Greenwich LifeSciences, Inc 8-K, filed Oct 9, 2020
Greenwich LifeSciences, Inc. (GLSI)
About this 8-K
Greenwich LifeSciences, Inc filed this 8-K on October 9, 2020, reporting on events of October 6, 2020.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
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) October 6, 2020
Greenwich LifeSciences, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-39555 | 20-5473709 | ||
| (State
or other jurisdiction of incorporation) |
(Commission File Number) |
(I.
R. S. Employer Identification No.) |
| 3992 Bluebonnet Dr, Building 14 |
| Stafford, TX 77477 |
| (Address of principal executive offices, including ZIP code) |
| (832) 819-3232 |
| (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, $0.001 par value | GLSI | The Nasdaq Stock Market LLC |
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 [X]
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.
Greenwich LifeSciences, Inc. (the “Company”) intends to conduct meetings with third parties in which its corporate slide presentation will be presented. A copy of the presentation materials is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01 and the document attached as Exhibit 99.1 are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), nor otherwise subject to the liabilities of that section, nor incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On October 6, 2020, the Company announced the completion of the manufacturing of the GP2 active ingredient for its planned Phase III clinical trial. On October 7, 2020, the Company announced that it was selected to present at the 2020 BIO Investor Forum conference to be held virtually from October 13-15, 2020 and will be participating at the BIO-Europe partnering conference to be held virtually from October 26-29, 2020. On October 8, 2020, the Company announced that two abstracts have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), including two corresponding posters. Copies of the press releases are attached hereto as Exhibits 99.2, 99.3 and 99.4, respectively, and are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit No. | Description | |
| 99.1 | Greenwich LifeSciences, Inc. Corporate Presentation | |
| 99.2 | Press release dated October 6, 2020 | |
| 99.3 | Press release dated October 7, 2020 | |
| 99.4 | Press release dated October 8, 2020 |
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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.
| Greenwich LifeSciences, Inc. | ||
| Date: October 9, 2020 | By: | /s/ Snehal Patel |
Snehal Patel Chief Executive Officer | ||
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Exhibit 99.1
Exhibit 99.2
Greenwich LifeSciences, Inc. Announces Completion of Manufacturing of Drug for its Planned Phase III Clinical Trial
STAFFORD, TX / [Business Wire] / October 6, 2020 / Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the completion of the manufacturing of the GP2 active ingredient for its planned Phase III clinical trial. After having met all drug specifications and release criteria in compliance with current Good Manufacturing Practice (cGMP), the GP2 active ingredient has been released for formulation and filling into vials, which is the last step before storage and distribution of GP2 to clinical sites.
Snehal Patel, CEO of Greenwich LifeSciences commented, “We are pleased to have completed this major manufacturing milestone. Last week we completed our IPO, in which members of senior management and directors invested funds aggregating in approximately 15% of the IPO gross proceeds. Our success in scaling up GP2 to large scale cGMP manufacturing and our recent fundraising moves us closer to commencing the upcoming Phase III clinical trial.”
The Company’s commercial manufacturing partner, Polypeptide Laboratories, located in San Diego, California and a specialist in the manufacture of clinical and commercial grade peptides, initiated this clinical lot in 2019, which is at a commercial scale that can produce 50,000 doses and treat up to 4,500 patients. In addition, analytical methods were validated and a stability program has been initiated per cGMP requirements.
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company’s website: www.greenwichlifesciences.com
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Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Team
Snehal Patel
Investor Relations
(832) 819-3232
info@greenwichlifesciences.com
View original source version: [Link to Original Source]
Source: Greenwich LifeSciences, Inc.
Released [Month Date, Year]
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Exhibit 99.3
Greenwich LifeSciences, Inc. to Participate at Upcoming Investor and Partnering Conferences
STAFFORD, TX / [Business Wire] / October 7, 2020 / Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that it was selected to present at the 2020 BIO Investor Forum conference to be held virtually from October 13-15, 2020 and will be participating at the BIO-Europe partnering conference to be held virtually from October 26-29, 2020.
At the BIO Investor Forum, Snehal Patel, CEO of Greenwich LifeSciences will present and will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. The presentation will highlight the Company’s GP2 program and its plans to commence a Phase III clinical trial, will include a pre-recorded audio track available to conference attendees on demand, and will be simultaneously made available on the investor section of the Company’s website at: https://investor.greenwichlifesciences.com/
At the BIO-Europe partnering conference, the Company will seek to meet with international pharmaceutical companies seeking to license marketing rights for promising therapeutics for their respective regions. The Company previously initiated a global and regional out-licensing process with industry leading advisor, Torreya Partners, which is expected to continue as the upcoming GP2 Phase III trial commences.
About BIO Investor Forum
The 19th annual BIO Investor Forum is an international biotech investor conference focused on early and established private companies as well as emerging public companies. The event features plenary sessions, business roundtables and therapeutic workshops, company presentations, and scheduled one-to-one meetings. For more information, please visit the conference website at: https://www.bio.org/events/bio-investor-forum-digital/why-attend
About BIO-Europe
The 26th annual BIO-Europe global life sciences partnering conference includes access to company pitches, program sessions, and sponsor and showcase company content. The event is expected to bring together over 4,000 executives from more than 2,000 life sciences companies spanning an estimated 60+ countries. Program content includes business development, therapeutic areas, startup innovations, digital health, and scheduled one-to-one meetings. For more information, please visit the conference website at: https://informaconnect.com/bioeurope/
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company’s website: www.greenwichlifesciences.com
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Team
Snehal Patel
Investor Relations
(832) 819-3232
info@greenwichlifesciences.com
View original source version: [Link to Original Source]
Source: Greenwich LifeSciences, Inc.
Released [Month Date, Year]
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Exhibit 99.4
Greenwich LifeSciences, Inc. Announces Acceptance of Two Abstracts at Upcoming Major Breast Cancer Conference
STAFFORD, TX / [Business Wire] / October 8, 2020 / Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced that two abstracts have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS), including two corresponding posters. SABCS 2020 will be held in a virtual format from December 8-11, 2020. SABCS anticipates publishing the abstracts in late November 2020 and the posters on December 9, 2020.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “While we previously reported that in the GP2 Phase IIb clinical trial that no recurrences were observed in the HER2/neu 3+ adjuvant setting after 5 years of follow-up if the patient received their primary GP2 treatments, we are pleased to be able to present the final 5 year analysis, including Kaplan-Meier disease free survival curves and patient demographics.”
Dr. F. Joseph Daugherty, CMO of Greenwich LifeSciences, commented, “We look forward to sharing this data with breast cancer key opinion leaders as we recruit clinicians and clinical sites for participation in our planned Phase III clinical trial. This data will further advance the development of GP2 and support our common goal to provide patients and clinicians with a safe and effective treatment option to prevent recurrences following surgery, and thereby prevent metastatic breast cancer.”
The first abstract and poster will present the final 5 year follow-up efficacy and demographic data across all patient populations from the completed prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb clinical study evaluating the reduction of recurrences. The presentation will include disease free survival curves for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including the demographics for stage of cancer, hormone receptor status, node status, and prior treatment with chemotherapy, radiation, endocrine therapy or trastuzumab.
The second abstract and poster will present the design of the planned Phase III clinical trial. The trial is designed as a single registration trial which will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by submission of a Biologics Licensing Application (BLA).
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The 2 abstracts and posters are entitled:
Program Number: PS10-23 - Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer
Program Number: OT-13-03 - A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer
About SABCS
The 43rd annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research began collaborations with SABCS in 2007. For more information, please visit the conference website at: https://www.sabcs.org/
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein. In a randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338). Of the 138 patients that have been treated with GP2 to date over 4 clinical trials, GP2 treatment was well tolerated and no serious adverse events were observed related to GP2 immunotherapy. Greenwich LifeSciences is planning to commence a Phase III clinical trial using a similar treatment regime as the Phase IIb clinical trial. For more information on Greenwich LifeSciences, please visit the company’s website: www.greenwichlifesciences.com
| -2- |
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Team
Snehal Patel
Investor Relations
(832) 819-3232
info@greenwichlifesciences.com
View original source version: [Link to Original Source]
Source: Greenwich LifeSciences, Inc.
Released [Month Date, Year]
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