iBio(IBIO)

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iBio(IBIO) - 2022 Q2 - Quarterly Report
2022-02-14 21:21
For the transition period from ___ to ___ Commission file number 001-35023 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 iBio, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorp ...
iBio(IBIO) - 2021 Q3 - Earnings Call Transcript
2021-11-16 03:55
iBio, Inc. (NYSE:IBIO) Q3 2021 Earnings Conference Call November 16, 2021 4:30 PM ET Company Participants Stephen Kilmer – Investor Relations Thomas Isett – Chairman and Chief Executive Officer Martin Brenner – Chief Scientific Officer Randy Maddux – Chief Operating Officer Robert Lutz – Chief Financial and Business Officer Conference Call Participants Kristen Kluska – Cantor Fitzgerald Norman Carlyle – Private investor Philip Barnett – Shareholder David Sandrock – Private Investor Operator Good day and tha ...
iBio(IBIO) - 2022 Q1 - Quarterly Report
2021-11-15 21:18
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission file number 001-35023 iBio, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incor ...
iBio(IBIO) - 2021 Q4 - Annual Report
2021-09-28 20:11
PART I [Business](index=4&type=section&id=Item%201.%20Business) iBio, Inc, a biopharmaceutical company, develops biologics using its plant-based FastPharming Manufacturing System® and operates through Biopharmaceuticals and Bioprocessing segments [Business Overview and Segments](index=4&type=section&id=Business%20Overview%20and%20Segments) iBio develops biopharmaceuticals using its sustainable FastPharming Manufacturing System® and operates through its Biopharmaceuticals and Bioprocessing segments - The company is structured into two main operating segments: **Biopharmaceuticals** and **Bioprocessing**[10](index=10&type=chunk) - The Biopharmaceuticals segment includes Therapeutics (oncology, fibrotic, infectious diseases) and Vaccines (human and animal health)[10](index=10&type=chunk) - The Bioprocessing segment includes Services (FastPharming, Process Development, Manufacturing) and Products (growth factors, lectins, antibodies for research)[10](index=10&type=chunk) [Biopharmaceutical Segment](index=4&type=section&id=Biopharmaceutical%20Segment) The Biopharmaceutical segment advances a proprietary pipeline including candidates for fibrosis (IBIO-100), oncology (IBIO-101), COVID-19 (IBIO-202), and Classical Swine Fever (IBIO-400) - The lead anti-fibrotic candidate, **IBIO-100**, has been granted orphan drug designation by the FDA for the treatment of systemic scleroderma[18](index=18&type=chunk) - In August 2021, the company licensed RTX-003 from RubrYc Therapeutics, an anti-CD25 monoclonal antibody for oncology, which will be advanced as **IBIO-101**[20](index=20&type=chunk)[23](index=23&type=chunk) - The company is developing **IBIO-202**, a subunit vaccine candidate for COVID-19 that targets the Nucleocapsid (N) protein, which is more conserved than the Spike (S) protein[30](index=30&type=chunk) - **IBIO-400** is a DIVA-capable subunit vaccine candidate for Classical Swine Fever that has shown complete protection in challenged pigs after a single dose[34](index=34&type=chunk)[35](index=35&type=chunk) [Bioprocess Segment](index=8&type=section&id=Bioprocess%20Segment) The Bioprocess segment provides contract development and manufacturing (CDMO) services and sells research and bioprocess products, with CDMO revenue growing 50% in fiscal 2021 CDMO Service Revenue | Fiscal Year | Revenue (in millions) | Year-over-Year Growth | | :--- | :--- | :--- | | 2021 | $2.4 | 50% | | 2020 | $1.6 | - | - The company launched its Research & Bioprocess Products (RBP) business during the fiscal year, offering recombinant proteins through a new e-shop[38](index=38&type=chunk) [FastPharming Technology](index=9&type=section&id=FastPharming%20Technology) FastPharming is a proprietary, plant-based protein production system offering advantages in speed, cost, quality, scalability, safety, and sustainability over traditional methods - The FastPharming System uses transiently-transfected Nicotiana benthamiana plants for protein production[41](index=41&type=chunk) - Key advantages of FastPharming include **speed** (weeks vs months), **cost-effectiveness**, **quality**, **scalability**, **safety** (no mammalian virus risk), and **sustainability**[43](index=43&type=chunk) - The system is established in iBio's **130,000 square foot facility** in Bryan, Texas, which houses automated hydroponic systems capable of growing over four million plants[42](index=42&type=chunk)[71](index=71&type=chunk) [Strategic Alliances, Collaborations, and Joint Ventures](index=10&type=section&id=Strategic%20Alliances%2C%20Collaborations%2C%20and%20Joint%20Ventures) The company leverages strategic alliances, including a key collaboration with RubrYc Therapeutics for its oncology pipeline and an exclusive license with the University of Pittsburgh - Entered into a series of agreements with RubrYc Therapeutics in August 2021, including an exclusive license for RTX-003, a collaboration for antibody discovery, and a **$5 million stock purchase** in RubrYc[51](index=51&type=chunk)[55](index=55&type=chunk)[60](index=60&type=chunk) - Holds an exclusive worldwide license from the University of Pittsburgh for endostatin peptides used in its IBIO-100 anti-fibrosis program, with specific development milestones required[64](index=64&type=chunk)[65](index=65&type=chunk) - The company's Bryan, Texas manufacturing facility is operated through iBio CDMO, a joint venture in which iBio holds a **99.99% interest**, with an affiliate of Eastern Capital Limited holding the remaining interest and acting as the sublandlord[68](index=68&type=chunk)[69](index=69&type=chunk) - Terminated its partnership with Planet Biotechnologies for the development of a recombinant ACE2-Fc protein for COVID-19[67](index=67&type=chunk) [Intellectual Property](index=15&type=section&id=Intellectual%20Property) The company's intellectual property portfolio consists of 102 patents, with expiration dates ranging from 2023 to 2036, covering its core technologies and product candidates Patent Portfolio Summary | Category | Count | | :--- | :--- | | Total Patents | 102 | | - Owned | 96 | | - Licensed | 6 | | U.S. Patents | 24 | | International Patents | 72 | - Patents expire between **2023 and 2036**[72](index=72&type=chunk) - Patented technologies include methods for transient gene expression in plants, recombinant carrier molecules, and specific antigens and vaccine compositions for various diseases[77](index=77&type=chunk) [Competition](index=16&type=section&id=Competition) iBio faces intense competition from large pharmaceutical companies, specialized biotech firms, and other contract manufacturers in its therapeutic and CDMO markets - The company competes with commercial pharmaceutical and biotech enterprises, academic institutions, and research institutions[80](index=80&type=chunk) - In the CDMO market, competition comes from full-service contract manufacturers and large pharmaceutical companies with excess capacity[81](index=81&type=chunk) - Key competitors in oncology and fibrosis include large, multinational biopharmaceutical companies such as **Roche**, **Boehringer Ingelheim**, **Gilead**, and **Bristol-Myers Squibb**[85](index=85&type=chunk)[86](index=86&type=chunk) - In the COVID-19 space, the company faces competition from established vaccine manufacturers like **Pfizer**, **Moderna**, and **AstraZeneca**, with over 231 vaccines and 612 therapeutics in development globally[87](index=87&type=chunk) [Government Regulation and Product Approval](index=18&type=section&id=Government%20Regulation%20and%20Product%20Approval) The company's products and services are subject to extensive regulation by the FDA and similar authorities, requiring a lengthy and rigorous approval process - Pharmaceutical products require rigorous preclinical testing and multi-phase clinical trials before they can be marketed, a process overseen by the FDA[93](index=93&type=chunk)[94](index=94&type=chunk) - The clinical trial process typically involves three sequential phases: **Phase 1** (safety), **Phase 2** (preliminary efficacy and dosage), and **Phase 3** (large-scale efficacy and safety)[98](index=98&type=chunk)[101](index=101&type=chunk)[105](index=105&type=chunk) - The company's CDMO facility is subject to FDA regulation and must comply with cGMPs, as well as environmental, health, and safety laws[118](index=118&type=chunk)[120](index=120&type=chunk) - The Orphan Drug Act may provide benefits like market exclusivity for products treating rare diseases affecting fewer than 200,000 individuals in the U.S[112](index=112&type=chunk) [Human Capital](index=23&type=section&id=Human%20Capital) As of June 30, 2021, the company had 75 employees and plans to expand its workforce in Fiscal 2022 to support growth objectives Employee Headcount as of June 30, 2021 | Entity | Employee Count | | :--- | :--- | | iBio, Inc. | 18 | | iBio CDMO | 57 | | **Total** | **75** | - The company plans to hire additional staff in Fiscal 2022 to meet growth objectives for its therapeutic, vaccine, and RBP product development[121](index=121&type=chunk) - Compensation programs include competitive wages, incentive pay, and a 401(k) plan with a **100% match** on employee contributions up to 5% of compensation[130](index=130&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including a history of financial losses, the need for additional capital, uncertainties in product development, and reliance on third parties - The company has a history of significant losses, with a **net loss of $23.2 million** in FY 2021 and an **accumulated deficit of $173.6 million** as of June 30, 2021[142](index=142&type=chunk) - The business depends on the success of its four product candidates, which are all in early stages of pre-clinical development and require significant testing before seeking regulatory approval[165](index=165&type=chunk) - The company's license agreement with the University of Pittsburgh for its lead fibrosis candidate, IBIO-100, contains specific milestone deadlines that it may not meet, potentially jeopardizing the license[247](index=247&type=chunk) - Operations are reliant on a single manufacturing facility in Texas, making the company vulnerable to disruptions from natural disasters, equipment failure, or other unforeseen events[265](index=265&type=chunk) - The company may not have a sufficient number of authorized shares of common stock for future equity financings or strategic transactions, which could impede growth[155](index=155&type=chunk)[156](index=156&type=chunk) [Property](index=58&type=section&id=Item%202.%20Property) iBio's primary operations are conducted at a 130,000-square-foot leased manufacturing facility in Texas and a newly leased R&D facility in California - The main facility is a **130,000 sq. ft.** Class A life sciences building in Bryan, Texas, leased until 2050[302](index=302&type=chunk) - The Bryan facility lease requires an annual base rent of **$2.1 million**, plus a tiered percentage of gross sales, with minimums applicable if sales targets are not met[303](index=303&type=chunk)[306](index=306&type=chunk) - A new lease was signed in September 2021 for approximately **11,383 sq. ft.** of lab and office space in San Diego, CA, to be used for R&D[307](index=307&type=chunk) [Legal Proceedings](index=59&type=section&id=Item%203.%20Legal%20Proceedings) In May 2021, iBio settled its litigation with Fraunhofer USA, Inc, resulting in a total cash payment of $28 million to the company - On May 4, 2021, the company entered into a settlement agreement with Fraunhofer USA, Inc. to resolve all claims in a lawsuit initiated in March 2015[308](index=308&type=chunk) - The settlement terms include cash payments to iBio totaling **$28 million**, with an estimated net cash recovery of approximately **$10.2 million** after legal fees and expenses[309](index=309&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=60&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NYSE American under the symbol "IBIO", and the company has never paid cash dividends on its common stock - The company's common stock trades on the NYSE American under the symbol **'IBIO'**[314](index=314&type=chunk) - **No cash dividends** have ever been declared or paid on common stock[315](index=315&type=chunk) - Accrued dividends on the Preferred Tracking Stock totaled approximately **$1,131,000** at June 30, 2021[316](index=316&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=60&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For fiscal year 2021, revenue increased 50% to $2.4 million, but a sharp rise in operating expenses led to a net loss of $23.2 million, while the cash position strengthened to $97.0 million [Results of Operations](index=61&type=section&id=Results%20of%20Operations) In fiscal 2021, revenue grew 50%, but surging R&D and G&A expenses widened the operating loss, partially offset by a significant legal settlement Fiscal Year 2021 vs. 2020 Results of Operations (in millions) | Metric | FY 2021 | FY 2020 | Change | | :--- | :--- | :--- | :--- | | Revenue | $2.4 | $1.6 | +50% | | R&D Expenses | $10.0 | $3.6 | +$6.4 | | G&A Expenses | $22.0 | $11.4 | +$10.6 | | Other Income (Expense) | $7.9 | ($2.4) | +$10.3 | - The increase in Other Income was primarily attributable to **$10.2 million** in settlement income from the Fraunhofer IP litigation[327](index=327&type=chunk) [Liquidity and Capital Resources](index=62&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company had $97.0 million in cash and investments, which is deemed sufficient to fund operations through the first quarter of calendar year 2023 - Cash and investments in debt securities totaled approximately **$97.0 million** as of June 30, 2021[330](index=330&type=chunk) - Management believes current cash is sufficient to support operations through the **first quarter of calendar year 2023**[330](index=330&type=chunk) Cash Flow Summary (in millions) | Activity | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Net Cash Used in Operating | ($30.1) | ($13.3) | | Net Cash Used in Investing | ($26.5) | ($1.1) | | Net Cash Provided by Financing | $78.8 | $65.2 | - During fiscal 2021, the company raised approximately **$68.8 million** through an "At-The-Market" facility with UBS and approximately **$41.5 million** through offerings with Cantor Fitzgerald[334](index=334&type=chunk) [Controls and Procedures](index=64&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of June 30, 2021 - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2021[346](index=346&type=chunk) - Based on an assessment using the 2013 COSO Framework, management concluded that internal control over financial reporting was **effective** as of June 30, 2021[350](index=350&type=chunk)[351](index=351&type=chunk) - As a smaller reporting company, this report does not include an attestation report from the independent registered public accounting firm regarding internal control over financial reporting[353](index=353&type=chunk) [Other Information](index=65&type=section&id=Item%209B.%20Other%20Information) On September 23, 2021, the Board of Directors approved a significant cash bonus and stock option grant for the Chairman and CEO - On September 23, 2021, the Board awarded CEO Thomas Isett a cash bonus of **$509,000** and an option to purchase **2,000,000 shares** of common stock at an exercise price of $1.17 per share[354](index=354&type=chunk) PART III Information required for Part III is incorporated by reference from the company's definitive proxy statement for its 2021 Annual Meeting of Stockholders - Information for Items 10 through 14 is incorporated by reference from the definitive proxy statement for the 2021 Annual Meeting of Stockholders[356](index=356&type=chunk) PART IV This part contains the list of exhibits filed with the Form 10-K, including governance documents, material contracts, and certifications [Exhibits and Financial Statement Schedules](index=67&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of all exhibits filed with or incorporated by reference into the Annual Report, including material contracts and governance documents - Lists all exhibits filed with the Form 10-K, including corporate governance documents, material agreements, and management compensation plans[368](index=368&type=chunk)[372](index=372&type=chunk)[375](index=375&type=chunk) Financial Statements [Consolidated Financial Statements](index=77&type=section&id=Consolidated%20Financial%20Statements) For fiscal year 2021, total assets grew significantly to $147.0 million, while the net loss widened to $23.2 million due to higher operating expenses Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | June 30, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $77,404 | $55,112 | | Total Assets | $146,968 | $94,189 | | Total Liabilities | $38,400 | $37,582 | | Total Stockholders' Equity | $108,568 | $56,607 | Consolidated Statement of Operations Highlights (in thousands) | Account | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Revenues | $2,371 | $1,638 | | Gross Profit | $909 | $935 | | Operating Loss | ($31,111) | ($14,003) | | Net Loss Attributable to iBio, Inc. | ($23,207) | ($16,439) | | Loss Per Share | ($0.12) | ($0.61) | Consolidated Statement of Cash Flows Highlights (in thousands) | Account | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($30,064) | ($13,345) | | Net Cash Used in Investing Activities | ($26,478) | ($1,154) | | Net Cash Provided by Financing Activities | $78,835 | $65,192 | | Net Increase in Cash | $22,292 | $50,691 | [Notes to Consolidated Financial Statements](index=82&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, segment information, lease obligations, significant equity transactions, and the financial impact of a major legal settlement - The company's revenue is primarily from fixed-fee contracts, recognized at a point in time upon completion of deliverables; in FY2021, **$2.371 million** was recognized at a point in time[432](index=432&type=chunk)[434](index=434&type=chunk) - The company's finance lease for its Bryan, TX facility has a remaining term of **28.58 years** with a weighted average discount rate of 7.606%; total future minimum lease payments amount to **$79.2 million**[494](index=494&type=chunk)[495](index=495&type=chunk) - In May 2021, the company settled litigation with Fraunhofer USA, resulting in a settlement income of **$10.2 million** and a total settlement receivable of the same amount[575](index=575&type=chunk)[577](index=577&type=chunk) - Subsequent to year-end, in August 2021, the company entered into a collaboration, license, and stock purchase agreement with RubrYc Therapeutics, investing **$5 million**[612](index=612&type=chunk)[621](index=621&type=chunk)
iBio(IBIO) - 2021 Q4 - Earnings Call Transcript
2021-09-27 15:54
iBio, Inc. (NYSE:IBIO) Q4 Fiscal 2021 Earnings Conference Call September 27, 2021 8:30 AM ET Company Participants Thomas Isett – Chairman & Chief Executive Officer Stephen Kilmer – Investor Relations Randy J Maddux – Chief Operating Officer Martin Brenner – Chief Scientific Officer Robert Lutz – Chief Financial and Business Officer Conference Call Participants Rick – Cantor Fitzgerald Matthew Herm – Matthew Herm LLC Operator Ladies and gentlemen, thank you for standing by and welcome to the iBio fiscal 2021 ...
iBio(IBIO) - 2021 Q3 - Quarterly Report
2021-05-17 20:34
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ⌧ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR (Exact name of registrant as specified in its charter) Delaware 26-2797813 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 8800 HSC Parkway, Bryan, TX 77807-1107 (Address of principal executive offices) (Zip Code) (979) 4 ...
iBio(IBIO) - 2021 Q2 - Quarterly Report
2021-02-16 21:12
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported increased revenue but a wider operating loss, though its cash position significantly improved due to financing activities [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and equity grew substantially due to a significant increase in cash and investments from recent capital raises Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2020 (Unaudited) | June 30, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $91,252 | $55,112 | | Investments in debt securities | $16,395 | $0 | | Total Current Assets | $110,882 | $61,748 | | Total Assets | $145,406 | $94,189 | | **Liabilities & Equity** | | | | Total Current Liabilities | $6,102 | $5,236 | | Total Liabilities | $38,085 | $37,582 | | Total Equity | $107,321 | $56,607 | | Total Liabilities and Equity | $145,406 | $94,189 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Revenues grew year-over-year, but higher operating expenses led to a larger operating loss of $14.5 million Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended Dec 31, 2020 | Six Months Ended Dec 31, 2019 | | :--- | :--- | :--- | | Revenues | $1,115 | $422 | | Total operating expenses | $15,584 | $7,432 | | Operating loss | $(14,469) | $(7,010) | | Consolidated net loss | $(15,665) | $(8,228) | | Net loss available to iBio, Inc. stockholders | $(15,793) | $(29,916) | | Loss per common share - basic and diluted | $(0.09) | $(1.02) | | Weighted-average common shares outstanding | 175,264 | 29,420 | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Significant cash from financing activities offset cash used in operations and investing, resulting in a net cash increase Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended Dec 31, 2020 | Six Months Ended Dec 31, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,489) | $(5,692) | | Net cash used in investing activities | $(19,556) | $(238) | | Net cash provided by financing activities | $71,185 | $5,146 | | **Net increase (decrease) in cash** | **$36,140** | **$(784)** | | Cash - beginning of period | $55,112 | $4,421 | | **Cash - end of period** | **$91,252** | **$3,637** | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail a strategic shift to biologics, significant capital raises ensuring liquidity, and segment performance - The company is a biotechnology firm and CDMO, shifting its primary focus to its **biologics development programs**[22](index=22&type=chunk)[23](index=23&type=chunk) - Based on cash, cash equivalents, and debt securities of approximately **$107.6 million**, management believes it has adequate cash to support activities through March 31, 2023[39](index=39&type=chunk) - The biologics development segment had an operating loss of **$5.6 million**, while the iBio CDMO segment had an operating loss of **$8.8 million**[195](index=195&type=chunk)[196](index=196&type=chunk) - In January 2021, the company issued an additional 4.24 million shares of common stock, receiving net proceeds of approximately **$4.7 million**[201](index=201&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=49&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses its strategic shift, rising expenses, and significantly improved liquidity from recent financing activities [Overview and Recent Developments](index=49&type=section&id=Overview%20and%20Recent%20Developments) The company advanced its COVID-19 vaccine candidate and secured significant funding through multiple financing agreements - The company selected **IBIO-201** as its lead candidate for the prevention of SARS-CoV-2 infection based on preclinical data[212](index=212&type=chunk) - On October 1, 2020, iBio entered a master services agreement with Safi Biosolutions, Inc and invested **$1.5 million** in Safi via a convertible promissory note[213](index=213&type=chunk) - The company raised approximately **$32.3 million** in net proceeds from an underwritten public offering in December 2020, and an additional **$4.7 million** in January 2021[219](index=219&type=chunk)[201](index=201&type=chunk) [Results of Operations](index=53&type=section&id=Results%20of%20Operations) Revenue increased by $0.7 million, while higher R&D and G&A expenses drove a larger operating loss of $14.5 million Comparison of Results of Operations (in thousands) | Expense Category | Six Months Ended Dec 31, 2020 | Six Months Ended Dec 31, 2019 | Change | | :--- | :--- | :--- | :--- | | Revenue | $1,115 | $422 | +$693 | | Research and Development | $4,206 | $1,865 | +$2,341 | | General and Administrative | $11,378 | $5,567 | +$5,811 | | **Total operating expenses** | **$15,584** | **$7,432** | **+$8,152** | - The increase in G&A expenses was primarily driven by increases in **professional and consulting fees (+$3.4M)**, facility repairs (+$0.9M), and personnel costs (+$0.5M)[233](index=233&type=chunk) [Liquidity and Capital Resources](index=55&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds a strong liquidity position of $107.6 million, deemed sufficient to fund operations through March 2023 - As of December 31, 2020, the company had cash, cash equivalents, and debt securities of approximately **$107.6 million** and believes this is sufficient to support operations through March 31, 2023[240](index=240&type=chunk)[245](index=245&type=chunk) - The company has incurred significant losses since inception, with an accumulated deficit of approximately **$166.1 million** as of December 31, 2020[244](index=244&type=chunk) Cash Flow Summary for Six Months Ended Dec 31, 2020 (in thousands) | Activity | Amount | | :--- | :--- | | Net Cash Used in Operating Activities | $(15,489) | | Net Cash Used in Investing Activities | $(19,556) | | Net Cash Provided by Financing Activities | $71,185 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=59&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, iBio is not required to provide the information for this item - The company is a smaller reporting company and is **not required to provide information** regarding quantitative and qualitative disclosures about market risk[253](index=253&type=chunk) [Item 4. Controls and Procedures](index=59&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes to internal controls - The Chief Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2020[255](index=255&type=chunk) - **No material changes** to the internal control over financial reporting were identified during the quarter ended December 31, 2020[256](index=256&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=60&type=section&id=Item%201.%20Legal%20Proceedings) The company is in ongoing litigation with Fraunhofer USA over technology ownership, with a trial scheduled for March 2021 - The company is engaged in a lawsuit against Fraunhofer USA regarding technology ownership rights, with a **trial scheduled for March 1-5, 2021**[258](index=258&type=chunk)[262](index=262&type=chunk) - On September 25, 2020, the Court **denied Fraunhofer's motion for summary judgment** on several key claims, allowing them to proceed to trial[260](index=260&type=chunk) [Item 1A. Risk Factors](index=61&type=section&id=Item%201A.%20Risk%20Factors) Material risks include a history of losses, significant customer concentration, and dependence on key technology licenses - The company has a history of significant losses, with a net loss of **$15.7 million** for the six months ended December 31, 2020, and an accumulated deficit of **$166.1 million**[270](index=270&type=chunk) - For the three months ended December 31, 2020, one customer accounted for **63.8% of total revenue**, indicating significant customer concentration risk[267](index=267&type=chunk) - The company's fibrosis product candidate, IBIO-100, is dependent on a license requiring an **IND filing by December 31, 2021**[268](index=268&type=chunk) - The market price of the company's common stock has been and may continue to be **volatile**[281](index=281&type=chunk) [Item 5. Other Information](index=65&type=section&id=Item%205.%20Other%20Information) There is no information to report under this item - None[285](index=285&type=chunk) [Item 6. Exhibits](index=66&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including agreements, plans, and required certifications [Signatures](index=68&type=section&id=SIGNATURES) - The report was signed on **February 16, 2021**, by Thomas F. Isett, Chairman and Chief Executive Officer, and John Delta, Principal Accounting Officer[290](index=290&type=chunk)
iBio(IBIO) - 2021 Q1 - Earnings Call Transcript
2020-11-17 03:44
iBio, Inc. (iBio) Q1 2021 Earnings Conference Call November 16, 2020 4:30 PM ET Company Participants Stephen Kilmer - IR Thomas Isett - Chairman and Chief Executive Officer John Delta - Principal Accounting Officer Conference Call Participants Ben Haynor - Alliance Global Patrick Wolf - Operator Good day ladies and gentlemen and thank you for standing by. Welcome to the iBio Fiscal 2021 First Quarter Financial Results Conference Call. At this time all participants are in a listen-only mode. After the speak ...
iBio(IBIO) - 2021 Q1 - Quarterly Report
2020-11-16 21:16
OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 (979) 446-0027 (Registrant's telephone number, including area code) For the transition period from ___ to ___ Commission file number 001-35023 iBio, Inc. (Exact name of registrant as specified in ...
iBio(IBIO) - 2020 Q4 - Annual Report
2020-10-13 21:17
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission file number 001-35023 (Address of principal executive offices) (Zip Code) iBio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2797 ...