Foghorn Therapeutics(FHTX)
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Foghorn Therapeutics(FHTX) - 2023 Q1 - Quarterly Report
2023-05-07 16:00
[PART I. FINANCIAL INFORMATION](index=1&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements, management's analysis of financial condition, market risk disclosures, and internal controls [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, highlighting a net loss increase and a decrease in total assets, supported by significant deferred revenue Condensed Consolidated Balance Sheets (in thousands) | Account | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total Assets** | **$372,883** | **$404,883** | | Cash and cash equivalents | $50,641 | $52,214 | | Marketable securities | $265,329 | $293,584 | | **Total Liabilities** | **$397,469** | **$404,771** | | Deferred revenue (Current & Non-current) | $331,511 | $336,820 | | **Total Stockholders' Equity (Deficit)** | **($24,586)** | **$112** | Condensed Consolidated Statements of Operations (in thousands) | Metric | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Collaboration revenue | $5,309 | $3,920 | | Total operating expenses | $38,626 | $31,724 | | Loss from operations | ($33,317) | ($27,804) | | **Net loss** | **($30,488)** | **($26,914)** | | **Net loss per share** | **($0.73)** | **($0.65)** | Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | ($31,180) | $271,534 | | Net cash provided by (used in) investing activities | $29,505 | ($159,409) | | Net cash provided by financing activities | $102 | $384 | | **Net decrease in cash, cash equivalents and restricted cash** | **($1,573)** | **$112,509** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's basis of presentation, significant accounting policies, and financial arrangements, including collaboration agreements and the establishment of a full valuation allowance against deferred tax assets - The company has incurred recurring net losses, totaling **$30.5 million** for the three months ended March 31, 2023, and had an accumulated deficit of **$403.6 million**. Management expects current cash reserves to fund operations for at least the next 12 months[74](index=74&type=chunk) - The Lilly Collaboration Agreement involves co-development and co-commercialization for two programs and includes three additional discovery programs. As of March 31, 2023, the unsatisfied performance obligation was **$315.1 million**, expected to be recognized as revenue through 2029 or beyond[112](index=112&type=chunk)[139](index=139&type=chunk) - Under the Merck Collaboration Agreement, the company received a **$15.0 million** upfront payment and is eligible for up to **$410.0 million** in milestones plus royalties. As of March 31, 2023, the unsatisfied performance obligation was **$16.4 million**, expected to be recognized through approximately 2028[42](index=42&type=chunk) - A full valuation allowance has been established against the company's net deferred tax assets due to a history of cumulative net losses and uncertainty about future profitability[116](index=116&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion attributes Q1 2023 results to increased collaboration revenue and rising operating expenses, leading to a wider net loss, with sufficient cash reserves for the next twelve months [Overview](index=16&type=section&id=Overview) Foghorn is a clinical-stage biotechnology company focused on gene expression, with two clinical-stage candidates and **$316.0 million** in cash, cash equivalents, and marketable securities - The company is a clinical-stage biopharmaceutical firm pioneering medicines that target the chromatin regulatory system to correct abnormal gene expression[121](index=121&type=chunk) - As of March 31, 2023, the company had **$316.0 million** in cash, cash equivalents, and marketable securities, funded primarily through an IPO, stock sales, and collaboration upfront payments from Merck (**$15.0 million**) and Lilly (**$300.0 million**)[15](index=15&type=chunk) - The company's lead candidate, FHD-286, is in Phase 1 studies for metastatic uveal melanoma and AML/MDS, though the AML/MDS study is on a full clinical hold by the FDA. Enrollment in the FHD-609 study has been paused[121](index=121&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Collaboration revenue increased while total operating expenses rose significantly, resulting in a higher net loss for the three months ended March 31, 2023 Comparison of Results for the Three Months Ended March 31 (in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Collaboration revenue | $5,309 | $3,920 | $1,389 | | Research and development | $29,985 | $24,508 | $5,477 | | General and administrative | $8,641 | $7,216 | $1,425 | | **Loss from operations** | **($33,317)** | **($27,804)** | **($5,513)** | | **Net loss** | **($30,488)** | **($26,914)** | **($3,574)** | - Collaboration revenue increased by **$1.4 million** YoY, driven by a **$0.9 million** increase from the Lilly collaboration and a **$0.5 million** increase from the Merck collaboration due to continued program advancements[12](index=12&type=chunk) - R&D expenses increased by **$5.5 million** YoY, primarily due to a **$2.5 million** increase in personnel costs from higher headcount, a **$1.9 million** increase in platform research, and a **$1.2 million** increase in facility-related expenses[184](index=184&type=chunk) - G&A expenses increased by **$1.4 million** YoY, mainly attributed to a **$1.7 million** rise in personnel-related costs, including stock-based compensation, due to increased headcount[185](index=185&type=chunk)[13](index=13&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$316.0 million** in cash, cash equivalents, and marketable securities, expecting it to fund operations for at least the next twelve months, but acknowledges future funding needs Sources and Uses of Cash (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2023 | Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | ($31,180) | $271,534 | | Net cash provided by (used in) investing activities | $29,505 | ($159,409) | | Net cash provided by financing activities | $102 | $384 | - The company expects its cash, cash equivalents, and marketable securities of **$316.0 million** (as of March 31, 2023) to be sufficient to fund operating expenses and capital expenditure requirements for at least the next twelve months[15](index=15&type=chunk)[191](index=191&type=chunk) - The company will require further funding through equity offerings, debt financings, or collaborations to advance its research and development programs. Failure to raise capital could force delays or discontinuation of programs[191](index=191&type=chunk)[5](index=5&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Foghorn Therapeutics Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[192](index=192&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) The company's disclosure controls and procedures were deemed effective as of March 31, 2023, with no material changes to internal control over financial reporting - Management concluded that as of March 31, 2023, the company's disclosure controls and procedures were effective at a reasonable assurance level[22](index=22&type=chunk)[193](index=193&type=chunk) - No changes occurred in the company's internal control over financial reporting during the three months ended March 31, 2023, that have materially affected, or are reasonably likely to materially affect, these controls[29](index=29&type=chunk) [PART II. OTHER INFORMATION](index=25&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, updates on risk factors, and a comprehensive list of exhibits filed with the report [Item 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material litigation or legal proceedings that would significantly impact its business - The company is not currently a party to any material litigation or legal proceedings[169](index=169&type=chunk)[43](index=43&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022 - There have been no material changes to the risk factors disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2022[196](index=196&type=chunk) [Item 6. Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including required certifications and XBRL-related documents List of Exhibits | Exhibit Number | Description | | :--- | :--- | | 31.1 | Certification of Principal Executive Officer (Sec. 302) | | 31.2 | Certification of Principal Financial Officer (Sec. 302) | | 32.1 | Certification of Principal Executive Officer (Sec. 906) | | 32.2 | Certification of Principal Financial Officer (Sec. 906) | | 101.INS | XBRL Instance Document | | 101.SCH | XBRL Taxonomy Extension Schema Document | | 101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | | 101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | | 101.LAB | XBRL Taxonomy Extension Label Linkbase Document | | 101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document |
Foghorn Therapeutics (FHTX) Investor Presentation - Slideshow
2023-04-17 01:30
FHD-609 SELECTIVELY DEGRADES BRD9 IN SYNOVIAL SARCOMA GLOBAL PROTEOMICS ANALYSES | BRD9 Is the Only Protein Significantly Degraded at Multiple Concentrations and Time Points - log10 (p-value) - log10 (p-value) - log10 (p-value) negative FC positive FC not significant 16nM (200x DC50) 78nM (1000x DC50) 4hrs in SYO1 16nM (200x DC50) 24hrs in SYO1 4hrs in SYO1 FHD-609 16nM 4h FHD-609 78nM 4h FHD-609 16nM 24h Enhanced Volcano Enhanced Volcano Enhanced Volcano Total = 7,437 Total = 7,437 Total = 7,437 log2 FC lo ...
Foghorn Therapeutics(FHTX) - 2022 Q4 - Annual Report
2023-03-08 16:00
Item 10. Directors, Executive Officers and Corporate Governance 103 Item 11. Executive Compensation 103 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 103 Item 13. Certain Relationships and Related Transactions, and Director Independence 103 Item 14. Principal Accountant Fees and Services 103 ITEM 1. BUSINESS 6 Table of Contents 3 Foghorn's science and potential have been validated by strategic collaborations with two world-leading pharmaceutical comp ...
Foghorm Therapeutics (FHTX) Investor Presentation - Slideshow
2022-11-23 19:42
FOGHO CORPORATE OVERVIEW Leveraging unique insights into the chromatin regulatory system to pioneer a new class of precision therapies in oncology and beyond November 2022 Forward-Looking Statements FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "could," "may," "might," "will," "l ...
Foghorn Therapeutics(FHTX) - 2022 Q3 - Quarterly Report
2022-11-07 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ______________________ FORM 10-Q _____________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-39634 ___________________ ...
Foghorn Therapeutics (FHTX) Investor Presentation - Slideshow
2022-09-15 17:29
FOGHO CORPORATE OVERVIEW Leveraging unique insights into the chromatin regulatory system to pioneer a new class of precision therapies in oncology and beyond September 2022 Forward-Looking Statements FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "could," "may," "might," "will," " ...
Foghorn Therapeutics(FHTX) - 2022 Q2 - Quarterly Report
2022-08-08 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ______________________ FORM 10-Q _____________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-39634 ______________________ F ...
Foghorn Therapeutics (FHTX) Investor Presentation - Slideshow
2022-06-09 19:36
FOGHO CORPORATE OVERVIEW Leveraging unique insights into the chromatin regulatory system to pioneer a new class of precision therapies in oncology and beyond June 2022 Forward-Looking Statements FORWARD LOOKING STATEMENTS This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "could," "may," "might," "will," "likel ...
Foghorn Therapeutics(FHTX) - 2022 Q1 - Quarterly Report
2022-05-08 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ______________________ FORM 10-Q _____________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-39634 ______________________ ...
Foghorn Therapeutics (FHTX) Investor Presentation - Slideshow
2022-03-12 15:56
Overview - The dysregulation of the Chromatin Regulatory System is implicated in approximately 50% of all cancers, representing a significant market opportunity[3] - Foghorn Therapeutics is well-positioned to discover and develop first-in-class precision medicines targeting cancer and other diseases[4] - Foghorn Therapeutics had $479.5 million in pro forma cash and equivalents as of September 30, 2021[5] Pipeline and Programs - FHD-286 (BRG1/BRM) is an enzyme inhibitor targeting AML and Uveal melanoma, with initial clinical data expected in H1 2022[8, 23] - FHD-609 (BRD9) is a protein degrader targeting Synovial Sarcoma, with initial clinical data expected as early as H1 2022[8, 23] - Selective BRM modulators, including enzyme inhibitors and protein degraders, are being developed for BRG1 mutated cancers, impacting over 100,000 patients per year[52] - Selective ARID1B protein degrader is in pre-clinical development for ARID1A mutated cancers, potentially impacting over 175,000 patients per year[60] Strategic Collaborations - Strategic collaboration with Loxo Oncology at Lilly includes $380 million upfront ($300 million cash and $80 million in Foghorn common stock at $20 per share), 50/50 U S economics on two programs, tiered ex-U S royalties, and $1.3 billion in potential milestones[10] - Merck collaboration to drug single specified transcription factor target includes $425 million in up-front, research, development and sales-based milestones and up to low double-digit royalties on product sales[68]