8-K
false 0001720725 0001720725 2021-07-01 2021-07-01

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 1, 2021

 

 

Oyster Point Pharma, Inc.

(Exact name of Registrant as Specified in Charter)

 

 

 

Delaware   001-39112   81-1030955

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

202 Carnegie Center, Suite 109

Princeton, New Jersey

  08540
(Address of Principal Executive Offices)   (Zip Code)

(609) 382-9032

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.001 per share   OYST   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 

 


Item 7.01

Regulation FD Disclosure

A presentation of Oyster Point Pharma, Inc. (the “Company”) dated July 1, 2021 regarding OC-01 (varenicline) nasal spray activity on SARS-CoV-2 infection is attached hereto as Exhibit 99.1 and is incorporated by reference herein. The Company intends to use this presentation, in whole or in part, in future meetings with analysts, investors and others from time to time.

Channels for Disclosure of Information

Investors and others should note that the Company may announce material information to the public through filings with the Securities and Exchange Commission (the “SEC”), the Company’s investor relations website (investors.oysterpointrx.com), press releases, public conference calls and public webcasts. The Company encourages investors and others to review the information disclosed through such channels as such information could be deemed to be material information. Please note that this list may be updated from time to time.

The information in this Item 7.01 of this Form 8-K and the attached Exhibits 99.1 are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

The information contained in the presentation is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the SEC and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company does not undertake any duty or obligation to update or revise the information contained in this report, although the Company may do so from time to time as the management team believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures. For important information about forward looking statements, see the slide titled “Disclaimers and Forward Looking Statements” in the Exhibit 99.1 attached hereto.

 

Item 8.01

Other Events.

Preclinical Data Highlighting Potent Activity of OC-01 (Varenicline) and OC-02 (simpinicline) against SARS-CoV-2 Virus and Variants Press Release

On July 1, 2021, the Company issued a press release announcing preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease, and preclinical data in in vitro models evaluating OC-02 (simpinicline) against SARS-CoV-2 alpha variant.

A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated by reference herein.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

99.1    July 1, 2021 Investor Slide Presentation
99.2    Press Release of Oyster Point Pharma, Inc. dated July 1, 2021
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    OYSTER POINT PHARMA, INC.
Dated: July 1, 2021      
    By:  

/s/ Jeffrey Nau

      Jeffrey Nau, Ph.D., M.M.S.
      President and Chief Executive Officer
EX-99.1

Slide 1

Varenicline Activity on SARS-CoV-2 Infection July 1, 2021 Exhibit 99.1


Slide 2

Disclaimers and Forward-looking Statements This presentation 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 presentation, including express or implied statements regarding product candidates, regulatory approvals, planned preclinical studies and clinical trials, expected results of preclinical or clinical trials, and their timing and likelihood of success, expected research and development costs, as well as plans and objectives of management for future operations, are forward-looking statements. The words “if approved,” “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 OC-01; the beneficial characteristics, safety, efficacy and therapeutic effects of OC-01; our plans relating to the further development and manufacturing of OC-01, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our future clinical trials; the uncertainties inherent in pharmaceutical research and development, including preclinical study and clinical trial results and additional analysis of existing data; the likelihood of our clinical trials demonstrating safety and efficacy of OC-01, and other positive results; our plans and potential for success relating to commercializing OC-01; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available; our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; existing regulations and regulatory developments in the United States and other jurisdictions; our continued reliance on third parties to conduct additional preclinical studies and clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; 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; 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 presentation as of this date and does not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise. The forward-looking statements in this presentation represent our views as of the date of this presentation. 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. 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. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. We have filed and will file Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K, and other documents with the SEC. You should read these documents for more complete information about us. You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov.  This presentation concerns products that are under clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. .


Slide 3

Varenicline was Observed to Reduce SARS-CoV-2 (wildtype) Infectivity in Calu-3 Cells


Slide 4

Varenicline was Observed to Reduce SARS-CoV-2 (wildtype) Infectivity in Caco-2 Cells


Slide 5

Varenicline was Observed to Reduce SARS-CoV-2-alpha (UK Variant) Infectivity in Calu-3 Cells


Slide 6

Varenicline was Observed to Reduce SARS-CoV-2-beta (South African Variant) Infectivity in Calu-3 Cells


Slide 7

Study Design for SARS-CoV-2 Challenge in Rhesus Macaques


Slide 8

Effect of OC-01 (varenicline) Nasal Spray on SARS-CoV-2 gRNA and sgRNA in Rhesus Macaques SARS-CoV-2 gRNA and sgRNA were measured by qRT-PCR in nasal swab samples taken at Day 2, Day 3, Day 5, and Day 6 of the study (equivalent to post-challenge days 1, 2, 4, and 5) for the control animals and Day 2, Day 4, and Day 6 of the study (equivalent to post-challenge days 1, 3, and 5) for the OC-01-treated animals. Animals were challenged with SARS-CoV-2 on Day 1 of the study, which is equivalent to 0 days post challenge in the figure. Dotted lines represent lowest level of detection for the assay.

EX-99.2

Exhibit 99.2

 

LOGO

Oyster Point Pharma Announces Preclinical Data Highlighting Potent Activity of OC-01 (varenicline) and OC-02 (simpinicline) Against of SARS-CoV-2 Virus and Variants

 

   

Administration of OC-01 (varenicline) nasal spray to non-human primates was observed to inhibit viral replication in the nose within 24 hours of infectious SARS-CoV-2 challenge with absence of subgenomic RNA at Day 3 and Day 5 postchallenge

 

   

Varenicline inhibits cellular entry and replication of SARS-CoV-2 and its alpha and beta variants in multiple human cell types

 

   

Simpinicline inhibits cellular entry and replication of SARS-CoV-2 alpha variant in Calu-3 human cells with additional variants under investigation

 

   

Oyster Point Pharma, collaborates with the Trudeau Institute for in vitro testing of varenicline, the active ingredient in OC-01 nasal spray and simpinicline, the active ingredient in OC-02 nasal spray

 

   

Oyster Point Pharma plans to present data at the upcoming Analyst Day, scheduled for July 15, 2021

PRINCETON, N.J., July 1, 2021 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease. Administration of OC-01 (varenicline) nasal spray, a highly selective nicotinic acetylcholine receptor agonist, protected rhesus macaques against SARS-CoV-2 nasal infection. The results were published on the preprint server bioRxiv (https://biorxiv.org/cgi/content/short/2021.06.29.450426v1).

“We believe this is the first in vivo and in vitro data illustrating a nicotinic acetylcholine receptor agonists’ potential to inhibit viral entry and disrupt replication of the SARS-CoV-2 virus and variants” said Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point. “We believe that OC-01 (varenicline) nasal spray has the potential to complement the current global vaccination strategy and prevent infection and reduce transmission of the SARS-CoV-2 virus with a mechanism of action that may have broad activity across multiple variants.”

On Day 1, using a viral infection model and following two administrations of 100 µl of OC-01 (varenicline) nasal spray (0.6 mg/ml varenicline) into each nostril, animals were challenged with a very high viral inoculum (approximately 70 thousand plaque-forming units) of active SARS-CoV-2, via both intranasal (nose) and intratracheal (lung) routes. Animals then received two additional administrations of OC-01 (varenicline) nasal spray into each nostril on Day 1, followed by four times daily for the following four days. Administration of OC-01 (varenicline) nasal spray resulted in inhibition of cellular entry and replication of SARS-CoV-2, illustrated by a decrease of detectable SARS-CoV-2 subgenomic RNA (sgRNA) by approximately 2 logs compared to controls with complete absence in all animals at 3 days and 5 days post-challenge. In control animals treated with the same lot of virus inoculum, nasal swabs reached a peak of approximately 10 million SARS-CoV-2 sgRNA copies within two days of viral challenge and


were present throughout the course of the study. The absence of sgRNA indicates that the SARS-CoV-2 virus had not significantly infected nasal mucosa cells to start the transcription process of building new infectious virions. The absence of sgRNA following this very high viral inoculum also suggests the possibility of transmission may be substantially reduced after treatment with OC-01 (varenicline) nasal spray.

SARS-CoV-2 has been shown to predominantly enter the human body via nasal epithelial cells1, specifically ciliated and mucous secreting cells of the nasal mucosa2,3. Therefore, the nasal cavity represents a highly susceptible mucosal surface for infection and amplification within the respiratory tree. The nasal cavity also allows for treatment with topical compounds that can be delivered in higher local concentrations with potentially lower systemic exposure that may not be achievable when administered as an oral tablet or IV infusion.

In a separate study, in collaboration with the Trudeau Institute, researchers evaluated the in vitro antiviral activity of varenicline against SARS-CoV-2 and SARS-CoV-2 alpha and beta variants using Calu-3 (human airway epithelial cells) and Caco-2 (colon epithelial cells) cell lines. “Varenicline has demonstrated potent antiviral activity against SARS-CoV-2 and variants, alpha and beta, in cell culture. The promising in vitro and in vivo data suggest a clinical path forward for OC-01, which could prove a potential treatment in preventing severe COVID-19 symptoms and the spread of infection. Further studies investigating the mechanism of action and its effect on other variants of concern, such as the gamma and delta variants are ongoing,” said Priya Luthra, PhD, Trudeau Institute Principal Investigator.

Additionally, OC-02 (simpinicline), a highly selective nicotinic acetylcholine receptor agonist was evaluated for in vitro antiviral activity against the SARS-CoV-2 alpha variant using Calu-3 cell lines. Simpinicline demonstrated potent antiviral activity against the SARS-CoV-2 variants in cell culture with an IC50 of 0.04 µM. Further studies investigating the antiviral effect on other variants of concern are ongoing.

Given the results of both the in vivo and in vitro studies, OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray warrant further investigation as an antiviral agent for pre-exposure prophylaxis, post-exposure prophylaxis, and/or prevention of transmission of SARS-CoV-2. Additional in vivo and in vitro studies are ongoing.

OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray have not been proven safe or effective to prevent SARS-CoV-2 infection or treat COVID-19 in humans nor has OC-01 (varenicline) or OC-02 (simpinicline) nasal spray been approved for any use by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021, with a planned U.S. launch in the fourth quarter of 2021, if approved by the FDA.

Oyster Point Pharma plans to present additional data at the upcoming Oyster Point Analyst Day, planned for July 15, 2021. Please use the following link to register for the Analyst Day (https://media.rampard.com/20210715/).

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 and biologic therapies to treat ophthalmic diseases.

About the Trudeau Institute

The Trudeau Institute, headquartered in Saranac Lake, N.Y., safeguards human health by combatting 21st-century global health crises, such as the rise of drug-resistant tuberculosis, COVID-19 and emerging pandemic viruses. Its roots can be traced to 1884, when Edward Livingston Trudeau launched the first American laboratory solely dedicated to tuberculosis research. Today, Trudeau scientists spearhead innovation by conducting urgent biomedical research on infectious disease and collaborating with national and international R&D partners to accelerate medical impact.


About OC-01 (varenicline) Nasal Spray

OC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy. Varenicline tartrate is a partial nicotinic acetylcholine receptor agonist of α4ß2 and α4α6ß2 receptors, a moderate α3ß4 and α3α5ß4 receptor agonist, and a full α7 receptor agonist. Varenicline has been hypothesized to form a complex with an epitope of the Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2) spike protein that may block binding to receptors important for cellular entry, resulting in the prevention of viral entry into tissues1. The administration of a nasal spray formulation of varenicline provides a high localized dose directly to the nasal mucosa, a frequent site of virus entry, replication and infection. Varenicline has been shown to inhibit viral entry and disrupt replication of SARS-CoV-2-alpha in an in vivo model and has been shown to have potent antiviral activity to SARS-CoV-2, SARS-CoV-2-alpha, and SARS-CoV-2-beta in in vitro assays. The Prescription Drug User Fee Act (PDUFA) target action date is October 17, 2021, with a planned U.S. launch of OC-01 (varenicline) nasal spray in this indication in the fourth quarter of 2021, if approved by the FDA. 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 been established.

About OC-02 (simpinicline) Nasal Spray

OC-02 (simpinicline) nasal spray is a highly selective cholinergic agonist. Simipinicline citrate is a strong nicotinic acetylcholine receptor agonist of activity at the α4ß2, α3ß4, α3α5ß4, and α4α6ß2 receptors and weak agonist activity at the α7 receptor. OC-02 has been previously studied in two Phase 2b clinical trials for dry eye disease.

About the SARS-CoV-2 Virus

The Severe Acute Respiratory Syndrome-related Coronavirus 2 (SARS-CoV-2) is the virus responsible for coronavirus disease 2019 (COVID-19). This virus is from the Coronaviridae family that are broadly distributed among humans, other mammals, and birds. SARS-CoV-2 is a positive-sense single-stranded RNA virus.

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 product candidates, regulatory approvals, planned preclinical studies and clinical trials, expected results of preclinical or clinical trials, and their timing and likelihood of success, expected research and development costs, as well as plans and objectives of management for future operations, are forward-looking statements. The words “if approved,” “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 OC-01; the beneficial characteristics, safety, efficacy and therapeutic effects of OC-01; our plans relating to the further development and manufacturing of OC-01, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our future clinical trials; the uncertainties inherent in pharmaceutical research and development, including preclinical study and clinical trial results and additional analysis of existing data; the likelihood of our clinical trials demonstrating safety and efficacy of OC-01, and other positive results; our plans and potential for success relating to commercializing OC-01; our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;


our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; existing regulations and regulatory developments in the United States and other jurisdictions; our continued reliance on third parties to conduct additional preclinical studies and clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; 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; 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.

 

1-

Alexandris, N., Lagoumintzis, G., Chasapis, C. T., Leonidas, D. D., Papadopoulos, G. E., Tzartos, S. J., ... & Farsalinos, K. (2021). Nicotinic cholinergic system and COVID-19: In silico evaluation of nicotinic acetylcholine receptor agonists as potential therapeutic interventions. Toxicology reports, 8, 73-83.

2-

Sungnak, W., Huang, N., Bécavin, C., Berg, M., Queen, R., Litvinukova, M., ... & Barnes, J. L. (2020). SARS-CoV-2 entry factors are highly expressed in nasal epithelial cells together with innate immune genes. Nature medicine, 26(5), 681-687.

3-

Gallo, O., Locatello, L. G., Mazzoni, A., Novelli, L., & Annunziato, F. (2020). The central role of the nasal microenvironment in the transmission, modulation, and clinical progression of SARS-CoV-2 infection. Mucosal immunology, 1-12.

Investor Contact:

Tim McCarthy

LifeSci Advisors, LLC

(212) 915-2564

investors@oysterpointrx.com

Media Contact:

Sheryl Seapy, Real Chemistry

(213) 262-9390

sseapy@realchemistry.com