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What changed in Immuneering Corp's 10-K — 2022 vs 2023

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Paragraph-level year-over-year comparison of Immuneering Corp's 2022 and 2023 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2023 report.

+1143 added−658 removedSource: 10-K (2024-03-01) vs 10-K (2023-03-06)

Top changes in Immuneering Corp's 2023 10-K

1143 paragraphs added · 658 removed · 435 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

2 edited+473 added−189 removed0 unchanged
Biggest changeImmuneering’s lead product candidate, IMM-1-104, is in a Phase 1/2a study in patients with advanced solid tumors harboring RAS mutations.
Biggest changeOur Universal-RAS product candidate, IMM-1-104, is currently being evaluated in a Phase 1/2a clinical trial in patients with advanced solid tumors harboring RAS mutations , and our Universal-RAS/RAF product candidate, IMM-6-415, is currently being evaluated in a Phase 1/2a clinical trial in patients with advanced solid tumors harboring RAS or RAF mutations.
Immuneering is a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim to therapeutically address universal-RAS. The company aims to achieve universal activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells.
Our Strategy We are a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients. Our aim is to achieve such universal activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells.
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Financial Statements ​ IMMUNEERING CORPORATION ​ CONSOLIDATED BALANCE SHEETS ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2022 December 31, 2021 ​ ​ ​ ​ ​ ​ ​ Assets ​ ​ Current assets: ​ ​ Cash and cash equivalents ​ $ 72,636,886 ​ $ 74,888,145 Marketable securities, current ​ ​ 32,887,970 ​ ​ 74,311,203 Accounts receivable ​ 12,417 ​ 246,040 Prepaids and other current assets ​ 3,209,536 ​ 2,888,608 Total current assets ​ 108,746,809 ​ 152,333,996 ​ ​ ​ ​ ​ ​ ​ Marketable securities, non-current ​ ​ — ​ ​ 996,560 Property and equipment, net ​ 1,369,608 ​ 807,223 Goodwill ​ ​ 6,690,431 ​ ​ 6,701,726 Intangible asset ​ ​ 408,947 ​ ​ 439,000 Right-of-use assets, net ​ 4,407,785 ​ 5,324,198 Other assets ​ 743,703 ​ 102,129 Total assets ​ $ 122,367,283 ​ $ 166,704,832 ​ ​ ​ ​ ​ ​ ​ Liabilities, convertible preferred stock and stockholders' equity ​ ​ Current liabilities: ​ ​ Accounts payable ​ $ 3,154,557 ​ $ 1,394,340 Accrued expenses ​ 4,500,993 ​ 3,965,447 Other liabilities, current ​ ​ 19,796 ​ ​ — Lease liabilities, current ​ 378,723 ​ 274,039 Total current liabilities ​ 8,054,069 ​ 5,633,826 ​ ​ ​ ​ ​ ​ ​ Long-term liabilities: ​ ​ Lease liabilities, non-current ​ 4,462,959 ​ 5,090,897 Total liabilities ​ 12,517,028 ​ 10,724,723 Commitments and contingencies (Note 13) ​ ​ Stockholders’ equity: ​ ​ Preferred stock, $0.001 par value; 10,000,000 shares authorized at December 31, 2022 and December 31, 2021; No shares issued or outstanding ​ ​ — ​ — Class A common stock, $0.001 par value, 200,000,000 shares authorized at December 31, 2022 and December 31, 2021; 26,418,732 and 26,320,199 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively ​ 26,419 ​ 26,320 Class B common stock, $0.001 par value, 20,000,000 shares authorized at December 31, 2022 and December 31, 2021 ; 0 shares issued and outstanding at December 31, 2022 and December 31, 2021 ​ — ​ — Additional paid-in capital ​ 219,640,912 ​ 215,276,186 Accumulated other comprehensive loss ​ ​ (30,120) ​ ​ (49,009) Accumulated deficit ​ (109,786,956) ​ (59,273,388) Total stockholders' equity ​ 109,850,255 ​ 155,980,109 Total liabilities, convertible preferred stock and stockholders' equity ​ $ 122,367,283 ​ $ 166,704,832 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ ​ 124 Table of Contents ​ IMMUNEERING CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2022 2021 ​ ​ ​ ​ ​ ​ ​ Revenue ​ $ 316,952 ​ $ 2,079,961 Cost of revenue ​ 158,122 ​ 1,153,073 ​ ​ ​ ​ ​ ​ ​ Gross profit ​ 158,830 ​ 926,888 ​ ​ ​ ​ ​ ​ ​ Operating expenses ​ ​ Research and development ​ 36,267,116 ​ 26,540,959 General and administrative ​ 15,606,529 ​ 8,271,998 Amortization of intangible asset ​ ​ 30,053 ​ ​ — Total operating expenses ​ 51,903,698 ​ 34,812,957 Loss from operations ​ (51,744,868) ​ (33,886,069) ​ ​ ​ ​ ​ ​ ​ Other income (expense) ​ ​ Interest income ​ 1,014,456 ​ 169,899 Other income (expense) ​ ​ 216,844 ​ ​ (127,063) Loss before income taxes ​ ​ (50,513,568) ​ ​ (33,843,233) Income tax benefit ​ ​ — ​ ​ 307,485 Net loss ​ $ (50,513,568) ​ $ (33,535,748) ​ ​ ​ ​ ​ ​ ​ Net loss per share attributable to common stockholders, basic and diluted ​ ​ (1.91) ​ ​ (2.46) Weighted-average common shares outstanding, basic and diluted ​ ​ 26,386,864 ​ ​ 13,612,677 ​ ​ ​ ​ ​ ​ ​ Other comprehensive loss: ​ ​ ​ ​ ​ ​ Unrealized gain (losses) from marketable securities ​ ​ 18,889 ​ ​ (49,009) Comprehensive Loss ​ $ (50,494,679) ​ $ (33,584,757) ​ The accompanying notes are an integral part of these consolidated financial statements. ​ ​ 125 Table of Contents IMMUNEERING CORPORATION ​ CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY FOR THE YEAR ENDED DECEMBER 31, 2022 AND 2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Convertible Preferred Stock ​ ​ Stockholders' Equity ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Accumulated other ​ ​ ​ ​ Total ​ ​ Series B ​ Series A ​ Convertible ​ ​ Class A Common Stock ​ Class B Common Stock ​ Paid-In ​ comprehensive ​ Accumulated ​ Stockholders' ​ Shares Amount Shares Amount Preferred Stock Shares Par Value Shares Par Value Capital loss ​ Deficit Equity ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2020 3,619,292 $ 36,983,910 ​ ​ 2,495,933 ​ $ 21,119,940 ​ $ 58,103,850 ​ ​ ​ 4,950,129 ​ $ 4,950 — $ — ​ $ 3,251,240 ​ $ — ​ $ (25,737,640) ​ $ (22,481,450) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Issuance of Series B convertible preferred stock, net of issuance costs 2,412,853 ​ ​ 24,788,851 ​ — ​ ​ — ​ 24,788,851 ​ ​ — ​ — — ​ — ​ — ​ — ​ — ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Issuance of common stock upon exercise of stock options — ​ ​ — ​ — ​ ​ — ​ — ​ ​ 117,846 ​ 118 — ​ — ​ 354,316 ​ — ​ — ​ 354,434 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Issuance of common stock upon exercise of warrants — ​ ​ — ​ — ​ ​ — ​ — ​ ​ 308,308 ​ 308 — ​ — ​ 926,817 ​ — ​ — ​ 927,125 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Conversion of Preferred Stock into common stock (6,032,145) ​ ​ (61,772,761) ​ (2,495,933) ​ ​ (21,119,940) ​ (82,892,701) ​ ​ 11,939,281 ​ 11,939 — ​ — ​ 82,880,762 ​ — ​ — ​ 82,892,701 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Issuance of common stock upon initial public offering, net of issuance costs ($2,124,317) — ​ ​ — ​ — ​ ​ — ​ — ​ ​ 8,625,000 ​ 8,625 — ​ — ​ 118,185,808 ​ — ​ — ​ 118,194,433 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Issuance of common stock for acquisition ​ — ​ ​ — ​ — ​ ​ — ​ — ​ ​ ​ 379,635 ​ ​ 380 ​ — ​ ​ — ​ ​ 7,874,620 ​ ​ — ​ ​ — ​ ​ 7,875,000 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stock-based compensation expense ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ 1,802,623 ​ ​ — ​ ​ — ​ ​ 1,802,623 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ (33,535,748) ​ ​ (33,535,748) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other comprehensive loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ (49,009) ​ ​ — ​ ​ (49,009) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2021 — $ — ​ ​ — ​ $ — ​ $ — ​ ​ ​ 26,320,199 ​ $ 26,320 — $ — ​ $ 215,276,186 ​ $ (49,009) ​ $ (59,273,388) ​ $ 155,980,109 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Issuance of common stock upon exercise of stock options ​ — ​ ​ — ​ — ​ — ​ — ​ ​ ​ 98,533 ​ ​ 99 ​ — ​ ​ — ​ ​ 300,280 ​ ​ — ​ ​ — ​ ​ 300,379 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stock-based compensation expense ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ 4,064,446 ​ ​ — ​ ​ — ​ ​ 4,064,446 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net loss ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ (50,513,568) ​ ​ (50,513,568) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other comprehensive income ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ 18,889 ​ ​ — ​ ​ 18,889 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Balance at December 31, 2022 — $ — ​ ​ — ​ $ — ​ $ — ​ ​ ​ 26,418,732 ​ $ 26,419 — $ — ​ $ 219,640,912 ​ $ (30,120) ​ $ (109,786,956) ​ $ 109,850,255 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ ​ ​ 126 Table of Contents ​ IMMUNEERING CORPORATION CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEAR ENDED DECEMBER 31, 2022 and 2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2022 2021 ​ ​ ​ ​ ​ ​ ​ Cash flows from operating activities: ​ ​ Net loss ​ $ (50,513,568) ​ $ (33,535,748) Adjustment to reconcile to net loss to net cash used in operating activities: ​ ​ ​ Depreciation expense ​ 247,199 ​ 45,467 Right-of-use asset amortization ​ 519,541 ​ 113,605 Amortization of intangibles ​ ​ 30,053 ​ ​ — Stock-based compensation expense ​ 4,064,446 ​ 1,802,623 Net amortization of premium (accretion of discount) on marketable securities ​ ​ (171,382) ​ ​ 130,240 Loss on disposal of fixed assets ​ ​ 5,170 ​ ​ — Deferred tax benefit ​ ​ — ​ ​ (307,485) Change in assets and liabilities: ​ ​ ​ ​ (Increase) decrease in: ​ ​ ​ ​ Accounts receivable ​ 233,623 ​ 279,713 Prepaid expenses and other current assets ​ (284,346) ​ (2,408,986) Other assets ​ ​ (360,200) ​ ​ — Increase (decrease) in: ​ ​ ​ ​ Accounts payable ​ 1,760,217 ​ (130,398) Accrued expenses ​ 474,568 ​ 3,240,940 Lease liability ​ (126,382) ​ (80,853) Other liabilities ​ ​ 19,796 ​ ​ — Net cash provided by (used in) operating activities ​ (44,101,265) ​ (30,850,882) Cash flows from investing activities: ​ ​ Purchases of property and equipment ​ (742,483) ​ (60,786) Purchases of marketable securities ​ ​ (50,104,515) ​ ​ (75,625,529) Maturities of marketable securities ​ ​ 92,678,000 ​ ​ — Cash acquired in business combination ​ ​ — ​ ​ 70,348 Net cash provided by (used in) investing activities ​ 41,831,002 ​ (75,615,967) Cash flows from financing activities: ​ ​ Proceeds from the issuance of Series B preferred stock, net of issuance costs ​ — ​ 24,788,851 Proceeds from initial public offering of common stock, net of commissions and underwriting ​ ​ — ​ ​ 120,318,750 Payment of initial public offering costs ​ ​ — ​ ​ (2,124,317) Payment of public offering costs ​ ​ (281,375) ​ ​ — Proceeds from exercise of stock options ​ 300,379 ​ 354,434 Proceeds from exercise of warrants ​ — ​ 927,125 Net cash provided by financing activities ​ 19,004 ​ 144,264,843 Net increase (decrease) in cash and cash equivalents ​ (2,251,259) ​ 37,797,994 Cash and cash equivalents at beginning of period ​ 74,888,145 ​ 37,090,151 Cash and cash equivalents at end of period ​ $ 72,636,886 ​ $ 74,888,145 Supplemental disclosures of noncash investing and financing information: ​ ​ Conversion of convertible Series A and B preferred stock into common stock ​ $ — ​ $ 82,892,701 Business combination non-cash ​ ​ — ​ ​ 7,804,652 Class A common stock issued for business combination ​ ​ — ​ ​ 7,875,000 Reduction of right-of-use asset and lease liability in connection with lease modification ​ ​ 396,901 ​ ​ — Property and equipment in accounts payable/accrued expenses ​ ​ 72,272 ​ ​ — ​ The accompanying notes are an integral part of these consolidated financial statements. ​ ​ 127 Table of Contents IMMUNEERING CORPORATION NOTES TO CONSOLIDATED FINANCIAL STATEMENTS ​ Note 1 – Organization and Nature of Business Immuneering Corporation, a Delaware corporation, (“Immuneering” or the “Company”) was incorporated in 2008.
Added
Item 1. Business We are a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients. We aim to achieve such universal RAS/RAF activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells.
Removed
The company’s development pipeline also includes IMM-6-415, which is designed to have an accelerated cadence relative to IMM-1-104, as well as several early-stage programs. ​ On October 30, 2019, Immuneering formed a wholly owned subsidiary, Immuneering Securities Corporation (“ISC”), a Massachusetts securities corporation, for the sole purpose of buying, selling and holding securities on the Company’s behalf.
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Our inclusive approach differentiates us from narrowly targeted precision therapies, which are limited to patients with tumors harboring select mutations. We are currently evaluating our lead product candidates, IMM-1-104 and IMM-6-415, in Phase 1/2a clinical trials in patients with advanced solid tumors harboring RAS and RAS/RAF mutations, respectively.
Removed
On December 22, 2021, the Company acquired all outstanding shares of capital stock of BioArkive, Inc. (“BioArkive”), a California corporation, which as a result became a wholly owned subsidiary. Immuneering, ISC and BioArkive are collectively referred to as “the Company” throughout these consolidated financial statements.
Added
IMM-1-104 is being developed as a once-daily oral therapy that aims to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway. By contrast, IMM-6-415 aims to achieve universal-RAS/RAF activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of the MAPK pathway.
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The Company is subject to a number of inherent risks associated with any biotechnology company that has substantial expenditures for research and development.
Added
Deep cyclic inhibition is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform.
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These risks include, but are not limited to, the need to obtain adequate additional funding, possible failure of clinical trials or other events demonstrating lack of clinical safety or efficacy of its product candidates, dependence on key personnel, reliance on third-party service providers for manufacturing drug product and conducting clinical trials, the ability to successfully secure its proprietary technology, and risks related to the regulatory approval and commercialization of a product candidate.
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The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our pipeline also includes Trifecta MEK, RAS modulators and other small molecule drug discovery programs.
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There can be no assurance that the Company’s research and development program will be successful. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees, advisors, and consultants.
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In September 2022, the FDA cleared our Investigational New Drug ("IND") application for IMM-1-104 and, i n November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the potential treatment of advanced RAS mutant solid tumors.
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On August 3, 2021, the Company completed its initial public offering (“IPO”) pursuant to which it issued and sold 8,625,000 shares of its Class A common stock, inclusive of 1,125,000 shares of its Class A common stock sold pursuant to the full exercise of the underwriters’ option to purchase additional shares.
Added
The Phase 1/2a clinical trial is designed to assess the safety, tolerability, pharmacokinetics ("PK"), pharmacodynamics ("PD"), and preliminary anti-tumor activity of IMM-1-104.
Removed
The aggregate net proceeds received by the Company from the IPO were $120,318,750, after deducting underwriting discounts and commissions, but before deducting offering costs payable by the Company, which were $2,124,317. Upon the closing of the IPO, all 8,528,078 shares of the Company’s convertible preferred stock then outstanding automatically converted into 11,939,281 shares of Class A common stock.
Added
The Phase 1 portion of the clinical trial includes dose escalation and dose exploration utilizing a Bayesian modified toxicity probability interval ("mTPI-2") statistical design to establish an optimized recommended Phase 2 dose ("RP2D") in solid tumor patients with evidence of any RAS mutation. The Phase 2a portion includes evaluating IMM-1-104 in multiple dose expansion arms.
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Upon the conversion of the convertible preferred stock, the Company reclassified the carrying value of the convertible preferred stock to common stock (at par value) and additional paid-in capital.
Added
In November 2023 we announced that we had expanded the IMM-1-104 Phase 1/2a clinical trial design by increasing the number of Phase 2a expansion arms to five, including two combination therapy arms and three monotherapy arms.
Removed
To date, the Company has funded its operations through service revenues, and with proceeds from the sale of its capital stock and convertible notes and, most recently, with proceeds from the IPO. The Company has incurred recurring losses over the past several years and as of December 31, 2022, the Company had an accumulated deficit of $109,786,956.
Added
In December 2023, the FDA cleared our IND application for IMM-6-415 and we began the process of enrolling patients in a Phase 1/2a clinical trial of IMM-6-415 for the potential treatment of patients with advanced solid tumors harboring RAF or RAS mutations.
Removed
The Company expects to continue to generate operating losses for the foreseeable future. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company’s inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies.
Added
The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial includes dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation.
Removed
There can be no assurances that additional funding will be available on terms acceptable to the Company, or at all. If the Company is unable to raise additional funds when needed, it may be required to delay, reduce the scope of, or eliminate development programs, which may adversely affect its business and operations.
Added
The Phase 2a portion includes exploring IMM-6-415 in multiple dose expansion arms.
Removed
Management considered whether or not there are conditions or events, in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern, and concluded that there are none as it estimates that its cash and cash equivalents and marketable securities will be 128 Table of Contents sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the consolidated financial statements. ​ The full extent to which coronavirus (“COVID-19”) pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, including expenses and research and development costs, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and its variants and the actions taken to contain or treat COVID-19 and its variants, as well as the economic impact on local, regional, national and international markets.
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Overview Our platform is enabled by two key elements: • Bioinformatics: our ability to efficiently analyze high-throughput molecular-level biochemical assays, including transcriptomics, genomics and/or proteomics, collectively referred to as Omics data; and • 3D Tumor Modeling: our ability to conduct in vitro studies in our own labs using proprietary humanized 3D tumor growth assays that we believe predict in vivo activity more accurately than traditional 2D cell culture models.
Removed
The Company has considered potential impacts arising from the pandemic related to COVID-19 and its variants and is not presently aware of any events or circumstances that would require the Company to update its estimates, judgements or revise the carrying values of its assets or liabilities. ​ Note 2 - Summary of Significant Accounting Policies Basis of Presentation The consolidated financial statements have been prepared in accordance with accounting standards set by the Financial Accounting Standards Board (“FASB”).
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These different types of biochemical and 3D tumor growth assays each provide us with unique information about the molecular mechanisms of disease biology and drug response and help to guide our translational planning and development. Since our inception, we have partnered with industry-leading pharmaceutical and biotechnology companies to perform a variety of analyses that utilize our expertise in translational bioinformatics.
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The FASB sets generally accepted accounting principles (“GAAP”) to ensure the consolidated financial statements are consistently reported. References to GAAP issued by the FASB in these footnotes are to the FASB Accounting Standards Codifications (“ASC”). The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
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Examples publicly disclosed by our partners include our analyses of ibrutinib, ipilimumab, daratumumab, glatiramer acetate and pridopidine. In early 2018, we began applying our proprietary platform and approach to internally develop our wholly owned pipeline of orally administered small molecule drug programs.
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Stock Split On July 23, 2021, the Company approved a one -for-1.4 stock split which was consummated in connection with the Company’s IPO.
Added
Our approach played a critical role in determining the most important characteristics for, and the creation of, IMM-1-104 and IMM-6-415.
Removed
All information in the accompanying financial statements and notes thereto regarding share amounts of common stock, price per share of common stock and the conversion factor for Series A and Series B Preferred Stock into common stock have been adjusted to reflect the application of the stock split on a retroactive basis.
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Specifically, our platform enables us to: • leverage insights from human data to identify disease transcriptional profiles we aim to counteract; 7 Table of Contents • identify novel biology, specifically evaluating potential new ways to drug an existing target by utilizing our proprietary Disease Cancelling Technology ("DCT"), and analyze mechanisms of existing drugs; • generate novel chemistry that is designed to overcome MAPK-feedback loops and other adaptive resistance mechanisms to achieve optimal signaling dynamics; and • profile IMM-1-104, IMM-6-415 and any other product candidates in a large number of proprietary humanized 3D tumor growth assays using our own translational planning to identify the types of cancer we believe most likely to be sensitive to the product candidates.
Removed
Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses during the reporting periods.
Added
Our current oncology programs are focused on tumors driven by mutations of the RAS/RAF/MEK/ERK ("MAPK") pathway, and other relevant signaling pathways. Existing drugs targeting the MAPK pathway are limited by toxicity, resistance and/or are narrowly focused on subpopulations with specific mutations.
Removed
These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying values of assets, liabilities and the recording of expenses that are not readily apparent from other sources.
Added
The MAPK pathway functions to drive cell proliferation, differentiation, survival and a variety of other cellular functions that are critical for the formation and progression of tumors.
Removed
Significant estimates reflected in these consolidated financial statements included but are not limited to, the research and development expenses, determination of fair value of stock-based awards, the valuation of common stock prior to the IPO, business combination, and the right-to-use assets and operating lease liability. Actual results may differ materially and adversely from these estimates.
Added
Fundamental Cancer Signaling Cellular Pathways Deep Cyclic Inhibition of Cancer Signaling Pathways Challenges the Prevailing Chronic Ablation Approach Each of the programs in our oncology pipeline is designed to drive cyclical disruption of abnormal activation of the MAPK signaling pathway or other relevant signaling pathways, with the goal of maximizing antitumor therapeutic effects while limiting drug-related toxicity and adaptive resistance.
Removed
Segments ​ Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker (“CODM”) in making decisions regarding resource allocation and assessing performance. The Company’s chief executive officer is the CODM, and he uses consolidated financial information in determining how to allocate resources and assess performance.
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Traditional targeted oncology drug development generally seeks to chronically sustain pathway inhibition, by prioritizing drugs with long to moderate half-lives and dosing them at intervals that maintain a sufficient level of drug, even at trough, to maintain target occupancy.
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The Company has determined that it operates in one segment. ​ ​ ​ ​ 129 Table of Contents Business Combination ​ Results of operations of acquired companies are included in the Company’s results of operations as of the respective acquisition dates.
Added
This prevailing chronic ablation approach can cause on-target drug-related toxicity and limit clinical durability as a result of drug holidays, treatment discontinuation, and/or adaptive resistance.
Removed
Acquired businesses are accounted for using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recorded at fair value, with limited exceptions. Any excess of the purchase price over the fair value of the net assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired Company are expensed as incurred.
Added
By contrast, our differentiated approach, based on counterintuitive insights derived from our translational bioinformatics platform, is to design novel drugs with at least three key aims: (1) achieve a manyfold higher C Max , (2) display a short plasma drug half-life, and (3) endow drugs with the ability to block feedback loops that would otherwise be susceptible to pathway reactivation.
Removed
The operating results of the acquired business are reflected in the consolidated financial statements after the date of acquisition. ​ If the acquired net assets do not constitute a business under the acquisition method of accounting, the transaction is accounted for as an asset acquisition and no goodwill is recognized.
Added
This design aims to provide enhanced mechanistic control of the target of interest and break tumor addiction, to prevent tumors from indefinitely self-replicating, metastasizing and evading the host’s immune system, among other capabilities.
Removed
Refer to Note 6, Business Combination for more information. ​ Cash and Cash Equivalents ​ Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. Cash is maintained at Federal Deposit Insurance Company (“FDIC”) insured financial institutions.
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By cyclically disrupting these core oncogenic signaling pathways in cancer cells (i.e., imposing normalized signaling dynamics), we believe we can create novel therapeutics that maximize therapeutic activity in broad patient populations while providing an improved tolerability profile and improved durability through reduced pressure stemming from adaptive resistance.
Removed
At times, the Company has maintained cash in excess of FDIC limits, however it has not experienced any losses with respect to its cash balances.
Added
We believe we are pioneers in this unique approach of therapeutically leveraging signaling dynamics against tumor addiction. 8 Table of Contents Pharmacokinetic Conceptual Visualization: Traditional Sustained Pathway Attenuation Versus Deep, Cyclic Inhibition Our Wholly Owned Pipeline Our oncology programs target clinically validated pathways while seeking to improve patient outcomes across a wide range of solid tumor types through our differentiated programs.
Removed
The Company regularly monitors the financial condition of the institutions in which it has depository accounts and believes the risk of loss is minimal. ​ Marketable Securities ​ Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities and are recorded at fair value.
Added
Our current pipeline of product candidates and discovery programs is depicted below. Universal-RAS Program (IMM-1-104) Our lead product candidate, IMM-1-104, is being developed as a once-daily oral therapy in RAS mutant tumors.
Removed
Unrealized gains/(losses) are included as a component of accumulated other comprehensive loss in the consolidated balance sheets and statements of convertible preferred stock and stockholders’ equity and a component of total comprehensive loss in the consolidated statements of comprehensive loss, until realized. The Company assesses its available-for-sale marketable securities for impairment on a quarterly basis.
Added
IMM-1-104 is designed to achieve a unique PK profile: it aims for a manyfold higher C Max to provide stronger inhibition of the MAPK pathway than has been observed with first and second generation MEK inhibitors, followed by a complete release of the MAPK pathway through a near-zero drug trough.
Removed
There were no impairments of the Company’s available-for-sale marketable securities measured and carried at fair value during the year ended December 31, 2022. Realized gains and losses are included in other income (expense) on a specific-identification basis. There were no realized gains or losses on marketable securities for the year ended December 31, 2022 and 2021, respectively.
Added
We believe this deep cyclic inhibition may enable broad universal-RAS activity with improved tolerability and limit the development of adaptive resistance.
Removed
Fair Value Measurements ​ We record cash equivalents and marketable securities at fair value. ASC 820, Fair Value Measurements and Disclosures, establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs).
Added
IMM-1-104 was observed to bind to mitogen-activated protein kinase kinase ("MEK") and acts as a highly selective inhibitor of mitogen-activated protein kinase kinase kinase ("ERK") activation (i.e., phosphorylation), with a “Dual MEK” function that is designed to block the CRAF-bypass feedback to prevent MAPK pathway reactivation.
Removed
The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability.
Added
IMM-1-104 is designed with a short plasma half-life that reduces sustained pathway inhibition (as depicted above). IMM-1-104 is also designed to prevent RAF-mediated activation of MEK, such as CRAF-bypass, by engagement of the RAF activation loop on MEK, and at elevated levels further disrupt the kinase suppressor of RAS 1 and 2 ("KSR").
Removed
Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.
Added
We believe this innovative method of pathway inhibition has the ability to normalize cancer cell signaling dynamics and limits unnecessary harm to 9 Table of Contents normal healthy cells.
Removed
Our financial assets, which include cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services or other observable market data. The pricing services utilize industry standard valuation models, including both income and market based approaches, and observable market inputs to determine value.
Added
Collectively, we believe these qualities differentiate IMM-1-104 from other treatment options for RAS mutant and other MAPK-addicted tumors, as well as from known MEK inhibitors, by potentially enabling IMM-1-104 to reduce drug resistance while improving tolerability.
Removed
After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of December 31, 2022.
Added
In preclinical studies, we observed that IMM-1-104 inhibited MEK and ERK across a wide range of human and murine solid tumor models, including those with activating mutations in KRAS, NRAS, HRAS, and BRAF.
Removed
Fair value 130 Table of Contents information for these assets, including their classification in the fair value hierarchy is included in Note 4 Fair Value Measurements . ​ There have been no changes to the valuation methods during the year ended December 31, 2022.
Added
In addition, in head-to-head preclinical studies, we evaluated IMM-1-104 in murine-based KRAS, NRAS, and BRAF mutant solid tumor models representing lung, colon, pancreas, and skin cancer, and observed tumor stasis or regression with insignificant body weight loss ("BWL") when compared to certain FDA-approved MEK inhibitors at reported human dose equivalent dose and schedules.
Removed
We evaluate transfers between levels at the end of each reporting period. ​ The carrying amounts reflected in the consolidated balance sheets for cash, accounts receivable, accounts payable and accrued expenses approximate their respective fair values because of the short-term maturity of those financial instruments. ​ Accounts Receivable ​ Accounts receivable are stated at the amount management expects to collect from outstanding balances.
Added
Given the data observed in these preclinical studies, we believe that IMM-1-104 has the potential to deliver clinical benefit as monotherapy and in select drug combinations for patients with RAS mutant solid tumors who currently have limited treatment options.
Removed
An allowance for doubtful accounts is estimated for those accounts receivable considered to be uncollectible based upon historical experience and management’s evaluation of outstanding accounts receivable. Bad debts are written off against the allowance when identified.
Added
In September 2022, the FDA cleared our IND for IMM-1-104 and, in November 2022 we commenced dosing in a Phase 1/2a clinical trial for IMM-1-104 in patients with advanced solid tumors harboring RAS mutations. The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-1-104.
Removed
At December 31, 2022 and 2021 there was no allowance for doubtful accounts. ​ Concentration of Credit Risk ​ Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of accounts receivable and revenue.
Added
The Phase 1 portion of the clinical trial includes dose escalation and dose exploration utilizing a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAS mutation. In April 2023, we announced initial PK, PD, and safety data from the Phase 1 portion of the Phase 1/2a clinical trial of IMM-1-104.
Removed
To manage accounts receivable credit risk, the Company continuously evaluates the creditworthiness of its customers and the need for an allowance for potential credit losses.
Added
As of April 10, 2023, we had PK, PD and safety data from four patients with pancreatic or colorectal cancer available for evaluation.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

362 edited+220 added−19 removed273 unchanged
Biggest changeThese provisions, among other things: ​ • establish a classified board of directors so that not all members of our board are elected at one time; ​ ​ • permit only the board of directors to establish the number of directors and fill vacancies on the board; ​ ​ • provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders; ​ ​ • authorize the issuance of “blank check” preferred stock that our board could use to implement a stockholder rights plan (also known as a “poison pill”); ​ ​ • eliminate the ability of our stockholders to call special meetings of stockholders; ​ ​ • prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; ​ ​ ​ • prohibit cumulative voting; ​ ​ • authorize our board of directors to amend the bylaws; ​ ​ • establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and ​ ​ • require a super-majority vote of stockholders to amend some provisions described above. ​ ​ In addition, Section 203 of the General Corporation Law of the State of Delaware, or the DGCL, prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years has owned, 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. ​ Any provision of our certificate of incorporation, bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our capital stock and could also affect the price that some investors are willing to pay for our Class A common stock. ​ Our amended and restated certificate of incorporation and amended and restated bylaws provides for an exclusive forum in the Court of Chancery of the State of Delaware for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees. ​ Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware or other state courts of the State of Delaware) is the exclusive forum for any derivative action 103 Table of Contents or proceeding brought on our behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim against us arising pursuant to the DGCL, our amended and restated certificate of incorporation or our amended and restated bylaws, or any action asserting a claim against us that is governed by the internal affairs doctrine; provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware.
Biggest changeThese provisions, among other things: • establish a classified Board so that not all members of our Board are elected at one time; • permit only the Board to establish the number of directors and fill vacancies on the Board; • provide that directors may only be removed “for cause” and only with the approval of two-thirds of our stockholders; • authorize the issuance of “blank check” preferred stock that our Board could use to implement a stockholder rights plan (also known as a “poison pill”); 99 Table of Contents • eliminate the ability of our stockholders to call special meetings of stockholders; • prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders; • prohibit cumulative voting; • authorize our Board to unilaterally amend the bylaws (as, for example, the Board did in February 2024); • establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and • require a super-majority vote of stockholders to amend some provisions described above.
Our losses have resulted principally from expenses incurred in research and development of our product candidates, from management and administrative costs and other expenses that we have incurred while building our business infrastructure.
Our losses have resulted principally from expenses incurred in research and development of our product candidates, from management and administrative costs and from other expenses that we have incurred while building our business infrastructure.
Our estimate as to how long we expect our existing cash and cash equivalents and marketable securities to be able to continue to fund our operating expenses and capital expenditures requirements is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
Our estimate as to how long we expect our existing cash, cash equivalents and marketable securities to be able to continue to fund our operating expenses and capital expenditures requirements is based on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
Although our research and development efforts to date have resulted in our discovery, preclinical and clinical development of IMM-1-104, it and other product candidates may not be safe or effective for the indications for which we study them in clinical trials, and we may not be able to develop any other product candidates.
Although our research and development efforts to date have resulted in our discovery, preclinical and clinical development of IMM-1-104 and other product candidates, it and other product candidates may not be safe or effective for the indications for which we study them in clinical trials, and we may not be able to develop any other product candidates.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; ​ • the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to the Centers for Medicare and Medicaid Services, or CMS, information regarding payments and other transfers of value to physicians (as defined by statute), certain non-physician providers including physician assistants and nurse practitioners, and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members.
Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation; • the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to the Centers for Medicare and Medicaid Services ("CMS") information regarding payments and other transfers of value to physicians (as defined by statute), certain non-physician providers including physician assistants and nurse practitioners, and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members.
On July 16, 2020, the Court of Justice of the European Union or the CJEU invalidated the EU-US Privacy Shield Framework, or Privacy Shield, under which personal information could be transferred from the EEA (and the UK) to relevant self-certified U.S. entities.
On July 16, 2020, the Court of Justice of the European Union or the CJEU invalidated the EU-US Privacy Shield Framework ("Privacy Shield") under which personal information could be transferred from the EEA (and the UK) to relevant self-certified U.S. entities.
We may be subject to a third party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review, or PGR, and inter partes review, or IPR, or other similar proceedings in the USPTO or foreign patent offices challenging our patent rights. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
We may be subject to a third party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review ("PGR"), and/or inter partes review ("IPR"), or other similar proceedings in the USPTO or foreign patent offices challenging our patent rights. The outcome following legal assertions of invalidity and unenforceability is unpredictable.
If we are unable to enter into such arrangements when needed, on acceptable terms, or at all, we may not be able to successfully commercialize any of our product candidates that receive regulatory approval or any such commercialization may experience delays or limitations.
If we are unable to enter into such arrangements when needed, on acceptable terms, or at all, we may not be able to successfully commercialize any of our product candidates that may receive regulatory approval or any such commercialization may experience delays or limitations.
The shares of Class A common stock that were sold in the initial public offering and shares of Class A common stock that will be sold under the registration statement filed with the SEC on August 10, 2022 are, or will be, as applicable, freely transferable without restrictions or further registration under the Securities Act, except for any shares acquired by our affiliates, as defined in Rule 144 under the Securities Act.
The shares of Class A common stock that were sold in the initial public offering and shares of Class A common stock that were or will be sold under the registration statement filed with the SEC on August 10, 2022 are, or will be, as applicable, freely transferable without restrictions or further registration under the Securities Act, except for any shares acquired by our affiliates, as defined in Rule 144 under the Securities Act.
This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims or make such lawsuits more costly for stockholders, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder.
This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees, agents or stockholders, which may discourage lawsuits with respect to such claims or make such lawsuits more costly for stockholders, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder.
If the interim, top-line, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, results of operations, prospects or financial condition.
If the interim, top-line, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and potentially commercialize, our product candidates may be harmed, which could harm our business, results of operations, prospects or financial condition.
In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act; ​ ​ • the federal Criminal Statute on False Statements Relating to Healthcare Matters, which makes it a crime to knowingly and willfully falsify, conceal, or cover up a material fact, make any materially false, fictitious, or fraudulent statements or representations, or make or use any materially false writing or document knowing the same to contain any materially false, 76 Table of Contents fictitious, or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items, or services; ​ • the federal Civil Monetary Penalties Law, which authorizes the imposition of substantial civil monetary penalties against an entity, such as a pharmaceutical manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services reimbursable by a federal healthcare program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known overpayment; ​ ​ • the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.
In addition, the government may assert that a claim including items or services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act; • the federal Criminal Statute on False Statements Relating to Healthcare Matters, which makes it a crime to knowingly and willfully falsify, conceal, or cover up a material fact, make any materially false, fictitious, or fraudulent statements or representations, or make or use any materially false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items, or services; • the federal Civil Monetary Penalties Law, which authorizes the imposition of substantial civil monetary penalties against an entity, such as a pharmaceutical manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim for services not provided as claimed or that is otherwise false or fraudulent in any way; (2) arranging for or contracting with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services reimbursable by a federal healthcare program; (3) violations of the federal Anti-Kickback Statute; or (4) failing to report and return a known overpayment; • the federal Health Insurance Portability and Accountability Act of 1996 ("HIPAA") prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed or precluded entirely. ​ Our CROs have the right to terminate their agreements with us in the event of an uncured material breach.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed or precluded entirely. Our CROs generally have the right to terminate their agreements with us in the event of an uncured material breach.
It is possible that governmental authorities will conclude that our business practices, including our arrangements with physicians, some of whom have ownership interests in us, may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
It is possible that governmental authorities will conclude that our business practices, including our arrangements with physicians, some of whom have had, have or may have ownership interests in us, may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.
Any failure or delay in the development of our internal sales, marketing and distribution capabilities could adversely impact the commercialization of any of our product candidates that we obtain approval to market, if we do not have arrangements in place with third parties to provide such services on our behalf.
Any failure or delay in the development of our internal sales, marketing and distribution capabilities could adversely impact the commercialization of any of our product candidates that we may obtain approval to market, if we do not have arrangements in place with third parties to provide such services on our behalf.
If we do not continue to successfully develop, get approval for and begin to commercialize any product candidates, we will face difficulty in obtaining product revenue in future periods, which could result in significant harm to our financial position and adversely affect our share price. ​ Even if we are successful in building our pipeline of product candidates, the potential product candidates that we identify may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to 63 Table of Contents have unacceptable toxicity or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance.
If we do not continue to successfully develop, get approval for and begin to commercialize any product candidates, we will face difficulty in obtaining product revenue in future periods, which could result in significant harm to our financial position and adversely affect our share price. 61 Table of Contents Even if we are successful in building our pipeline of product candidates, the potential product candidates that we identify may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable toxicity or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance.
These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
These laws, rules, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.
We will not be able to market and sell our product candidates we develop in combination with an unapproved cancer therapy for a combination indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product.
We will not be able to market and sell our product candidates we develop in combination with an unapproved therapy for a combination indication if that unapproved therapy does not ultimately obtain marketing approval either alone or in combination with our product.
If the FDA does not accept or approve our NDAs for our product candidates, it may require that we conduct additional clinical, preclinical, or manufacturing validation studies and submit that data before it will reconsider our applications.
If the FDA does not accept or approve our NDAs for our product candidates, it may require that we conduct additional clinical trials, preclinical or manufacturing validation studies and submit that data before it will reconsider our applications.
A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation; ​ ​ • the federal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government, with potential liability including mandatory treble damages and significant per claim penalties per false claim or statement.
A person or entity does not need to have actual knowledge of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation; 73 Table of Contents • the federal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government, with potential liability including mandatory treble damages and significant per claim penalties per false claim or statement.
We have systems in place to remind us to pay these fees, and we rely on third parties to pay these fees when due. Additionally, the USPTO and various foreign patent offices require compliance with a number of procedural, 95 Table of Contents documentary, fee payment and other similar provisions during the patent application process.
We have systems in place to remind us to pay these fees, and we rely on third parties to pay these fees when 91 Table of Contents due. Additionally, the USPTO and various foreign patent offices require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.
Collaborations involving our product candidates could pose numerous risks to us, including the following: ​ • collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected; ​ ​ • collaborators may deemphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; ​ ​ • collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; ​ ​ • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; ​ 72 Table of Contents • a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products; ​ ​ • collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings; ​ ​ • disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources; ​ ​ • collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; ​ ​ • collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; and ​ ​ • if a collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our drug development or commercialization program could be delayed, diminished or terminated. ​ ​ Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements. ​ We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities.
Collaborations involving our product candidates could pose numerous risks to us, including the following: • collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations and may not perform their obligations as expected; • collaborators may de-emphasize or not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborators’ strategic focus, including as a result of a sale or disposition of a business unit or development function, or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; • collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing; • collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if, for example, the collaborators believe that such competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; • a collaborator with marketing and distribution rights to multiple products may not commit sufficient resources to the marketing and distribution of our product relative to other products; • collaborators may not properly obtain, maintain, defend or enforce our intellectual property rights or may use our proprietary information and intellectual property in such a way as to invite litigation or other intellectual property related proceedings that could jeopardize or invalidate our proprietary information and intellectual property or expose us to potential litigation or other intellectual property related proceedings; • disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or arbitration that diverts management attention and resources; • collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates; • collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all; and • if a collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our drug development or commercialization program could be delayed, diminished or terminated. 70 Table of Contents Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
Any of these occurrences may harm our business, financial condition and prospects significantly. ​ If our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with approved or other investigational products we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.
Any of these occurrences may harm our business, financial condition and prospects significantly. 57 Table of Contents If our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with approved or other investigational products, we may need to interrupt, delay or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.
We may also encounter unexpected delays or increased costs due to new government regulations, including future legislation or administrative action, or changes in FDA policy during the period of drug development, clinical trials and FDA regulatory review. ​ Any delay or failure in seeking or obtaining required approvals would have a material and adverse effect on our ability to generate revenue from the particular product candidate for which we are developing and seeking approval.
We may also encounter unexpected delays or increased costs due to new government regulations, including future legislation or administrative action, or changes in FDA policy during the period of drug development, clinical trials and FDA regulatory review. 60 Table of Contents Any delay or failure in seeking or obtaining required approvals would have a material and adverse effect on our ability to generate revenue from the particular product candidate for which we are developing and seeking approval.
If independent investigators or CROs fail to devote sufficient resources to the development of our product candidates, or if CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or 70 Table of Contents for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
If independent investigators or CROs fail to devote sufficient resources to the development of our product candidates, or if CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our product candidates.
We cannot be certain that the claims in our pending patent applications related to composition of matter of our product candidates will be considered patentable by the United States Patent and Trademark Office, or USPTO, or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid and enforceable by courts in the United States or foreign countries.
We cannot be certain that the claims in our pending patent applications related to composition of matter of our product candidates will be considered patentable by the USPTO or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid and enforceable by courts in the United States or foreign countries.
Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we initiate and conduct clinical trials, and seek marketing approval for our current and any future product candidates.
Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we initiate and conduct preclinical studies and clinical trials, and seek marketing approval for our current and any future product candidates.
For example, the 59 Table of Contents FDA could require us to adopt a REMS to ensure that the benefits of treatment with such product candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and costlier than what is typical for the industry.
For example, the FDA could require us to adopt a REMS to ensure that the benefits of treatment with such product candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and costlier than what is typical for the industry.
Our amended and restated certificate of incorporation and amended and restated bylaws also provide that the federal district courts of the United States of America is the exclusive forum for the resolution of any complaint asserting a cause or causes of action against any defendant arising under the Securities Act.
Our amended and restated certificate of incorporation and amended and restated bylaws also provide that a federal district court of the United States of America is the exclusive forum for the resolution of any complaint asserting a cause or causes of action against any defendant arising under the Securities Act.
Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw accelerated approval. ​ We may in the future seek an accelerated approval for one or more of our product candidates.
Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw accelerated approval. We may seek an accelerated approval for one or more of our product candidates.
Because patent applications are maintained as confidential for a certain period of time, until the relevant application is published we may be unaware of third-party patents that may be infringed by commercialization of any of our product candidates, and we cannot be certain that others have not filed patent applications for a product candidate or technology covered by our pending patent applications, or that we were the first to file a patent application related to a product candidate or technology.
Because patent applications are maintained as confidential for a certain period of time, until the relevant application is published we may be unaware of third-party patents that may be infringed by commercialization of any of our product candidates, and we cannot be certain that others have not filed patent applications for a product candidate or technology covered by our pending patent 86 Table of Contents applications, or that we were the first to file a patent application related to a product candidate or technology.
Those factors may include the design or results of 71 Table of Contents clinical trials, the likelihood of approval by the FDA or comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to our ownership of intellectual property and industry and market conditions generally.
Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to our ownership of intellectual property and industry and market conditions generally.
We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of hazardous and flammable materials, including chemicals and biological materials. ​ 80 Table of Contents In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.
We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of hazardous and flammable materials, including chemicals and biological materials. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations.
Our future licensors may retain certain rights under their agreements with us, including the right to use the underlying technology for use in fields other than the fields licensed to us or for use in noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of 89 Table of Contents information relating to the technology.
Our future licensors may retain certain rights under their agreements with us, including the right to use the underlying technology for use in fields other than the fields licensed to us or for use in noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology.
While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive-forum provisions, and there can be no assurance that such provisions will be enforced by a court in those other jurisdictions.
While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive-forum provisions, and there can be no assurance that such provisions will be enforced by a court in those 100 Table of Contents other jurisdictions.
Regulatory authorities may not approve the price we intend to charge for products we may develop, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims 53 Table of Contents necessary or desirable for the successful commercialization of that product candidate.
Regulatory authorities may not approve the price we intend to charge for products we may develop, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.
If we were to experience an unexpected loss of supply of any of our product candidates or any of our future product candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials. ​ We expect to continue to rely on third-party manufacturers for the commercial supply of any of our product candidates for which we obtain marketing approval.
If we were to experience an unexpected loss of supply of any of our product candidates or any of our future product candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, we could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing clinical trials. 71 Table of Contents We expect to continue to rely on third-party manufacturers for the commercial supply of any of our product candidates for which we may obtain marketing approval.
Moreover, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
Moreover, there has been 80 Table of Contents heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.
If we decide to license our product candidate to others, we may need to rely on the marketing assistance and guidance of those collaborators. ​ Factors that may affect our ability to commercialize our product candidates on our own include recruiting and retaining adequate numbers of effective sales and marketing personnel, obtaining access to or persuading adequate numbers of physicians to prescribe our product candidates and other unforeseen costs associated with creating an independent sales and marketing organization.
If we decide to license our product candidates to others, we may need to rely on the marketing assistance and guidance of those collaborators. 65 Table of Contents Factors that may affect our ability to commercialize our product candidates on our own include recruiting and retaining adequate numbers of effective sales and marketing personnel, obtaining access to or persuading adequate numbers of physicians to prescribe our product candidates and other unforeseen costs associated with creating an independent sales and marketing organization.
Foreign regulatory authorities impose similar requirements. The time required to obtain approval by the FDA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved.
The time required to obtain approval by the FDA and other comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved.
In addition, approval policies, regulations or the type and 52 Table of Contents amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application.
In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application.
If we do not receive marketing approvals for IMM-1-104, or any other product candidate we develop, we may not be able to continue our operations. ​ 66 Table of Contents We are substantially dependent on our platform, including our proprietary technologies such as DCT and Fluency, which are supported by our information technology systems.
If we do not receive marketing approvals for IMM-1-104, IMM-6-415, or any other product candidate we develop, we may not be able to continue our operations. 64 Table of Contents We are substantially dependent on our platform, including our proprietary technologies such as DCT and Fluency, which are supported by our information technology systems.
In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data as support for an application 77 Table of Contents for marketing approval unless the study is well-designed and well-conducted in accordance with GCP requirements and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary.
The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. A maximum of one patent may be extended per FDA-approved product as compensation for 94 Table of Contents the patent term lost during the FDA regulatory review process.
The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. A maximum of one patent may be extended per FDA-approved product as compensation for the patent term lost during the FDA regulatory review process.
The ACA, among other things, subjected biologic products to potential competition by lower-cost biosimilars; increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the average manufacturer price; required collection of rebates for drugs paid by Medicaid managed care organizations; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs; implemented a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; expanded eligibility criteria for Medicaid programs; expanded the types of entities eligible for the 340B Drug Pricing Program; created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and established a Center for Medicare & Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending. ​ Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA.
The ACA, among other things, subjected biologic products to potential competition by lower-cost biosimilars; increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the average manufacturer price; required collection of rebates for drugs paid by Medicaid managed care organizations; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs; implemented a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; expanded eligibility criteria for Medicaid programs; expanded the types of entities eligible for the 340B Drug Pricing Program; created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and established a Center for Medicare & Medicaid Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.
The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective.
The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically 62 Table of Contents important improvement from a patient and public health perspective.
Some open source licenses contain express requirements that we make available source code for modifications or derivative works we create based upon the type of open source software we use, or grant other licenses to our intellectual property.
Some open source licenses contain express requirements that we make available source code for modifications or derivative works we 93 Table of Contents create based upon the type of open source software we use, or grant other licenses to our intellectual property.
We may also face increased cybersecurity risks due to our reliance on internet technology and the number of our employees who are working remotely, 104 Table of Contents which may create additional opportunities for cybercriminals to exploit vulnerabilities.
We may also face increased cybersecurity risks due to our reliance on internet technology and the number of our employees who are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
Internal Revenue Code of 1986, as amended, or the Code, a corporation that undergoes an “ownership change,” generally defined as a greater than 50% change by value in its equity ownership over a three-year period is subject to limitations on its ability to utilize its pre-change NOLs and other tax attributes such as research tax credits to offset future taxable income.
Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an “ownership change,” generally defined 51 Table of Contents as a greater than 50% change by value in its equity ownership over a three-year period is subject to limitations on its ability to utilize its pre-change NOLs and other tax attributes such as research tax credits to offset future taxable income.
In addition, the USPTO might require that the term of a patent issuing from a pending patent application to be disclaimed and limited 86 Table of Contents to the term of another patent that is commonly owned or names a common inventor.
In addition, the USPTO might require that the term of a patent issuing from a pending patent application to be disclaimed and limited to the term of another patent that is commonly owned or names a common inventor.
We have not yet demonstrated our ability to successfully complete any clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
We have not yet demonstrated our ability to successfully complete any clinical trials, obtain 48 Table of Contents marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.
Developing a sales and marketing organization will be expensive and time-consuming and could delay the launch of our product candidates. We may not be able to build an effective sales and marketing organization.
Developing a sales and marketing organization will be expensive and time-consuming and could delay the launch of our product candidates. We may not be able to build an effective sales and marketing organization, if at all.
To date, we have devoted substantially all of our resources and efforts to providing computational biology services to pharmaceutical and biotechnology companies, organizing and staffing our company, business planning, executing partnerships, raising capital, discovering, identifying and developing potential product candidates, securing related intellectual property rights and undertaking research and preclinical and clinical studies of our product candidates, including our ongoing Phase 1/2a clinical trial of IMM-1-104 for the treatment of advanced solid tumors in patients harboring RAS mutant tumors.
To date, we have devoted substantially all of our resources and efforts to providing computational biology services to pharmaceutical and biotechnology companies, organizing and staffing our company, business planning, executing partnerships, raising capital, discovering, identifying and developing potential product candidates, securing related intellectual property rights and undertaking research and preclinical studies and clinical trials of our product candidates, including our ongoing Phase 1/2a clinical trials of IMM-1-104 and IMM-6-415 for the treatment of advanced solid tumors in patients harboring RAS or RAS/RAF mutant tumors, respectively.
Patients treated with our product candidates may also be undergoing surgical, radiation and chemotherapy treatments, which can cause side effects or adverse events that are unrelated to our product candidate, but may still impact the success of our clinical trials.
Patients treated with our product candidates may also be undergoing surgical, radiation, chemotherapy or other aggressive treatments, which can cause side effects or adverse events that are unrelated to our product candidate, but may still negatively impact the success of our clinical trials.
Further, since January 1, 2021, companies have to comply with the GDPR and also the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law.
Further, since January 1, 2021, companies have to comply with the GDPR and also the UK GDPR, which, together with the amended UK Data Protection Act 2018, retains the GDPR in UK national law. The UK GDPR mirrors the fines under the GDPR.
We face similar risks for our applications in foreign jurisdictions. ​ We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. ​ Before obtaining marketing approval from the FDA or other comparable foreign regulatory authorities for the sale of our product candidates, we must complete preclinical development and extensive clinical trials to demonstrate the safety and efficacy of our product candidates.
We may encounter substantial delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. Before obtaining marketing approval from the FDA or other comparable foreign regulatory authorities for the sale of our product candidates, we must complete preclinical development and extensive clinical trials to demonstrate the safety and efficacy of our product candidates.
An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be 92 Table of Contents harmed if the prevailing party does not offer us a license on commercially reasonable terms.
An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms.
Because the design and outcome of our current and anticipated 50 Table of Contents clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any product candidate we develop. We also expect to incur additional costs associated with operating as a public company.
Because the design and outcome of our current and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any product candidate we develop. We also expect to continue to incur the costs associated with operating as a public company.
For example, in 2022, due to macroeconomic conditions including inflation and higher interest rates, the stock price of biotech companies, including ours, has generally declined, which makes fundraising in our industry more difficult and on less favorable terms.
For example in 2022, due to macroeconomic conditions including inflation and higher interest rates, the stock price of biotech companies, including ours, generally declined, making fundraising in our industry more difficult and on less favorable terms.
We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with product produced under cGMP regulations.
We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP regulations. In addition, our clinical trials must be conducted with investigational drug substance produced under cGMP regulations.
Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays.
Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic, and any resurgence of the virus or emergence of new variants, pandemics or other widespread adverse health events may lead to further inspectional delays.
Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired.
Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against 74 Table of Contents us, our business may be impaired.
In order to commercialize any product candidates, if approved, we must build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in which we may have approval to sell or market our product candidates.
In order to commercialize any product candidates, if approved, we must build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in which we may have approval to sell or market our product candidates. We may not be successful in accomplishing these required tasks.
These risks and uncertainties include the following: ​ • the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; ​ ​ • patent applications may not result in any patents being issued; ​ ​ ​ ​ • patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; ​ ​ • our competitors, many of whom have substantially greater resources than we or our potential licensors do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or block our ability to make, use and sell our product candidates; ​ ​ • there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and ​ ​ • countries other than the United States may have patent laws less favorable to patentees than the patent law typically applied by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing products. ​ ​ The patent prosecution process is also expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous.
These risks and uncertainties include the following: • the USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; • patent applications may not result in any patents being issued; • patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; • our competitors, many of whom have substantially greater resources than we or our potential licensors do and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or block our ability to make, use and sell our product candidates; • there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and • countries other than the United States may have patent laws less favorable to patentees than the patent law typically applied by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing products.
Additionally, our clinical trials will compete with other clinical trials for product candidates that focusing on the same therapeutic targets (e.g., evaluating patients harboring RAS mutant tumors) as our current and potential future product candidates, which may further limit enrollment of eligible patients or may result in slower enrollment than we anticipate.
Additionally, our clinical trials will compete with other clinical trials for product candidates that focusing on the same therapeutic targets (e.g., in the case of IMM-1-104, evaluating patients harboring RAS mutant tumors, and in the case of IMM-6-415, evaluating patients harboring RAS or RAF mutant tumors) as our current and potential future product candidates, which may further limit enrollment of eligible patients or may result in slower enrollment than we anticipate.
Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
For example, the U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations.
The acceptance of study data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all.
We may conduct international clinical trials in the future. The acceptance of study data from clinical trials conducted outside the U.S. or another jurisdiction by the FDA or comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all.
An intermediate clinical endpoint is a clinical 64 Table of Contents endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.
Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including: ​ • the failure of the third party to manufacture our product candidates according to our schedule, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them; ​ ​ • the reduction or termination of production or deliveries by suppliers, or the raising of prices or renegotiation of terms; ​ ​ • the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us; ​ ​ • the breach by the third-party contractors of our agreements with them; ​ ​ • the failure of third-party contractors to comply with applicable regulatory requirements; ​ ​ • the failure of the third party to manufacture our product candidates according to our specifications; ​ ​ • the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; ​ • clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and 74 Table of Contents ​ • the misappropriation of our proprietary information, including our trade secrets and know-how. ​ ​ We do not have complete control over all aspects of the manufacturing process of, and are dependent on, our contract manufacturing partners for compliance with cGMP regulations for manufacturing both active drug substances and finished drug products.
Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including: • the failure of the third party to manufacture our product candidates according to our schedule, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them; • the reduction or termination of production or deliveries by suppliers, or the raising of prices or renegotiation of terms; • the termination or nonrenewal of arrangements or agreements by our third-party contractors at a time that is costly or inconvenient for us; • the breach by the third-party contractors of our agreements with them; • the failure of third-party contractors to comply with applicable regulatory requirements; • the failure of the third party to manufacture our product candidates according to our specifications; • the mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified; • clinical supplies not being delivered to clinical sites on time, leading to clinical trial interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales; and • the misappropriation of our proprietary information, including our trade secrets and know-how.
As a result, we expect that it will be several years, if ever, 49 Table of Contents before we have a commercialized product and generate revenue from product sales.
As a result, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales.
Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining enrollment of such patients in our clinical trials. ​ Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success. ​ Even if our product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, healthcare payors and others in the medical community.
Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining enrollment of such patients in our clinical trials. 59 Table of Contents Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major tornado, flood, fire, earthquake, power loss, terrorist activity, future pandemics or other disasters and do not have a recovery plan for such disasters.
We have not undertaken a systematic analysis of the potential consequences to our business and financial results from a major tornado, flood, fire, earthquake, power loss, terrorist activity, geopolitical conflicts, military conflict, future pandemics, public health crises or other disasters and do not have a recovery plan for such disasters.
Any failure of these or other elements of our platform will materially harm our business. ​ We are substantially dependent on our platform, including our proprietary technologies such as DCT and Fluency, which are supported by our information technology systems, for significant elements of our drug discovery process, bioinformatics and computational biology software systems, database of information relating to our product candidates and their role in the targeted disease process, amongst others.
We are substantially dependent on our platform, including our proprietary technologies such as DCT and Fluency, which are supported by our information technology systems, for significant elements of our drug discovery process, bioinformatics and computational biology software systems, database of information relating to our product candidates and their role in the targeted disease process, amongst others.
Accordingly, we cannot assure you that we will ever be able to discover, develop, obtain regulatory approval of, commercialize or generate significant revenue from our other product candidates. ​ 67 Table of Contents We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators. ​ We have never commercialized a product candidate, and we currently have no sales force, marketing or distribution capabilities.
Accordingly, we cannot assure you that we will ever be able to discover, develop, obtain regulatory approval of, commercialize or generate significant revenue from our other product candidates. We have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators.
To the extent that we raise additional capital through the sale of equity or convertible debt or equity securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
To the extent that we raise additional capital through the sale of equity or convertible debt or equity securities, for example, as we did in April 2023, your ownership interest may be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.
We are currently unable to predict whether 107 Table of Contents such changes will occur. If such changes are enacted or implemented as well as the scope of any such changes, we are currently unable to predict the ultimate impact on our business. ​ Item 1B. Unresolved Staff Comments None
If such changes are enacted or implemented as well as the scope of any such changes, we are currently unable to predict the ultimate impact on our business. Item 1B. Unresolved Staff Comments None.
Additional time may be required to obtain regulatory approval for our product candidates if they are combination products. Our product candidates that may be biologic/drug combination products will require coordination within the FDA and other comparable foreign regulatory authorities for review of their biologic and drug components.
Additional time may be required to obtain regulatory approval for any of our current or future product candidates if or when they are developed as potential combination products. Any of our product candidates that may be biologic/drug combination products will require coordination within the FDA and other comparable foreign regulatory authorities for review of their biologic and drug components.
While an inadvertent lapse, including due to the effect of the pandemic related to COVID-19 and its variants, our patent maintenance vendors or law firms, can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
While an inadvertent lapse, including due to the effect of a widespread adverse health event, our patent maintenance vendors or law firms, can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.
We may also experience manufacturing delays or other delays with IND-enabling studies. Moreover, we cannot be sure that submission of an IND or comparable document will result in the FDA or other comparable foreign regulatory authorities allowing further clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials.
Moreover, we cannot be sure that submission of an IND or comparable document will result in the FDA or other comparable foreign regulatory authorities allowing further clinical trials to begin, or that, once begun, issues will not arise that suspend or terminate clinical trials.
Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. ​ We use third-party open source software, which could negatively affect our ability to offer our solutions and subject us to litigation or other actions. ​ We use open source software licensed to us by third-party authors under “open source” licenses in our platform and solutions and expect to continue to use such open source software in the future.
Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. We use third-party open source software, which could negatively affect our ability to offer our solutions and subject us to litigation or other actions.

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Item 2. Properties

Properties — owned and leased real estate

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Biggest changeAdditionally, we lease approximately 190 square feet of office space in New York, New York under a service agreement that currently runs through February 28, 2024 and automatically renews unless we provide 60 days advance notice to terminate; and approximately 66 square feet of office space in San Francisco, California under an agreement that currently runs through July 31, 2023.
Biggest changeIn February 2023, we subleased the Site 2 space to a third-party through the remainder of the term of the lease. Additionally, we lease approximately 190 square feet of office space in New York, New York under a service agreement that currently runs through August 31, 2024.
We also lease the following properties in San Diego, California: (i) approximately 3,657 square feet of office space; under a lease that terminates on October 1, 2023 and is currently being subleased to a third-party through the remainder of the term of the lease; (ii) approximately 38,613 square feet of office and laboratory space under a lease that terminates on April 30, 2032; and (iii) 4,760 square feet of office and laboratory space (“Site 3”) under a lease that terminates on March 31, 2024.
We also lease the following properties in San Diego, California: (i) approximately 38,613 square feet of office and laboratory space under a lease that terminates on April 30, 2032; and (ii) 4,760 square feet of office and laboratory space (“Site 2”) under a lease that terminates on March 31, 2024.
We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed. Item 3. Legal Proceedings From time to time we may be involved in claims and proceedings arising in the course of our business.
We believe that our facilities are sufficient to meet our current needs and that suitable additional space will be available as and when needed.
Removed
In February 2023, we subleased the Site 3 space to a third-party through the remainder of the term of the lease.
Removed
The outcome of any such claims or proceedings, regardless of the merits, is inherently uncertain. We are not currently party to any material legal proceedings. Item 4. Mine Safety Disclosures Not applicable PART II — OTHER INFORMATION

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

5 edited+0 added−1 removed0 unchanged
Biggest changeWe currently anticipate that we will retain all available funds and future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Securities Authorized for Issuance Under Equity Compensation Plans See Item 12, Part III of this Form 10-K.
Biggest changeDividend Policy We have never declared or paid any cash dividends on our common stock. We currently anticipate that we will retain all available funds and future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future, if ever.
Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the quarterly period ended December 31, 2022. ​ Item 6. [Reserved] ​
Issuer Purchases of Equity Securities We did not purchase any of our registered equity securities during the quarterly period ended December 31, 2023. Item 6. [Reserved]
Item 5. Market For The Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information for Common Stock Our common stock trades under the symbol “IMRX” on the Nasdaq Global Market. Holders of Our Common Stock As of February 27, 2023, there were approximately 60 registered holders of record of our common stock.
Item 5. Market For The Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information for Common Stock Our common stock trades under the symbol “IMRX” on the Nasdaq Global Market. Holders of Our Common Stock As of February 23, 2024, there were approximately 60 registered holders of record of our common stock.
Unregistered Sales of Equity Securities During the period covered by this Annual Report on Form 10-K, we did not issue any securities which were unregistered under the Securities Act and required to be disclosed herein.
Securities Authorized for Issuance Under Equity Compensation Plans See Item 12, Part III of this Form 10-K. Unregistered Sales of Equity Securities During the period covered by this Annual Report on Form 10-K, we did not issue any securities which were unregistered under the Securities Act and required to be disclosed herein.
The actual number of holders of our common stock is greater than this number of record holders and includes stockholders who are 108 Table of Contents beneficial owners, but whose shares are held in “street name” by brokers or held by other “nominees”.
The actual number of holders of our common stock is greater than this number of record holders and includes stockholders who are beneficial owners, but whose shares are held in “street name” by brokers or held by other “nominees”. The number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Removed
The number of holders of record also does not include stockholders whose shares may be held in trust by other entities. Dividend Policy We have never declared or paid any cash dividends on our common shares.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

63 edited+15 added−12 removed36 unchanged
Biggest changeThe primary objective of our investment policy is capital preservation. ​ Other income (expense) Other income (expense) consists of the amortization of premiums or accretion of discounts related to our marketable securities. ​ Income tax benefit Income tax benefit in 2021 is due to a release of a valuation reserve because of the business combination. ​ 114 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2022 and 2021 The following table summarizes our results of operations for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ Change ​ ​ ​ 2022 2021 $ % ​ ​ ​ (in thousands, except percentages) ​ Revenue ​ $ 317 ​ $ 2,080 ​ $ (1,763) ​ (84.8) % Cost of revenue ​ ​ 158 ​ ​ 1,153 ​ ​ (995) ​ (86.3) % Gross profit ​ ​ 159 ​ ​ 927 ​ ​ (768) ​ (82.8) % Operating expenses ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Research and development ​ ​ 36,267 ​ ​ 26,541 ​ ​ 9,726 ​ 36.6 % General and administrative ​ ​ 15,607 ​ ​ 8,272 ​ ​ 7,335 ​ 88.7 % Amortization of intangible asset ​ ​ 30 ​ ​ — ​ ​ 30 ​ N/M % Total operating expenses ​ ​ 51,904 ​ ​ 34,813 ​ ​ 17,091 ​ 49.1 % Loss from operations ​ ​ (51,745) ​ ​ (33,886) ​ ​ (17,859) ​ 52.7 % ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Other income (expense) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Interest income ​ ​ 1,014 ​ ​ 170 ​ ​ 844 ​ 496.5 % Other income (expense) ​ ​ 217 ​ ​ (127) ​ ​ 344 ​ (270.9) % Loss before income taxes ​ ​ (50,514) ​ ​ (33,843) ​ ​ (16,671) ​ 49.3 % Income tax benefit ​ ​ — ​ ​ 307 ​ ​ (307) ​ (100.0) % Net loss ​ $ (50,514) ​ $ (33,536) ​ ​ ​ ​ ​ ​ ​ N/M – Not meaningful Revenue The following table summarizes the revenue recognized for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, Change ​ 2022 2021 $ % ​ (in thousands, except percentages) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue ​ $ 317 ​ $ 2,080 ​ $ (1,763) ​ (84.8) % ​ Revenue decreased by approximately $1.8 million, or 84.8% to approximately $0.3 million for the year ended December 31, 2022 compared to approximately $2.1 million for the year ended December 31, 2021.
Biggest changeResults of Operations Comparison of the Years Ended December 31, 2023 and 2022 The following table summarizes our results of operations for the periods indicated: Year Ended December 31, Change 2023 2022 $ % (in thousands, except percentages) Revenue $ — $ 317 $ (317) (100.0) % Cost of revenue — 158 (158) (100.0) % Gross profit — 159 (159) (100.0) % Operating expenses Research and development 41,624 36,267 5,357 14.8 % General and administrative 16,760 15,607 1,153 7.4 % Amortization of intangible asset 29 30 (1) (3.3) % Total operating expenses 58,413 51,904 6,509 12.5 % Loss from operations (58,413) (51,745) (6,668) 12.9 % Other income (expense) Interest income 3,607 1,014 2,593 255.7 % Other income, net 1,334 217 1,117 514.7 % Net loss $ (53,472) $ (50,514) $ (2,958) 5.9 % 111 Table of Contents Revenue The following table summarizes the revenue recognized for the periods indicated: Year Ended December 31, Change 2023 2022 $ % (in thousands, except percentages) Revenue $ — $ 317 $ (317) (100.0) % Revenue decreased by approximately $0.3 million, or 100.0%, to $0 for the year ended December 31, 2023 compared to approximately $0.3 million for the year ended December 31, 2022.
In addition, if and when we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
In addition, if and when we seek and obtain regulatory approval to commercialize any product candidate, we will also incur increased expenses in connection with commercialization and marketing of any such product candidate. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities.
Net Cash Provided by Financing Activities During the year ended December 31, 2022, net cash provided by financing activities was approximately $19 thousand, consisting primarily of approximately $0.3 million in net proceeds from the exercise of stock options, offset by approximately $0.3 million from the payment of deferred offering costs.
During the year ended December 31, 2022, net cash provided by financing activities was approximately $19 thousand, consisting primarily of approximately $0.3 million in net proceeds from the exercise of stock options, offset by approximately $0.3 million from the payment of deferred offering costs.
The Black-Scholes option-pricing model uses as inputs, the fair value of our common stock and assumptions we make for the volatility of our common stock, the expected term of our stock options, the risk-free interest rate for a period that approximates the expected term of our stock options, and our expected dividend yield.
The Black-Scholes option-pricing model uses as inputs: the fair value of our common stock, the assumptions we make for the volatility of our common stock, the expected term of our stock options, the risk-free interest rate for a period that approximates the expected term of our stock options, and our expected dividend yield.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. Critical Accounting Policies and Use of Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States, or GAAP.
We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. Critical Accounting Policies and Use of Estimates Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States ("GAAP").
We expect our general and administrative expenses will substantially increase for the foreseeable future as we continue to increase our general and administrative headcount to support our continued research and development activities and, if any product candidates receive marketing approval, commercialization activities, as well as to support our operations generally.
We expect our general and administrative expenses will increase for the foreseeable future as we continue to increase our general and administrative headcount to support our continued research and development activities and, if any product candidates receive marketing approval, commercialization activities, as well as to support our operations generally.
In estimating the duration of a clinical study, we evaluate the start-up, treatment and wrap up periods, compensation arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.
In estimating the duration of a clinical trial, we evaluate the start-up, treatment and wrap up periods, compensation arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.
The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, such as: ● successful completion of preclinical studies and initiation of clinical trials for future product candidates; ● successful enrollment and completion of clinical trials for our current product candidates; ● data from our clinical programs that support an acceptable risk-benefit profile of our product candidates in the intended patient populations; ● acceptance by the FDA or other applicable regulatory agencies of IND applications, clinical trial applications and/or other regulatory filings for our product candidates; ● expansion and maintenance of a workforce of experienced scientists and others to continue to develop our product candidates; 112 Table of Contents ● successful application for and receipt of marketing approvals from applicable regulatory authorities; ● obtainment and maintenance of intellectual property protection and regulatory exclusivity for our product candidates; ● making of arrangements with contract manufacturing organizations for, or establishment of, commercial manufacturing capabilities; ● establishment of sales, marketing and distribution capabilities and successful launch of commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; ● acceptance of our product candidates, if and when approved, by patients, the medical community and third-party payors; ● effective competition with other therapies; ● obtainment and maintenance of coverage, adequate pricing and adequate reimbursement from third-party payors, including government payors; ● maintenance, enforcement, defense and protection of our rights in our intellectual property portfolio; ● avoidance of infringement, misappropriation or other violations with respect to others ’ intellectual property or proprietary rights; and ● maintenance of a continued acceptable safety profile of our products following receipt of any marketing approvals.
The duration, costs and timing of preclinical studies and clinical trials and development of our product candidates will depend on a variety of factors, such as, without limitation: • successful completion of preclinical studies and initiation of clinical trials for future product candidates; • successful enrollment and completion of clinical trials for our current product candidates; • data from our clinical programs that support an acceptable risk-benefit profile of our product candidates in the intended patient populations; • acceptance by the FDA or other applicable regulatory agencies of IND applications and amendments, clinical trial applications and/or other regulatory filings for our product candidates; • expansion and maintenance of a workforce of experienced scientists and others to continue to develop our product candidates; • successful application for and receipt of marketing approvals from applicable regulatory authorities; • obtainment and maintenance of intellectual property protection and regulatory exclusivity for our product candidates; • making of arrangements with contract manufacturing organizations for, or establishment of, commercial manufacturing capabilities; 109 Table of Contents • establishment of sales, marketing and distribution capabilities and successful launch of commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; • acceptance of our product candidates, if and when approved, by patients, the medical community and third-party payors; • effective competition with other therapies; • obtainment and maintenance of coverage, adequate pricing and adequate reimbursement from third-party payors, including government payors; • maintenance, enforcement, defense and protection of our rights in our intellectual property portfolio; • avoidance of infringement, misappropriation or other violations with respect to others’ intellectual property or proprietary rights; and • maintenance of a continued acceptable safety profile of our products following receipt of any marketing approvals, if any.
As we expand our operations, we also expect to incur increased expenses associated with operating as a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and rules and regulations of the Securities and Exchange Commission (“SEC”), Sarbanes-Oxley Act, director and officer insurance costs, and investor and public relations costs.
As we 110 Table of Contents expand our operations, we also expect to incur increased expenses associated with operating as a public company, including costs related to accounting, audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and rules and regulations of the Securities and Exchange Commission (“SEC”), Sarbanes-Oxley Act, director and officer insurance costs, and investor and public relations costs.
We may remain classified as an EGC until the end of the fiscal year following the fifth anniversary of our IPO, although if the market value of our common stock that is held by non-affiliates exceeds $700 million as of June 30 of any year before that time, or if we have annual gross revenues of $1.235 billion or more in any fiscal year, we would cease to be an EGC as of December 31 of the applicable year.
We may remain classified as an EGC until December 31, 2026, which is the end of the fiscal year following the fifth anniversary of our IPO, although if the market value of our common stock that is held by non-affiliates exceeds $700 million as of June 30 of any year before that time, or if we have annual gross revenues of $1.235 billion or more in any fiscal year, we will cease to be an EGC as of December 31 of the applicable year.
As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements.
As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources including, without limitation, potential collaborations, licenses or similar arrangements.
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K. 120 Table of Contents Emerging Growth Company Status As an emerging growth company, or EGC, under the Jumpstart Our Business Startups Act of 2012, or JOBS Act, we may delay the adoption of certain accounting standards until such time as those standards apply to private companies.
Recently Issued Accounting Pronouncements A description of recently issued accounting pronouncements that may potentially impact our financial position, results of operations or cash flows is disclosed in Note 2 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K. 116 Table of Contents Emerging Growth Company Status As an emerging growth company ("EGC") under the JOBS Act, we may delay the adoption of certain accounting standards until such time as those standards apply to private companies.
In particular, we expect our expenses to increase as we continue our development of, and seek 110 Table of Contents regulatory approvals for, our internally developed product candidates as well as add operational, financial and management informational systems and personnel to support our product development.
In particular, we expect our expenses to increase as we continue our development of, and seek regulatory approvals for, our internally developed product candidates as well as add operational, financial and management informational systems and personnel to support our product development.
Other significant general and administrative expenses include legal fees relating to intellectual 113 Table of Contents property and corporate matters, professional fees for accounting, tax and consulting services, insurance costs, travel expenses and facility related expenses not otherwise included in research and development expenses.
Other significant general and administrative expenses include legal fees relating to intellectual property and corporate matters, professional fees for accounting, tax and consulting services, insurance costs, travel expenses and facility related expenses not otherwise included in research and development expenses.
Amortization of Intangible Asset Amortization of intangible asset of $30 thousand in the year ended December 31, 2022 is related to the technology acquired for the BioArkive acquisition completed in December 2021.
Amortization of Intangible Asset Amortization of intangible asset of $29 thousand in the year ended December 31, 2023 and $30 thousand in the year ended December 31, 2022 is related to the technology acquired for the BioArkive acquisition completed in December 2021.
On August 10, 2022, we entered into an Equity Distribution Agreement, or the Sales Agreement, with Piper Sandler & Co, or the Sales Agent, to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through an “at the market” equity offering program.
On August 10, 2022, we entered into an Equity Distribution Agreement (the "Sales Agreement") with Piper Sandler & Co, to sell shares of our common stock with aggregate gross proceeds of up to $50 million, from time to time, through an “at 113 Table of Contents the market” equity offering program ("ATM Program").
We also would cease to be an EGC if we issue more than $1.0 billion of non-convertible debt over a three-year period. Item 7A.
We also will cease to be an EGC if we issue more than $1.0 billion of non-convertible debt over a three-year period.
Net Cash Used in Investing Activities During the year ended December 31, 2022, cash provided from investing activities was approximately $41.8 million, primarily related to maturities of marketable securities of $92.7 million, offset by purchases of marketable securities of $50.1 million and $0.7 million for purchases of property and equipment.
During the year end December 31, 2022, cash provided from investing was approximately $41.8 million, primarily related to maturities of marketable securities of $92.7 million, offset by purchases of marketable securities of $50.1 million and $0.7 million for purchases of property and equipment.
We base our estimates on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis.
We base our estimates on historical experience, 115 Table of Contents known trends and events and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
As of December 31, 2022, we have contractual obligations related to various leases of $0.8 million for 2023, $0.7 million for 2024, $0.7 million for 2025, $0.8 million for 2026, $0.8 million for 2027 and $3.7 million for the periods thereafter.
As of December 31, 2023, we have contractual obligations related to various leases of $0.7 million for 2024, $0.7 million for 2025, $0.8 million for 2026, $0.8 million for 2027, $0.8 million for 2028 and $2.9 million for the periods thereafter.
As of the date of this Annual Report on Form 10-K, we cannot reasonably determine or accurately project total program-specific expenses through commercialization.
As of the date of this Annual Report on Form 10-K, we cannot reasonably determine or accurately project total program-specific expenses through commercialization, if such were to occur.
Based upon our current business plans, we believe that our existing cash and cash equivalents and marketable securities will be sufficient to fund our development activities and other operations into the fourth quarter of 2024. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Based on our current business plans, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our development activities and other operations into the second half of 2025. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
We received aggregate net proceeds of approximately $120.3 million from the IPO, after deducting underwriting discounts and commissions, but before deducting offering costs payable by us, which were $2.1 million. Since inception, we have had significant annual operating losses. Our net loss was approximately $50.5 million and $33.5 million for the years ended December 31, 2022 and 2021, respectively.
The aggregate net proceeds received from the offering were $28.2 million, after deducting underwriting discounts and commissions, but before deducting offering costs payable by us, which were $0.2 million. Since our inception, we have had significant annual operating losses. Our net loss was approximately $53.5 million and $50.5 million for the years ended December 31, 2023 and 2022, respectively.
The timing and amount of our operating and capital expenditures will depend largely on: ● the costs and results of our ongoing clinical trial for IMM-1-104 and potential future clinical trials for our other product candidates; ● the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials for our other product candidates; ● the costs, timing and outcome of regulatory review of our product candidates; ● our ability to enter into contract manufacturing arrangements for supply of active pharmaceutical ingredient, or API, and manufacture of our product candidates and the terms of such arrangements; ● the payment or receipt of milestones and receipt of other collaboration-based revenues, if any; ● the costs and timing of any future commercialization activities, including product manufacturing, sales, marketing and distribution, for any of our product candidates for which we may receive marketing approval; ● the amount and timing of revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; ● the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property related claims; ● the extent to which we acquire or in-license other products, product candidates, technologies or data referencing rights; ● our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements; ● our ability to access the private and public capital markets or to obtain financing at commercially reasonable rate; ● the ability to receive additional non-dilutive funding, including grants from organizations and foundations; ● the costs of operating as a public company; and ● the impacts of the pandemic related to COVID-19 and its variants and potential future pandemics. ​ We believe that our existing cash, cash equivalents and marketable securities, will enable us to fund our operating expenses and capital expenditure requirements for at least the next twelve months and into the fourth quarter of 2024.
The timing and amount of our operating and capital expenditures will depend largely on: • the costs and results of our ongoing clinical trials for IMM-1-104 and IMM-6-415 and potential future clinical trials for our other product candidates; • the scope, progress, results and costs of discovery research, preclinical development, laboratory testing and clinical trials for our other product candidates; • the costs, timing and outcome of regulatory review of our product candidates; • our ability to enter into contract manufacturing arrangements for supply of active pharmaceutical ingredient ("API"), and manufacture of our product candidates and the terms of such arrangements; • the payment or receipt of milestones and receipt of other collaboration-based revenues, if any; • the costs and timing of any future commercialization activities, including product manufacturing, sales, marketing and distribution, for any of our product candidates for which we may receive marketing approval; • the amount and timing of revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property related claims; • the extent to which we acquire or in-license other products, product candidates, technologies or data referencing rights; • our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such arrangements; • our ability to access the private and public capital markets or to obtain financing at commercially reasonable rate; • the ability to receive additional non-dilutive funding, including grants from organizations and foundations; • the costs of operating as a public company; and • the impacts of any ongoing or potential future pandemics, or other widespread adverse health events.
Our direct research and development expenses are tracked on a program-by-program basis once they are in Phase 1 and consist of external costs and fees paid to consultants, contractors, contract manufacturing organizations, or CMOs, and CROs in connection with our preclinical and clinical development and manufacturing activities.
We expense research and development costs in the periods in which they are incurred. Our direct research and development expenses are tracked on a program-by-program basis once they are in Phase 1 and consist of external costs and fees paid to consultants, contractors, CMOs, and CROs in connection with our preclinical and clinical development and manufacturing activities.
Amortization of intangible asset Amortization of intangible asset relates to the technology acquired in the BioArkive acquisition. Other Income (Expense) Interest income Interest income consists of interest earned on our cash and cash equivalents balances and our marketable securities.
Amortization of intangible asset Amortization of intangible asset relates to the technology acquired in the BioArkive acquisition. Other Income (Expense) Interest income Interest income consists of interest earned on our cash, cash equivalents, and marketable securities balances. The primary objective of our investment policy is capital preservation.
During the year ended December 31, 2021, operating activities used approximately $30.9 million of cash, primarily resulting from our net loss of approximately $33.5 million, deferred tax benefit of $0.3 million, and cash provided by changes in our operating assets and liabilities of approximately $0.9 million, partially offset by stock-based compensation expense of approximately $1.8 million, net amortization of premium (accretion of discount) on marketable securities of $0.1 million, and $0.2 million for right of use amortization and depreciation.
During the year ended December 31, 2022, operating activities used approximately $44.1 million of cash, primarily resulting from our net loss of approximately $50.5 million and net amortization of premium (accretion of discount) on marketable securities of $0.2 million, partially offset by stock-based compensation expense of approximately $4.1 million, cash provided by changes in our operating assets and liabilities of approximately $1.7 million, and $0.8 million for right of use amortization and depreciation.
Since 2018, we have also focused significant effort on our own internal research and development programs. We have financed our operations through service revenues, the issuance of convertible debt and the sale of convertible preferred stock and common stock.
Since 2018, we have focused significant effort on our own internal research and development programs, and since December 2022 have exclusively focused our efforts on such programs. We have financed our operations through service revenues (which have since ceased), the issuance of convertible debt and the sale of convertible preferred stock and common stock.
As of December 31, 2022, we had an accumulated deficit of approximately $109.8 million and approximately $105.5 million in cash and cash equivalents and marketable securities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses.
As of December 31, 2023, we had an accumulated deficit of approximately $163.3 million and approximately $85.7 million in cash, cash equivalents and marketable securities. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our accounts payable and accrued expenses.
Our indirect costs include: ● personnel-related expenses, consisting of employee salaries, bonuses, benefits and stock-based compensation expense and recruiting costs for personnel engaged in research and development activities; and ● facility and equipment related expenses, consisting of indirect and allocated expenses for rent, depreciation, maintenance of facilities, insurance, and other supplies.
Our indirect costs include: • personnel-related expenses, consisting of employee salaries, bonuses, benefits and stock-based compensation expense, and recruiting costs for personnel engaged in research and development activities; • contractor and consulting fees related to the preparation and ongoing support of clinical trials; and • facility and equipment related expenses, consisting of indirect and allocated expenses for rent, depreciation, maintenance of facilities, insurance, and other supplies.
We recognized revenue over time by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress, which depicts the performance in transferring control of the associated services to the customer.
Our contracts specified the period of time over which these professional services would be provided. We recognized revenue over time by measuring the progress toward complete satisfaction of the performance obligation using a single method of measuring progress, which depicts the performance in transferring control of the associated services to the customer.
While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements. 119 Table of Contents Research and Development Costs We incur substantial expenses associated with manufacturing and clinical trials.
While our significant accounting policies are described in more detail in Note 2 to our consolidated financial statements appearing at the end of this Annual Report on Form 10-K, we believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Our direct costs include: ● expenses incurred under agreements with third-party contract research organizations, or CROs, and other vendors that conduct our preclinical and clinical activities on our behalf; including clinical trial sites that conduct research and development activities on our behalf; ● laboratory expenses related to the execution of discovery programs, preclinical studies and clinical trials; ● costs related to production of clinical and preclinical materials, including fees paid to contract manufacturers; and ● consulting fees and expenses related to preparation of initiation of clinical trials.
Our research and development expenses consist primarily of direct and indirect costs incurred in connection with the development of our research platform, product candidates, discovery efforts and preclinical and clinical activities related to our program pipeline. 108 Table of Contents Our direct costs include: • expenses incurred under agreements with third-party CROs and other vendors that conduct our preclinical and clinical activities on our behalf, including clinical trial sites that conduct research and development activities on our behalf; • laboratory expenses related to the execution of discovery programs, preclinical studies and clinical trials; and • costs related to production of clinical and preclinical materials, including fees paid to contract manufacturers.
Our actual results may differ from these estimates under different assumptions or conditions.
We evaluate our estimates and assumptions on an ongoing basis. Our actual results may differ from these estimates under different assumptions or conditions.
This cyclic inhibition was engineered using our proprietary informatics-based discovery platform. The development of our pipeline is translationally guided by our 109 Table of Contents proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches.
The development of our pipeline is translationally guided by our proprietary, human-aligned 3D tumor modeling platform that we combine with bioinformatics-driven patient profiling, which we believe has the potential to increase the probability of success in clinical development versus traditional drug development approaches. Our pipeline also includes Trifecta MEK, RAS modulators and other small molecule drug discovery programs.
The Phase 1 portion of the clinical trial includes a dose escalation and expansion portion and will evaluate IMM-1-104 using a Bayesian modified toxicity probability interval, or mTPI-2, statistical design to establish an optimized recomm ended Phase 2 dose in solid tumor patients with evidence of any RAS mutation.
The Phase 1 portion of the clinical trial includes dose escalation and dose exploration utilizing a Bayesian mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAS mutation. The Phase 2a portion includes evaluating IMM-1-104 in multiple dose expansion arms at the candidate RP2D.
For the year ended December 31, 2022, we did not sell any shares of common stock under the Sales Agreement.
During the years ended December 31, 2023 and 2022, we did not sell any shares of common stock pursuant to the Sales Agreement under the ATM Program.
To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We have not had any internally developed products approved for sale. We do not expect to generate any product sales unless and until we successfully complete development and obtain regulatory approval for one or more of our internally developed product candidates.
We have not had any internally developed products approved for sale. We do not expect to generate any product sales unless and until we successfully complete development of, obtain regulatory approval for, and successfully bring to market 107 Table of Contents one or more of our internally developed product candidates.
Accounting for clinical trials relating to activities performed by contract research organizations, or CROs, and other external vendors requires management to exercise significant estimates in regard to the timing and accounting for these expenses. We estimate costs of research and development activities conducted by service providers, which include the conduct of sponsored research, preclinical studies and contract manufacturing activities.
Research and Development Costs We incur substantial expenses associated with manufacturing and clinical trials. Accounting for clinical trials relating to activities performed by CROs and other external vendors requires management to exercise significant estimates in regard to the timing and accounting for these expenses.
The increase of approximately $9.7 million was primarily due to an increase of approximately $2.5 million related to direct research and development expenses, of which $1.4 million related to IMM-1-104 and $1.1 million for earlier stage programs.
The increase of approximately $5.4 million was primarily due to an increase of approximately $4.1 million related to direct research and development expenses, consisting of a $7.9 million increase related to the IMM-1-104 program and a $5.2 million increase related to IMM-6-415 program, offset by a $9.0 million decrease for expenses for earlier stage and neuroscience programs as compared to the same prior year period.
Operating Expenses Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses. 111 Table of Contents Research and Development Research and development expenses account for a significant portion of our total operating expenses.
Research and Development Research and development expenses account for a significant portion of our total operating expenses.
The increase of approximately $7.3 million was primarily due to increased employee-related costs of approximately $3.6 116 Table of Contents million as a result of increased headcount, increased professional fees incurred for accounting, auditing, legal, public relations and tax services of approximately $1.0 million, increased facilities expenses of approximately $1.4 million, approximately $1.1 million increase in stock-based compensation expense.
The increase of approximately $1.2 million was primarily due to increased stock-based compensation of approximately $1.0 million, increased employee-related costs of $0.7 million, an increase of $0.5 million in other expenses, and increased professional fees incurred for accounting, auditing, legal, public relations and tax services of approximately $0.2 million, offset by decreased facilities and outside consulting expenses of approximately $1.2 million in the aggregate.
Other Income (expense) Interest income increased by approximately $0.8 million due to the interest earned on our cash and cash equivalents and marketable securities balances due to the increased in the interest rates during 2022 as compared to 2021. Other income (expense) increased by $0.3 million, primarily driven by the amortization of premiums related to our marketable securities.
Other Income, net Interest income increased by approximately $2.6 million due to the interest earned on our cash, cash equivalents and marketable securities balances, due to the increase in interest rates during 2023 as compared to 2022.
The decrease in revenue was due to the wind down of our computational biology professional services and completion of existing customer services contracts during the year compared to the year ended December 31, 2021. ​ 115 Table of Contents Cost of Revenue Cost of revenue decreased by approximately $1.0 million, or 86.3%, to approximately $0.2 million for the year ended December 31, 2022 compared to approximately $1.2 million for the year ended December 31, 2021.
The decrease in revenue was due to the wind down of our computational biology professional services and completion of existing customer services contracts during the year ended December 31, 2022.
During the year end December 31, 2021, cash used from investing was approximately $75.6 million, primarily related to purchases of marketable securities of approximately $75.6 million, $0.1 million for the purchases of property and equipment offset by cash acquired in business combination of approximately $0.1 million.
Net Cash Used in Investing Activities During the year ended December 31, 2023, cash provided from investing activities was approximately $7.3 million, primarily related to maturities of marketable securities of $52.3 million, offset by purchases of marketable securities of $44.7 million and $0.3 million for purchases of property and equipment.
Research and Development The following table summarizes the components of our research and development expenses for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, Change ​ ​ 2022 2021 ​ $ % ​ ​ (in thousands, except percentages) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Direct research and development expenses by program: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ IMM-1-104 ​ $ 1,374 ​ $ — ​ $ 1,374 ​ N/M % Other Programs ​ ​ 18,387 ​ ​ 17,307 ​ ​ 1,080 ​ 6.2 % Unallocated research and development expenses: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Employee related costs ​ ​ 13,957 ​ ​ 8,001 ​ ​ 5,956 ​ 74.4 % Stock-based compensation expense ​ ​ 1,978 ​ 769 ​ 1,209 ​ 157.2 % Facilities and other allocated expenses ​ 413 ​ 434 ​ (21) ​ (4.8) % Depreciation ​ ​ 158 ​ 30 ​ 128 ​ 426.7 % Total research and development ​ $ 36,267 ​ $ 26,541 ​ $ 9,726 ​ 36.6 % ​ Research and development expenses increased by approximately $9.7 million, or 36.6%, to approximately $36.3 million for the year ended December 31, 2022 as compared to approximately $26.5 million for the year-ended December 31, 2021.
Research and Development The following table summarizes the components of our research and development expenses for the periods indicated: Year Ended December 31, Change 2023 2022 $ % (in thousands, except percentages) Direct research and development expenses by program: IMM-1-104 $ 9,289 $ 1,374 $ 7,915 576.1 % IMM-6-415 5,171 — 5,171 100.0 % Other programs 9,395 18,387 (8,992) (48.9) % Unallocated research and development expenses: Employee-related costs 13,564 13,957 (393) (2.8) % Stock-based compensation expense 2,669 1,978 691 34.9 % Facilities and other expenses 1,313 413 900 217.9 % Depreciation/amortization 223 158 65 41.1 % Total research and development $ 41,624 $ 36,267 $ 5,357 14.8 % Research and development expenses increased by approximately $5.4 million, or 14.8%, to approximately $41.6 million for the year ended December 31, 2023 as compared to approximately $36.3 million for the year-ended December 31, 2022.
We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for the next several years, if at all. To date, our operations have been financed primarily by service revenues and proceeds from sales of our debt and equity securities.
Since our inception, we have incurred significant operating losses. We have not yet commercialized any of our product candidates, and we do not expect to generate revenue from sales of any product candidates for the next several years, if at all.
However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities.
Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs.
Our second product candidate, IMM-6-415, aims to achieve universal-MAPK activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of the MAPK pathway. IMM-6-415 is currently in Investigational New Drug application, or IND, enabling studies.
By contrast, IMM-6-415 aims to achieve universal-RAS/RAF activity with an accelerated twice-daily oral dosing cadence, also through deep cyclic inhibition of the MAPK pathway.
Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, reflected in the change in our outstanding accounts payable and accrued expenses. Since our inception, we have incurred significant operating losses.
Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, reflected in the change in our outstanding accounts payable and accrued expenses.
We have no off-balance sheet arrangements that have a material current effect or that are reasonably likely to have a material future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources. 117 Table of Contents Cash Flows The following table summarizes our sources and uses of cash for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2022 2021 ​ ​ (in thousands) Net cash (used in) provided by: ​ ​ ​ ​ ​ ​ Operating activities ​ $ (44,101) ​ $ (30,851) Investing activities ​ ​ 41,831 ​ ​ (75,616) Financing activities ​ ​ 19 ​ ​ 144,265 Net increase (decrease) in cash and cash equivalents ​ $ (2,251) ​ $ 37,798 ​ Net Cash Used in Operating Activities During the year ended December 31, 2022, operating activities used approximately $44.1 million of cash, primarily resulting from our net loss of approximately $50.5 million and net amortization of premium (accretion of discount) on marketable securities of $0.2 million, partially offset by stock-based compensation expense of approximately $4.1 million, cash provided by changes in our operating assets and liabilities of approximately $1.7 million, and $0.8 million for right of use amortization and depreciation.
Cash Flows The following table summarizes our sources and uses of cash for the periods indicated: Year Ended December 31, 2023 2022 (in thousands) Net cash (used in) provided by: Operating activities $ (48,969) $ (44,101) Investing activities 7,296 41,831 Financing activities 28,441 19 Net decrease in cash and cash equivalents $ (13,232) $ (2,251) Net Cash Used in Operating Activities During the year ended December 31, 2023, operating activities used approximately $49.0 million of cash, primarily resulting from our net loss of approximately $53.5 million, changes in our operating assets and liabilities of $1.0 million, and net amortization of premium (accretion of discount) on marketable securities of $1.0 million, partially offset by stock-based compensation expense of approximately $5.7 million and $0.7 million for the reduction in carrying amount of right-of-use assets and depreciation.
We have ceased accepting new services contracts in order to focus on developing our wholly-owned internal pipeline. In September 2022, we completed our last remaining services contract associated with the computational biology professional services business. At this time, we do not anticipate entering into any new service contracts or agreements.
We ceased accepting new services contracts in order to focus on developing our wholly-owned internal pipeline. In September 2022, we completed our last remaining services contract associated with the computational biology professional services business. We also discontinued our biosample storage business, which was acquired through the BioArkive transaction, to external parties.
General and Administrative The following table summarizes the components of our general and administrative expenses for the periods indicated: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, Change ​ ​ 2022 2021 ​ $ % ​ ​ (in thousands, except percentages) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Employee related costs ​ $ 8,123 ​ $ 4,506 ​ $ 3,617 ​ 80.3 % Stock-based compensation expense ​ 2,077 ​ 931 ​ 1,146 ​ 123.1 % Professional fees ​ 3,096 ​ 1,803 ​ 1,293 ​ 71.7 % Public relations ​ — ​ 262 ​ (262) ​ (100.0) % Outside consultants ​ 68 ​ 75 ​ (7) ​ (9.3) % Facilities and other allocated expenses ​ 1,513 ​ 125 ​ 1,388 ​ 1,110.4 % Other ​ 730 ​ 570 ​ 160 ​ 28.1 % Total general and administrative ​ $ 15,607 ​ $ 8,272 ​ $ 7,335 ​ 88.7 % ​ General and administrative expenses increased by approximately $7.3 million, or 88.7%, to approximately $15.6 million for the year ended December 31, 2022 compared to approximately $8.3 million for the year ended December 31, 2021.
The remaining increase was driven by unallocated research and development costs of approximately $1.3 million, consisting of a $1.0 million increase related to depreciation, facilities, and other allocated expenses in aggregate and a $0.7 million increase related to stock-based compensation expense, offset by a $0.4 million decrease in employee-related costs. 112 Table of Contents General and Administrative The following table summarizes the components of our general and administrative expenses for the periods indicated: Year Ended December 31, Change 2023 2022 $ % (in thousands, except percentages) Employee-related costs $ 8,802 $ 8,123 $ 679 8.4 % Stock-based compensation expense 3,058 2,077 981 47.2 % Professional fees 3,283 3,096 187 6.0 % Outside consultants — 68 (68) (100.0) % Facilities and other allocated expenses 417 1,513 (1,096) (72.4) % Other 1,200 730 470 64.4 % Total general and administrative $ 16,760 $ 15,607 $ 1,153 7.4 % General and administrative expenses increased by approximately $1.2 million, or 7.4%, to approximately $16.8 million for the year ended December 31, 2023 compared to approximately $15.6 million for the year ended December 31, 2022.
We charged an agreed upon rate per hour based on the aggregate level of personnel assigned to work on the project or a fixed fee for a defined scope of work. Our contracts specified the period of time over which these professional services would be provided.
Components of Our Results of Operations Revenue Our revenue was historically generated by providing computational biology professional services to pharmaceutical and biotechnology companies. We charged an agreed upon rate per hour based on the aggregate level of personnel assigned to work on the project or a fixed fee for a defined scope of work.
We have also discontinued our biosample storage business, which was acquired through the BioArkive transaction, to external parties. In December 2022, we completed our last remaining contract. The revenue earned associated with the biosample storage business for the year ended December 31, 2022 is immaterial to the financial statements.
In December 2022, we completed our last remaining storage contract. The revenue earned associated with the biosample storage business for the year ended December 31, 2022 is immaterial to the financial statements. At this time, we do not anticipate entering into any new service or storage contracts or agreements.
In February 2023, we suspended our neuroscience programs, which was in the early stages of drug discovery, in order to focus on advancing our core oncology pipeline. ​ For the period from inception through 2017, we devoted substantially all of our efforts to business planning, service revenue generation, developing tools to aid in drug discovery, and recruiting management and technical staff.
The Phase 2a portion includes exploring IMM-6-415 in multiple dose expansion arms at the candidate RP2D. For the period from inception through 2017, we devoted substantially all of our efforts to business planning, service revenue generation, developing tools to aid in drug discovery, and recruiting management and technical staff.
The decrease was primarily due to decreased employee-related costs of approximately $1.0 million related to services contracts that were completed during this year.
Cost of Revenue Cost of revenue decreased by approximately $0.2 million, or 100.0%, to $0 for the year ended December 31, 2023 compared to approximately $0.2 million for the year ended December 31, 2022. The decrease was primarily due to decreased employee-related costs related to services contracts that were discontinued as of September 2022.
The Phase 1/2a clinical trial is designed to assess the safety, tolerability, pharmacokinetics, or PK, pharmacodynamics, or PD, and preliminary anti-tumor activity of IMM-1-104.
In September 2022, the FDA cleared our IND application for IMM-1-104 and, i n November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the treatment of advanced RAS mutant solid tumors. The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-1-104.
IMM-1-104 is being developed as a once-daily oral monotherapy that aims to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway. Deep cyclic inhibition is a novel approach that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling.
Deep cyclic inhibition is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through 106 Table of Contents a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform.
Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures, and to a lesser extent, general and administrative expenditures.
As of December 31, 2023, we had an accumulated deficit of $163.3 million and $85.7 million in cash, cash equivalents and marketable securities. Cash and cash equivalents are comprised of deposits at major financial banking institutions and highly liquid investments with an original maturity of three months or less at the date of purchase.
Liquidity and Capital Resources Sources of Liquidity Since our inception, we have financed our operations through service revenues, the issuance of convertible notes payable, convertible preferred stock, common stock, and the exercise of stock options. As of December 31, 2022, we had an accumulated deficit of $109.8 million and $105.5 million in cash and cash equivalents and marketable securities.
Other income, net was approximately $1.3 million in the year ended December 31, 2023, primarily driven by the accretion of discounts related to our marketable securities. Liquidity and Capital Resources Sources of Liquidity We finance our operations through the issuance of convertible notes payable, convertible preferred stock, common stock, and the exercise of stock options.
During the year ended December 31, 2021, net cash provided by financing activities was approximately $144.3 million, consisting primarily of approximately $24.8 million in net proceeds received from the issuance of Series B preferred stock, approximately $118.2 million from the net proceeds from our initial public offering, approximately $0.9 million in net proceeds from the exercise of warrants and approximately $0.4 million from the exercise of stock options. 118 Table of Contents Future Funding Requirements We expect that our expenses will increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development.
Future Funding Requirements We expect that our expenses will increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials for our product candidates in development.
Our inclusive approach differentiates us from narrowly targeted precision therapies, which are limited to patients with tumors harboring select mutations. We are currently evaluating our lead product candidate, IMM-1-104, in a Phase 1/2a clinical trial in patients with advanced solid tumors harboring RAS mutations.
We are currently evaluating our lead product candidates, IMM-1-104 and IMM-6-415, in Phase 1/2a clinical trials in patients with advanced solid tumors harboring RAS and RAS/RAF mutations, respectively. IMM-1-104 is being developed as a once-daily oral therapy that aims to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway.
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Overview We are a clinical-stage oncology company developing medicines for broad populations of cancer patients. Our initial aim is to develop a universal-RAS therapy, an approach designed to include patients with solid tumors driven by any mutation in KRAS, NRAS, or HRAS.
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Overview We are a clinical-stage oncology company seeking to develop universal-RAS/RAF medicines for broad populations of cancer patients. We aim to achieve universal RAS/RAF activity through deep cyclic inhibition of the MAPK pathway, impacting cancer cells while sparing healthy cells, Our inclusive approach differentiates us from narrowly targeted precision therapies, which are limited to patients with tumors harboring select mutations.
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Our pipeline also includes Trifecta MEK, RAS modulators, and other small molecule drug discovery programs. ​ In November 2022, we commenced dosing in our Phase 1/2a clinical trial of IMM-1-104 for the treatment of advanced RAS mutant solid tumors.
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In November 2023 we announced that we had expanded the IMM-1-104 Phase 1/2a clinical trial design by increasing the number of Phase 2a expansion arms to five, including two combination therapy arms and three monotherapy arms.
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The planned Phase 2a portion will evaluate IMM-1-104 at the recommended Phase 2 dose in an expanded cohort of solid tumor patients with certain RAS mutated cancers, including potentially pancreatic, melanoma, colorectal and lung. IMM-1-104 is currently in the dose escalation portion of the trial.
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In December 2023, the FDA cleared our IND application for IMM-6-415 and we began the process of enrolling patients in a Phase 1/2a clinical trial of IMM-6-415 for the treatment of patients with advanced solid tumors harboring RAF or RAS mutations.
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We anticipate reporting initial PK and safety data from Phase 1 portion of the clinical trial in mid-2023, and additional safety and PK and initial PD modeling data in the second half of 2023.
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The Phase 1/2a clinical trial is designed to assess the safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMM-6-415. The Phase 1 portion of the clinical trial includes dose escalation and dose exploration for IMM-6-415, using a mTPI-2 statistical design to establish an optimized RP2D in solid tumor patients with evidence of any RAF or RAS mutation.
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Subject to results from the Phase 1 portion of the trial, including safety and tolerability data, we anticipate initiating the Phase 2a portion of the trial in mid-2024. In addition, we plan to submit an IND, for IMM-6-415 to the U.S. Food and Drug Administration, or FDA, in the fourth quarter of 2023.
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On April 20, 2023, we completed an underwritten offering, pursuant to which we issued and sold 2,727,273 shares of our Class A common stock at an offering price of $11.00 per share.
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Our operations have been financed primarily by service revenues and aggregate net proceeds of approximately $81.4 million from the issuance of convertible notes payable, convertible preferred stock (Series A and B) including gross proceeds of approximately $24.8 million from the issuance of shares in the second tranche of Series B Preferred in April and May 2021, common stock, and exercise of stock options.
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To finance our operations beyond that point we will need to raise additional capital, which cannot be assured. We may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all.
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On August 3, 2021, we completed our IPO pursuant to which we issued and sold 8,625,000 shares of Class A common stock, inclusive of 1,125,000 shares sold by us pursuant to the full exercise of the underwriters’ option to purchase additional shares.
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As a result of the discontinued service contracts and bio-sample storage business, the cost of revenue incurred for the year ended December 31, 2022 is immaterial to the financial statements and not applicable for the year ended December 31, 2023. Operating Expenses Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
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If we are unable to raise capital, we will need to delay, reduce or terminate planned activities to reduce costs. Components of Our Results of Operations Revenue Our revenue has historically been generated by providing computational biology professional services to pharmaceutical and biotechnology companies.
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Other income, net Other income consists of the accretion of discounts related to our marketable securities.
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Our research and development expenses consist primarily of direct and indirect costs incurred in connection with the development of our research platform, product candidates, discovery efforts and preclinical and clinical activities related to our program pipeline.

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