0000950170-24-051565.txt : 20240502 0000950170-24-051565.hdr.sgml : 20240502 20240502070917 ACCESSION NUMBER: 0000950170-24-051565 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20240502 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240502 DATE AS OF CHANGE: 20240502 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GERON CORP CENTRAL INDEX KEY: 0000886744 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 752287752 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-20859 FILM NUMBER: 24905243 BUSINESS ADDRESS: STREET 1: 919 EAST HILLSDALE BOULEVARD STREET 2: SUITE 250 CITY: FOSTER CITY STATE: CA ZIP: 94404 BUSINESS PHONE: 6504737700 MAIL ADDRESS: STREET 1: 919 EAST HILLSDALE BOULEVARD STREET 2: SUITE 250 CITY: FOSTER CITY STATE: CA ZIP: 94404 FORMER COMPANY: FORMER CONFORMED NAME: GERON CORPORATION DATE OF NAME CHANGE: 19960521 8-K 1 gern-20240502.htm 8-K 8-K
0000886744false00008867442024-05-022024-05-02

 

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): May 2, 2024

 

GERON CORPORATION

(Exact name of registrant as specified in its charter)

 

Delaware

000-20859

75-2287752

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification No.)

 

919 E. HILLSDALE BLVD., 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:

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

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.

1


Item 2.02

. Results of Operations and Financial Condition

On May 2, 2024, Geron Corporation (the "Company") issued a press release announcing its financial results and business highlights for the three months ended March 31, 2024. A copy of the press release is attached as Exhibit 99.1.

 

The information contained in Item 2.02 and in the accompanying Exhibit 99.1 to this Current Report shall be deemed to be “furnished” and shall not be deemed to be “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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and shall not be incorporated by reference into any filing made by the Company with the U.S. Securities and Exchange Commission under the Securities Act or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

 

 

 

 

 

 

 

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press release dated May 2, 2024

104

 

Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL

document)

 

 


 

 

2


SIGNATURE

 

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

 

Date:

 May 2, 2024

 

By:

/s/ Scott A. Samuels

 

 

 

Name:

Scott A. Samuels

 

 

 

Title:

Executive Vice President,

 

 

 

 

Chief Legal Officer and

 

 

 

 

Secretary

 

 

 

 

 

3


EX-99.1 2 gern-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

img50521483_0.jpg 

Geron Corporation Reports First Quarter 2024 Financial Results and Business Highlights

 

 

June 16, 2024 PDUFA date for imetelstat NDA for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS

 

FOSTER CITY, Calif., May 2, 2024 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing investigational first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, today reported financial results and business highlights for the first quarter 2024.

 

“Since the FDA ODAC’s 12 to 2 vote in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk MDS in March, we have continued working with the FDA as they complete their review of our New Drug Application, which has a June 16, 2024 PDUFA target action date,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “We are actively preparing for a successful launch of imetelstat in the U.S., if approved, including most recently onboarding our sales force last month, refining our market research and completing buildout of our enterprise capabilities and systems to support our transition from a clinical to commercial-stage company.”

 

U.S. Commercial Preparation

 

Geron has now completed onboarding its commercial team, with the buildout of the full sales organization in April. Other commercial preparations for the U.S. are ongoing and on target, including enhancing and/or establishing company processes and systems to support an expected commercial launch, refining market research in TD LR-MDS, and engaging in marketing, commercial access, payer, and reimbursement preparatory efforts.

 

Clinical Development Update

 

The Phase 3 IMpactMF clinical trial, which has a primary endpoint of overall survival, is ongoing in myelofibrosis patients who are relapsed/refractory to JAK inhibitors. Last month, the data monitoring committee evaluated unblinded data and recommended the clinical trial continue. In addition, the Company reviewed enrollment rates and blinded death rates, which are lower than anticipated based on initial planning assumptions. Accordingly, guidance is being updated to extend the timelines by half a year, with the interim analysis now expected in early 2026 and the final analysis expected in early 2027.

 

First Quarter 2024 Financial Results

 

As of March 31, 2024, the Company had approximately $465 million in cash and marketable securities, including proceeds from an underwritten public offering of common stock and a pre-funded warrant in March 2024 for net proceeds of approximately $141 million.

 

For the first quarter of 2024, the Company reported a net loss of $55.4 million, or $0.09 per share, compared to $38.1 million, or $0.07 per share, for the first quarter of 2023.

 

Revenues for the first quarter of 2024 were $304,000, compared to $21,000 for the same period in 2023. Royalty revenues in 2024 and 2023 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.

 

Total operating expenses for the first quarter of 2024 were $56.4 million, compared to $40.1 million for the same period in 2023. Research and development expenses for the first quarter of 2024 were $29.4 million, compared to $27.2 million for the same period in 2023. The increase in research and development expenses for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects the net result of higher

 


 

manufacturing costs due to the timing of imetelstat manufacturing batches and increased personnel-related expenses for additional headcount. We expect research and development expenses to remain consistent in the future as we support IMpactMF, IMproveMF and IMpress, as well as the long-term treatment and follow-up of remaining patients in IMerge. General and administrative expenses for the first quarter of 2024 were $27.1 million, compared to $12.9 million for the same period in 2023. The increase in general and administrative expenses for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects new costs for commercial preparatory activities and higher personnel-related expenses for additional headcount.

 

Interest income for the first quarter of 2024 was $4.2 million, compared to $3.9 million for the same period in 2023. The increase in interest income for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten offering completed in March 2024, as well as higher yields from recent marketable securities purchases.

 

Interest expense for the first quarter of 2024 was $3.4 million, compared to $1.9 million for the same period in 2023. The increase in interest expense for the three months ended March 31, 2024, compared to the same period in 2023, primarily reflects higher interest rates. Currently, we have $80.0 million in principal debt outstanding. Interest expense reflects interest owed under our loan facility.

 

2024 Financial Guidance

 

For fiscal year 2024, the Company expects total operating expenses to be in the range of approximately $270 million to $280 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.

 

The fiscal year 2024 financial guidance reflects costs to support regulatory processes with the FDA and EMA in 2024; continued support of ongoing clinical trials; manufacturing of commercial inventory of imetelstat; build out of our commercial organization to support the potential U.S. commercial launch of imetelstat in the U.S.; increases in headcount in preparation for transition to a commercial-stage company; and interest payments on outstanding debt.

 

Based on our current operating plans and our assumptions regarding the timing of the potential approval and commercial launch of imetelstat in lower risk MDS in the U.S., we believe that our existing cash, cash equivalents, and current and noncurrent marketable securities, together with projected revenues from U.S. sales of imetelstat, if approved, potential proceeds from the exercise of our outstanding warrants, and potential future drawdowns under our loan facility, will be sufficient to fund our projected operating requirements into the second quarter of 2026.

 

As of March 31, 2024, we had 162 full-time employees, prior to the onboarding of our salesforce in April 2024. Subject to approval of imetelstat in the U.S., the Company plans to grow to a total of approximately 250-300 employees by year-end 2024.

 

Conference Call

 

Geron will host a conference call at 8:00 a.m. ET on Thursday, May 2, 2024, to discuss business updates and first quarter financial results.

 

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

 

Participants may access the webcast by registering online using the following link, https://events.q4inc.com/attendee/934891352

 

2

 


 

About Imetelstat

 

Imetelstat is a novel, first-in-class investigational telomerase inhibitor exclusively owned by Geron and being developed by Geron in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies, resulting in malignant cell apoptosis. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk myelofibrosis (MF) whose disease has relapsed after or is refractory to Janus kinase (JAK) inhibitor treatment. Imetelstat is currently not approved by any regulatory authority.

 

About IMpactMF

 

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis (MF) who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

 

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

 

About Geron

 

Geron is a late-stage clinical biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Our first-in-class investigational telomerase inhibitor, imetelstat, harnesses Nobel Prize-winning science in a treatment that may alter the underlying drivers of disease. The New Drug Application (NDA) for imetelstat for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (TD LR-MDS) who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs), based on the results from the Phase 3 IMerge clinical trial, is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 16, 2024. In addition, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for the same proposed indication and is under review. Furthermore, Geron currently has an ongoing pivotal Phase 3 clinical trial evaluating imetelstat in relapsed/refractory myelofibrosis (R/R MF). To learn more, visit www.geron.com or follow us on LinkedIn.

 

Use of Forward-Looking Statements

 

Except for the historical information contained herein, this press release 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 Company’s work with the FDA to complete the review of the NDA for imetelstat in lower-risk MDS; (ii) preparations for a potential launch in TD LR-MDS in the U.S. upon potential approval by the FDA (PDUFA date June 16, 2024); (iii) that the interim analysis of IMpactMF is expected in early 2026 and the final analysis is expected in early 2027; (iv) the Company’s projections and expectations regarding the sufficiency of its cash resources and expected available resources to fund its projected operating requirements into Q2 2026, and the assumptions underlying such projections and expectations; (v) the Company’s projections for total operating expenses for fiscal 2024 and employee headcount as of the end of 2024; (vi) that imetelstat has the potential to demonstrate disease-modifying activity in patients; (vii) that IMpactMF has registrational intent; and (viii) 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) whether Geron overcomes all of the potential delays and other adverse impacts caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual

3

 


 

property, manufacturing and regulatory challenges in order to have the financial resources for, and to meet the expected timelines, planned milestones and expenses noted herein; (b) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (c) whether imetelstat has demonstrated sufficient safety, efficacy and clinical benefit in IMerge Phase 3 to enable regulatory approval; (d) whether any future safety or efficacy results of imetelstat treatment cause the benefit-risk profile of imetelstat to become unacceptable; (e) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (f) that Geron may seek to raise substantial additional capital in order to complete the development and commercialization of imetelstat to meet the expected timelines, planned milestones and expenses noted herein; (g) whether regulatory authorities require an additional clinical trial for approval of imetelstat in TD LR-MDS, or post-approval; (h) whether there are failures or delays in manufacturing or supplying sufficient quantities of imetelstat or other clinical trial materials that impact a commercial launch in TD LR-MDS or the continuation of the IMpactMF trial; (i) that the projected timing for the interim and final analyses of the IMpactMF trial may vary depending on actual enrollment and death rates in the trial; and (j) whether the FDA and EMA will approve imetelstat for the treatment of TD LR-MDS or other indications on the timelines expected, or at all. 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 Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s annual report on Form 10-K for the year ended December 31, 2023, and subsequent filings and reports by Geron. 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, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

 

Financial table follows.

4

 


 

GERON CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

UNAUDITED

Three Months Ended March 31,

(In thousands, except share and per share data)

2024

2023

 

 

Revenues:

   Royalties

 $ 304

 $ 21

Operating expenses:

Research and development

            29,373

            27,219

General and administrative

           27,065

              12,894

Total operating expenses

           56,438

           40,113

Loss from operations

          (56,134)

          (40,092)

Interest income

              4,239

                 3,853

Interest expense

             (3,433)

             (1,922)

Other income and (expense), net

                   (62)

                  39

Net loss

 $ (55,390)

 $ (38,122)

Basic and diluted net loss per share:

   Net loss per share

 $ (0.09)

 $ (0.07)

   Shares used in computing net loss per share

 603,493,451

  544,459,004

 

 

 

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

March 31,

December 31,

(In thousands)

2024

2023

(Unaudited)

(Note 1)

Current assets:

Cash, cash equivalents and restricted cash

  $ 190,880

  $ 71,138

Current marketable securities

               253,288

               263,676

Other current assets

                   7,341

                    6,534

      Total current assets

             451,509

               341,348

Noncurrent marketable securities

              20,782

                     43,298

Property and equipment, net

                    1,681

                       1,117

Deposits and other assets

                    8,102

                    8,253

  $ 482,074

  $ 394,076

Current liabilities

  $ 123,158

  $ 108,070

Noncurrent liabilities

                  14,048

38,057

Stockholders’ equity

                344,868

                  247,949

   $ 482,074

   $ 394,076

 

 

 

 

Note 1: Derived from audited financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2023.

 

 


 

CONTACT:

Aron Feingold

Vice President, Investor Relations and Corporate Communications

 

Kristen Kelleher

Associate Director, Investor Relations and Corporate Communications

 

investor@geron.com

media@geron.com

 

###

 


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Province Trading Symbol Soliciting Material Entity Address, City or Town Written Communications CIK Entity Central Index Key Entity Tax Identification Number Registrant Name Entity Registrant Name Current Fiscal Year End Date Period End Date Document Period End Date Entity Address, Postal Zip Code Entity Incorporation, State or Country Code Local Phone Number City Area Code Pre-commencement Tender Offer Cover Cover [Abstract] Security Exchange Name Entity Emerging Growth Company Amendment Amendment Flag Securities Act File Number Entity Address, Address Line Two Entity Address, Address Line One Title of 12(b) Security Document Type Document Type XML 6 R1.htm IDEA: XBRL DOCUMENT v3.24.1.u1
Cover
May 02, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date May 02, 2024
Securities Act File Number 000-20859
Entity Registrant Name GERON CORPORATION
Entity Central Index Key 0000886744
Entity Tax Identification Number 75-2287752
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 919 E. HILLSDALE BLVD
Entity Address, Address Line Two SUITE 250
Entity Address, City or Town FOSTER CITY
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94404
City Area Code 650
Local Phone Number 473-7700
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.001 par value
Trading Symbol GERN
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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