iBio Inc
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 12, 2024
IBIO$0.74+1.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-13.
0001420720-24-000020
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0001420720-24-000054
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 144 previous paragraphs and 135 current paragraphs.
68 unchanged; 30 reworded; 33 added; 36 removed; 10 previous and 4 current paragraphs rearranged.
Tables are not compared: 15 previous and 22 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (33)
Current report
Although bispecific antibodies and antibody-drug conjugates have proven to be highly efficacious, they have also raised safety concerns. Our ShieldTx technology is an integrated part of the discovery process, designed to allow antibodies to be masked and rendered inactive until they reach the intended tissue (e.g., a tumor), where the mask is removed and the antibody is activated. ShieldTx is believed to have the capability of reducing or eliminating adverse effects stemming from off-target tissue effects, increase the probability of success in identifying a fitting mask, and reduce development time.
Current report
Lastly, our StableHu technology, coupled with mammalian display technology, has been shown in pre-clinical studies to allow for the reduction of lead optimization times by utilizing single-shot multi-dimensional optimization techniques. This also improves the developability of lead antibodies early in the discovery process.
Current report
Collaborations and Partnerships
Current report
We are currently in the process of building and advancing our preclinical pipeline by leveraging our technology stack focused on hard-to-drug targets and molecules offering differentiation in both in obesity and cardiometabolic disease space, as well as immune-oncology. As we continue to leverage our technology stack and develop our existing immune-oncology pre-clinical pipeline, we are also seeking strategic partners with the capabilities to more rapidly advance these programs towards the clinic. We also continue to assess our option rights to license three of the four assets under the AstralBio collaboration to add obesity and cardiometabolic programs into our pre-clinical pipeline. Under this strategic collaboration with AstraBio, it affords us the opportunity to expand pipeline and build a presence in the cardiometabolic disease space.
Current report
Obesity/Cardiometabolic Diseases
Current report
Myostatin, also known as growth differentiation factor 8 (GDF8), is a transforming growth factor-β (TGF-β) family member that functions to limit skeletal muscle growth and inhibits muscle growth. A loss of function in the myostatin gene leads to a reduction or absence of this inhibitory effect, resulting in increased muscle mass and strength. This genetic alteration can cause significant muscle hypertrophy and hyperplasia, meaning individuals or animals with myostatin loss of function have larger and more numerous muscle fibers. While this can be beneficial for muscle development, it may also have implications for overall metabolism and cardiovascular health.
Current report
In November 2024, we have completed an initial manufacturing run of non-cGMP material of our lead molecule in order to complete the initial dosing within anin vivo non-human primate (NHP) study with potential early readouts in early calander 2025.
Current report
In vitro characterization of IBIO-101 demonstrated potent binding to recombinant CD25 while preserving IL-2 signaling. Further assessment of IBIO-101 showed selective Treg depletion and sparing of Teffs.
Current report
We have progressed IBIO-101 to the IND-enabling phase and entrusted its Chemistry, Manufacturing, and Controls (CMC) development to a Contract Research Organization (CRO). In the initial stages of this process, IBIO-101 has exhibited promising attributes for CMC progression. Notably, we've pinpointed optimal cell lines for master cell bank creation and have set in place a CMC methodology to produce IBIO-101 in compliance with current Good Manufacturing Practice, or cGMP, standards.
Current report
An anti-CD25 antibody, such as IBIO-101, could be applicable in a number of indications including solid tumors, leukemia, and potentially additional orphan diseases. The Company continues to review the IL-2 sparing anti-CD25 antibody program, IBIO-101, including evaluating whether it can be utilized in certain orphan diseases. If such evaluation is promising, the Company will determine whether to initiate discussions with FDA before the end of calendar year 2025 to outline a potential clinical pathway for the program.
Current report
Brenner Amended and Restated Employment Agreement
Current report
On July 23, 2024, we entered into an amended and restated employment agreement (the “Restated Brenner Employment Agreement”), effective as of July 1, 2024 with Martin Brenner, our Company’s Chief Executive Officer and Chief Scientific Officer. Pursuant to the Restated Brenner Employment Agreement, Dr. Brenner’s base salary is $522,365 (the “Base Salary”) and his bonus target was increased, effective for fiscal year 2025, to 50% of the Base Salary. For the fiscal year ended June 30, 2024, Dr. Brenner’s bonus target will remain at 40% of the Base Salary.
Current report
The Restated Brenner Employment Agreement provides that Dr. Brenner is eligible to participate in all benefit and fringe benefit plans generally made available to our other executive officers.
Current report
Dr. Brenner’s employment is on an “at will” basis and may be terminated at any time by him or us. If Dr. Brenner is terminated for any reason or no reason, he is entitled to receive the following standard termination benefits: his accrued and unpaid base salary, any unreimbursed expenses accrued through the termination date, any earned but unpaid annual bonus form prior year and nay amounts payable under any benefit plans in which he was a participant.
Current report
In the event of a termination by Dr. Brenner for Good Reason (as defined in the Restated Brenner Employment Agreement) or by us without “Cause” (as defined in the Restated Brenner Employment Agreement), in addition to the standard termination benefits Dr. Brenner will receive: (i) an amount equal to his then current base salary for twelve months, to be paid out in equal installments in accordance with our regular payroll dates; (ii) a pro rata share of any bonus earned by him during the fiscal year in which the separation occurs based on the actual attainment of metrics upon which the bonus is calculated (as determined by our Board of Directors (the “Board”), to be paid in a lump sum at the time we pay bonuses to similarly-situated employees; and (iii) if he elects continuation coverage for health insurance under COBRA, we will pay the full cost of this benefit for a period of twelve (12) months following the termination.
Current report
The Restated Brenner Employment Agreement further provides that the event of a termination by Dr. Brenner for good reason within twelve months after a “Sale Event” (as defined in our 2023 Omnibus Incentive Plan (the “2023 Plan”)) or by us without cause one month prior or twelve months after a Sale Event, in addition to the standard termination benefits Dr. Brenner will receive: (i) an amount equal to his then current base salary for eighteen months, paid out in equal installments in accordance with our regular payroll dates; (ii) an amount equal to the target bonus for which Dr. Brenner would have been eligible during the fiscal year in which he terminates employment, to be paid within thirty (30) days of his execution of a separation agreement; and (iii) vesting of any unvested time-vested equity awards held by him and (iv) if he elects continuation coverage for health insurance under COBRA, we will pay the full cost of this benefit for a period of eighteen (18) months following the termination.
Current report
Severance payments begin upon expiration of the revocation period under a general release of claims.
Current report
Dr. Brenner has agreed to assign to us all of his rights in any Inventions, including all Intellectual Property Rights (as such terms are defined in the employment agreements) that are made, conceived or reduced to practice, in whole or in part, alone or with others, by him during his employment with us and has agreed to certain non-solicitation terms.
Current report
At Market Issuance Sales Agreement
Current report
On July 3, 2024, we entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with Chardan Capital Markets, LLC and Craig-Hallum Capital Group LLC (the “Sales Agents”) providing for the sale by us of our shares of Common Stock, from time to time, through the Sales Agents, with certain limitations on the amount of Common Stock that may be offered and sold by us as set forth in the ATM Agreement (the “Offering”).
Current report
Offers and sales of shares of Common Stock by us, if any, under the ATM Agreement, is subject to the effectiveness of our shelf registration statement on Form S-3 (File No. 333-280680), filed with the Securities and Exchange Commission (the “SEC”) on July 3, 2024 (the “Registration Statement”) under the Securities Act of 1933, as amended (the “Securities Act”). The aggregate market value of the shares of Common Stock eligible for sale under the ATM prospectus supplement included in the Registration Statement is currently $7,350,000, which is based on the limitations of General Instruction I.B.6 of Form S-3.
Current report
Pursuant to the ATM Agreement, we will set the parameters for the sale of shares of Common Stock, including the number of shares of Common Stock to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the ATM Agreement, the Sales Agents may sell the shares by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on the NYSE American (“NYSE American”) or on any other existing trading market for the Common Stock. In addition, with our prior written approval, the Sales Agents may also sell shares by any other method permitted by law, including in privately negotiated transactions.
Current report
Upon delivery of a placement notice and subject to the terms and conditions of the ATM Agreement, the Sales Agents will use their commercially reasonable efforts, consistent with their respective normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of the NYSE American, to sell shares of Common Stock from time to time based upon our instructions. We have no obligation to sell any shares of Common Stock under the ATM Agreement and may at any time suspend solicitation and offers under the ATM Agreement. The Sales Agents are not obligated to purchase any shares of Common Stock on a principal basis pursuant to the ATM Agreement.
Current report
The ATM Agreement provides that we will pay the Sales Agents commissions for its services in acting as agent in the sale of shares of Common Stock pursuant to the ATM Agreement. The Sales Agents will be entitled to compensation at a fixed commission rate of up to 3.0% of the gross proceeds from the sale of shares of Common Stock pursuant to the ATM Agreement. We have agreed to provide the Sales Agents and certain of their affiliates of the Sales Agents with customary indemnification and contribution rights, including for liabilities under the Securities Act. We also agreed to reimburse the Sales Agents for certain specified expenses in connection with entering into the ATM Agreement, including the reasonable and documented out-of-pocket fees and disbursements of counsel to the Sales Agents up to $75,000 plus (i) an additional $5,000 per quarter so long as the ATM Agreement remains in effect and the Sales Agents perform standard quarterly due diligence with the Company, excluding any period during which a Suspension (as defined in the ATM Agreement) is in place pursuant to Section 4 of the ATM Agreement, and (ii) $25,000 in connection with any filing of an additional prospectus supplement which constitutes a Prospectus Supplement (as defined in the ATM Agreement). The ATM Agreement contains customary representations and warranties and conditions to the placements of shares of Common Stock pursuant thereto, obligations to sell shares under the ATM Agreement are subject to satisfaction of certain conditions, including the effectiveness of the Registration Statement and other customary closing conditions.
Current report
The Offering of shares of Common Stock pursuant to the ATM Agreement will terminate upon the earlier of (i) the sale of all shares of Common Stock subject to the ATM Agreement, or (ii) termination of the ATM Agreement as permitted therein. No Common Stock was sold under this agreement as of September 30, 2024.
Current report
Amendment to Code of Ethics
Current report
On July 2, 2024, we approved and adopted an updated Code of Business Conduct and Ethics (the “Code”), which applies to all of our directors, officers and employees. The Code supersedes the existing Code of Business Conduct and Ethics adopted by the Board.
Current report
The Code has been updated to modernize its language and structure, promote mitigation of risk with our personnel, and better reflect changes in our day-to-day operations and work environment.
Current report
In an effort to mitigate the substantial doubt about continuing as a going concern and increase cash reserves, we have raised funds from time to time through equity offerings or other financing alternatives, reduced our workforce, entered into a collaboration agreement to discover and develop novel antibodies for obesity and other cardiometabolic diseases and sold certain intellectual property rights. Potential options being considered to further increase liquidity, focusing product development on a select number of product candidates, the sale or out-licensing of certain product candidates, raising money from the capital markets, grant revenue or collaborations, or a combination thereof. However, we anticipate that our expenses will increase as it continues its research and development activities and conducts clinical trials.
Current report
On July 3, 2024, we entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with Chardan Capital Markets, LLC and Craig-Hallum Capital Group LLC (the “Sales Agents”) providing for the sale by the Company of its common stock, par value $0.001 per share (the “Common Stock”), from time to time, through the Sales Agents, with certain limitations on the amount of Common Stock that may be offered and sold by us as set forth in the ATM Agreement (the “ATM”). Offers and sales of shares of Common Stock by us, if any, under the ATM Agreement, is subject to the effectiveness of our shelf registration statement on Form S-3, filed with the SEC on July 3, 2024 which became effective on August 6, 2024. The aggregate market value of the shares of Common Stock eligible for sale under the ATM prospectus supplement included in the Registration Statement is currently $7,350,000, which is based on the limitations of General Instruction I.B.6 of Form S-3. No Common Stock was sold under this agreement as of September 30, 2024.
Current report
Our cash, cash equivalents and restricted cash of approximately $11.3 million as of September 30, 2024, is anticipated to be sufficient to support operations into the first quarter of fiscal year 2026, unless we reduce our burn rate further or raise additional capital. Regardless of whether we are able to reduce our burn rate or sell or out-license certain assets or parts of the business, we will need to raise additional capital in order to fully execute our longer-term business plans. It is the our goal to implement one or more potential options described above to allow us to have a cash runway for at least 12 months from the date of the filing of this Report. However, there can be no assurance that we will be successful in implementing any of the options that we are evaluating.
Current report
Net cash provided by investing activities of approximately $0.7 million for the three months ended September 30, 2024 was due to the payment received for interest and principal on the promissory note receivable. Net cash provided by investing activities was approximately $0.1 million for the three months ended September 30, 2023.
Current report
Net cash used in financing activities during the three months ended September 30, 2024, was approximately ($0.2) million and was attributable to payments towards debt, including the finance lease obligations, term promissory not and equipment financing loan. Net cash provided by financing activities was approximately $2.5 million for the three months ended September 30, 2023.
Removed paragraphs (36)
Previous report
Partnerships
Previous report
We are currently in the process of building and advancing our pipeline. The focus of our pipeline is expanding beyond immuno-oncology, with the addition of obesity and cardiometrabolic diseases. By leveraging our technology stack, the pipeline is geared towards hard-to-drug targets and molecules offering differentiation. To reduce target risk and leverage competitor insights, one of the Company’s strategic approaches involves focusing on best-in-class therapies. The Company’s approach by targeting molecules that have already been partially validated allows the Company to benefit from the progress made by others in the field. A second strategy is dedicated to pioneering first-in-class therapies. Utilizing the Company’s AI Discovery Platform, it innovates by creating antibodies aimed at hard-to-drug targets, maximizing the potential of our cutting-edge technology.
Previous report
We continue to advance our IL-2 sparing anti-CD25 antibody, IBIO-101, and intend moving the program from IND-enabling stage to an IND filing during the calendar year 2025, subject to positive competitor data and funding availability.
Previous report
Obesity and Cardiometabolic Diseases
Previous report
Myostatin, also known as growth differentiation factor 8 (GDF8), is a transforming growth factor-β (TGF-β) family member that functions to limit skeletal muscle growth. Loss-of-function mutations in myostatin result in a pronounced increase in muscle mass in humans and various animals, while its overexpression leads to severe muscle atrophy. Myostatin also elicits effects on bone metabolism, as demonstrated by enhanced bone mineral density and bone regeneration in myostatin deficient mice.
Previous report
Our aim is to use our AI-driven technology, specifically our StableHu AI technology and mammalian display to identify molecules that
Previous report
Anti-myostatin therapies are most validated for their role in enhancing muscle growth and differentiation in animals. However, they may also positively impact other tissues, such as bone and adipose tissue, either directly or indirectly. Such multifaceted benefits position anti-myostatin treatments as promising options for a spectrum of human conditions, including obesity, sarcopenia, and diabetes, among others.
Previous report
On January 16, 2024, we entered into a credit and security agreement (the “Credit and Security Agreement”) with Loeb Term Solutions LLC, an Illinois limited liability company (“Lender”), for a term loan or equipment line of credit loan (the “Loan”) pursuant to which we issued to Lender a term promissory note in the principal amount of $1,071,572 (the “2024 Term Note”) bearing interest at the Prime Rate, as quoted in the Wall Street Journal plus 8.5% (the “Effective Rate”), for proceeds of $1,027,455.23 after payment of $42,862.88 to Lender as an origination fee, $1,172.89 for appraisal costs, and $75.00 for bank wire fees. The 2024 Term Note provides for monthly payments of principal and interest based on a four-year amortization period, with a balloon payment of all principal, accrued interest and any other amounts due on the two year anniversary of the 2024 Term Note. The Credit and Security Agreement granted to Lender a security interest in substantially all of our assets other than any intellectual property related to any of our filed patents (the “Loeb Collateral”) to secure our obligations under the 2024 Term Note. The 2024 Term Note is subject to a prepayment fee of: 4% of the principal amount being prepaid if the 2024 Term Note is prepaid during the first 12 months from its issuance, and 3% of the principal amount being prepaid if the 2024 Term Note is prepaid during the second 12 months from its issuance date. See Note 13 – Debt to the notes to financial statements for additional information regarding the Loan and Credit and Security Agreement.
Previous report
On February 25, 2024, we closed the sale to Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) pursuant to which we sold of our early-stage PD-1 Assets developed or held for development in consideration of $1,000,000. The PD-1 Purchase Agreement also provides for a potential contingent payment of $2,500,000 upon the achievement of specified developmental milestones and a second potential contingent payment of $50,000,000 upon the achievement of specified milestones following commercialization.
Previous report
On March 26, 2024, we entered into the PIPE Purchase Agreement with several institutional investors and an accredited investor for the issuance and sale in a Private Placement of the following securities for gross proceeds of approximately $15.1 million: (i) 2,701,315 shares of our Common Stock, (ii) Pre-Funded Warrants to purchase up to 2,585,963 shares of our Common Stock at an exercise price of $0.0001 per share, and (iii) Series E Warrants to purchase up to 5,287,278 shares of our Common Stock at an exercise price of $2.64 per share. The Series E Warrants are exercisable at any time after the six-month anniversary of the Initial Exercise Date at an exercise price of $2.64 per share and have a term of exercise equal to five years from the date of issuance. The combined purchase price for one share of common stock and the accompanying Series E Warrant was $2.85 and the purchase price for one pre-funded warrant and the accompanying Series E Warrant was $2.849. Chardan served as the exclusive placement agent in connection with the Private Placement and was paid (i) a cash fee equal to 6.0% of the aggregate gross proceeds of the Private Placement (reduced to 4.0% with respect to certain investors), and (ii) up to $50,000 for legal fees and other out-of-pocket expenses. The Private Placement closed on April 1, 2024. The Company received net proceeds of approximately $14.1 million from the Private Placement, after deducting estimated offering expenses payable by the Company, including placement agent fees and expenses. No Seried E Warrants were exercised during the three and nine months ended March 31, 2024.
Previous report
In connection with the Private Placement, we entered into a side letter agreement (the “Letter Agreement”) with one investor, Lynx1 Capital Management LP (the “Investor”). Subject to the terms of the Letter Agreement, the Investor will be entitled to nominate one individual to serve as a director on our Board of Directors for one three-year term commencing with our 2024 Annual Meeting of Stockholders.
Previous report
On March 28, 2024, iBio CDMO and Woodforest entered into the Ninth Amendment (the “Ninth Amendment”) to the Credit Agreement, which amendment among other things, amends the Credit Agreement to: (i) set the maturity date of the term loan to the earlier of (a) May 15, 2024, or (b) the acceleration of maturity of the term loan in accordance with the Credit Agreement.
Previous report
In an effort to mitigate the substantial doubt about continuing as a going concern and increase cash reserves, we raised funds through equity offerings or other financing alternatives including entering into an equipment line of credit, sold certain intellectual property rights, reduced our work force by approximately 60% (a reduction of approximately 69 positions) in November 2022, ceased operations of our 130,000 square foot cGMP facility located in Bryan, Texas (the “Facility”) thereby reducing annual spend on expenses by approximately 58% and generating cash savings of approximately 46% when comparing the nine months ended March 31, 2024 to the nine months ended March 31, 2023. Although the Facility is listed for sale, we do not currently have a buyer for the Property for amounts near or above the outstanding amounts owed under the Term Loan. If a sale of the Facility is not consummated prior to the May 15, 2024 maturity date of the Term Loan for an amount near or above the outstanding amounts owed under the Term Loan or the maturity date is not further extended or the terms of the term Loan are not otherwise restructered, we will not have sufficient funds to repay the Term Loan on its maturity date and support our operations for at least 12 months from the date of filing this Quarterly Report for the quarterly period ended March 31, 2024. Based upon the current terms of the Term Loan and current interest received for the purchase of the Property, even if we able to sell the Facility, it is unlikely the proceeds from such sale will be sufficient to pay the entire remaining outstanding balance of the Term Loan, unless the Term Loan is restructed. The Term Loan has an outstanding balance of $12.7 million as of March 31, 2024. There can be no assurance that we will be able to sell the Facility or that we will be able to sell the Facility for an amount that will allow us to repay all outstanding amounts under the Term Loan and have sufficient remaining cash to support our operations through the first quarter of Fiscal 2025. (See Note 3 – Discontinued Operations for more information.)
Previous report
During the first quarter ended on September 30, 2023, we completed at-the-market offerings and sold 170,989 shares of Common Stock for which we received approximately $1.7 million. We also sold 181,141 shares of Common Stock under ourpurchase agreement entered into on August 4, 2023 (the “Purchase Agreement”), with Lincoln Park Capital Fund, LLC (“Lincoln Park”) and received approximately $1.2 million in proceeds. During the second quarter ended December 31, 2023, we sold an additional 21,457 shares to Lincoln Park under the Purchase Agreement for approximately $0.1 million. (See Note 16 – Stockholder’s Equity for more information.) No shares remain available for sale under the Purchase Agreement at March 31, 2024.
Previous report
On December 7, 2023, we closed the 2023 Offering pursuant to which we sold in the 2023 Offering, (i) 600,000 Shares of our Common Stock, (ii) 1,650,000 Pre-Funded Warrants exercisable for an aggregate of 1,650,000 shares of Common Stock, (iii) 2,250,000 Series C Common Warrants exercisable for an aggregate of 2,250,000 shares of Common Stock, and (iv) 2,250,000 Series D Common Warrants exercisable for an aggregate of 2,250,000 shares of Common Stock. A.G.P. acted as lead placement agent, and Brookline acted as the Placement Agents for the 2023 Offering. We received approximately $4.5 million in gross proceeds from the 2023 Offering, including the exercise of all Pre-Funded Warrants and prior to deducting placement agent fees and other estimated offering expenses payable by us and excluding the net proceeds, if any, from the exercise of the Common Warrants. (See Note 16 – Stockholders’ Equity for more information.)
Previous report
On April 1, 2024, we closed the Private Placement pursuant to which we sold, (i) 2,701,315 Shares of our Common Stock, (ii) Pre-Funded Warrants exercisable for an aggregate of 2,585,963 shares of our Common Stock, and (iii) Series E Warrants exercisable for an aggregate 5,287,278 shares of our Common Stock. We received net proceeds of approximately $14.1 million from the Private Placement, after deducting estimated offering expenses paid by us, including placement agent fees and expenses. (See Note 16 – Stockholders’ Equity for more information.)
Previous report
During the third quarter of Fiscal 2024, 414,000 of 2023 Pre-Funded Warrants, 1,131,500 Series C Common Warrants and 1,006,500 Series D Common Warrants were exercised for proceeds of $4,276,000. In April 2024, 48,000 Series C Common Warrants and 48,000 Series D Common Warrants were exercised for proceeds of $192,000. [Need to update if any other warrants are exercised before the filing date.]
Previous report
Our cash, cash equivalents and restricted cash was approximately $6.4 million as of March 31, 2024, which is inclusive of restricted cash of $1.1 million, of which $0.9 million was deposited in accordance with the Fourth Amendment with Woodforest. Subsequent to March 31, 2024, we received Private Placement net proceeds of approximately $14.1 million. As of the filing of this Quarterly Report on Form 10-Q our cash balance of approximately $17.9 million, which is inclusive of $1.1 million of restricted cash, is not anticipated to be sufficient to support operations through the first quarter of Fiscal 2025, unless we sell the Facility for amounts near or above our Term Loan or the Term Loan is restructured. We are evaluating a possible transaction based on current interest in the Facility which would minimize cash outlay and allow us to have a cash runway for at least 12 months from the date of the filing of this Quarterly Report. However, there can be no assurance that we will be successful in implementing.
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Revenue
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Research and development expenses for the nine months ended March 31, 2024 and 2023 were $4.0 million and $8.0 million, respectively, a decrease of approximately $4.0 million. The decrease in R&D expenses is mainly due to a decrease in spending for
Previous report
General and administrative expenses for the nine months ended March 31, 2024 and 2023 were approximately $9.2 million and $16.4 million, respectively, a decrease of $7.2 million. The decrease is primarily attributable to the reduction in personnel costs, a decrease in spending for consultants or outside services, a decrease in insurance premiums, and an intangible impairment recorded in the second quarter of Fiscal 2023. The decrease in spend was partially offset by an increase in legal fees.
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Total Operating Expenses
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Discontinued Operations
Previous report
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 AI-driven precision antibody discovery and development company. In conjunction with the divestment, we completed 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 nine months ended March 31, 2024 were approximately ($4.9) million and consisted of an impairment of fixed assets ($3.1) million, interest related to the Term Note on the Facility ($0.9) million, and costs related to maintaining the Facility of ($0.9). Losses for Discontinued Operations for the nine months ended March 31, 2023 were approximately ($34.6) million and consisted of an impairment of fixed assets ($17.6) million, personnel costs including severance of ($7.5) million, costs related to maintaining the Facility of ($5.0) million, consumables and inventory write-down of ($4.9) million, interest related to the Term Note on the Facility approximately ($0.6) million offset by $0.3 milion of net revenues and $0.8 million in gains from the sales of fixed assets..
Previous report
Net Loss from Continuing Operations
Previous report
Net loss from continuing operations for the nine months ended March 31, 2024, was ($12.2) million, or ($5.43) per share. Net loss from continuing operations for the nine months ended March 31, 2023, was approximately ($24.4) million or ($46.00) per share.
Previous report
Net cash provided by investing activities of approximately $1.1 million for the nine months ended March 31, 2024 was mainly attributable to sale of intangible assets.
Previous report
Net cash provided by financing activities during the nine months ended March 31, 2024, was approximately $11.5 million and was mainly attributable to the proceeds from the sale of securities and proceeds from the term promissory note (see Note 13 – Debt for further details), offset by payments towards debt, including the term note made to Woodforest (see Note 13 – Debt for further details).
Previous report
See Liquidity and Capital Resources above for further information.
Previous report
Impairment of Fixed Assets
Previous report
On November 3, 2022, we announced we are seeking to divest our contract development and manufacturing organization (iBio CDMO) in order to complete our transformation into an antibody discovery and development company. Through the process of seeking to divest its contract development and manufacturing organization, we continue to market for sale the Facility. The decision to divest triggered a quantitative impairment analysis at the end of the second quarter of Fiscal 2023 of our CDMO fixed assets, including the building in Bryan, Texas totaling $22.65 million and machinery and equipment totaling $13.4 million.
Previous report
We utilized a market approach in the second quarter of Fiscal 2023, using independent third-party appraisals, including comparable assets, in addition to bids received from prospective buyers, to estimate the fair value of the Facility, the machinery and equipment. We recorded an impairment charge of $6.3 million for the Facility and $11.3 million for the machinery and equipment in the quarter ended December 31, 2022. The key assumption in the valuation analysis was the expected sale price of $21.1 million for the Facility and the
Previous report
associated machinery and equipment less approximate costs to sell of $2.7 million. In the first quarter of Fiscal 2024, we entered into an agreement for the sale of the Facility for $17.25 million, and an additional impairment of $0.3 million was recorded as of June 30, 2023 to reflect the agreed upon sales price of $17.25 million less estimated costs to sell. The CDMO Equipment was sold during Fiscal 2023.
Previous report
On November 7, 2023, we received written notice terminating the agreement for the sale of the Property. Upon receiving the termination notice, we reassessed the CDMO fixed assets for impairment which included obtaining appraisal values as of November 9, 2023. We utilized a market approach, using an independent third-party appraisal, including comparable assets, in addition to bids received from prospective buyers, to estimate the fair value of the Facility and concluded that fair value of the assets approximated their carrying value and no further impairment was required at that time.
Previous report
During the second quarter of Fiscal 2024, we made the decision to auction the Facility. We utilized a market approach, using an independent third-party appraisal, including comparable assets, to estimate the fair value of the Facility. An additional $3.1 million fixed asset impairment was recorded the second quarter of Fiscal 2024 in discontinued operations to write down the carrying value of the Facility to its fair value. The key assumption in the valuation analysis is the expected sale price of $13.8 million for the Facility less approximate costs to sell of $0.7 million.** **
Previous report
During the third quarter of Fiscal 2024, we utilized a market approach, using an independent third-party appraisal, including comparable assets, in addition we considered to previous bids from prospective buyers and the nearing maturity date of the term note and concluded that fair value of the assets approximated their carrying value and no further impairment was required. We may have to record a further, potentially material, impairment to the fair value of the Facility if we do not realize a sale transaction for the expected sales price.
Reworded paragraphs (30)
Previous wording
The following information should be read together with the consolidated 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, 2023, as filed with the SEC on September 27, 2023 (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.
Current wording
The following information should be read together with the consolidated 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, 2024, as filed with the SEC on September 20, 2024, as amended on September 24, 2024 (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.
Previous wording
iBio, Inc. (“iBio,” “we,” “us,” or “our”) is a pioneering biotechnology company at the intersection of AI and biologics, committed to reshaping the landscape of discovery. Our core mission is to harness the potential of AI and machine learning to unveil elusive biologics that stand out and have evaded other scientists. Through our innovative platform, we champion a culture of innovation by identifying novel targets, forging strategic collaborations to enhance efficiency, diversify pipelines, and with the goal of accelerating preclinical processes.
Current wording
iBio, Inc. (“iBio,” “we,” “us,” or “our”) is a preclinical stage biotechnology company leveraging the power of Artificial Intelligence (AI) for the development of hard-to-drug precision antibodies. Our core mission is to harness the potential of AI and machine learning (ML) to unveil elusive biologics that stand out and have evaded other scientists. Through our innovative platform, we champion a culture of innovation by identifying novel targets, forging strategic collaborations to enhance efficiency, diversify pipelines, and with the goal of accelerating preclinical processes. Our proprietary technology stack is designed to minimize downstream development risks by employing AI-guided epitope-steering and monoclonal antibody (mAb) optimization.
Previous wording
Additionally, our groundbreaking EngageTx™ technology enables us to target bi-specific molecules. With the ability to navigate sequence diversity and promote Human-Cyno cross reactivity while mitigating cytokine release, our goal is to enhance agility and bolster preclinical safety assessments.
Current wording
Our groundbreaking EngageTx™ technology enables us to target bi-specific molecules. With the ability to navigate sequence diversity and promote Human-Cyno cross reactivity while mitigating cytokine release, our goal is to enhance agility and bolster preclinical safety assessments. Another key feature of our technology stack is our ShieldTx™ masking technology in order to keep antibodies inactive until they reach diseased tissue, where the masks are removed, and the antibodies are activated, all with the goal of broadening the therapeutic window, potentially improving efficacy and safety of treatments.
Previous wording
In essence, we are sculpting a future where cutting-edge AI-driven biotechnology propels the discovery of intricate biologics, fostering partnerships, accelerating innovation, and propelling the advancement of science.
Current wording
In essence, we believe that we are sculpting a future where cutting-edge AI-driven biotechnology propels the discovery of intricate biologics, fostering partnerships, accelerating innovation, and propelling the advancement of science.
Previous wording
Our platform comprises five key components, each playing a crucial role in the discovery and optimization of precision antibodies.
Current wording
Our platform comprises of five key components, each playing a crucial role in the discovery and optimization of precision antibodies.
Previous wording
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies. The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. Next, we use our EngageTx T-cell engager platform to create
Current wording
The first layer, epitope engineering, leverages the patented AI-engine to target specific regions of proteins, allowing us to engineer antibodies with high specificity and efficacy. The second layer involves the proprietary antibody library, which is built on clinically validated frameworks and offers a rich diversity of human antibodies. The third layer of the technology stack is the antibody optimizing StableHu AI technology, coupled with mammalian display technology. Next, we use our EngageTx T-cell engager platform to create bispecific antibodies. And last, antibodies are transformed into conditionally activated antibodies by ShieldTx, our antibody masking technology. Each layer of the tech stack is designed to work synergistically, enabling us to rapidly advance antibodies from concept to in vivo proof-of-concept (POC).
Previous wording
As noted above, one of the three pillars of value creation that structures of our strategic business approach are strategic partnerships. At the center of such pillar is our AI Discovery Platform.
Current wording
As noted above, one of the three pillars of value creation that structures of our strategic business approach are strategic collaborations and partnerships. At the center of such pillar is our AI Discovery Platform.
Previous wording
In March 2024, we entered into a collaboration with AstralBio. As part of the collaboration, we granted an exclusive license to our AI-powered technology to identify and engineer four (4) targets for the treatment of cardiometabolic disease, of which AstralBio may continue the pre-clinical development and deploy its drug development expertise to advance candidates to an IND application. We have the exclusive option to license three (3) cardiometabolic targets from AstralBio and will receive the rights to develop, manufacture and commercialize those targets upon exercise. As a result of this collaboration, we have agreed with AstralBio to initiate the development of a novel lead program focused on targeting the transforming growth factor beta (TGFb) superfamily for the treatment of muscle wasting and obesity.
Current wording
In March 2024, we entered into a collaboration with AstralBio to discover and develop novel antibodies for obesity and other cardiometabolic diseases. As part of the collaboration, we granted an exclusive license to AstralBio of our AI-powered technology to identify and engineer four (4) targets for the treatment of obesity and cardiometabolic diseases, of which AstralBio may continue the pre-clinical development and deploy its proven drug development expertise to advance candidates to an Investigational New Drug (IND) application. We have the exclusive option to license three (3) obesity and cardiometabolic targets from AstralBio and as a result, we will receive the rights to develop, manufacture and commercialize those targets upon exercise. As a result of this collaboration, one of the first programs is initiating the development of an anti-myostatin antibody program focused on targeting the transforming growth factor beta (TGFb) superfamily for the treatment of muscle wasting and obesity. Upon mutual consent with AstralBio, we may also expand the collaboration to include additional targets in other fields.
Previous wording
In June 2023, we entered into a research collaboration with the NIAID, a component of the NIH, to investigate the potential of our patented AI-driven epitope steering platform for the development of a vaccine for Lassa fever, a sometimes fatal viral disease endemic to parts of West Africa. Under the collaboration, we worked with the NIAID’s Vaccine Research Center to determine whether using our AI Discovery Platform to steer immunity toward viral epitopes identified by the vaccine center’s researchers could offer advantages over other vaccine development approaches. We designed ten engineered epitopes for the collaboration, which were screened for binding to three known Lassa fever neutralizing antibodies, alongside the NIAID 's Vaccines Research Center’s internal epitope designs. Importantly, our engineered epitopes showed binding to the Lassa neutralizing antibodies and were among the top-ranked hits regarding expression, an important consideration for cost-effective vaccine production. While the NIAID elected not to proceed with joint
Current wording
In June 2023, we entered into a research collaboration with the NIAID, a component of the NIH, to investigate the potential of our patented AI-driven epitope steering platform for the development of a vaccine for Lassa fever, a sometimes fatal viral disease endemic to parts of West Africa. Under the collaboration, we worked with the NIAID’s Vaccine Research Center to determine whether using our AI Discovery Platform to steer immunity toward viral epitopes identified by the vaccine center’s researchers could offer advantages over other vaccine development approaches. We designed ten engineered epitopes for the collaboration, which were screened for binding to three known Lassa fever neutralizing antibodies, alongside the NIAID 's Vaccines Research Center’s internal epitope designs. Importantly, our engineered epitopes showed binding to the Lassa neutralizing antibodies and were among the top-ranked hits regarding expression, an important consideration for cost-effective vaccine production. While the NIAID elected not to proceed with joint optimization of the lead hits, we enhanced our discovery process as a result of the collaboration, incorporating diffusion-based generative
Previous wording
optimization of the lead hits, we enhanced our discovery process as a result of the collaboration, incorporating diffusion-based generative AI models into our engineered epitope designs. The new models are already contributing to our pipeline development and are being used with current partners.
Current wording
AI models into our engineered epitope designs. The new models are already contributing to our pipeline development and are being used with current partners.
Previous wording
are differentiated against competitor anti-myostatin antibodies. The discovery campaign will be designed to, among other goals, optimize potency, specificity, developability and half-life of novel molecules.
Current wording
Through our discovery collaboration with AstralBio, we are using our StableHu and mammalian display technology to discover and identify antibodies against myostatin, the first of four targets for the treatment of obesity and cardiometabolic diseases. This initial campaign’s goal is to design antibodies preventing it from binding to the myostatin receptor and which are differentiated against competitor anti-myostatin antibodies. Pharmacological intervention targeting myostatin can be achieved by either blocking myostatin from interacting with its receptor or by targeting the receptor directly. The discovery campaign will be designed to, among other goals, optimize potency, specificity, developability and half-life of novel molecules.
Previous wording
Targeting depletion of Treg cells to control tumors emerged as an area of interest in oncology over the past several years. Since Treg cells express interleukin-2 Rα (“IL-2Rα” or “CD25”), it was envisioned mAbs could be developed that bind CD25 and thereby trigger depletion by Natural Killer cells, resulting in stimulation of anti-tumor immunity.
Current wording
IBIO-101 is a second-generation anti-CD25 mAb that has demonstrated in preclinical models of disease the ability to bind and deplete immunosuppressive regulatory T (“Treg”) cells to inhibit the growth of solid tumors. Targeting depletion of Treg cells to control tumors emerged as an area of interest in oncology over the past several years. Since Treg cells express interleukin-2 Rα (“IL-2Rα” or “CD25”), it was envisioned mAbs could be developed that bind CD25 and thereby trigger depletion by Natural Killer cells, resulting in stimulation of anti-tumor immunity.
Previous wording
Using our patented epitope steering AI platform, our innovative approach to this challenge allows our new mAbs to bind to a specific region of MUC16 that is not shed or glycosylated, circumventing both tumor evasion mechanisms and potentially providing a powerful tool in the fight against cancer. During its immunization and screening campaign, we identified several hits that specifically bound to the non-shed region of MUC16 while no binding to the shed fragment of MUC16 was observed. During pre-clinical studies, our MUC16 molecule has demonstrated binding to MUC16 on OVCAR-3 ovarian cancer cells. After engineering the leading MUC16 molecule with a fully human framework, the MUC16 molecule retained potent binding to the engineered epitope and maintained binding to human OVCAR-3 ovarian cancer cells. We have utilized our EngageTX platform to engineer MUC x CD3 bispecific antibodies and have further optimized the molecules to be double-masked on the MUC16 and the CD3 binding arms of the antibody.
Current wording
Using our patented epitope steering AI platform, our innovative approach to this challenge allows our new mAbs to bind to a specific region of MUC16 that is not shed or glycosylated, circumventing both tumor evasion mechanisms and potentially providing a powerful tool in the fight against cancer. During its immunization and screening campaign, we identified several hits that specifically bound to the non-shed region of MUC16 while no binding to the shed fragment of MUC16 was observed. Establishing antibodies with the ability to bind to a recombinant version of their target protein represents a vital initial step in the validation process. However, it's crucial to ensure such antibodies maintain their binding affinity in a whole cell context, specifically when the target protein is expressed on a cell's surface. To best predict therapeutic efficacy, it's recommended to utilize tumor cells as a means to demonstrate and confirm this cell binding capability. During pre-clinical studies, our lead MUC16 molecule has demonstrated binding to MUC16 on OVCAR-3 ovarian cancer cells.
Previous wording
Our hit molecules have demonstrated strong binding to the tumor-specific EGFRvIII protein without targeting the wildtype EGFR. Additionally, these molecules have effectively eliminated tumor cells, while sparing healthy ones, in in vitro cell killing tests. Our lead anti-EGFRvIII antibody was specially engineered to enhance its ability to attack cancer cells and has proven effective in a mouse model for head and neck cancer. In preclinical studies, our anti-EGFRvIII antibody demonstrated a 43 percent reduction in tumor growth compared to untreated animals.
Current wording
Our hit molecules have demonstrated strong binding to the tumor-specific EGFRvIII protein without targeting the wildtype EGFR. Additionally, these molecules have effectively eliminated tumor cells, while sparing healthy ones, in in vitro cell killing tests. Our lead anti-EGFRvIII antibody was specially engineered to enhance its ability to attack cancer cells and has proven effective in a mouse model
Previous wording
The history of significant losses, the negative cash flow from operations, the upcoming maturity of the Term Loan, the limited cash resources on hand and the dependence by us on obtaining additional financing to fund our operations after the current cash resources are exhausted raises substantial doubt about our ability to continue as a going concern. Our management concluded that the current financing and business plans have not mitigated such substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the date of filing this Quarterly Report for the quarterly period ended March 31, 2024. Our auditors also included
Current wording
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. 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 from the date of filing this Report for the quarterly period ended September 30, 2024. Our auditors also included an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended June 30, 2024 with respect to this uncertainty.
Previous wording
Revenue from the CDMO operations is now included in discontinued operations and not broken out separately on the financial statements. Revenue was otherwise immaterial. Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue in the next few years and ii) on our AI-driven discovery platform for which we do not expect substantial revenue in the next few years. Revenue for the nine months ended March 31, 2024 was related to a research licensing agreement utilizing our AI-driven discovery platform.
Current wording
Our ongoing business is primarily focused on i) development of our pipeline for which we do not expect revenue for many years, if at all, and ii) on our AI-driven discovery platform for which to date we have not generated any material revenue. We may have revenue with the AI-driven discovery platform in the future. No revenue was recognized for the three months ended September 30, 2024. Revenue for the three months ended September 30, 2023 was related to a research licensing agreement utilizing our AI-driven discovery platform.
Previous wording
R&D expenses for the three months ended March 31, 2024 and 2023 were $0.9 million and $2.6 million, respectively, a reduction of approximately ($1.7) million. The decrease in R&D expenses is mainly due to the reduction in personnel costs, a decrease in spending for consultants or outside services due to certain tasks and assays being performed in-house which were previously outsourced and a decrease in spend on consumable supplies.
Current wording
R&D expenses for the three months ended September 30, 2024 and 2023 were $1.3 million and $1.6 million, respectively, a reduction of approximately ($0.3) million. The decrease in R&D expenses is mainly due to the reduction in personnel costs and decrease spend for consultants or outside services due to certain tasks and assays being performed in-house which were previously outsourced.
Previous wording
G&A expenses for the three months ended March 31, 2024 and 2023 were approximately $2.7 million and $3.5 million, respectively, a decrease of ($0.8) million. The decrease in expenses is primarily attributable to a decrease in spending for consultants or outside services, the reduction in personnel costs, and a decrease in insurance premiums. The decreases were partially offset by an increase in legal fees.
Current wording
G&A expenses for the three months ended September 30, 2024 and 2023 were approximately $2.8 million and $3.5 million, respectively, a decrease of ($0.7) million. The decrease in expenses is primarily attributable to the reduction in personnel costs, a decrease in insurance premiums and a decrease in legal and consulting fees. The decreases were partially offset by an increase in accounting fees and travel expeses.
Previous wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended March 31, 2024 were approximately $3.6 million, compared to approximately $6.2 million in the same period of Fiscal year 2023.
Current wording
Total operating expenses, consisting primarily of R&D and G&A expenses, for the three months ended September 30, 2024 were approximately $4.1 million, compared to approximately $5.2 million in the same period of fiscal year 2023.
Previous wording
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 AI-driven precision antibody discovery and development company. In conjunction with the divestment, we completed a workforce reduction of approximately 60% and discontinued CDMO operations. CDMO operations remain treated as a discontinued operation on our financial statements. Losses for Discontinued Operations for the three months ended March 31, 2024 were approximately ($0.5) million which consisted of interest related to the Term Note on the Facility ($0.3) million and costs to maintain the Facility ($0.2) million. Losses for Discontinued Operations for the three months ended March 31, 2023 were approximately ($1.0) million which consisted mainly of personnel related expenses of ($1.5) million, Facility related costs of ($0.3) million and ($0.2) million of interest related to the Term Note on the Facility offset by $0.2 milion of net revenues and $0.8 million in gains from the sales of fixed assets.
Current wording
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 AI-driven precision antibody discovery and development company. In conjunction with the divestment, we completed a workforce reduction and discontinued the CDMO operations. CDMO operations were classified as discontinued operations on our financial statements through the fiscal year ended June 30, 2024. The loss for Discontinued Operations for the three months ended September 30, 2023 was approximately ($0.7) million which consisted mainly of interest related to the iBio CDMO entered into a Credit Agreement, dated November 1, 2021 (the “Credit Agreement”), with Woodforest National Bank (“Woodforest”) pursuant to which Woodforest provided iBio CDMO a $22,375,000 secured term loan (the “Term Loan”) to purchase the 130,000 square foot cGMP facility located in Bryan, Texas (the “Facility”), which Term Loan was evidenced by a term note (the “Term Note”) on the Facility and costs to maintain the Facility.
Previous wording
Net loss from continuing operations for the three months ended March 31, 2024 was ($2.6) million, or ($0.71) per share. Net loss from continuing operations for the three months ended March 31, 2023 was approximately ($6.3) million, or ($9.53) per share.
Current wording
Net loss from continuing operations for the three months ended September 30, 2024 was ($3.9) million, or ($0.46) per share. Net loss from continuing operations for the three months ended September 30, 2023 was approximately ($5.1) million, or ($4.24) per share.
Previous wording
Net cash used in operating activities was approximately ($13.7) million for the nine months ended March 31, 2024. The use of cash was primarily attributable to funding our net loss for the period.
Current wording
Net cash used in operating activities was approximately ($3.7) million for the three months ended September 30, 2024, compared to net cash used in operating activities of ($5.3) million for the three months ended September 30, 2023. The use of cash was primarily attributable to funding our net loss for the period.
Previous wording
Net Cash Provided by Financing Activities
Current wording
Net Cash (Used in) Provided by Financing Activities
Previous wording
We have incurred significant losses and negative cash flows from operations since our spin-off from Integrated BioPharma in August 2008. As of March 31, 2024, our accumulated deficit was approximately ($306.1) million and we used approximately ($13.7) million of cash for operating activities during the nine months ended March 31, 2024.
Current wording
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, 2024, our accumulated deficit was approximately ($317.8) million and we used approximately ($3.7)
Previous wording
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 possible sale of the CDMO entity or the Facility, through potential proceeds from the sale or out-licensing of assets, and through proceeds from the sale of additional equity or other securities. However, there can be no assurance that we will be successful in implementing these plans, many of which will take several years before we will realize proceeds. If we should default on the Credit Agreement and Woodforest does not waive the default, and if Woodforest makes a demand for the acceleration of all payments due to this default, it could result in all obligations that are guaranteed being due and payable immediately without further notice. If the Term Loan matures and is not extended or the Term Loan payment is not otherwise restructured and we do not at the time of maturity date receive proceeds from the sale of the Facility that will allow for the full outstanding Term Loan balance to be repaid, it could result in us being required to pay any shortfall. In such event we will need to raise capital again in the next few months and we cannot be certain funding will be available to us on favorable terms or available at all. If we are unable to raise funds when required or on favorable terms, we may have to: a) significantly delay, scale back, or discontinue the product application and/or commercialization of our proprietary technologies or restructure our Company including a further work force reduction; 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. If we can satisfy the Term Loan with the proceeds of a sale of the Facility without cash outlay, we would have a cash runway of greater than twelve months from the filing of this Quarterly Report.
Current wording
We plan to fund our future business operations using cash on hand, through proceeds realized in connection with the commercialization of our technologies, through potential proceeds from the sale or out-licensing of assets, and through proceeds from the sale of additional equity or other securities. However, there can be no assurance that we will be successful in implementing these plans, many of which will take several years before we realize proceeds. We cannot be certain that such funding will be available on favorable terms or available at all. 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.
Previous wording
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations. The following accounting estimate had a material impact on our results of operations for the three and nine months ended March 31, 2024.
Current wording
Critical accounting estimates are those estimates made in accordance with U.S. GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our financial condition or results of operations. The following accounting estimate had a material impact on our results of operations for the three months ended September 30, 2024.
Previous wording
We tested for impairment of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million at March 31, 2024. The key impairment trigger was a delay in the business plan with respect to IBIO-101 which prompted us to update our future cash flow model. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the asset. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.
Current wording
During the fourth quarter of the fiscal year ended June 30, 2024, we performed our annual impairment testing of the IBIO-101 therapeutic technology (or “IP”), classified as an indefinite-lived intangible asset, which had a carrying amount of $5 million at June 30, 2024. We engaged a third party to perform valuation assistance with estimating the fair value of IBIO-101 and preparing a market capitalization reconciliation. The Multi-Period Excess Earnings Method (“MPEEM”) under the income approach was utilized to value the indefinite-lived asset. The MPEEM determines the value of a specified asset by calculating the present value of future earnings attributed to the asset. Since IBIO-101 is currently in its pre-clinical development phase, a probability of success was applied to the cash flows to account for the probability of reaching each step of development. The MPEEM requires that charges for the use of other contributory assets be subtracted under the theory that the owner of the subject asset does not own the other contributory assets and would have to rent/lease them in order to earn the cash flows related to the subject asset.
Previous wording
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 14.0% discount rate, which was based on iBio’s weighted-average cost of capital. The sum of the discounted excess earnings and the present value of the tax benefit related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $5.9 million as of the March 31, 2024, valuation date. Given that the carrying amount of the asset was $5.0 million at March 31, 2024, it was concluded that no impairment existed.
Current wording
The resulting probability of success adjusted “excess earnings” were discounted to the present value using a 16% discount rate, which was based on iBio’s weighted average cost of capital. The sum of the discounted excess earnings and the present value of the tax benefit
Previous wording
We will continue to monitor the value of the IP, since we believe it is at risk for impairment. The primary impairment indicators that may arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.
Current wording
There were no triggering events identified in the first quarter of fiscal 2025. We will continue to monitor the value of the IP as part of our annual accounting policy for impairment of long-lived assets. The primary impairment indicators that may arise in the near future are (1) any sustained decline in our common stock market price and (2) FDA decisions on similar competing technologies that are applying for Phase 1 approval.
Previous wording
Our remaining critical accounting estimates remain consistent with the information disclosed in the same section in our last annual report on Form 10-K for the year ended June 30, 2023.
Current wording
Our remaining critical accounting estimates remain consistent with the information disclosed in the same section in our last annual report on Form 10-K/A for the year ended June 30, 2024.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
Another critical step in antibody optimization is the humanization of molecules originally raised in mice or other species. Humanization efforts of antibodies carry the risk of, among other things, losing binding strength. After engineering the leading MUC16 molecule with a fully human framework, our MUC16 molecule retained potent binding to the engineered epitope and maintained binding to human OVCAR-3 ovarian cancer cells.
Current report — wording carried from elsewhere
for head and neck cancer. In preclinical studies, our anti-EGFRvIII antibody demonstrated a 43 percent reduction in tumor growth compared to untreated animals.
Current report — wording carried from elsewhere
million of cash for operating activities during the three months ended September 30, 2024. As of September 30, 2023, our accumulated deficit was approximately ($294.7) million and we used approximately ($5.3) million of cash for operating activities during the three months ended September 30, 2023.
Current report — wording carried from elsewhere
related to amortization of the IBIO-101 indefinite-lived intangible indicated that the fair value was $5.9 million as of the June 30, 2024, valuation date. Given that the carrying amount of the asset was $5 million at June 30, 2024, it was concluded that no impairment existed.
Rearranged previous paragraphs (10)
Previous report — wording carried elsewhere
bispecific antibodies. And last, antibodies are transformed into conditionally activated antibodies by ShieldTx, our antibody masking technology. Each layer of the tech stack is designed to work synergistically, enabling us to rapidly advance antibodies from concept to in vivo proof-of-concept (POC).
Previous report — wording carried elsewhere
In August 2021, we signed a worldwide exclusive licensing agreement with RubrYc to develop and commercialize RTX-003 (now referred to as IBIO-101), an anti-CD25 monoclonal antibody (“mAb”). In September 2022, we acquired exclusive ownership rights to IBIO-101. IBIO-101 is a second-generation anti-CD25 mAb that has demonstrated in preclinical models of disease the ability to bind and deplete immunosuppressive regulatory T (“Treg”) cells to inhibit the growth of solid tumors.
Previous report — wording carried elsewhere
an explanatory paragraph in its report on our consolidated financial statements as of and for the year ended June 30, 2023 with respect to this uncertainty.
Previous report — wording carried elsewhere
Revenue from the CDMO operations is 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 for which we do not expect substantial revenue in the next few years. No revenue was recognized for the three months ended March 31, 2024.
Previous report — wording carried elsewhere
Results of Operations - Comparison of the nine months ended March 31, 2024 and 2023
Previous report — wording carried elsewhere
Research and Development Expenses (“R&D”)
Previous report — wording carried elsewhere
consultants or outside services since certain tasks and assays being performed in-house which were previously outsourced, a decrease in spend on consumable supplies and the reduction in personnel costs.
Previous report — wording carried elsewhere
General and Administrative Expenses (“G&A”)
Previous report — wording carried elsewhere
Total operating expenses, consisting primarily of R&D and G&A expenses, for the nine months ended March 31, 2024, were approximately $13.3 million, compared to approximately $24.4 million in the same period of Fiscal year 2023.
Previous report — wording carried elsewhere
We monitor fixed assets for impairment indicators throughout the year. When necessary, charges for impairments of long-lived assets are recorded for the amount by which the fair value is less than the carrying value of these assets. Changes in our business strategy or adverse changes in market conditions could impact impairment analyses and require the recognition of an impairment charge. Although we base our estimates on historical experience and various other assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.