UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ___ to ___
Commission file number
(Exact name of registrant as specified in its charter)
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(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large, accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large, accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated Filer ☐ |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
Shares of Common Stock outstanding as of November 7, 2022:
iBio, Inc.
TABLE OF CONTENTS
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 30 | |
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2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited).
iBio, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In Thousands, except share and per share amounts)
September 30, | June 30, | |||||
2022 | 2022 | |||||
(Unaudited) | (See Note 2) | |||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | | $ | | ||
Investments in debt securities |
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Accounts receivable - trade |
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Settlement receivable - current portion | | | ||||
Prepaid expenses and other current assets |
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Current assets held for sale | | | ||||
Total Current Assets |
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Restricted cash | | | ||||
Noncurrent assets held for sale | — | | ||||
Convertible promissory note receivable and accrued interest | | | ||||
Finance lease right-of-use assets, net of accumulated amortization |
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Operating lease right-of-use asset | | | ||||
Fixed assets, net of accumulated depreciation |
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Intangible assets, net of accumulated amortization | | | ||||
Prepaid expenses - noncurrent | | | ||||
Security deposits | | | ||||
Total Assets | $ | | $ | | ||
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Liabilities and Equity |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued expenses |
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Finance lease obligations - current portion | | — | ||||
Operating lease obligation - current portion | | | ||||
Current liabilities related to assets held for sale | | | ||||
Term note payable - net of deferred financing costs | | | ||||
Contract liabilities |
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Total Current Liabilities |
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Finance lease obligations - net of current portion | | — | ||||
Operating lease obligation - net of current portion | | | ||||
Noncurrent liabilities related to assets held for sale | — | | ||||
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Total Liabilities |
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Equity |
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iBio, Inc. Stockholders’ Equity: |
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Series 2022 Convertible Preferred Stock – $ |
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Common stock - $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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Accumulated deficit | ( | ( | ||||
Total iBio, Inc. Stockholders’ Equity |
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Total Liabilities and Equity | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
iBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited; in Thousands, except per share amounts)
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| Three Months Ended | ||||
| September 30, | |||||
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| 2022 |
| 2021 | ||
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Revenues | $ | | $ | | ||
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Operating expenses: |
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Research and development |
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General and administrative (related party of $ |
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Total operating expenses |
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Operating loss |
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Other income: |
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Interest income |
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Consolidated net loss from continuing operations |
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Net loss attributable to noncontrolling interest |
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Net loss attributable to iBio, Inc. from continuing operations |
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Preferred stock dividends - iBio CDMO Tracking Stock |
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Net loss available to iBio, Inc. stockholders from continuing operations | ( | ( | ||||
Loss from discontinued operations | ( | ( | ||||
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Net loss available to iBio, Inc. stockholders | $ | ( | $ | ( | ||
Comprehensive loss: |
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Consolidated net loss | $ | ( | $ | ( | ||
Other comprehensive loss - unrealized loss on debt securities |
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Comprehensive loss | $ | ( | $ | ( | ||
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Loss per common share attributable to iBio, Inc. stockholders - basic and diluted - continuing operations | ( | ( | ||||
Loss per common share attributable to iBio, Inc. stockholders - basic and diluted - discontinued operations | ( | ( | ||||
Loss per common share attributable to iBio, Inc. stockholders - basic and diluted - total | ( | ( | ||||
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Weighted-average common shares outstanding - basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
iBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Equity
(Unaudited; in thousands)
Three Months Ended September 30, 2022
| Accumulated | ||||||||||||||||||||||
| Additional | Other | |||||||||||||||||||||
| Preferred Stock | Common Stock | Paid-In | Comprehensive | Accumulated | ||||||||||||||||||
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| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Loss |
| Deficit |
| Total | |||||||
Balance as of July 1, 2022 | | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | | |||||||||
Capital raise | — | — | | — | | — | — | | |||||||||||||||
Conversion of preferred stock to common stock |
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Common stock issued - RubrYc transaction | — | — | | — | | — | — | | |||||||||||||||
Vesting of RSUs | — | — | | — | — | — | — | — | |||||||||||||||
Share-based compensation | — | — | — | — | | — | — | | |||||||||||||||
Unrealized loss on available-for-sale debt securities | — | — | — |
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Net loss | — | — | — |
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Balance as of September 30, 2022 | — | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | | |||||||||
Three Months Ended September 30, 2021
| Accumulated | |||||||||||||||||||||||||
| Additional | Other | ||||||||||||||||||||||||
| Preferred Stock | Common Stock | Paid-In | Comprehensive | Accumulated | Noncontrolling | ||||||||||||||||||||
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| Shares |
| Amount |
| Shares |
| Amount |
| Capital |
| Loss |
| Deficit |
| Interest |
| Total | ||||||||
Balance as of July 1, 2021 | — | $ | — | | $ | | $ | | $ | ( | $ | ( | $ | ( | $ | | ||||||||||
Exercise of stock options | — | — | | — | | — | — | — | | |||||||||||||||||
Share-based compensation |
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Unrealized loss on debt securities | — | — | — | — | — | ( | — | — | ( | |||||||||||||||||
Net loss | — | — | — |
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Balance as of September 30, 2021 |
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| $ | ( |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
iBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited; in Thousands)
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| Three Months Ended | |||||
| September 30, | ||||||
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| 2022 |
| 2021 | |||
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Cash flows from operating activities: | |||||||
Consolidated net loss | $ | ( | $ | ( | |||
Adjustments to reconcile consolidated net loss to net cash used in operating activities: |
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Share-based compensation |
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Amortization of intangible assets |
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Amortization of finance lease right-of-use assets | | | |||||
Amortization of operating lease right-of-use assets | | | |||||
Depreciation of fixed assets |
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Accrued interest receivable on convertible promissory note receivable | ( | ( | |||||
Amortization of premiums on debt securities | | | |||||
Amortization of deferred financing costs | | | |||||
Inventory reserve | | | |||||
Forgiveness of note payable and accrued interest - SBA loan | | ( | |||||
Settlement of revenue contract | | ( | |||||
Changes in operating assets and liabilities: |
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Accounts receivable – trade |
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Inventory |
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Prepaid expenses and other current assets |
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Prepaid expenses - noncurrent | | ( | |||||
Accounts payable |
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Accrued expenses |
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Operating lease obligations |
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Contract liabilities |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Purchases of debt securities | | ( | |||||
Redemption of debt securities | | | |||||
Purchase of equity security | | ( | |||||
Additions to intangible assets |
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Purchases of fixed assets |
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Payment for RubrYc asset acquisition | ( | | |||||
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Net cash provided by (used in) investing activities |
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Cash flows from financing activities: |
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Proceeds from sales of common stock | | | |||||
Payment of finance lease obligation |
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Net cash provided by (used in) provided by financing activities |
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Net decrease in cash, cash equivalents and restricted cash |
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Cash, cash equivalents and restricted cash - beginning |
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Cash, cash equivalents and restricted cash - end | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
iBio, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited; in Thousands)
| Three Months Ended | ||||||
September 30, | |||||||
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| 2022 |
| 2021 | |||
Schedule of non-cash activities: |
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Increase in operating lease ROU assets for new lease - net of lease incentive | $ | | $ | | |||
Increase in operating lease obligation for new lease | $ | | $ | | |||
Increase in finance lease ROU assets for new leases | $ | | $ | | |||
Increase in finance lease obligation for new leases | $ | | $ | | |||
Fixed assets included in accounts payable in prior period, paid in current period | $ | | $ | | |||
Unpaid fixed assets included in accounts payable | $ | | $ | | |||
Unpaid portion of RubrYc transaction | $ | | $ | | |||
Unrealized loss on available-for-sale debt securities | $ | | $ | | |||
Lease incentive for construction in progress | $ | | $ | | |||
Settlement of revenue contract | $ | | $ | | |||
RubrYc asset acquisition by issuance of common stock | $ | | $ | | |||
Proceeds from options exercised included in prepaid expenses and OCA | $ | | $ | | |||
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Supplemental cash flow information: |
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Cash paid during the period for interest | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
iBio, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Nature of Business
iBio, Inc. (“we”, “us”, “our”, “iBio”, “iBio, Inc” or the “Company”) is an Artificial Intelligence (“AI”)-driven innovator of precision antibody immunotherapies. The Company has a pipeline of innovative primarily immuno-oncology antibodies against hard-to-drug targets where we may face reduced competition and with antibodies that may be more selective. The Company plans to use its AI-driven discovery platform to continue adding antibodies against hard-to-drug targets or to work with partners on AI-driven drug development.
Therapeutics Pipeline
IBIO-101: an anti-CD25 molecule that works by depletion of immunosuppressive T-regulatory cells (Tregs) via antibody-dependent cellular cytotoxicity (“ADCC”), without disrupting activation of effector T-cells (Teffs) in the tumor microenvironment. IBIO-101 could potentially be used to treat solid tumors, hairy cell leukemia, relapsed multiple myeloma, lymphoma, or head and neck cancer.
EGFRvIII: binds a tumor-specific mutation of EGFR variant III with an afucosylated antibody for high ADCC. Because of its specificity binding to the tumor-specific mutation, it could potentially reduce toxicity and/or expand the therapeutic window compared to simple broad EGFR-targeted alternatives. . EGFRvIII is constantly “switched on” which can lead to the development of a range of different cancers. An EGFRvIII antibody could potentially be used to treat glioblastoma, head and neck cancer or non-small cell lung cancer.
CCR8: targets depletion of highly immunosuppressive CCR8+ Tregs in the tumor microenvironment via an ADCC mechanism with selective binding to CCR8 over its closely related cousin, CCR4, to avoid off-target effects. A CCR8 program could potentially be broadly applicable in solid tumors and/or as a prospective combination therapy.
PD-1 Agonist: Selectively binds PD-1 to suppress auto-reactive T-cells without PD-L1/PD-L2 blocking. A PD-1 agonist could potentially be used to treat inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis or other inflammatory diseases.
In addition to the programs described above, the Company also has six additional early discovery programs that have the potential to advance into later stages of preclinical development and are designed to tackle hard-to-drug targets.
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IBIO-100 and Endostatin E4
Our lead anti-fibrotic candidate is IBIO-100, and its design is based in part upon work by Dr. Carol Feghali-Bostwick, Professor of Medicine at the Medical University of South Carolina and Vice-Chair of the Scleroderma Foundation. Her initial work was conducted at the University of Pittsburgh, and we have licensed the patents relevant for the continued development of the molecule from the university.
As part of the Company’s review of potential options, the Company intends to continue to review the data from its research and development efforts and determine how to proceed with the development of IBIO-100 in Fibrosis.
To align with the Company’s focus on the immuno-oncology pipeline, the Company also intends to continue to pursue the E4 endostatin peptide, from which IBIO-100 is derived, as an oncology target in collaboration with University of Texas Southwestern.
AI Drug Discovery Platform
In September 2022, iBio purchased substantially all of the assets of RubrYc Therapeutics (for a complete description of the transaction please see Note 6 – Significant Transactions). The AI Drug Discovery platform technology is designed to be used to discover antibodies that bind to hard-to-target subdominant and conformational epitopes for further development within our existing portfolio or in partnership with outside entities. The RubrYc AI platform is built upon 3 key technologies.
1. | Epitope Targeting Engine: A proprietary machine-learning platform that combines computational biology and 3D-modeling to identify molecules that mimic hard-to-target binding sites on target proteins, specifically, subdominant and conformational epitopes. The creation of these small mimics enables the engineering of therapeutic antibody candidates that can selectively bind immune and cancer cells better than ”trial and error” antibody engineering and screening methods that are traditionally focused on dominant epitopes. |
2. | RubrYcHuTM Library: An AI-generated human antibody library free of significant sequence liabilities that provides a unique pool of antibodies to screen. The combination of the Epitope Targeting Engine and screening with the RubrYcHu Library has been shown to reduce the discovery time from ideation to in vivo proof-of-concept (PoC) by up to 4 months. This has the potential to enable more, and better, therapeutic candidates to reach the clinic, faster. |
3. | StableHuTM Library: An AI-powered sequence optimization library used to improve antibody performance. Once an antibody has been advanced to the lead optimization stage, StableHu allows precise and rapid optimization of the antibody binding regions to rapidly move a candidate molecule into the IND-enabling stage. |
2. Basis of Presentation
Interim Financial Statements
The accompanying unaudited condensed consolidated financial statements have been prepared from the books and records of the Company and include all normal and recurring adjustments which, in the opinion of management, are necessary for a fair presentation in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial information and Rule 8-03 of Regulation S-X promulgated by the U.S. Securities and Exchange Commission (the “SEC”). Accordingly, these interim financial statements do not include all of the information and footnotes required for complete annual financial statements. Interim results are not necessarily indicative of the results that may be expected for the full year. Interim unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2022, filed with the SEC on October 11, 2022 (the “Annual Report”), from which the accompanying condensed consolidated balance sheet dated June 30, 2022 was derived.
Principles of Consolidation
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated as part of the consolidation. Non-controlling interest in the consolidated financial statements represented the share of the loss in iBio CDMO, LLC (“iBio CDMO”) for an affiliate of Eastern Capital Limited (“Eastern Capital”) through November 1, 2021, the date the Company acquired the remaining interest in iBio CDMO. See Note 6 – Significant Transactions.
9
Going Concern
The history of significant losses, the negative cash flow from operations, the limited cash resources on hand and the dependence by the Company on its ability to obtain additional financing to fund its operations after the current cash resources are exhausted raises substantial doubt about the Company's ability to continue as a going concern. In an effort to remain a going concern and increase cash reserves, the Company recently announced it was selling its CDMO business and facility, reducing its work force by approximately 60% (a reduction of approximately 69 positions), and ceasing operations of its CDMO thereby reducing annual spending by approximately 50%. (See Note 3 – Discontinued Operations for more information.) Potential options being considered to further increase liquidity include lowering the Company’s expenses further, focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from capital markets, grant revenue or collaborations, or a combination thereof. During the first quarter of fiscal year 2023, the Company completed at-the-market (“ATM”) offerings and raised
The Company’s cash, cash equivalents, restricted cash and investments in debt securities of $
The accompanying financial statements do not include any adjustments related to the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the Company to continue as a going concern.
Reverse Stock Split
On September 22, 2022, the Company's Board of Directors approved the implementation of a reverse stock split at a ratio of one-for-twenty five (1:
) shares of the Company's Common Stock (the “Reverse Split”). The Reverse Split was effective as of October 7, 2022. All share and per share amounts of our common stock presented have been retroactively adjusted to reflect the Reverse Split. See Note 16 – Stockholders’ Equity for more information.3. Discontinued Operations
In November 2022, the Company announced it is seeking to divest its contract development and manufacturing organization (iBio CDMO, LLC) in order to complete its transformation into an antibody discovery and development company. In conjunction with the divestment, the Company commenced a workforce reduction of approximately 60% of the current Company staffing levels (a reduction of approximately 69 positions). The Company expects to substantially complete the employee reduction by January 2, 2023. The Company expects it may be able to complete a transaction for the sale of its contract development and manufacturing organization in calendar 2023, although there is no assurance as to when, or for how much, the Company may be able to sell the iBio CDMO, LLC organization, including the 130,000-square-foot cGMP facility location in Bryan, Texas. The Company expects to incur pre-tax charges of approximately $
As such, the results of iBio CDMO's operations are reported as discontinued operations for the three months ended September 30, 2022. The Company has retrospectively recast its consolidated statement of operations for the three months ended September 30, 2021 presented. In addition, those assets and liabilities associated with the discontinued operations of the CDMO that the Company intends to sell have been classified as “held for sale” as of September 30, 2022. The Company has retrospectively recast its consolidated balance sheet as of June 30, 2022 for assets and liabilities held for sale. The Company has chosen not to segregate the cash flows of iBio CDMO in the consolidated statement of cash flows. Supplemental disclosures related to discontinued operations for the statements of cash flows has been provided below. Unless noted otherwise, discussion in the Notes to the Condensed Consolidated Financial Statements refers to the Company's continuing operations.
10
The following table presents a reconciliation of the major financial lines constituting the results of operations for discontinued operations to the loss from discontinued operations presented separately in the consolidated statements of operations (in thousands):
September 30, | September 30, | |||||
2022 | 2021 | |||||
Revenues | | $ | | $ | | |
Cost of goods sold | | | ||||
Gross profit | | | ||||
Operating expenses: | ||||||
Research and development | | | ||||
General and administrative | | | ||||
Total operating expenses | | | ||||
Other income (expenses): | ||||||
Interest expense - term note payable | ( | — | ||||
Interest expense - related party | — | ( | ||||
Forgiveness of note payable and accrued interest - SBA loan | — | | ||||
Other | ( | ( | ||||
Total other expenses | | ( | ( | |||
Loss from discontinued operation | | $ | (10,593) | $ | (3,751) |
The following table presents net carrying values related to the major classes of assets that were classified as held for sale at September 30, 2022 and June 30, 2022 (in thousands):
September 30, | June 30 | |||||
2022 | 2022 | |||||
Current assets: | ||||||
Inventory | $ | $ | | |||
Operating lease right-of-use assets | | — | ||||
Property and equipment, net | | — | ||||
Total current assets | $ | | $ | | ||
Other assets: | ||||||
Property and equipment, net | $ | — | $ | | ||
Operating lease right-of-use assets | — | | ||||
Total other assets | $ | — | $ | 37,240 | ||
Current liabilities: | ||||||
Operating lease obligation | $ | | $ | | ||
Long-term liabilities: | ||||||
Operating lease obligation | $ | — | $ | |
The following table presents the supplemental disclosures related to discontinued operations for the statements of cash flows (in thousands):
Three Months Ended | Three Months Ended | |||||
September 30, | September 30, | |||||
2022 | 2021 | |||||
Depreciation expense | | $ | | $ | | |
Amortization of finance lease ROU assets | | | ||||
Purchase of fixed assets | | | ||||
Investing noncash transactions: | ||||||
Fixed assets included in accounts payable in prior period, paid in current period | | | ||||
Unpaid fixed assets included in accounts payable | | |
11
4. Summary of Significant Accounting Policies
The Company’s significant accounting policies are described in Note 3 of the Notes to Financial Statements in the Annual Report.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. These estimates include liquidity assertions, the valuation of intellectual property, legal and contractual contingencies and share-based compensation. Although management bases its estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.
Accounts Receivable
Accounts receivable are reported at their outstanding unpaid principal balances net of allowances for uncollectible accounts. The Company provides for allowances for uncollectible receivables based on its estimate of uncollectible amounts considering age, collection history, and other factors considered appropriate. Management’s policy is to write off accounts receivable against the allowance for doubtful accounts when a balance is determined to be uncollectible. At September 30, 2022 and June 30, 2022, the Company determined that an allowance for doubtful accounts was not needed.
Revenue Recognition
The Company accounts for its revenue recognition under Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers. Under this standard, the Company recognizes revenue when a customer obtains control of promised services or goods in an amount that reflects the consideration to which the Company expects to receive in exchange for those goods or services. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from customer contracts.
The Company’s contract revenue consists primarily of amounts earned under contracts with third-party customers and reimbursed expenses under such contracts. The Company analyzes its agreements to determine whether the elements can be separated and accounted for individually or as a single unit of accounting. Allocation of revenue to individual elements that qualify for separate accounting is based on the separate selling prices determined for each component, and total contract consideration is then allocated pro rata across the components of the arrangement. If separate selling prices are not available, the Company will use its best estimate of such selling prices, consistent with the overall pricing strategy and after consideration of relevant market factors.
In general, the Company applies the following steps when recognizing revenue from contracts with customers: (i) identify the contract, (ii) identify the performance obligations, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations and (v) recognize revenue when a performance obligation is satisfied. The nature of the Company’s contracts with customers generally falls within the three key elements of the Company’s business plan: CDMO Facility Activities; Product Candidate Pipeline, and Facility Design and Build-out /Technology Transfer services.
Recognition of revenue is driven by satisfaction of the performance obligations using one of two methods: revenue is either recognized over time or at a point in time. Contracts containing multiple performance obligations classify those performance obligations into separate units of accounting either as standalone or combined units of accounting. For those performance obligations treated as a standalone unit of accounting, revenue is generally recognized based on the method appropriate for each standalone unit. For those performance obligations treated as a combined unit of accounting, revenue is generally recognized as the performance obligations are satisfied, which generally occurs when control of the goods or services have been transferred to the customer or client or once the client or customer is able to direct the use of those goods and/or services as well as obtaining substantially all of its benefits. As such, revenue for a combined unit of accounting is generally recognized based on the method appropriate for the last delivered item but due to the specific nature of certain project and contract items, management may determine an alternative revenue recognition method as appropriate, such as a contract whereby one deliverable in the arrangement clearly comprises the overwhelming majority of the value of the overall combined unit of accounting. Under this circumstance, management may determine revenue recognition for the combined unit of accounting based on the revenue recognition guidance otherwise applicable to the predominant deliverable.
If a loss on a contract is anticipated, such loss is recognized in its entirety when the loss becomes evident. When the current estimates of the amount of consideration that is expected to be received in exchange for transferring promised goods or services to the customer indicates a loss will be incurred, a provision for the entire loss on the contract is made. At September 30, 2022 and June 30, 2022, the Company had
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The Company generates (or may generate in the future) contract revenue under the following types of contracts:
Fixed-Fee
Under a fixed-fee contract, the Company charges a fixed agreed upon amount for a deliverable. Fixed-fee contracts have fixed deliverables upon completion of the project. Typically, the Company recognizes revenue for fixed-fee contracts after projects are completed, delivery is made and title transfers to the customer, and collection is reasonably assured.
Revenue can be recognized either 1) over time or 2) at a point in time. All revenue was recognized at a point in time for all periods presented.
For the three months ended September 30, 2021, revenue was from the settlement of a revenue contract.
Time and Materials
Under a time and materials contract, the Company charges customers an hourly rate plus reimbursement for other project specific costs. The Company recognizes revenue for time and material contracts based on the number of hours devoted to the project multiplied by the customer’s billing rate plus other project specific costs incurred.
Contract Assets
A contract asset is an entity’s right to payment for goods and services already transferred to a customer if that right to payment is conditional on something other than the passage of time. Generally, an entity will recognize a contract asset when it has fulfilled a contract obligation but must perform other obligations before being entitled to payment.
Contract assets consist primarily of the cost of project contract work performed by third parties for which the Company expects to recognize any related revenue at a later date, upon satisfaction of the contract obligations. At both September 30, 2022 and June 30, 2022, contract assets were $
Contract Liabilities
A contract liability is an entity’s obligation to transfer goods or services to a customer at the earlier of (1) when the customer prepays consideration or (2) the time that the customer’s consideration is due for goods and services the entity will yet provide. Generally, an entity will recognize a contract liability when it receives a prepayment.
Contract liabilities consist primarily of consideration received, usually in the form of payment, on project work to be performed whereby the Company expects to recognize any related revenue at a later date, upon satisfaction of the contract obligations. At September 30, 2022 and June 30, 2022, contract liabilities were $
Leases
The Company accounts for leases under the guidance of Accounting Standards Codification ("ASC") 842, "Leases" ("ASC 842"). The standard established a right-of-use (“ROU”) model requiring a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months and classified as either an operating or finance lease. The adoption of ASC 842 had a significant effect on the Company’s balance sheet, resulting in an increase in non-current assets and both current and non-current liabilities.
In accordance with ASC 842, at the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present and the classification of the lease including whether the contract involves the use of a distinct identified asset, whether the Company obtains the right to substantially all the economic benefit from the use of the asset, and whether the Company has the right to direct the use of the asset. Leases with a term greater than one year are recognized on the balance sheet as ROU assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less under practical expedient in paragraph ASC 842-20-25-2. For contracts with lease and non-lease components,
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The lease liabilities and the corresponding ROU assets are recorded based on the present value of lease payments over the expected remaining lease term. The implicit rate within the Company’s existing finance (capital) lease was determinable and, therefore, used at the adoption date of ASC 842 to determine the present value of lease payments under the finance lease. The implicit rate within the Company’s operating lease was not determinable and, therefore, the Company used the incremental borrowing rate at the lease commencement date to determine the present value of lease payments. The determination of the Company’s incremental borrowing rate requires judgment. The Company will determine the incremental borrowing rate for each new lease using its estimated borrowing rate.
An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain the Company will exercise that option. An option to terminate is considered unless it is reasonably certain the Company will not exercise the option.
Cash, Cash Equivalents and Restricted Cash
The Company considers all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. Cash equivalents at September 30, 2022 and June 30, 2022 consisted of money market accounts. Restricted cash consisted of collateral held for letters of credit obtained to the term note payable for the purchase of the 130,000 square foot cGMP manufacturing facility in Bryan, Texas located at 8800 HSC Parkway, Bryan, Texas 77807 (the “Facility”) (see Note 6 – Significant Transactions) and the San Diego operating lease (see Note 15 – Operating Lease Obligations) and a Company purchasing card. The Company’s bank required an additional 5% collateral held above the actual letters of credit issued. Restricted cash was approximately $6 million at both September 30, 2022 and June 30, 2022. On October 11, 2022, the Company, as part of the First Amendment to the Credit Agreement with Woodforest, paid down $5.5M of the term loan and subsequently Woodforest cancelled the irrevocable letter of credit issued by JPMorgan Chase Bank upon closing of the amendment. The change in restricted cash will be reflected in second quarter of fiscal year 2023 financials.
The following table summarizes the components of total cash, cash equivalents and restricted cash in the condensed consolidated statements of cash flows (in thousands):
September 30, | June 30, | |||||
2022 | 2021 | |||||
Cash and equivalents | | $ | | $ | | |
Collateral held for letter of credit - term note payable | | | ||||
Collateral held for letter of credit - San Diego lease | | | ||||
Collateral held for Company purchasing card | | | | |||
Total cash, cash equivalents and restricted cash | | $ | | $ | |
Investments in Debt Securities
Debt investments are classified as available-for-sale. Changes in fair value are recorded in other comprehensive income (loss). Fair value is calculated based on publicly available market information. Discounts and/or premiums paid when the debt securities are acquired are amortized to interest income over the terms of the debt securities. See Note 8 – Investments in Debt Securities.
Inventory
Inventory is stated at the lower of cost or net realizable value on the first-in, first-out basis. Inventory held is related to the CDMO business and has been classified as held for sale.
Research and Development
The Company accounts for research and development costs in accordance with the Financial Accounting Standards Board (“FASB”) ASC 730-10, Research and Development (“ASC 730-10”). Under ASC 730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed or as milestone results have been achieved. For the three month periods ending September 30, 2022 and 2021 research and development expense was reported in both continuing and discontinued operations.
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Right-of-Use Assets
Assets held under the terms of finance (capital) leases are amortized on a straight-line basis over the terms of the leases or the economic lives of the assets. Obligations for future lease payments under finance (capital) leases are shown within liabilities and are analyzed between amounts falling due within and after one year. See Note 9 - Finance Lease ROU Assets and Note 14 - Finance Lease Obligations for additional information.
Fixed Assets
Fixed assets are stated at cost net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets ranging from
Intangible Assets
The Company accounts for intangible assets at either their historical cost or allocated purchase price at asset acquisition and records amortization utilizing the straight-line method based upon their estimated useful lives. Patents are amortized over a period of
Share-based Compensation
The Company recognizes the cost of all share-based payment transactions at fair value. Compensation cost, measured by the fair value of the equity instruments issued, adjusted for estimated forfeitures, is recognized in the financial statements as the respective awards are earned over the performance or service period. The Company uses historical data to estimate forfeiture rates.
The impact that share-based payment awards will have on the Company’s results of operations is a function of the number of shares awarded, the trading price of the Company’s stock at the date of grant or modification, the vesting schedule and forfeitures. Furthermore, the application of the Black-Scholes option pricing model employs weighted-average assumptions for expected volatility of the Company’s stock, expected term until exercise of the options, the risk-free interest rate, and dividends, if any, to determine fair value.
Expected volatility is based on historical volatility of the Company’s common stock (the “Common Stock”); the expected term until exercise represents the weighted-average period of time that options granted are expected to be outstanding giving consideration to vesting schedules and the Company’s historical exercise patterns; and the risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the option. The Company has not paid any dividends since its inception and does not anticipate paying any dividends for the foreseeable future, so the dividend yield is assumed to be
Concentrations of Credit Risk
Cash
The Company maintains principally all cash balances in two financial institutions which, at times, may exceed the insured amounts. The exposure to the Company is solely dependent upon daily balances and the strength of the financial institutions. The Company has not incurred any losses on these accounts. At September 30, 2022 and June 30, 2022, amounts in excess of insured limits were approximately $
Revenue
During the three months ended September 30, 2022, the Company reported no revenue from continuing operations and generated 100% of its revenue reported in discontinued operations from
During the three months ended September 30, 2021, the Company reported revenue from continuing operations from one customer related to the settlement of a revenue contract and generated 100% of revenue reported in discontinued operations from
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Recently Issued Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires an entity to assess impairment of its financial instruments based on its estimate of expected credit losses. Since the issuance of ASU 2016-13, the FASB released several amendments to improve and clarify the implementation guidance. In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates, which amended the effective date of the various topics. As the Company is a smaller reporting company, the provisions of ASU 2016-13 and the related amendments are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022 (quarter ending September 30, 2023, for the Company). Entities are required to apply these changes through a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The Company does not expect the adoption of ASU 2016-13 to have a significant impact on the Company’s consolidated financial statements.
Management does not believe that any other recently issued, but not yet effective, accounting standard if currently adopted would have a material effect on the accompanying condensed consolidated financial statements. Most of the newer standards issued represent technical corrections to the accounting literature or application to specific industries which have no effect on the Company’s condensed consolidated financial statements.
5. Financial Instruments and Fair Value Measurement
The carrying values of cash and cash equivalents, accounts receivable, accounts payable, accrued expenses and term note payable in the Company’s condensed consolidated balance sheets approximated their fair values as of September 30, 2022 and June 30, 2022 due to their short-term nature. The carrying value of the convertible promissory note receivable, the term note payable and finance lease obligation approximated fair value as of September 30, 2022 and June 30, 2022 as the interest rates related to the financial instruments approximated market value.
The Company accounts for its investments in debt securities at fair value. The following provides a description of the three levels of inputs that may be used to measure fair value under the standard, the types of investments that fall under each category, and the valuation methodologies used to measure these investments at fair value.
• | Level 1 – Inputs are based upon unadjusted quoted prices for identical instruments in active markets. |
• | Level 2 – Inputs to the valuation include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in inactive markets, inputs other than quoted prices that are observable for the asset or liability, and inputs that are derived principally from or corroborated by observable market data by correlation or other means. If the asset or liability has a specified (contractual) term, the Level 2 input must be observable for substantially the full term of the asset or liability. All debt securities were valued using Level 2 inputs. |
• | Level 3 – Inputs to the valuation methodology are unobservable and significant to the fair value measurement. |
6. Significant Transactions
Affiliates of Eastern Capital Limited
On November 1, 2021, the Company and its subsidiary, iBio CDMO (“iBio CDMO”, and collectively with the Company, the “Purchaser”) entered into a series of agreements (the “Transaction”) with College Station Investors LLC (“College Station”), and Bryan Capital Investors LLC (“Bryan Capital” and, collectively with College Station, “Seller”), each affiliates of Eastern Capital Limited (“Eastern,” a former significant stockholder of the Company) described in more detail below whereby in exchange for a certain cash payment and a warrant the Company:
(i) | acquired both the Facility where iBio CDMO at that time and currently conducts business and also the rights as the tenant in the Facility’s ground lease; |
(ii) | acquired all of the equity owned by one of the affiliates of Eastern in the Company and iBio CDMO; and |
(iii) | otherwise terminated all agreements between the Company and the affiliates of Eastern. |
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The Facility is a life sciences building located on land owned by the Board of Regents of the Texas A&M University System (“Texas A&M”) and is designed and equipped for the manufacture of plant-made biopharmaceuticals. iBio CDMO had held a sublease for the Facility through 2050, subject to extension until 2060 (the “Sublease”) until the purchase of the Facility described below.
The Purchase and Sale Agreement
On November 1, 2021, the Purchaser entered into a Purchase and Sale Agreement (the “Purchase and Sale Agreement”) with the Seller pursuant to which: (i) the Seller sold to Purchaser all of its rights, title and interest as the tenant in the Ground Lease Agreement (the “Ground Lease Agreement”) that it entered into with Texas A&M (the “Landlord’’) related to the property at which the Facility is located together with all improvements pertaining thereto (the “Property”), which previously had been the subject of the Sublease; (ii) the Seller sold to Purchaser all of its rights, title and interest to any tangible personal property owned by Seller and located on the Property including the Facility; (iii) the Seller sold to Purchaser all of its rights, title and interest to all licensed, permits and authorization for use of the Property; and (iv) College Station and iBio CDMO terminated the Sublease. The total purchase price for the Property, the termination of the Sublease and other agreements among the parties, and the equity described below is $
As discussed above, iBio CDMO is being accounted for as a discontinued operation. As such, the assets acquired and/or leased are now classified as assets held for sale on the September 30, 2022 and June 30, 2022 condensed consolidated balance sheets.
The Equity Purchase Agreement
The Company also entered into an Equity Purchase Agreement with Bryan Capital on November 1, 2021 (the “Equity Purchase Agreement”) pursuant to which the Company acquired for $
The Credit Agreement
In connection with the Purchase and Sale Agreement, iBio CDMO entered into a Credit Agreement, dated November 1, 2021, with Woodforest pursuant to which Woodforest provided iBio CDMO a $
The Credit Agreement contains customary events of default (which are in some cases subject to certain exceptions, thresholds, notice requirements and grace periods), including, but not limited to, nonpayment of principal or interest, failure to perform or observe covenants, breaches of representations and warranties, cross-defaults with certain other indebtedness, certain bankruptcy-related events or proceedings, final monetary judgments or orders and certain change of control events. The covenants include a prohibition on the incurrence of Debt (as defined in the Credit Agreement) except permitted Debt (as defined in the Credit Agreement) and Liens (as defined in the Credit Agreement) and termination of the Ground Lease Agreement. In addition, the Company initially was required to maintain unrestricted cash of no less than $
The Company opened an irrevocable letter of credit in the amount of approximately $
The proceeds of the Term Loan were used (a) to fund a portion of the purchase price under the Purchase Agreement, and (b) to pay closing costs in connection with the Credit Agreement. The term loan is secured by (a) a leasehold deed of trust on the Facility, (b) a letter of credit issued by JPMorgan Chase Bank, and (c) a first lien on all assets of iBio CDMO including the Facility.
On October 11, 2022, we and Woodforest amended the Credit Agreement to: (i) include a payment of $5,500,000 of the outstanding principal balance owed under the Credit Agreement on the date of the amendment, (ii) include a payment of $5,100,000 of the outstanding principal balance owed under the Credit Agreement within two (2) business days upon our receipt of such amount owed to us by Fraunhofer as part of our legal settlement with them (see Note 19 – Fraunhofer Settlement for more information), (iii) include
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principal payments of $250,000 per month in debt amortization for a 6 month period commencing the date of the amendment through March 2023, (iv) include an amendment fee of $22,375 and all costs and expenses, (v) require delivery of a report detailing cash flow expenditures every two (2) weeks for the period prior to the delivery of the last report and a monthly 12-month forecast (vi) reduce the liquidity covenant in the Guaranty (as defined in the Credit Agreement) from $10 million to $7.5 million with the ability to lower the liquidity covenant to $5.0 million upon the occurrence of a specific milestone in the Credit Agreement, and (vii) change the annual filing requirement solely for the fiscal year ended June 30, 2022, such that the filing is acceptable with or without a “going concern” designation. In addition, Woodforest cancelled the irrevocable letter of credit issued by JPMorgan Chase Bank upon closing of the amendment. If we fail to successfully extend our cash runway via strategic options or other alternatives as described, we would be in violation of the liquidity covenant on December 31, 2022.
As a result of the foregoing, at both September 30, 2022 and June 30, 2022, the Term Loan has been classified as short term. At September 30, 2022, the balance was $22,201,000 which consisted of the Term note of $22,375,000, net of approximately $174,000 of deferred finance costs. At June 30, 2022, the balance was $22,161,000 which consisted of the Term Note of $22,375,000, net of approximately $214,000 of deferred finance costs. Interest expense incurred under the Credit Agreement for the three months ended September 30, 2022 amounted to $186,000. Amortization of deferred finance costs amounted to $40,000 for the three months ended September 30, 2022 and is included in interest expense. Both interest expense amounts are classified under loss from discontinued operations.
Security and Pledge Agreements, Guaranties and Deed of Trust
iBio CDMO also entered into a Security Agreement on November 1, 2021 with Woodforest (the “Security Agreement”) providing Woodforest a security interest in the following assets of iBio CDMO (subject to certain exclusions): all personal and fixture property of every kind and nature, including, without limitation, all goods (including, but not limited to, all equipment and any accessions thereto), all inventory, instruments (including promissory notes), documents, accounts, chattel paper (whether tangible or electronic), deposit accounts, securities accounts, letter-of-credit rights (whether or not the letter of credit is evidenced by a writing), money, commercial tort claims, securities and all other investment property, supporting obligations, contracts, contract rights, other rights to the payment of money, insurance claims and proceeds, software, fixtures, vehicles and rolling stock (whether or not subject to a certificate of title statute), leasehold improvements, general intangibles (including all payment intangibles), and all of iBio CDMO’s company and other business books, reports, memoranda, customer lists, credit files, data compilations, and computer software, in any form, including, without limitation, whether on tape, disk, card, strip, cartridge, or any other form, pertaining to any and all of the foregoing property, and all products and proceeds of the foregoing.
The Company also entered into a Guaranty for the benefit of Woodforest (the “Guaranty”) pursuant to which it guaranteed all of the obligations of iBio CDMO to Woodforest.
In addition, iBio CDMO entered into a Leasehold Deed of Trust, Assignment of Rents, Security Agreement and UCC Financing Statement for Fixture Filing (the “Deed of Trust”) with the trustee named therein and Woodforest as beneficiary, securing all of iBio CDMO’s obligations to Woodforest by a senior priority security interest in the Property.
The Company and iBio CDMO also entered into an Environmental Indemnity Agreement in favor of Woodforest (the “Environmental Indemnity Agreement”).
The Warrant
As part of the consideration for the purchase and sale of the rights set forth above, the Company issued to Bryan Capital a Warrant to purchase
RubrYc
On August 23, 2021, the Company entered into a series of agreements with RubrYc Therapeutics, Inc. (“RubrYc”) described in more detail below:
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Collaboration and License Agreement
The Company entered into a collaboration and licensing agreement (the “RTX-003 License Agreement”) with RubrYc to further develop RubrYc’s immune-oncology antibodies in its RTX-003 campaign. Under the terms of the agreement, the Company is solely responsible for worldwide research and development activities for development of the RTX-003 antibodies for use in pharmaceutical products in all fields. RubrYc was also entitled to receive royalties in the mid-single digits on net sales of RTX-003 antibodies, subject to adjustment under certain circumstances. The RTX-003 License Agreement was terminated when the Company acquired substantially all of the assets of RubrYc in September 2022.
Collaboration, Option and License Agreement
The Company entered into an agreement with RubrYc (the “Collaboration, Option and License Agreement”) to collaborate for up to
Stock Purchase Agreement
In connection with the entry into the Collaboration Agreement and RTX-003 License Agreement, the Company also entered into a Stock Purchase Agreement (“Stock Purchase Agreement”) with RubrYc whereby the Company purchased a total of
The Company accounted for the agreements as an asset purchase and allocated the purchase price of $
Preferred stock | | $ | |
Intangible assets | | ||
Prepaid expenses | | | |
| $ | |
RubrYc ceased its operations, and the Company recorded an impairment of the investment in the amount of $1,760,000 in 2022. The amount was recorded in the consolidated statement of operations and comprehensive loss under general and administrative expense. The Company also recorded an impairment of current and non-current prepaid expense of $288,000 and $864,000, respectively, in 2022. The amount was recorded in the consolidated statement of operations and comprehensive loss under research and development expense.
On September 16, 2022, the Company entered an Asset Purchase Agreement with RubrYc pursuant to which it acquired substantially all of the assets of RubrYc. The Company issued 102,354 shares of the Company’s common stock with an approximate market value of $1,000,000 (the “Closing Shares”). Pursuant to the Asset Purchase Agreement, the shares are subject to an initial lockup period and the estimated fair value was calculated as $650,000. The Company also agreed to make potential additional payments of up to $5,000,000 upon the achievement of specified developmental milestones on or before the fifth anniversary of the closing date, payable in cash or shares of the Company’s common stock, at the Company’s option. In addition, the Company had advanced RubrYc $484,000 to support their operation costs during the negotiation period and incurred transaction costs totaling $208,000, which were also capitalized as part of the assets acquired. The assets acquired include an AI drug discovery platform, all rights with no future milestone payments or royalty obligations, to IBIO-101, in addition to CCR8, EGFRvIII, and two additional immuno-oncology candidates plus a partnership-ready PD-1 agonist. The Purchase Agreement contained representations, warranties and covenants of RubrYc and the Company. The acquisition closed on September 19, 2022 after receipt of approval of the NYSE American.
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The Company accounted for the agreements as an asset purchase and allocated the purchase price of approximately $1,342,000 as follows:
Intangible assets | | $ | 1,228,000 |
Fixed assets | | 114,000 | |
| $ | 1,342,000 |
In addition, the Company assumed three equipment leases that were accounted for as finance leases totaling approximately $814,000. See Note 9 – Finance Lease ROU Assets and Note 14 – Finance Lease Obligations.
7. Convertible Promissory Note Receivable
On October 1, 2020, the Company entered into a master services agreement with Safi Biosolutions, Inc. (“Safi”). In addition, the Company invested $
8. Investments in Debt and Equity Securities
Debt Securities
Investments in debt securities consist of AA and A rated corporate bonds bearing interest at rates from
September 30, | June 30, | |||||
2022 | 2022 | |||||
Adjusted cost | | $ | | $ | | |
Gross unrealized losses | | ( | ( | |||
Fair value | | $ | | $ | |
The fair value of available-for-sale debt securities, by contractual maturity, was as follows (in thousands):
September 30, | June 30 | |||||
Fiscal period ending: | | 2022 | 2021 | |||
2023 | | $ | $ | |||
2024 | ||||||
| $ | $ |
Amortization of premiums paid on the debt securities amounted to $36,000 and $102,000 for the three months ended September 30, 2022 and 2021, respectively.
9. Finance Lease ROU Assets
As discussed above, the Company assumed three equipment leases as part of the RubrYc asset acquisition. In addition, the Company also leases a mobile office trailer.
See Note 14 – Finance Lease Obligation for more details of the terms of the leases.
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The following table summarizes by category the gross carrying value and accumulated amortization of finance lease ROU (in thousands):
| September 30, |
| June 30, | |||
2022 | 2022 | |||||
ROU - Equipment | $ | | $ | | ||
Accumulated amortization |
| ( |
| ( | ||
Net finance lease ROU | $ | | $ | |
Amortization of finance lease ROU assets was approximately $13,000 and $12,000 for three months ended September 30, 2022 and 2021, respectively.
10. Operating Lease ROU Assets
San Diego, California
On September 10, 2021, the Company entered into a lease for approximately
Bryan, Texas
On November 1, 2021, as discussed above, iBio CDMO acquired the Facility and became the tenant under the ground lease for the Property upon which the Facility is located. Based on the terms of the lease payments, the Company recorded an operating lease right of use asset of $
See Note 15 - Operating Lease Obligation for additional information.
11. Fixed Assets
Substantially all of the fixed assets at September 30, 2022 are included in assets held for sale. The depreciation expense for the three months ended September 30, 2022 and 2021 is classified as part of loss from discontinued operations.
Fixed assets at September 30, 2022 and June 30, 2022 reported in continuing operations represents the construction in progress for the new San Diego research facility. These assets were placed into service on October 1, 2022.
12. Intangible Assets
The Company has two categories of intangible assets – intellectual property and patents. Intellectual property consists of all technology, know-how, data, and protocols for producing targeted proteins in plants and related to any products and product formulations for pharmaceutical uses and for other applications. Intellectual property includes, but is not limited to, certain technology for the development and manufacture of novel vaccines and therapeutics for humans and certain veterinary applications acquired in December 2003 from Fraunhofer USA Inc., acting through its Center for Molecular Biotechnology (“Fraunhofer”), pursuant to a Technology Transfer Agreement, as amended (the “TTA”). The Company designates such technology further developed and acquired from Fraunhofer as iBioLaunchTM or LicKMTM or FastPharming Technology. The value on the Company’s books attributed to patents owned or controlled by the Company is based only on payments for services and fees related to the protection of the Company’s patent portfolio. The intellectual property also includes certain trademarks.
On August 23, 2021, the Company entered into a series of agreements with RubrYc described in more detail above (see Note 6 – Significant Transactions) whereby in exchange for a $7.5 million investment in RubrYc, the Company acquired a worldwide exclusive license to certain antibodies that RubrYc develops under what it calls its RTX-003 campaign, which are promising immuno-oncology antibodies that bind to the CD25 protein without interfering with the IL-2 signaling pathway thereby potentially depleting T regulatory (T reg) cells while enhancing T effector (T eff) cells and encouraging the immune system to attack cancer cells. The Company accounted for this license as an indefinite-lived intangible asset until the completion or abandonment of the associated research and development efforts. In addition, the Company also received preferred shares and an option for future collaboration licenses.
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On September 16, 2022, the Company entered an Asset Purchase Agreement with RubrYc described in more detail above (see Note 6 – Significant Transactions) pursuant to which it acquired substantially all of the assets of RubrYc. The assets acquired include an AI drug discovery platform, all rights with no future milestone payments or royalty obligations, to IBIO-101, in addition to CCR8, EGFRvIII, and two additional immuno-oncology candidates, plus a partnership-ready PD-1 agonist.
In January 2014, the Company entered into a license agreement with the University of Pittsburgh whereby iBio acquired exclusive worldwide rights to certain issued and pending patents covering specific candidate products for the treatment of fibrosis (the "Licensed Technology") which license agreement was amended in August 2016 and again in December 2020 and February 2022. The license agreement provides for payment by the Company of a license issue fee, annual license maintenance fees, reimbursement of prior patent costs incurred by the university, payment of a milestone payment upon regulatory approval for sale of a first product, and annual royalties on product sales. In addition, the Company has agreed to meet certain diligence milestones related to product development benchmarks. As part of its commitment to the diligence milestones, the Company successfully commenced production of a plant-made peptide comprising the Licensed Technology before March 31, 2014. The next milestone – filing an Investigational New Drug Application with the FDA or foreign equivalent covering the Licensed Technology ("IND") – initially was required to be met by December 1, 2015, and on November 2, 2020, was extended to be required to be met by December 31, 2021 and on February 8, 2022 was further extended to December 31, 2023. In addition, the amounts of the annual license maintenance fee and payment upon completion of various regulatory milestones were amended.
The Company accounts for intangible assets at their historical cost and records amortization utilizing the straight-line method based upon their estimated useful lives. Patents are amortized over a period of
There were no impairments for the three months ended September 30, 2022 and 2021.
The following table summarizes by category the gross carrying value and accumulated amortization of intangible assets (in thousands):
|
| September 30, |
| June 30, | ||
2022 | 2022 | |||||
Intellectual property – gross carrying value | $ | | $ | | ||
Patents and licenses – gross carrying value |
| |
| | ||
| |
| | |||
Intellectual property – accumulated amortization |
| ( |
| ( | ||
Patents and licenses – accumulated amortization |
| ( |
| ( | ||
| ( |
| ( | |||
Total definite lived intangible assets, net of accumulated amortization | 1,010 | 676 | ||||
License - indefinite lived | 5,003 | 4,175 | ||||
Total net intangible assets | $ | | $ | |
Amortization expense of intangible assets was approximately $67,000 and $88,000 for the three months ended September 30, 2022 and 2021, respectively.
13. Note Payable – PPP Loan
On April 16, 2020, the Company received $600,000 related to its filing under the Paycheck Protection Program and Coronavirus Aid, Relief, and Economic Security Act (the "CARES Act"). The Company elected to treat the SBA Loans as debt under ASC 470, “Debt”.
On July 21, 2021, iBio was granted forgiveness in repaying the loan. In accordance with ASC 405-20-40, “Liabilities - Extinguishments of Liabilities – Derecognition”, the Company derecognized the liability and accrued interest of approximately $7,000 in the first quarter of Fiscal 2022. The forgiveness is included in loss from discontinued operations (see Note 3 – Discontinued Operations).
14. Finance Lease Obligation
Sublease
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As discussed above, until November 1, 2021, iBio CDMO leased the Facility as well as certain equipment from College Station under the Sublease.
The Sublease was terminated on November 1, 2021, when iBio CDMO acquired the Facility and became the tenant under the ground lease for the property upon which the Facility is located. See Note 15 – Operating Lease Obligations for additional information related to the ground lease.
General and administrative expenses related to College Station, including rent related to the increases in CPI and real estate taxes, were approximately $189,000 for the three months ended September 30, 2021. Interest expense related to College Station was approximately $608,000 for the three months ended September 30, 2021. Such expenses were classified as part of loss from discontinued operations.
Equipment
As discussed above, the Company assumed three equipment leases that were accounted for as finance leases totaling $813,822 as part of the RubrYc Asset Purchase Agreement. The monthly rental for the three leases is approximately $14,000 per month and all three expire on August 1, 2025.
Mobile Office Trailer
Commencing April 1, 2021, the Company is leasing a mobile office trailer at a monthly rental of $
The following tables present the components of lease expense and supplemental balance sheet information related to the finance lease obligation (in thousands).
| Three Months Ended | Three Months Ended | ||||
September 30, | September 30, | |||||
2022 | 2021 | |||||
Finance lease cost: |
|
|
| |||
Amortization of ROU assets | $ | 13 | $ | 12 | ||
Interest on lease liabilities |
| |
| | ||
Total lease cost | $ | | $ | | ||
|
|
|
| |||
Other information: |
|
|
|
| ||
Cash paid for amounts included in the measurement lease liabilities: |
|
|
|
| ||
Operating cash flows from finance lease | $ | — | $ | — | ||
Financing cash flows from finance lease obligations | $ | | $ | |
September 30, | June 30, | |||||||
2022 | 2022 | |||||||
Finance lease ROU assets | $ | | $ | | ||||
Finance lease obligation - current portion | $ | | $ | | ||||
Finance lease obligation - noncurrent portion | $ | | $ | | ||||
Weighted average remaining lease term - finance lease |
| | years |
| years | |||
Weighted average discount rate - finance lease obligation |
| | % |
| | % |
Future minimum payments under the finance lease obligation are due as follows (in thousands):
Fiscal period ending on September 30: |
| Principal |
| Interest |
| Total | |||
2023 | $ | | $ | | $ | | |||
2024 | | | | ||||||
2025 |
| |
| |
| | |||
|
|
|
|
|
| ||||
Total minimum lease payments |
| | $ | | $ | | |||
Less: current portion |
| ( |
|
|
|
| |||
Long-term portion of minimum lease obligations | $ | |
|
|
|
| |||
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15. Operating Lease Obligation
Texas Ground Lease
As discussed above, as part of the Transaction, iBio CDMO became the tenant under the Ground Lease Agreement for the Property until 2060 upon exercise of available extensions. The base rent payable under the Ground Lease Agreement, which was $
San Diego
On September 10, 2021, the Company entered into a lease for approximately
● | The length of term of the lease is |
● | The lease commencement date was estimated to be on or around January 1, 2022. |
● | The monthly rent for the first year of the lease is $ |
● | The lease provides for a base rent abatement for months through in the first year of the lease. |
● | The landlord is providing a tenant improvement allowance of $ |
● | The Company is responsible for other expenses such as electric, janitorial, etc. |
● | The Company opened an irrevocable letter of credit in the amount of $ |
As discussed above, the lease provides for scheduled increases in base rent and scheduled rent abatements. Rent expense is charged to operations using the straight-line method over the term of the lease which results in rent expense being charged to operations at inception of the lease in excess of required lease payments. This excess (formerly classified as deferred rent) is shown as a reduction of the operating lease ROU asset in the accompanying balance sheet. As the Company has already started making improvements to the facility, the rent expense will be recognized.
The following tables present the components of lease expense and supplemental balance sheet information related to the operating lease obligation (in thousands).
Three Months Ended | Three Months Ended | ||||
September 30, | September 30, | ||||
2022 | 2021 | ||||
Operating lease cost: | $ | | $ | 35 | |
Total lease cost | $ | | $ | 35 | |
|
|
|
| ||
Other information: |
|
|
|
| |
Cash paid for amounts included in the measurement lease liability: |
|
|
|
| |
Operating cash flows from operating lease | $ | | $ | 35 | |
Operating cash flows from operating lease obligation | $ | | $ | — |
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Future minimum payments under the operating lease obligation are due as follows (in thousands):
Fiscal period ending on September 30: |
| Principal |
| Imputed Interest |
| Total | |||
2023 | $ | | $ | | $ | | |||
2024 | | | | ||||||
2025 |
| |
| |
| | |||
2026 |
| |
| |
| | |||
2027 |
| |
| |
| | |||
Thereafter |
| |
| |
| | |||
|
|
|
|
|
| ||||
Total minimum lease payments |
| | $ | | $ | | |||
Less: current portion |
| ( |
|
|
|
| |||
Long-term portion of minimum lease obligation | $ | |
|
|
|
|
16. Stockholders’ Equity
Preferred Stock
The Company’s Board of Directors is authorized to issue, at any time, without further stockholder approval, up to
Series 2022 Convertible Preferred Stock (“Series 2022 Preferred”)
On May 9, 2022, the Board of Directors of the Company created the Series 2022 Preferred, par value $0.001 per share, out of the Company’s 1 million authorized shares of preferred stock. Each share of Series 2022 Preferred was convertible at a ratio of one-for-one (1:1) shares of the Company's Common Stock on a pre-split basis.
The Company issued 1,000 shares of Series 2022 Preferred and received proceeds of $270. Pursuant to the terms of the preferred stock, the Company’s Board of Directors converted the Preferred Stock to 40 shares of Common Stock on July 19, 2022 on a post-split basis.
iBio CMO Preferred Tracking Stock
On February 23, 2017, the Company entered into an exchange agreement with Bryan Capital pursuant to which the Company acquired substantially all of the interest in iBio CDMO held by Bryan Capital and issued
On February 23, 2017, the Board of Directors of the Company created the Preferred Tracking Stock out of the Company’s
On November 1, 2021, iBio purchased the iBio CMO Preferred Tracking Stock held by Bryan Capital. No iBio CMO Preferred Tracking Stock remains outstanding. As a result, the iBio CDMO subsidiary and its intellectual property are now wholly owned by iBio.
Common Stock
The number of authorized shares of the Company’s common stock is 275 million. In addition, the Company has reserved 1,280,000 shares of Common Stock for issuance pursuant to the grant of new awards under the Company’s 2020 Omnibus Incentive Plan (the “2020 Plan”).
Reverse Stock Split
On June 30, 2022, the Company held a special meeting of its stockholders at which the stockholders approved a proposal to effect an amendment to the Company's certificate of incorporation, as amended, to implement a reverse stock split at a ratio of one-for-twenty
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five (1:25). On September 22, 2022, the Company's Board of Directors approved the implementation of the reverse stock split of the Company's Common Stock. As a result of the reverse stock split, every twenty five (25) shares of the Company's Common Stock either issued and outstanding or held by the Company in its treasury immediately prior to the effective time was, automatically and without any action on the part of the respective holders thereof, combined and converted into one (1) share of the Company's common stock. No fractional shares were issued in connection with the reverse stock split. Stockholders who otherwise were entitled to receive a fractional share in connection with the reverse stock split instead were eligible to receive a cash payment, which was not material in the aggregate, instead of shares. On October 7, 2022, the Company filed a Certificate of Amendment of its Certificate of Incorporation, as amended with the Secretary of State of Delaware effecting a one-for-twenty five (1:25) reverse stock split of the shares of the Company’s common stock, either issued or outstanding, effective October 7, 2022. The Company’s Common Stock began trading on a reverse split adjusted basis when the market opened Monday, October 10, 2022.
Recent issuances of Common Stock include the following:
Cantor Fitzgerald Underwriting
On November 25, 2020, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. ("Cantor Fitzgerald") to sell shares of common stock, from time to time, through an “at the market offering” program having an aggregate offering price of up to $100,000,000 through which Cantor Fitzgerald would act as sales agent. Between July 25, 2022, and August 17, 2022, Cantor Fitzgerald sold as sales agent pursuant to the Sales Agreement 175,973 shares of Common Stock. The Company received net proceeds of approximately $1.2 million.
RubrYc Transaction
On September 19, 2022, iBio issued 102,354 shares valued at approximately $1,000,000 to RubrYc Therapeutics as part of the payment for purchasing the assets of RubrYc Therapeutics.
Vesting of Restricted Stock Units “RSUs”
On August 23, 2022, RSUs for 1,057 shares of Common Stock were vested.
The Warrant
As discussed above, the Company issued to Bryan Capital a Warrant to purchase
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17. Earnings (Loss) Per Common Share
Basic earnings (loss) per common share is computed by dividing the net income (loss) allocated to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period. For purposes of calculating diluted earnings (loss) per common share, the denominator includes both the weighted-average number of shares of common stock outstanding during the period and the number of common stock equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock equivalents potentially include stock options and warrants using the treasury stock method. The following table summarizes the components of the earnings (loss) per common share calculation (in thousands, except per share amounts):
Three Months Ended | |||||||
September 30, | |||||||
| 2022 |
| 2021 | ||||
Basic and diluted numerator: | |||||||
| |||||||
Net loss attributable to iBio, Inc. from continuing operations | $ | ( |
| $ | ( | ||
Preferred stock dividends – iBio CMO Preferred Tracking Stock |
| |
| ( | |||
Net loss available to iBio, Inc. stockholders from continuing operations | $ | ( | $ | ( | |||
Net loss available to iBio, Inc. stockholders from discontinued operations | $ | ( | $ | ( | |||
Net loss available to iBio, Inc. stockholders - total | $ | ( | $ | ( | |||
Basic and diluted denominator: | |||||||
Weighted-average common shares outstanding |
| |
| | |||
|
| ||||||
Per share amount - continuing operations | ( | ( | |||||
Per share amount - discontinued operations | ( | ( | |||||
Per share amount - total | ( | ( |
In Fiscal 2023 and Fiscal 2022, the Company incurred net losses which cannot be diluted; therefore, basic and diluted loss per common share is the same. As of September 30, 2022 and 2021, shares issuable which could potentially dilute future earnings were as follows:
September 30, | ||||
|
| 2022 |
| 2021 |
| (in thousands) | |||
Stock options |
| |
| |
Warrant issued under the Transaction |
| 51 |
| — |
Restricted stock units |
| |
| |
Shares excluded from the calculation of diluted loss per share |
| |
| |
18. Share-Based Compensation
The following table summarizes the components of share-based compensation expense in the condensed consolidated statements of operations (in thousands):
|
| Three Months Ended | ||||
September 30, | ||||||
| 2022 |
| 2021 | |||
Research and development | $ | | $ | | ||
General and administrative |
| |
| | ||
Total | $ | | $ | |
In addition, share-based compensation expense included in loss from discontinued operations totaled approximately $96,000 and $101,000 for the three months ended September 30, 2022 and 2021, respectively.
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Stock Options
iBio, Inc. 2020 Omnibus Equity Incentive Plan (the “2020 Plan”)
On December 9, 2020, the Company adopted the 2020 Plan for employees, officers, directors and external service providers. The total number of shares of Common Stock reserved under the 2020 Plan is
Vesting of service awards are determined by the Board of Directors and stated in the award agreements. In general, vesting occurs ratably on the anniversary of the grant date over the service period, generally three or five years, as determined at the time of grant. Vesting of performance awards occurs when the performance criteria is satisfied. The Company uses historical data to estimate forfeiture rates.
Stock options issued
During the first quarter of Fiscal 2023, the Company granted stock option agreements to various employees to purchase 303,869 shares of the Company's common stock at exercise prices between $6.75 and $9.50 per share. The options vest 25% after one year and then in equal quarterly installments over a 36-month period and expire on the tenth anniversary of the grant date.
The Company estimated the fair value of options granted using the Black-Scholes option pricing model with the following assumptions:
|
| |||
Weighted average risk-free interest rate | 3.21% - 3.61 | % | ||
Dividend yield |
| 0 | % | |
Volatility |
| 115.52 - 116.93 | % | |
Expected term (in years) |
| 7 |
|
RSUs
On August 29, 2022, the Company issued RSUs to acquire 6,954 shares of common stock to various employees at a market value of $7.06 per share. The RSU’s vest over a four-year period. The grant-date fair value of the RSUs totaled approximately $49,000.
19. Fraunhofer Settlement
On May 4, 2021, the Company and Fraunhofer USA, Inc. (“FhUSA”) entered into a Confidential Settlement Agreement and Mutual Release (the “Settlement Agreement”) to settle all claims and counterclaims in the litigation captioned iBio, Inc. v. Fraunhofer USA, Inc. (Case No. 10256-VCF) in Delaware Chancery Court (the “Lawsuit”). The Settlement Agreement, among other things, resolves the Company’s claims to ownership of certain plant-based technology developed by FhUSA from 2003 through 2014, and sets forth the terms of a license of intellectual property. The Lawsuit was commenced against FhUSA by the Company in March 2015 in the Court of Chancery of the State of Delaware and is described in more detail in the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2020. The Settlement Agreement is not an admission of liability or fault of the parties.
The terms of the Settlement Agreement provide for cash payments to the Company of $
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As of June 30, 2021, the Company held receivables related to the settlement in the amount of $
The Company would recognize the $
As of September 30, 2022, the Company holds a settlement receivable balance of $5,100,000, which has been pledged to Woodforest - see Note 6 - Significant Transactions, related to the settlement and a trade receivable balance of $
20. Income Taxes
The Company recorded
21. Contingencies
COVID-19
As a result of the pandemic, the Company has at times experienced reduced capacity to provide CDMO services as a result of instituting social distancing at work procedures in our Texas facility, restricting access to essential workers, as well as taking other precautions. In July 2022 after we experienced a rise in COVID-19 cases within our Texas facility, for approximately one week, we mandated only those involved in mission critical manufacturing activities were to be permitted within our Texas facility.
The Company has ascertained that certain risks associated with further COVID-19 developments may adversely impact its operations and liquidity, and its business and share price may also be affected by the COVID-19 pandemic. However, the Company does not anticipate any significant threat to its operations at this point in time. The future progression of the pandemic and its effects on the Company’s business and operations are uncertain. The Company may face difficulties recruiting or retaining patients in its planned clinical trials if patients are affected by the virus or are fearful of traveling to clinical trial sites because of the outbreak. The Company and its third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to the Company’s research and development activities, including, for example, medical and laboratory supplies used in preclinical studies, in each case, that are sourced from abroad or for which there are shortages because of ongoing efforts to address the outbreak. Due to the general unknown nature surrounding the crisis, the Company cannot reasonably estimate the potential for any future impacts on its operations or liquidity.
The outbreak and spread of COVID-19 and continued progress in various countries around the world, including the United States, has led authorities around the globe to take various extraordinary measures to stem the spread of the disease, such as emergency travel and transportation restrictions, school closures, quarantines and social distancing measures. The outbreak of COVID-19 has had an adverse effect on global markets and may continue to affect the economy in the United States and globally, especially if new strains of SARS-CoV-2 emerge.
War in Ukraine
On February 24, 2022, Russia launched an invasion of Ukraine which has resulted in increased volatility in various financial markets and across various sectors. The United States and other countries, along with certain international organizations, have imposed economic sanctions on Russia and certain Russian individuals, banking entities and corporations as a response to the invasion. The extent and duration of the military action, resulting sanctions and future market disruptions in the region are impossible to predict. Moreover, the ongoing effects of the hostilities and sanctions may not be limited to Russia and Russian companies and may spill over to and negatively impact other regional and global economic markets of the world, including Europe and the United States. Presently, the Company does not have any existing Russian suppliers or contractors. While it is difficult to estimate the impact of current or future sanctions on the Company’s business and financial position, or global supply chains or service provisions that could have an impact on the availability or price of goods and services that the Company requires, the Company is not aware of any company-specific risks related to the war in Ukraine at this time.
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Inflation
Although the Company has not experienced any material adverse effects on our business due to increasing inflation, it has raised operating costs for many businesses and, in the future, could impact demand or pricing of manufacturing services, foreign exchange rates or employee wages. We are actively monitoring the effects these disruptions and increasing inflation could have on the Company’s operations.
22. Employee 401(K) Plan
Commencing January 1, 2018, the Company established the iBio, Inc. 401(K) Plan (the “Plan”). Eligible employees of the Company may participate in the Plan, whereby they may elect to make elective deferral contributions pursuant to a salary deduction agreement and receive matching contributions upon meeting age and length-of-service requirements. The Company will make a
23. Subsequent Events
On October 12, 2022, the Company entered into an equipment financing master lease agreement and a lease supplement whereby $500,000 was borrowed over 36 months at an interest rate of 5.6% and securitized by certain assets purchased for the San Diego research site.
On November 10, 2022, as previous disclosed in relation to the Employment Agreement with Thomas F. Isett 3rd, the Company’s Chief Executive Officer, dated April 30, 2021, the Company granted Mr. Isett RSUs to acquire 200,000 shares of common stock, $0.001 par value per share (the “Common Stock”), on a post-split basis. The RSUs vest over a three-year period commencing April 30, 2021 provided the vesting is subject to the following performance conditions: (i) submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application, or alternatively, if the Board approves not to file an IND, (ii) consummation of a disposition of iBio CDMO, LLC, or (iii) outlicensing, with full global rights, any of its investigational product candidates prior to the submission to the FDA an IND application. The grant-date fair value of the RSUs totaled approximately $296,000.
On November 11, 2022, the Company granted Mr. Robert Lutz, the Company’s Chief Financial and Business Officer, RSUs to acquire 100,057 shares of the Company’s Common Stock in exchange for Mr. Lutz’ agreement to continue employment with the Company through July 1, 2023. The RSUs vest the earlier of: (i) July 1, 2023, or (ii) the successful achievement of the Company’s 2023 objectives, as defined by the Board of Directors. The grant-date fair value of the RSUs totaled approximately $175,100.
On November 11, 2022, the Company granted Mr. Martin Brenner, the Company’s Chief Scientific Officer, RSUs to acquire 95,348 shares of the Company’s Common Stock in exchange for Mr. Brenner’s agreement to continue employment with the Company through July 1, 2023. The RSUs vest the earlier of: (i) July 1, 2023, or (ii) the successful achievement of the Company’s 2023 objectives, as defined by the Board of Directors. The grant-date fair value of the RSUs totaled approximately $166,860
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following information should be read together with the financial statements and the notes thereto and other information included elsewhere in this Quarterly Report on Form 10-Q (this “Report”) and in our Annual Report on Form 10-K for the year ended June 30, 2022, as filed with the SEC on October 11, 2022 (the “Annual Report”). Unless the context requires otherwise, references in this Report to “iBio,” the “Company,” “we,” “us,” or “our” and similar terms mean iBio, Inc.
Forward-Looking Statements
This Report contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). For this purpose, any statements contained herein regarding our strategy, future operations, financial position, future revenues, projected costs and expenses,
30
prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “may,” “plan,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements reflect our current views with respect to future events. Because these forward-looking statements involve known and unknown risks and uncertainties, actual results, performance or achievements could differ materially from those expressed or implied by these forward-looking statements for a number of important reasons, including those discussed in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Report, as well as in the section titled “Risk Factors” in the Company’s Annual Report. We cannot guarantee any future results, levels of activity, performance or achievements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Report as anticipated, believed, estimated or expected. The forward-looking statements contained in this Report represent our estimates as of the date of this Report (unless another date is indicated) and should not be relied upon as representing our expectations as of any other date. While we may elect to update these forward-looking statements, we specifically disclaim any obligation to do so unless otherwise required by securities laws.
Overview
We are an Artificial Intelligence (“AI”)-driven innovator of precision antibody immunotherapies. We have a pipeline of innovative primarily immuno-oncology antibodies against hard-to-drug targets where we may face reduced competition and with antibodies that may be more selective. We plan to use our AI-driven discovery platform to continue adding antibodies against hard-to-drug targets or to work with partners on AI-driven drug development.
Therapeutics Pipeline
IBIO-101: an anti-CD25 molecule that works by depletion of immunosuppressive T-regulatory cells (Tregs) via antibody-dependent cellular cytotoxicity (“ADCC”), without disrupting activation of effector T-cells (Teffs) in the tumor microenvironment. IBIO-101 could potentially be used to treat solid tumors, hairy cell leukemia, relapsed multiple myeloma, lymphoma, or head and neck cancer.
EGFRvIII: binds a tumor-specific mutation of EGFR variant III with an afucosylated antibody for high ADCC. Because of its specificity binding to the tumor-specific mutation, it could potentially reduce toxicity and/or expand the therapeutic window compared to simple broad EGFR-targeted alternatives. . EGFRvIII is constantly “switched on” which can lead to the development of a range of different cancers. An EGFRvIII antibody could potentially be used to treat glioblastoma, head and neck cancer or non-small cell lung cancer.
CCR8: targets depletion of highly immunosuppressive CCR8+ Tregs in the tumor microenvironment via an ADCC mechanism with selective binding to CCR8 over its closely related cousin, CCR4, to avoid off-target effects. A CCR8 program could potentially be broadly applicable in solid tumors and/or as a prospective combination therapy.
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PD-1 Agonist: Selectively binds PD-1 to suppress auto-reactive T-cells without PD-L1/PD-L2 blocking. A PD-1 agonist could potentially be used to treat inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis or other inflammatory diseases.
In addition to the programs described above, we also have six additional early discovery programs that have the potential to advance into later stages of preclinical development and are designed to tackle hard-to-drug targets.
IBIO-100 and Endostatin E4
Our lead anti-fibrotic candidate is IBIO-100, and its design is based in part upon work by Dr. Carol Feghali-Bostwick, Professor of Medicine at the Medical University of South Carolina and Vice-Chair of the Scleroderma Foundation. Her initial work was conducted at the University of Pittsburgh, and we have licensed the patents relevant for the continued development of the molecule from the university.
As part of the Company’s our review of potential options, we intend to continue to review the data from our research and development efforts and determine how to proceed with the development of IBIO-100 in Fibrosis.
To align with the Company’s focus on the immuno-oncology pipeline, we also intend to continue to pursue the E4 endostatin peptide, from which IBIO-100 is derived, as an oncology target in collaboration with University of Texas Southwestern.
AI Drug Discovery Platform
In September 2022, we purchased substantially all of the assets of RubrYc Therapeutics (for a complete description of the transaction please see Note 6 – Significant Transactions). The AI Drug Discovery platform technology is designed to be used to discover antibodies that bind to hard-to-target subdominant and conformational epitopes for further development within our existing portfolio or in partnership with outside entities. The RubrYc AI platform is built upon 3 key technologies.
1. | Epitope Targeting Engine: A proprietary machine-learning platform that combines computational biology and 3D-modeling to identify molecules that mimic hard-to-target binding sites on target proteins, specifically, subdominant and conformational epitopes. The creation of these small mimics enables the engineering of therapeutic antibody candidates that can selectively bind immune and cancer cells better than ”trial and error” antibody engineering and screening methods that are traditionally focused on dominant epitopes. |
2. | RubrYcHuTM Library: An AI-generated human antibody library free of significant sequence liabilities that provides a unique pool of antibodies to screen. The combination of the Epitope Targeting Engine and screening with the RubrYcHu Library has been shown to reduce the discovery time from ideation to in vivo proof-of-concept (PoC) by up to 4 months. This has the potential to enable more, and better, therapeutic candidates to reach the clinic, faster. |
3. | StableHuTM Library: An AI-powered sequence optimization library used to improve antibody performance. Once an antibody has been advanced to the lead optimization stage, StableHu allows precise and rapid optimization of the antibody binding regions to rapidly move a candidate molecule into the IND-enabling stage. |
Recent Developments
On October 11, 2022, we and Woodforest amended the Credit Agreement to: (i) include a payment of $5,500,000 of the outstanding principal balance owed under the Credit Agreement on the date of the amendment, (ii) include a payment of $5,100,000 of the outstanding principal balance owed under the Credit Agreement within two (2) business days upon our receipt of such amount owed to us by Fraunhofer as part of our legal settlement with them (see Note 19 – Fraunhofer Settlement for more information), (iii) include principal payments of $250,000 per month in debt amortization for a 6 month period commencing the date of the amendment through March 2023, (iv) include an amendment fee of $22,375 and all costs and expenses, (v) require delivery of a report detailing cash flow expenditures every two (2) weeks for the period prior to the delivery of the last report and a monthly 12-month forecast (vi) reduce the liquidity covenant in the Guaranty (as defined in the Credit Agreement) from $10 million to $7.5 million with the ability to lower the liquidity covenant to $5.0 million upon the occurrence of a specific milestone in the Credit Agreement, and (vii) change the annual filing requirement solely for the fiscal year ended June 30, 2022, such that the filing was acceptable with or without a “going concern” designation. In addition, Woodforest cancelled the irrevocable letter of credit issued by JPMorgan Chase Bank upon closing of the amendment. If we fail to successfully extend our cash runway via strategic options or other alternatives as described we would be in violation of the liquidity covenant on December 31, 2022.
On November 2, 2022, we announced our plans to divest our contract development and manufacturing organization (iBio CDMO, LLC) in order to complete our transformation into an antibody discovery and development company. In conjunction with the divestment, we
32
have commenced, on October 31, 2022 a workforce reduction of approximately 60% of our current staffing levels (a reduction of 69 positions). We expect to substantially complete the employee reduction within approximately 60 days of November 2, 2022. We expect we may be able to complete a transaction in 2023, although there is no assurance as to when, or for how much, we may be able to sell our CDMO assets. We expect to incur pre-tax charges of approximately $1.7 million for the employee reduction, most of which is expected to be incurred in the second and third quarter of fiscal year 2023. These charges will be substantially settled in cash and almost entirely consist of severance obligations, continuation of salaries and benefits over a 60-day transitional period during which impacted employees remain employed but are not expected to provide active service, and other customary employee benefit payments in connection with an employee reduction. The transition to a focused AI-Biotech business is expected to reduce our monthly burn rate by approximately half, with an approximate range of $2.5-3.0 million per month. Although we expect to decrease burn, our long-term business plan would be to increase R&D and commence clinical trials that could be costly if conducted without a licensing partner.
On November 1, 2022, Mr. Chip Clark was appointed as the Company’s Chairman of the Board.
On November 2, 2022, the Company announced that its Board of Directors has initiated a search for a new Chief Executive Officer. It is expected that Mr. Tom Isett will remain as the Chief Executive Officer of the Company through this transformation.
Results of Operations - Comparison of the three months ended September 30, 2022 and 2021
Revenue
Revenues for the three months ended September 30, 2022 and 2021 were approximately $- million and $0.1 million respectively, a decrease of approximately ($0.1) million. Revenue from the CDMO operations is in now included in discontinued operations and not broken out separately on the financial statements. Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue and ii) on our AI-driven discovery platform. We may have revenue with the AI-driven discovery platform in future. The $.1M in revenue in Q1 FY2022 related to a customer settlement.
Research and Development Expenses (“R&D”)
Research and development expenses for the three months ended September 30, 2022 and 2021 were $2.5 million and $1.1 million, respectively, an increase of approximately $1.4 million. The increase was primarily related to increases in personnel related to a full year of operation, investment into the San Diego facility, investments into our pipeline including IBIO-101, and EGFRIII, and expenses related to our AI-driven discovery platform.
General and Administrative Expenses (“G&A”)
General and administrative expenses for the three months ended September 30, 2022 and 2021 were approximately $5.1 million and $4.2 million, respectively, an increase of $0.9 million. The increase resulted primarily from an increase in headcount, and an increase in consulting costs to support the portfolio of proprietary therapeutics and vaccines.
Total Operating Expenses
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended September 30, 2022, were approximately $7.6 million, compared to approximately $5.3 million in the same period of 2021.
Total Other Income (Expense)
Total Other Income (expense) for the three months ended September 30, 2022 and 2021 was approximately $0.1 million and $0.0 million respectively. For the three months ended September 30, 2022 Total Other Income was from interest income. For September 30, 2021, Total Other Income (expense) primarily included interest expense of approximately ($0.6) million incurred under the finance lease offset by $0.6 million for the forgiveness of the PPP loan.
Discontinued Operations:
On November 2, 2022, iBio, Inc. announced its plans to divest its contract development and manufacturing organization (iBio CDMO, LLC) in order to complete its transformation into an AI-driven precision antibody discovery and development company. In conjunction with the divestment, iBio initiated a workforce reduction of approximately 60% and discontinued CDMO operations. CDMO operations are now treated as a discontinued operation on our financial statements. Losses for Discontinued Operations for the three months ended September 30, 2022 and 2021 were approximately ($10.6) million and ($3.8) million respectively. The increase primarily related to a consumables and inventory write-off of ($4.1) million with the remaining variance related to personnel fees and other professional fees.
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Net Loss Attributable to iBio, Inc. Stockholders
Net loss attributable to iBio, Inc. stockholders for the three months ended September 30, 2022, was ($7.5) million, or ($0.85) per share. Net loss attributable to iBio, Inc. stockholders for the three months ended September 30, 2021, was approximately ($5.2) million or ($0.60) per share.
Liquidity and Capital Resources
As of September 30, 2022, we had cash and cash equivalents plus debt securities of approximately $23.5 million, including approximately $6 million of restricted cash, as compared to $39.5 million as of June 30, 2022. In an effort to improve liquidity and runway, we recently announced we were selling our CDMO business and facility, reducing its work force by approximately 60% (a reduction of approximately 69 positions), and ceasing operations of its CDMO thereby reducing annual spending by approximately 50%. Potential options being considered to further increase liquidity include lowering our expenses further, focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from capital markets, grant revenue or collaborations, or a combination thereof. During the first quarter of fiscal year 2023, we completed at-the-market (“ATM”) offerings and raised $1.1M selling approximately 176,000 shares of common stock.
The Company’s cash, cash equivalents and investments in debt securities is not anticipated to be sufficient to support operations beyond Q3 of Fiscal 2023 unless the Company reduces its burn rate further or increases its capital as described above. Regardless of whether the Company is able to reduce its burn rate or sell or out-license certain assets or parts of the business, the Company will need to raise additional capital in order to fully execute its longer-term business plan. It is the Company’s goal to implement one or more potential options described above to allow the Company to have a cash runway for at least 12 months from the date of the filing of this Quarterly Report on Form 10-Q. However, there can be no assurance that the Company will be successful in implementing any of the options that we are evaluating.
Net Cash Used in Operating Activities
Net cash used in operating activities was approximately ($14.0) million for the three months ended September 30, 2022. The use of cash was primarily attributable to funding our net loss for the period.
Net Cash Used in Investing Activities
Net cash used in investing activities of approximately $0.0 million for the three months ended September 30, 2022 attributable primarily to the redemption of debt securities of $3.2 million, the purchase of fixed assets of ($2.5) million, and ($.7) million associate with the asset purchase of RubrYc Therapeutics, Inc. (Refer to Note 6 – Significant Transactions for details.)
Net Cash Provided by Financing Activities
Net cash used in financing activities during the three months ended September 30, 2022, was approximately $1.1 million and mainly attributable to the proceeds from the sale of common stock.
Funding Requirements
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of September 30, 2022, our accumulated deficit was approximately $ (242.0) million and we used approximately ($14.0) million of cash for operating activities during the three months ended September 30, 2022.
We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through proceeds from the sale of the iBio CDMO, through the collection or proceeds from our license agreement with Fraunhofer, through potential proceeds from the sale or out-licensing of assets, and through proceeds from the sale of additional equity or other securities. We cannot be certain that such funding will be available on favorable terms or available at all. Based on current trends and activities, there is significant doubt that iBio can continue as a going concern beyond Q3 of Fiscal 2023. If we fail to successfully extend our cash runway via strategic options or other alternatives as described we would be in violation of the liquidity covenant on December 31, 2022. To the extent that the Company raises additional funds by issuing equity securities, its stockholders may experience significant dilution. If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly cease operations.
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Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities (SPEs), which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually limited purposes. As of September 30, 2022, we were not involved in any SPE transactions.
Critical Accounting Estimates
A critical accounting policy is one that is both important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.
Our condensed consolidated financial statements are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of September 30, 2022, have been taken into consideration in preparing the condensed consolidated financial statements. The preparation of condensed consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures. Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates. The following accounting policies and estimates have been highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our condensed consolidated financial statements:
● | Valuation of intellectual property; |
● | Revenue recognition; |
● | Liquidity assertions; |
● | Useful lives of fixed assets; |
● | Lease accounting; |
● | Legal and contractual contingencies; |
● | Research and development expenses; and |
● | Share-based compensation expenses. |
We base our estimates, to the extent possible, on historical experience. Historical information is modified as appropriate based on current business factors and various assumptions that we believe are necessary to form a basis for making judgments about the carrying value of assets and liabilities. We evaluate our estimates on an on-going basis and make changes when necessary. Actual results could differ from our estimates.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As a smaller reporting company, we are not required to provide the information required by this Item 3.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, under the direction of our Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as amended, as of September 30, 2022. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act
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is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. The Company’s disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on our evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of September 30, 2022.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the quarter ended September 30, 2022, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently subject to any material legal proceedings.
Item 1A. Risk Factors
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. The following information updates, and should be read in conjunction with, the information disclosed in Part I, Item 1A, “Risk Factors,” contained in the Annual Report. Except as described below, our risk factors as of the date of this Report have not changed materially from those described in “Part I, Item 1A. Risk Factors” of our Annual Report.
We are reviewing potential options to extend our cash runway. This review could impact our future operations and financial position.
We are currently evaluating a number of potential options to expand our cash runway, the implementation of which will impact the Company’s liquidity. In an effort to improve liquidity and runway, we recently announced that we were selling our CDMO business and facility, reducing our work force by approximately 60%, and ceasing operations of our CDMO thereby reducing annual spending by approximately 50%. Potential options being considered to further increase liquidity include lowering our expenses further, focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from capital markets, grant revenue or collaborations, or a combination thereof.
Our cash, cash equivalents and investments in debt securities of $23.5 million as of September 30, 2022, is not anticipated to be sufficient to support our operations for at least 12 months from the date of the filing of this Quarterly Report on Form 10-Q unless we reduce our burn rate further or increase our capital. Regardless of whether we are able to reduce our burn rate or sell or out-licensing of certain assets or parts of the business, we will need to raise additional capital in order to fully execute our longer-term business plan.
There can be no assurance that we will be able to sell the CDMO or that if we are able to do so that we do so on favorable terms or that he exploration of potential options will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Although we expect to be able to sell the CDMO in 2023, no guaranteed timetable has been established for the completion of this process, and we do not expect to disclose developments unless and until we have a material update to provide or the Board of Directors has concluded that disclosure is appropriate or required. If we determine to change our business strategy, our future business, prospects, financial position and operating results could be significantly different than those in historical periods or projected by our management. Because of the significant uncertainty regarding our future plans, we are not able to accurately predict the impact of a potential change in our business strategy and future funding requirements.
Our historical operating results indicate substantial doubt exists related to our ability to operate as a going concern.
We have incurred net losses and used significant cash in operating activities since inception, and we expect to continue to generate operating losses for the foreseeable future. As of September 30, 2022, we have an accumulated deficit of $242 million.
We held cash, cash equivalents and investments in debt securities of $23.5 million as of September 30, 2022. Based on current trends and activities, there is significant doubt that we can continue as a going concern beyond Q3 of Fiscal 2023. We have announced that we
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are implementing cost savings measures to expand our cash runway, the implementation of which will impact our liquidity but these measures alone will not be sufficient to provide the financing needed to meet our long term goals . Potential options being considered to increase liquidity include further lowering our expenses through decreasing spending and focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates or parts of the business, raising money from capital markets, grant revenue or collaborations, or a combination thereof. Regardless of whether we are able to reduce our burn rate or sell or out-licensing certain assets or parts of the business, we will need to raise additional capital in order to fully execute our longer-term business plan. We believe based on input from expert advisors, that it is likely we will be able to implement one or more options that will extend our cash runway for 12 months or more from the date of the filing of this Quarterly Report on Form 10-Q. However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating.
Our consolidated audited financial statements as of and for the year ended September 30, 2022, have been prepared under the assumption that we will continue as a going concern for the next 12 months. Our management concluded that our recurring losses from operations and the fact that we have not generated significant revenue or positive cash flows from operations raise substantial doubt about our ability to continue as a going concern for the next 12 months after issuance of our financial statements. Our auditors also included an explanatory paragraph in its report on our financial statements as of and for the year ended June 30, 2022 with respect to this uncertainty. If we continue to experience operating losses, and we are not able to generate additional liquidity through a capital raise or other cash infusion, we might need to secure additional sources of funds, which may or may not be available to us. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to further scale back or discontinue the development of our product candidates or other research and development initiatives or initiate steps to cease operations.
We need additional funding to fully execute our business plan, which funding may not be available on commercially acceptable terms or at all. If we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate the commercialization of our development and manufacturing services and efforts for our product development programs.
Even if we are able to sell the CDMO upon favorable terms, we will need additional capital to fully implement our current long-term business, operating and development plans as we do not anticipate that any of our product candidates will generate revenue in the next few years, if at all. To the extent that we initiate or continue clinical development without securing collaborator or licensee funding, our research and development expenses could increase substantially.
When we elect to raise additional funds or additional funds are required, we may raise such funds from time to time through public or private equity offerings, debt financings, corporate collaboration and licensing arrangements or other financing alternatives. Additional equity or debt financing or corporate collaboration and licensing arrangements may not be available on acceptable terms, if at all. We currently have no committed sources of funding. On November 25, 2020, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. ("Cantor Fitzgerald") to sell shares of common stock, from time to time, through an “at the market offering” program having an aggregate offering price of up to $100,000,000 through which Cantor Fitzgerald would act as sales agent (the “Sales Agent”). There can be no assurance that we will meet the requirements to be able to sell securities pursuant to the Sales Agreement, of if we meet the requirements that we will be able to raise sufficient funds on favorable terms. If we are unable to raise capital in sufficient amounts when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or commercialization efforts and our ability to generate revenues and achieve or sustain profitability will be substantially harmed.
If we are unable to raise funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies; b) seek collaborators for our technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise dispose of rights to technologies, product candidates, or products that we would otherwise seek to develop or commercialize; or d) possibly cease operations.
Changes in general economic conditions, geopolitical conditions, domestic and foreign trade policies, monetary policies
and other factors beyond our control may adversely impact our business and operating results.
The uncertain financial markets, disruptions in supply chains, mobility restraints, and changing priorities as well as volatile asset values could impact our business in the future. We and our third-party contract manufacturers, contract research organizations, and clinical sites may also face disruptions in procuring items that are essential to our research and development activities, including, for example, medical and laboratory supplies used in our clinical trials or preclinical studies, in each case, that are sourced from abroad or for which there are shortages because of ongoing efforts to address the outbreak. These minor disruptions have had an immaterial effect on business, which we have been able to address with minimal impact to our business operations to date. Further, although we have not experienced any material adverse effects on our business due to increasing inflation, it has raised operating costs for many businesses and, in the future, could impact demand or pricing manufacturing of our drug candidates or services providers, foreign exchange rates or employee wages. We are actively monitoring the effects these disruptions and increasing inflation could have on our operations.
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Our operations and performance depend on global, regional and U.S. economic and geopolitical conditions. Russia’s invasion and military attacks on Ukraine have triggered significant sanctions from U.S. and European leaders. These events are currently escalating and creating increasingly volatile global economic conditions. Resulting changes in U.S. trade policy could trigger retaliatory actions by Russia, its allies and other affected countries, including China, resulting in a “trade war.” Furthermore, if the conflict between Russia and Ukraine continues for a long period of time, or if other countries, including the U.S., become further involved in the conflict, we could face significant adverse effects to our business and financial condition.
The above factors, including a number of other economic and geopolitical factors both in the U.S. and abroad, could ultimately have material adverse effects on our business, financial condition, results of operations or cash flows, including the following:
● | effects of significant changes in economic, monetary and fiscal policies in the U.S. and abroad including currency fluctuations, inflationary pressures and significant income tax changes; |
● | supply chain disruptions; |
● | industrial policies in various countries that favor domestic industries over multinationals or that restrict foreign companies altogether; |
● | new or stricter trade policies and tariffs enacted by countries, such as China, in response to changes in U.S. trade policies and tariffs; |
Due to the discontinuance of the CDMO business, we will not be generating material revenue from CDMO operations going forward.
As a result of the discontinuance of the CDMO business, we will not generate material revenue from the CDMO operations any longer.
Item 5. Other Information.
On November 10, 2022, as previous disclosed in relation to the Employment Agreement with Thomas F. Isett 3rd, the Company’s Chief Executive Officer, dated April 30, 2021, the Company granted Mr. Isett Restricted Stock Units (the “RSUs”) to acquire 200,000 shares of common stock, $0.001 par value per share (the “Common Stock”), on a post-split basis. The RSUs vest over a three-year period commencing April 30, 2021 provided the vesting is subject to the following performance conditions: (i) submission to the U.S. Food and Drug Administration (FDA) of an Investigational New Drug (IND) application, or alternatively, if the Board approves not to file an IND, (ii) consummation of a disposition of iBio CDMO, LLC, or (iii) outlicensing, with full global rights, any of its investigational product candidates prior to the submission to the FDA an IND application. The grant-date fair value of the RSUs totaled approximately $296,000.
On November 11, 2022, the Company granted Mr. Robert Lutz, the Company’s Chief Financial and Business Officer, RSUs to acquire 100,057 shares of the Company’s Common Stock in exchange for Mr. Lutz’ agreement to continue employment with the Company through July 1, 2023. The RSUs vest the earlier of: (i) July 1, 2023, or (ii) the successful achievement of the Company’s 2023 objectives, as defined by the Board of Directors. The grant-date fair value of the RSUs totaled approximately $175,100.
On November 11, 2022, the Company granted Mr. Martin Brenner, the Company’s Chief Scientific Officer, RSUs to acquire 95,348 shares of the Company’s Common Stock in exchange for Mr. Brenner’s agreement to continue employment with the Company through July 1, 2023. The RSUs vest the earlier of: (i) July 1, 2023, or (ii) the successful achievement of the Company’s 2023 objectives, as defined by the Board of Directors. The grant-date fair value of the RSUs totaled approximately $166,860.
Item 6. Exhibits.
Exhibit No. |
| Description |
3.1 |
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3.2 |
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3.3 |
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3.4 | ||
3.5 | ||
10.1 | ||
10.2* | ||
10.3* | Lease dated September 10, 2021 by and between iBio, Inc., and San Diego Inspire 4, LLC | |
10.4+* | ||
31.1* |
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31.2* |
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32.1* |
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32.2* | ||
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101.INS |
| Inline XBRL Instance* |
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101.SCH |
| Inline XBRL Taxonomy Extension Schema* |
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101.CAL |
| Inline XBRL Taxonomy Extension Calculation* |
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101.DEF |
| Inline XBRL Taxonomy Extension Definition* |
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101.LAB |
| Inline XBRL Taxonomy Extension Labeled* |
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101.PRE |
| Inline XBRL Taxonomy Extension Presentation* |
104 | Cover page Interactive Data File (embedded within the Inline XBRL document) |
* Filed herewith.
+ Certain portions of this exhibit indicated therein by [**] have been omitted in accordance with Item 601(b)(10) of Regulation 8-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| iBio, Inc. |
| (Registrant) |
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Date: November 14, 2022 | /s/ Thomas F. Isett 3rd |
| Thomas F. Isett 3rd |
| Chief Executive Officer |
| |
Date: November 14, 2022 | /s/ Robert Lutz |
| Robert Lutz |
| Chief Financial Officer |
| Principal Financial Officer and Principal Accounting Officer |
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