OC-01's novel mechanism of action activates the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film coating is responsible for forming the primary refracting surface of the cornea, as well as protecting and moisturizing the cornea.
About Dry Eye Disease
Dry eye disease is a chronic, progressive condition that impacts more than 30 million people in the United States 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 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 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray's novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions and on information currently available to us. The forward-looking statements in this press release represent our views as of the date of this press release. These statements may include but are not limited to statements regarding future events, including our plans for and the anticipated benefits of and safety of our product candidates, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones, including potential timing of NDA submission and potential commercialization. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties.
Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Sheryl Seapy, W2O Group
(213) 262-9390
[email protected]
-
View Full Article Hide Full Article
- OC-01 New Drug Application (NDA) Submission to U.S. Food and Drug Administration (FDA) for Signs and Symptoms of Dry Eye Disease Remains on Track for Q4 2020
- OC-01 Investigational New Drug (IND) Application Submission to FDA for Neurotrophic Keratitis (NK) Remains on Track for Q4 2020
- Cash and Cash Equivalents of $214.3 million as of September 30, 2020
- Conference Call and Webcast Scheduled for 4:30 pm ET today
PRINCETON, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), 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 third quarter of 2020, and provided an overview of recent business highlights.
"Following the positive top-line results of the ONSET-2 Phase 3 clinical trial announced in May, we plan to submit a NDA for OC-01 for the treatment of signs and symptoms of dry eye disease to the FDA in the fourth quarter of 2020. If approved by the FDA, we remain on track for a planned U.S. launch of OC-01 in the fourth quarter of 2021. In addition, the Company continues to advance its R&D pipeline and will begin clinical development to support the potential for additional indications for OC-01" said Jeffrey Nau, PhD, MMS president and chief executive officer of Oyster Point Pharma. "I am excited for the Oyster Point team to initiate the clinical development of OC-01 to treat neurotrophic keratitis. Based on OC-01's novel mechanism of action, we believe that the production of natural tear film may have the ability to provide a therapeutic benefit for a number of ocular surface diseases."
Recent Business Highlights
- OC-01 Dry Eye Disease NDA Submission on Track for Q4 2020: Planned U.S. launch of OC-01 in the fourth quarter of 2021, if FDA-approved.
- Launch Readiness Plan Progresses: With a planned U.S. launch of OC-01 in the fourth quarter of 2021, the Company continues to add key talent across the organization, including medical affairs, market access, commercial operations, and marketing.
- OC-01 IND Application Submission on Track for NK: IND Application remains on track for submission in Q4 2020 with planned enrollment of the first patient in the OLYMPIA Phase 2 Study in 1H 2021.
Overview of Financial and Operating Results
Third Quarter Financial Results
- Cash Position: As of September 30, 2020, cash and cash equivalents were $214.3 million, compared to $139.1 million as of December 31, 2019.
- R&D Expenses: Total research and development expenses for the third quarter of 2020 were $8.2 million compared to $8.1 million for the same period in 2019. The Company's clinical, preclinical expense was $1.2 million lower during the third quarter of 2020 primarily due to the completion of the ONSET-2 Phase 3 clinical trial in May 2020. The Company incurred higher CMC and other research and development expense of $1.3 million primarily due to the continued advancement of OC-01, as well as costs associated with the NDA submission planned in the fourth quarter of 2020.
- G&A Expenses: Total general and administrative expenses for the third quarter of 2020 were $8.1 million compared to $3.8 million for the same period in 2019. The increase was due to higher headcount and reflects an increase in payroll-related expense, including stock-based compensation of $2.1 million. The Company incurred higher commercial planning expenses of $1.0 million in anticipation of a U.S. launch of OC-01, if approved, in the fourth quarter of 2021. Additionally, there was an increase in other general and administrative expenses of $1.2 million due to expansion of the Company's organization and operating as a publicly traded company.
- Net Loss: For the third quarter of 2020, the Company had a net loss of $16.3 million, or $(0.63) per share, compared to a net loss of $11.5 million, or $(8.10) 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 third 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 5769185. 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/ivg2xbnt.
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 5769185. 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 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray's novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit.
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 Keratitis
Neurotrophic keratitis (NK), also known as neuroparalytic keratitis or neurotrophic keratopathy, 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. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions and on information currently available to us. The forward-looking statements in this press release represent our views as of the date of this press release. These statements may include but are not limited to statements regarding future events, including any potential impacts of any government measures in response thereto, or future financial and operating performance and our plans for and the anticipated benefits of new hires, our product candidates, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones, including potential timing of NDA submission and potential commercialization. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the "Risk Factors" section in reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties.
Investor Contact
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact
Sheryl Seapy, W2O Group
(213) 262-9390
[email protected]Oyster Point Pharma, Inc.
Select Balance Sheet Data
(in thousands)
(unaudited)September 30, 2020 December 31, 2019 Cash and cash equivalents $ 214,331 $ 139,147 Working capital* $ 205,745 $ 136,781 Total assets $ 216,496 $ 143,209 Stockholders' equity $ 206,673 $ 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)
(unaudited)Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Operating expenses: Research and development $ 8,210 $ 8,088 $ 28,104 $ 18,594 General and administrative 8,112 3,809 20,641 8,546 Total operating expenses 16,322 11,897 48,745 27,140 Loss from operations (16,322 ) (11,897 ) (48,745 ) (27,140 ) Other income, net 17 400 457 1,153 Net loss and comprehensive loss $ (16,305 ) $ (11,497 ) $ (48,288 ) $ (25,987 ) Net loss per share, basic and diluted $ (0.63 ) $ (8.10 ) $ (2.05 ) $ (18.37 ) Weighted average shares outstanding, basic and diluted 25,797,282 1,419,064 23,544,035 1,414,475 - OC-01 New Drug Application (NDA) Submission to U.S. Food and Drug Administration (FDA) for Signs and Symptoms of Dry Eye Disease Remains on Track for Q4 2020
-
View Full Article Hide Full Article
PRINCETON, N.J., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced that it will report third quarter 2020 financial results on Thursday, November 5, 2020, after the market close. The announcement will be followed by a live audio webcast and conference call at 4:30 pm Eastern Time.
Conference Call Details
To access the live call by phone, please dial (855) 548-1220 (US/Canada) or (602) 563-8619 (International). The conference ID number is 5769185. 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 5769185.Webcast Details
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. 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 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray's novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit (LFU).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.Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Sheryl Seapy, W2O Group
(213) 262-9390
[email protected] -
View Full Article Hide Full Article
Ali Behbahani, M.D. takes on role of Chairperson of the Board
Michael G. Atieh joins the Board of Directors as Chairperson of the Audit Committee
PRINCETON, N.J., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced changes to its Board of Directors, consistent with the company's strategic evolution in a pivotal year of growth.
Effective immediately, Dr. Ali Behbahani, who has served as a member of Oyster Point's Board of Directors since July 2017, will step into the role of Chairperson of the Board, replacing Dr. Michael Ackermann, who will step down to focus on new company creation and his positions as Chief Executive Officer of Presidio Medical and Chairperson of Tarsus Pharmaceuticals, two earlier-stage healthcare companies. Dr. Ackermann will continue to provide Oyster Point his expertise as an external strategic consultant going forward.
"We've experienced incredible growth and strengthened our capabilities under Dr. Ackermann's leadership as Founder and Chairperson of the company, and I'd like to thank him for his contributions and expert guidance that have undoubtedly positioned Oyster Point for continued momentum and success," said Jeffrey Nau, Ph.D., M.M.S., president and chief executive officer of Oyster Point. "As we transition from a clinical-stage company to an emerging commercial organization, we are excited to have Dr. Behbahani in his new role as Chairperson, building on his experience and roles as a board member of multiple biopharmaceutical companies across the industry."
"It has been a great privilege to serve as Chairman of Oyster Point's Board of Directors, alongside some of the brightest minds in our industry. I'd like to thank Jeff, his team, and the board for several terrific and fun years and look forward to watching them accomplish even more great things in the months and years to come," said Michael Ackermann.
Michael Atieh, who most recently served as Executive Vice President and Chief Financial and Business Officer of Ophthotech Corporation (now IVERIC Bio), will join Oyster Point's Board of Directors and step into the role of Chairperson of the Audit Committee. Mark Murray, who has served as a member of Oyster Point's Board of Directors since October 2017 and previously as Chief Financial Officer, will transition from Chairperson of the Audit Committee and continue as a member of the board.
"It's been truly remarkable to watch Oyster Point evolve as a public company and emerge as a disruptor in the ocular surface industry," said Michael G. Atieh. "I'm honored to join Oyster Point's Board and lead the audit committee as Chairperson while collaborating with Drs. Nau and Behbahani, Mr. Murray and the other esteemed members of the board."
About Michael G. Atieh
Michael G. Atieh serves as a director of Immatics, N.V., a clinical-stage biopharmaceutical company, and electroCore, Inc., a medical technology company. Mr. Atieh also serves as a director of Chubb Limited, the parent company of the Chubb Group of Companies focused on global insurance and reinsurance services.
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 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray's novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit (LFU).Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Sheryl Seapy, W2O Group
(213) 262-9390
[email protected] -
View Full Article Hide Full Article
PRINCETON, N.J., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Oyster Point Pharma, Inc. (NASDAQ:OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced that the Company will participate in a live Q&A at the Morgan Stanley Virtual 18th Annual Global Healthcare Conference on Friday, September 18, 2020 at 8:00 a.m. ET and host investor meetings.
To access the live webcast, please visit the "Investors and News" section of the Oyster Point Pharma website at https://investors.oysterpointrx.com/.
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 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray's novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit (LFU).Investor Contact:
Tim McCarthy
LifeSci Advisors, LLC
(212) 915-2564
[email protected]Media Contact:
Jeffrey Nau PhD, MMS
President and Chief Executive Officer
[email protected]