Geron Corp (GERN) 10K Annual Reports & 10Q SEC Filings

Unless the context indicates otherwise, the terms “we,” “us” and “our” refer to Geron Corporation, a Delaware corporation, and its subsidiary on a consolidated basis. This Exhibit 99.1 includes trademarks, service marks and trade names owned by us or other companies. All trademarks, service marks and trade names included in this Exhibit 99.1 are the property of their respective owners.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Exhibit 99.1 contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements about:

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the therapeutic potential of imetelstat and its expected uses and benefits;

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our plans to submit a New Drug Application, or NDA, and a marketing authorization application, or MAA, for imetelstat in Low or Intermediate-1 risk myelodysplastic syndromes, or lower risk MDS, and the anticipated timing thereof;

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the progress, timing, magnitude, scope and costs of clinical development, manufacturing and commercialization of imetelstat, including the number of indications which are or may in the future be pursued, subject to clearances and approvals by the U.S. Food and Drug Administration, or FDA, and other regulatory authorities;

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the continued enrollment in, and the continued conduct and completion of, IMpactMF, our Phase 3 clinical trial in relapsed/refractory myelofibrosis, or MF, IMproveMF, our Phase 1 combination clinical trial in frontline Intermediate-2 or High Risk MF, and IMpress, an investigator-led Phase 2 clinical trial in Intermediate-2 or High-Risk myelodysplastic syndromes and acute myeloid leukemia;

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the achievement and timing of clinical trial events related to IMpactMF, IMproveMF and IMpress, including the completion of patient enrollment and anticipated timing of data availability;

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other potential planned future clinical development plans for imetelstat;

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our plans to market and sell imetelstat, upon regulatory approval or clearance, in the U.S. and in Europe, whether alone or with new collaborative partners, and the anticipated timing thereof;

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our ability to obtain and maintain potential new collaborative arrangements to assist us in the development and potential commercialization of imetelstat, especially outside the U.S.;

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the availability of coverage and adequate third-party reimbursement for imetelstat, if any;

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our ability to consistently and reproducibly manufacture imetelstat;

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our ability to meaningfully reduce manufacturing costs of imetelstat;

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the impacts of the ongoing COVID-19 global pandemic, macroeconomic conditions, such as rising inflation rates, uncertain credit and global financial markets and supply chain disruptions, and geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, on the foregoing;

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our ability to establish and maintain agreements with third-party service providers to support the development of imetelstat;

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the size and timing of expenditures and whether there are unanticipated expenditures;

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our ability to manage the anticipated growth of our business, including our ability to recruit and retain key personnel to support the development and potential future commercialization of imetelstat;

The following information was filed by Geron Corp (GERN) on Wednesday, January 4, 2023 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

ChatGPT says Geron Corporation Developing Imetelstat for Lower Risk MDS

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Inside Geron Corp's 10-K Annual Report:

Financial - Income Highlight
We cannot assure you that our existing capital resources, including net cash proceeds from our recent underwritten public offering in January 2023, future interest income, future proceeds from potential cash exercises of currently outstanding warrants and potential future sales of our common stock, including under the 2020 Sales Agreement with B. Riley or potential future drawdowns, if available, of the remaining up to $55.0 million under the Loan Agreement (which are subject to the achievement of certain clinical and regulatory milestones and satisfaction of certain capitalization and other requirements, as well as approval by an investment committee comprised of Hercules and SVB (or its successor, if any) for the final $25.0 million tranche), will be sufficient to fund our operating plans.

Other - Other Highlight
In this regard, the effects of the COVID-19 pandemic have increased market volatility and could result in a significant long-term disruption of global financial markets, which could reduce or eliminate our ability to raise additional funds through financings, and could negatively impact the terms upon which we may raise those funds.
Revenue - Product Highlight
Financing activities in 2022, 2021 and 2020 primarily reflect the receipt of net cash proceeds of $69.9 million from the underwritten public offering of common stock, pre-funded warrant and stock purchase warrants completed in April 2022, cash proceeds from the exercise of warrants, receipt of net cash proceeds from the sales of our common stock under the 2020 Sales Agreement in 2021, the receipt of $140.2 million in net cash proceeds from the underwritten public offering of common stock, pre-funded warrant and stock purchase warrants in May 2020, receipt of net cash proceeds from the sales of our common stock under the 2018 Sales Agreement with B. Riley in 2020 and aggregate drawdowns of $25.0 million in each of 2021 and 2020 under the Loan Agreement with Hercules and SVB.
Revenue - Product Highlight
We pay B. Riley an aggregate commission rate equal to up to 3.0% of the gross proceeds of the sales price per share for common stock sold through B. Riley under the 2020 Sales Agreement.
Other - Other Highlight
A critical accounting estimate is defined as one that is both material to the presentation of our consolidated financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations.
Other - Other
However, if we incorrectly estimate...Read more
Other - Other
Specifically, critical accounting estimates have...Read more
Other - Other
Net cash used in investing...Read more
Revenue - Geography
In Europe, we anticipate review...Read more
Financial - Income
The increase in interest income...Read more
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The increase in interest expense...Read more
Financial - Shares
In the first quarter of...Read more
Other - Other
In addition, under the amended...Read more
Other - Other
Net cash provided by investing...Read more
Legal - Other
In addition, our plans and...Read more
Financial - Expense
The increase in research and...Read more
Financial - Debt
The receptivity of the public...Read more
Financial - Expense
In addition, personnel-related expenses have...Read more
Other - Other
Moreover, while we did not...Read more
M & A - Other
Availability of such financing sources...Read more
Financial - Expense
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Financial - Expense
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Financial - Income
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Other - Other
This license was terminated effective...Read more
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Other - Other
If the NDA is accepted...Read more
Other - Other
As such, significant management judgment...Read more
Other - Other
Financial instruments classified as Level...Read more
Revenue - Product
On September 4, 2020, we...Read more
Financial - Shares
For the year ended December...Read more
Financial - Debt
Our investment portfolio does not...Read more
Financial - Shares
During the first quarter of...Read more
Other - Other
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Other - Other
In the absence of potential...Read more
Other - Other
Moreover, if we raise additional...Read more
Financial - Shares
In 2022, warrants to purchase...Read more
Other - Other
In deriving this assumption, we...Read more
Financial - Expense
Research and Development Expenses During...Read more
Other - Other
Consideration is given to the...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Geron Corp provided additional information to their SEC Filing as exhibits

Exhibit 21: Subsidaries Of The Registrant

Exhibit 23: Consents Of Experts And Counsel

Exhibit 31: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32: Section 1350 Certification

Ticker: GERN
CIK: 886744
Form Type: 10-K Annual Report
Accession Number: 0000950170-23-008437
Submitted to the SEC: Thu Mar 16 2023 4:02:52 PM EST
Accepted by the SEC: Thu Mar 16 2023
Period: Saturday, December 31, 2022
Industry: Pharmaceutical Preparations