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): March 29, 2022
GERON CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware | | 000-20859 | | 75-2287752 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
919 E. HILLSDALE BOULEVARD, SUITE 250
FOSTER CITY, California 94404
(Address of principal executive offices, including zip code)
(650) 473-7700
(Registrant's telephone number, including area code)
N/A
(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:
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☐ | | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ | | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ | | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ | | 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:
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Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, $0.001 par value | GERN | 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 ☐
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 1.01 Entry into a Material Definitive Agreement.
On March 29, 2022, Geron Corporation (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Stifel, Nicolaus & Company, Incorporated and Robert W. Baird & Co. Incorporated, as representatives of the several underwriters named therein (collectively, the “Underwriters”), relating to the issuance and sale (the “Offering”) of 53,333,334 shares of the Company’s common stock (“Common Stock”), and pre-funded warrants to purchase 18,095,238 shares of Common Stock (the “Pre-Funded Warrants”), together with accompanying warrants to purchase 35,714,286 shares of Common Stock (the “Purchase Warrants”, and together with the Pre-Funded Warrants, the “Warrants”). The combined offering price to the public of each share of Common Stock and accompanying Purchase Warrant is $1.05. The combined offering price to the public of each Pre-Funded Warrant and accompanying Purchase Warrant is $1.049. The gross proceeds to the Company from the Offering are expected to be approximately $75.0 million, before deducting underwriting discounts and estimated offering expenses. All of the securities in the Offering are being sold by the Company. The Offering is expected to close on April 1, 2022, subject to satisfaction of customary closing conditions.
Each Pre-Funded Warrant will have an initial exercise price per share of $0.001, subject to certain adjustments. The Pre-Funded Warrants will be exercisable immediately and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. A holder (together with its affiliates and other attribution parties) may not exercise any portion of a Pre-Funded Warrant to the extent that immediately prior to or after giving effect to such exercise the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, which percentage may be changed at the holder's election to a lower or higher percentage not in excess of 19.99% (if exceeding such percentage would result in a change of control under Nasdaq Listing Rule 5635(b) or any successor rule) upon 61 days’ notice to the Company subject to the terms of the Pre-Funded Warrants.
Each Purchase Warrant will have an initial exercise price per share of $1.45, subject to certain adjustments. The Purchase Warrants will be exercisable immediately and will expire on the earlier to occur of (a) the date that is 30 business days following the date on which the Company first issues a press release announcing, if applicable, that the United States Food and Drug Administration (the “FDA”) has accepted for filing a New Drug Application submitted to the FDA for imetelstat in Low or Intermerdiate-1 risk myelodysplastic syndromes (or, if such date is not a business day, then the next business day following such date) and (b) April 1, 2027. A holder (together with its affiliates and other attribution parties) may not exercise any portion of a Purchase Warrant to the extent that immediately prior to or after giving effect to such exercise the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, which percentage may be changed at the holder's election to a lower or higher percentage not in excess of 19.99% (if exceeding such percentage would result in a change of control under Nasdaq Listing Rule 5635(b) or any successor rule) upon 61 days’ notice to the Company subject to the terms of the Purchase Warrants.
The Offering is being made pursuant to the Company’s shelf registration statement on Form S-3 filed with the Securities and Exchange Commission (the “SEC”) on September 4, 2020, which became effective on November 6, 2020 (Registration Statement No. 333-248637), and a prospectus supplement thereunder (the “Prospectus Supplement”).
The Underwriting Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Underwriters, including for liabilities arising under the Securities Act other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting Agreement were made only for the purposes of such agreement and as of specific dates, and were solely for the benefit of the parties to such agreement.
The foregoing descriptions of the terms of the Underwriting Agreement, Pre-Funded Warrants and Purchase Warrants are each qualified in their entirety by reference to the Underwriting Agreement, form of Pre-Funded Warrant and form of Purchase Warrant, respectively, which are attached as Exhibit 1.1, Exhibit 4.1 and Exhibit 4.2 hereto, respectively, and incorporated by reference herein.
A copy of the legal opinion of Cooley LLP relating to the validity of the issuance and sale of the securities in the Offering is attached as Exhibit 5.1 hereto.
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Special Note Regarding Forward-Looking Statements
Except for the historical information contained herein, this Current Report on Form 8-K contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) the completion and anticipated proceeds of the Offering; (ii) potential positive top-line safety and efficacy results from IMerge Phase 3; and (iii) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) the satisfaction of customary closing conditions related to the Offering and whether the Company will be able to complete the Offering on the anticipated terms, or at all; (b) whether the current or evolving effects of the COVID-19 pandemic and/or the Russia/Ukraine conflict cause resulting global economic and financial disruptions that materially and adversely impact the Company’s business and business prospects, its financial condition and the future of imetelstat; (c) whether the Company overcomes all of the potential delays and other adverse impacts caused by the evolving effects of the COVID-19 pandemic and/or the Russia/Ukraine conflict, and overcomes the clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to complete the development and commercialization of imetelstat to meet all of the Company’s expected timelines and planned milestones; (d) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (e) whether imetelstat is demonstrated to be safe and efficacious in IMerge Phase 3 and IMpactMF to enable regulatory approval; (f) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients; (h) that the Company may seek to raise substantial additional capital in order to complete the development and commercialization of imetelstat to meet all of the Company’s expected timelines and planned milestones; (i) whether regulatory authorities require an additional clinical trial for approval even if IMerge Phase 3 or IMpactMF meet their respective primary endpoints; (j) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials in a timely manner, or at all; (k) whether the patient follow-up period of 12 months in IMerge Phase 3 results in not obtaining adequate data to demonstrate safety and efficacy, including transfusion independence, for achieving success in the primary analysis; (l) whether the Company can accurately project or attain complete enrollment in IMerge, whether due to the evolving effects of the COVID-19 pandemic and/or the Russia/Ukraine conflict or otherwise; (l) whether the Company is able to enroll its clinical trials at a pace that would enable the financial resources for, and to meet the Company’s expected timelines and planned milestones; and (m) if the FDA does not grant priority review for the IMerge data, then the launch date in lower risk MDS may be later than the first half of 2024. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in the Company’s filings and periodic reports filed with the SEC under the heading “Risk Factors” and elsewhere in such filings and reports, including in the Prospectus Supplement. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, the Company disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
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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.
| | GERON CORPORATION |
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Date: March 30, 2022 | | By:/s/ Stephen Rosenfield |
| | Stephen N. Rosenfield |
| | Executive Vice President, Chief Legal Officer |
| | and Corporate Secretary |
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