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4D Molecular Therapeutics(FDMT) - 2022 Q2 - Quarterly Report
2022-08-10 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 47-3506994 (State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share FDMT The Nasdaq Global Select Market Non-accelerated filer ☒ Smaller reporting company ☒ FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...
4D Molecular Therapeutics(FDMT) - 2022 Q1 - Quarterly Report
2022-05-11 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ 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 001-39782 4D Molecular Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-3506994 (State or other ...
4D Molecular Therapeutics(FDMT) - 2021 Q4 - Annual Report
2022-03-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 001-39782 4D Molecular Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-3506994 (State or other juri ...
4D Molecular Therapeutics (FDMT) WORLDSymposium 2022 - 4D-310 Updated Interim Clinical Data - Slideshow
2022-02-17 18:36
| --- | --- | |-----------------------------------------------------------------|-------| | | | | An Open-label, Phase 1/2 Trial of Gene Therapy | | | 4D-310 in Adult Males with Fabry Disease Jerry Vockley, MD, PhD | | | University of Pittsburgh, Pittsburgh, Pennsylvania, USA | | 4D-310 Product Design: Unique Dual Mechanism-of-Action INVENTED FOR LOW DOSE IV DELIVERY TO TARGET ORGANS INCLUDING HEART & HIGH SERUM AGA Patient with Fabry Disease Biodistribution to affected organs Blood vessel dysfunction Cardi ...
4D Molecular Therapeutics(FDMT) - 2021 Q3 - Quarterly Report
2021-11-09 16:00
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details the company's unaudited condensed financial statements, management's analysis of operations and financial condition, and market risk disclosures [Item 1. Condensed Unaudited Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Unaudited%20Financial%20Statements) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations, and cash flows, for the periods ended September 30, 2021, detailing the company's financial position and performance [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$240.6 million** from **$288.3 million**, primarily due to reduced cash, while total liabilities decreased to **$16.5 million** from **$31.9 million** Condensed Balance Sheet Highlights (in thousands) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $90,989 | $276,726 | | Marketable securities | $136,180 | $0 | | Total current assets | $165,733 | $282,656 | | **Total assets** | **$240,618** | **$288,331** | | **Liabilities & Equity** | | | | Total current liabilities | $11,373 | $16,744 | | Deferred revenue, total | $4,738 | $19,812 | | **Total liabilities** | **$16,484** | **$31,944** | | **Total stockholders' equity** | **$224,134** | **$256,387** | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) Net loss increased to **$22.2 million** in Q3 2021 and **$46.2 million** for the nine months, driven by decreased revenue and higher operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2021 | Q3 2020 | Nine Months 2021 | Nine Months 2020 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $1,366 | $7,421 | $17,946 | $14,589 | | Research and development | $15,840 | $11,555 | $43,832 | $40,433 | | General and administrative | $8,187 | $3,682 | $20,683 | $10,398 | | Loss from operations | ($22,661) | ($7,816) | ($46,569) | ($36,242) | | **Net loss** | **($22,239)** | **($7,833)** | **($46,234)** | **($36,146)** | | Net loss per share | ($0.82) | ($1.51) | ($1.72) | ($6.97) | [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$47.3 million**, with **$140.4 million** used in investing activities, resulting in a **$185.7 million** net decrease in cash Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2021 | Nine Months Ended Sep 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($47,298) | ($33,410) | | Net cash used in investing activities | ($140,389) | ($492) | | Net cash provided by financing activities | $1,950 | $73,005 | | **Net (decrease) increase in cash** | **($185,737)** | **$39,103** | | Cash and cash equivalents, end of period | $90,989 | $88,755 | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail the company's liquidity, including a **November 2021 Follow-on Offering**, and the impact of the **Roche collaboration termination** on revenue recognition - In November 2021, the company completed a Follow-on Offering, raising net proceeds of **$110.8 million** from the sale of 4,750,000 shares at $25.00 per share[31](index=31&type=chunk)[161](index=161&type=chunk) - The collaboration and license agreement with Roche was terminated without cause by Roche, effective September 16, 2021, reverting all rights to the 4D-110 program to the company[103](index=103&type=chunk) - Management believes that cash, cash equivalents, marketable securities, and the net proceeds from the November 2021 Follow-on Offering are sufficient to fund planned operations for at least one year[32](index=32&type=chunk) - In October 2021, following the IND clearance for 4D-710, the Cystic Fibrosis Foundation (CFF) invested an additional **$4.0 million** in exchange for 125,715 shares of common stock[160](index=160&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results, attributing the Q3 2021 revenue decrease to the Roche agreement termination and increased expenses to higher headcount, while confirming sufficient liquidity [Overview](index=31&type=section&id=Overview) 4D Molecular Therapeutics is a clinical-stage gene therapy company with three product candidates in clinical trials and two with cleared INDs, primarily funded by equity offerings - The company has three product candidates in Phase 1/2 clinical trials: 4D-125 for XLRP, 4D-110 for choroideremia, and 4D-310 for Fabry disease[165](index=165&type=chunk) - INDs have been cleared by the FDA for two additional product candidates: 4D-150 for wet AMD and 4D-710 for cystic fibrosis lung disease[165](index=165&type=chunk) - The company completed a Follow-on Offering in November 2021, raising net proceeds of **$110.8 million**[167](index=167&type=chunk) [Results of Operations](index=34&type=section&id=Results%20of%20Operations) Q3 2021 revenue decreased by **82%** due to the Roche agreement termination, while R&D and G&A expenses increased by **37%** and **122%** respectively, driven by personnel costs Comparison of Results for the Three Months Ended September 30 (in thousands) | Account | 2021 | 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $1,366 | $7,421 | ($6,055) | (82%) | | Research and development | $15,840 | $11,555 | $4,285 | 37% | | General and administrative | $8,187 | $3,682 | $4,505 | 122% | | **Net loss** | **($22,239)** | **($7,833)** | **($14,406)** | **184%** | Comparison of Results for the Nine Months Ended September 30 (in thousands) | Account | 2021 | 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenue | $17,946 | $14,589 | $3,357 | 23% | | Research and development | $43,832 | $40,433 | $3,399 | 8% | | General and administrative | $20,683 | $10,398 | $10,285 | 99% | | **Net loss** | **($46,234)** | **($36,146)** | **($10,088)** | **28%** | [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2021, the company held **$227.2 million** in cash and marketable securities, bolstered by a **$110.8 million** November 2021 Follow-on Offering, deemed sufficient for at least one year of operations - As of September 30, 2021, the company had cash, cash equivalents, and marketable securities of **$227.2 million**[201](index=201&type=chunk) - The company raised an additional **$110.8 million** in net proceeds from its Follow-on Offering in November 2021[202](index=202&type=chunk) - The company believes its existing cash and marketable securities will fund planned operations for at least one year from the date of the report's issuance[208](index=208&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity on its **$227.2 million** cash and marketable securities, though a **10%** rate change is not expected to materially impact fair value due to short-term maturities - The company's main market risk is interest rate sensitivity on its cash and marketable securities[230](index=230&type=chunk) - Due to the short-to-medium term nature of its investments, a **10%** change in interest rates is not expected to have a material effect on the fair value of its holdings[230](index=230&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2021, with no material changes to internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[234](index=234&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to materially affect, internal controls[235](index=235&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information including legal proceedings, risk factors, equity sales, and other required disclosures [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[237](index=237&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including its early development stage, history of net losses, need for additional capital, and challenges with novel AAV gene therapy technology, clinical trials, and manufacturing - The company is an early-stage drug development company with a limited operating history, recurring net losses, and no products approved for commercial sale[241](index=241&type=chunk) - The company will require substantial additional capital and may be forced to delay or eliminate programs if it is unable to raise funds on acceptable terms[242](index=242&type=chunk) - All product candidates are based on a novel AAV gene therapy technology, which makes the time and cost of development and regulatory approval difficult to predict and potentially longer and more expensive than for other modalities[243](index=243&type=chunk) - Gene therapies are complex and difficult to manufacture, which could lead to production problems, delays, and limited supply[244](index=244&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=104&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section discloses the **October 2021 unregistered sale** of common stock to CFF for **$4.0 million** and confirms no material change in the use of proceeds from the **December 2020 IPO** - In October 2021, the company issued 125,715 shares of common stock to the Cystic Fibrosis Foundation (CFF) for **$4.0 million** in a private placement following the IND clearance for its 4D-710 product candidate[618](index=618&type=chunk) - The use of proceeds from the December 2020 IPO, which raised net proceeds of **$204.7 million**, has not materially changed from the plans described in the final prospectus[619](index=619&type=chunk)[621](index=621&type=chunk) [Item 3. Default Upon Senior Securities](index=104&type=section&id=Item%203.%20Default%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[622](index=622&type=chunk) [Item 4. Mine Safety Disclosures](index=104&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reports no mine safety disclosures - None[623](index=623&type=chunk) [Item 5. Other Information](index=104&type=section&id=Item%205.%20Other%20Information) The company reports no other information - None[624](index=624&type=chunk) [Item 6. Exhibits](index=105&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents and officer certifications - The report includes standard corporate governance documents and certifications from the CEO and CFO as exhibits[626](index=626&type=chunk)[631](index=631&type=chunk)[632](index=632&type=chunk)
4D Molecular Therapeutics(FDMT) - 2021 Q2 - Quarterly Report
2021-08-11 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 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 001-39782 4D Molecular Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-3506994 (State or other ...
4D Molecular Therapeutics(FDMT) - 2021 Q1 - Quarterly Report
2021-05-12 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 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 001-39782 4D Molecular Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Delaware 47-3506994 (State or other ...