On May 17, 2021 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the first quarter ended March 31, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, MAY 17, 2021, View Source [SID1234580152]).

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"This quarter, we have made tremendous progress advancing the clinical development of one of our lead programs, ZN-c3, underscored by strong data recently presented in a late-breaking session at AACR (Free AACR Whitepaper)," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "These initial results from the Phase 1 monotherapy trial not only demonstrated signals of single-agent efficacy and a superior safety profile compared to other WEE1 inhibitors in development, but also generated multiple confirmed Exceptional Responses across differing solid tumor types. With the recommended dose selected, we look forward to pursuing many planned trials with ZN-c3 this year and exploring its best-in-class potential both as a monotherapy and in combination."

Continued Dr. Sun, "In parallel, we continue to make great headway with the development of our additional differentiated oncology candidates – ZN-c5, ZN-d5 and ZN-e4 – with numerous trials on track to initiate in 2021. Looking ahead to our catalyst-rich year, we remain focused on executing on our clinical strategy and creating value for our stakeholders, in hopes of delivering innovative treatments to help improve the lives of cancer patients."

Program Highlights:

In April 2021, Zentalis reported initial results from the Phase 1 portion of a Phase 1/2 trial of ZN-c3 in advanced solid tumors in a late-breaking session at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which was further discussed at a webcast event with Key Opinion Leaders.
ZN-c3 generated three Exceptional Responses in heavily pretreated patients with ovarian cancer, colorectal cancer and non-small cell lung cancer, as well as two unconfirmed Partial Responses in patients with uterine serous carcinoma;
Showcased favorable safety results with a wide therapeutic window;
A Unique Predictive Biomarker was identified for the Exceptional Responders, with plans to further investigate the biomarker in this patient population;
Selected Recommended Phase 2 Dose for ZN-c3 to be 300 mg QD with continuous dosing.

In April 2021, we entered into a Clinical Trial Collaboration and Supply Agreement with GSK to investigate the combination of ZN-c3, our oral WEE1 inhibitor, and niraparib, GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with advanced epithelial ovarian cancer. The Company expects to initiate a Phase 1b trial with this combination in the second half of 2021.

Zentera Therapeutics, Zentalis’ majority-owned joint venture, filed four Clinical Trial Applications (CTAs, China equivalent of IND) and three have been approved in China to date for ZN-c5, ZN-c3, and ZN-c3 in combination. A fourth CTA was submitted earlier this month for ZN-d5.

In February 2021, Zentalis entered into a strategic collaboration with Tempus to leverage its patient-derived organoid biological modeling platform to aid Zentalis in discovering and developing novel oncology therapies. The collaboration will assist in the validation of Zentalis’ mechanistic discoveries, initially focusing on its WEE1 inhibitor, ZN-c3, across patient tumor populations.
Anticipated Milestones:

The Company plans to report interim results from numerous ongoing trials with ZN-c5 and to share guidance on future development plans for this product candidate in the second quarter of 2021.
Zentalis expects to initiate several studies in the coming months, including:
A Phase 2 trial of ZN-c3 in uterine serous carcinoma in the third quarter of 2021;
A Phase 1/2 trial of ZN-c3 in combination with chemotherapy in osteosarcoma in the third quarter of 2021; and
A Phase 1/2 trial of ZN-c3 in combination with GSK’s niraparib in ovarian cancer in the second half of 2021.
Corporate Highlights:

In February 2021, the Company appointed Enoch Kariuki, Pharm.D., to the Board of Directors. Dr. Kariuki most recently served as Chief Financial Officer at VelosBio and has over a decade of experience in life sciences investment banking, strategic advising and business development.
First Quarter 2021 Financial Results

Cash and Marketable Securities Position: As of March 31, 2021, Zentalis had cash, cash equivalents and marketable securities of $298.4 million. Zentalis expects that its existing cash, cash equivalents and marketable securities, which includes the net proceeds of approximately $155.2 million from the August 2020 follow-on offering, will enable the Company to fund its operating expenses and capital expenditure requirements into 2023.

Research and Development Expenses: Research and development expenses for the three months ended March 31, 2021 were $38.4 million, compared to $13.3 million for the three months ended March 31, 2020. The increase of $25.1 million was primarily due to increases in external research and development expenses related to our lead product candidates, as we advanced our Phase 1/2 clinical trials for each of ZN-c5, ZN-c3, ZN-d5 and ZN-e4. In addition, in the three months ended March 31, 2021, we conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials. Unallocated research and development expenses increased by $14.0 million primarily due to $6.6 million of additional employee related costs, of which $3.0 million was driven by non-cash stock-based compensation from incentive grants and increased headcount to support our platform development. Expenses attributable to collaborations and strategic alliances increased by $3.0 million while allocated expenses, including software, supplies and insurance increased by $2.4 million and outside services increased by $2.0 million to support our growth.

General and Administrative Expenses: General and administrative expenses for the three months ended March 31, 2021 were $11.9 million, compared to $3.1 million during the three months ended March 31, 2020. This increase of $8.8 million was primarily attributable to an increase of $8.3 million in employee-related costs, of which $6.4 million was driven by non-cash stock-based compensation from incentive grants, and from increased headcount to support our growth. Consulting and outside services increased by $0.7 million, and fees increased by $0.3 million to support the increased operations of the organization. Insurance costs increased by $0.7 million due to operating as a public company offset by allocated expenses.

Net Loss: Net loss was $50.4 million for three months ended March 31, 2021, compared to $16.2 million for the three months ended March 31, 2020. The increase of $34.2 million was primarily the result of the increases in research and development and general and administrative expenses discussed above.

Impact from COVID-19 Pandemic: Though the impact of the COVID-19 pandemic to our business and operating results presents additional uncertainty and cannot be predicted with confidence, we continue to use the best information available to inform our critical accounting estimates.

On May 17, 2021 GT Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE) protein biologic technology platform reported financial results for the first quarter ended March 31, 2021 and provided a general business update (Press release, GT Biopharma, MAY 17, 2021, View Source [SID1234580170]).

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"In the first quarter of 2021, and in the weeks since, we were very pleased to report exciting and encouraging data from our ongoing Phase I/II clinical trial of GTB-3550 in MDS and AML," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "Both from efficacy and safety perspectives, our GTB-3350 TriKE program appears to be delivering the TriKE’s unique therapeutic potential which has been well tolerated in all of our patients. Our differentiated approach stimulating NK cell activity, reinforces our rationale to proceed with additional programs in solid tumor and hematologic cancers. In addition, with our $28.7M financing completed and a key strategic manufacturing partnership in place, we are well equipped and positioned to capitalize on the potential we are already seeing from these innovative new therapies. We again thank the patients and their families for their contribution, as we advance towards the prospect of an off-the-shelf monotherapy cancer therapeutic that can be therapeutically effective without supplemental engineered NK cells or the need for any combination drugs."

Clinical Highlights

Updated Interim Results from First-in-Human GTB-3550 TriKE Phase I/II Clinical Trial for the Treatment of High-Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML): In March and April 2021, GT Biopharma announced updated interim results from the Phase I dose-escalation portion of the Phase I/II expansion clinical trial of GTB-3550 TriKE from 9 patients with MDS and AML. Results demonstrated up to 63.7% reduction in bone marrow blast levels, restoration of endogenous NK cell function, proliferation and immune surveillance. All patients treated displayed no signs of any grade of cytokine release syndrome (CRS) across all dose cohorts. GTB-3550 TriKE is currently being administered to patients at doses significantly higher than the reported maximum tolerated dose (MTD) for continuous infusion of recombinant human interleukin-15 (IL-15).
Enrollment in Phase I Portion of GTB-3550 TriKE Phase I/II Clinical Trial in MDS and AML Continues: In April 2021, GT Biopharma announced the enrollment of patient 10 in its GTB-3550 TriKE Phase I/II Clinical Trial in high-risk MDS and AML patients. The patient was dosed at 100mcg/kg/day.
Additional New Findings Supporting GTB-3550 TriKE Monotherapy: In April 2021, GT Biopharma announced additional interim results demonstrating that GTB-3550 TriKE monotherapy is able to rescue the patient’s otherwise exhausted/inhibited/non-functional endogenous NK cell population, and target direct killing of the patient’s AML and MDS cancer cells without the need for the co-administration addition of supplemental progenitor-derived or autologous/allogenic engineered NK cells.
Announced Preliminary Phase II Clinical Trial Design: In May 2021, GT Biopharma announced updates to the Phase 2 design of the ongoing Phase I/II clinical trial of GTB-3550 TriKE monotherapy. The Phase II portion intends to enroll patients with CD33 expression ≥50% in independent cohorts (higher-risk MDS and AML); treat patients with two cycles of GTB-3550 therapy with a rest period between cycles as opposed to the single-cycle used during Phase 1; enroll patients with fewer prior treatment lines; and, (evaluate the potential use of minimal residual disease (MRD) based endpoints that may allow for accelerated approval.
Corporate Highlights

Closed $28.7 Million Public Offering and Successful Nasdaq Listing: In February 2021, GT Biopharma announced the closing of an underwritten public offering extending GT Biopharma’s cash runway through 2022. The Company also retired over $32 million in debt and consolidated capital structure to 28,637,000 shares issued and outstanding.
Strengthened Leadership Team with Key Appointments: In April 2021, GT Biopharma announced the appointment of Gregory Berk, M.D., as Chief Medical Officer and the transition of Jeffrey S. Miller, M.D., from Consulting Chief Medical Officer to Consulting Chief Scientific Officer. Additionally, in January 2021, GT Biopharma announced the appointments of Michael Breen and Rajesh Shrotriya, M.D., as independent directors to the Company’s Board of Directors.
Expanded GMP Manufacturing Agreement with Cytovance Biologics: In February 2021, GT Biopharma announced that it signed an expanded GMP manufacturing agreement with Cytovance Biologics for the manufacturing of all TriKE product candidates.
First Quarter 2021 Financial Results:

Cash Position: As of March 31, 2021, cash, cash equivalents and investments were $27.6 million, compared to $5.3 million as of December 31, 2020. The increase in cash, cash equivalents and investments was primarily due to the completed public offering of 4,945,000 shares of common stock for net proceeds of $24,679,000 after deducting underwriting discounts, commissions and other direct offering expenses. As of May 14th, current cash position of $35,000,000.
Research and Development Expenses: Research and development expenses were $1.6 million for the first quarter of 2021, compared to $.3 million for the same period in 2020. The increase in research and development expenses for the first quarter 2021 was primarily due to the issuance of 189,753 shares of common stock as payment of a fee valued at $1,355,000. We anticipate our direct clinical costs to increase in the remainder of 2021 upon the continuation of a phase one/two clinical trial of our most advanced TriKE product candidate, GTB-3550.
General Administrative Expenses: General administrative expenses were $27.3 million for first quarter 2021, compared to $.7 million for the same period in 2020. The increase in selling, general and administrative expenses is primarily attributable the increase in stock-based compensation. In the period ended March 31, 2021 we incurred $21,535,000 of stock-based compensation, we incurred no such expenses during 2020.
Net Loss: Net loss was $29.7million for the first quarter of 2021, resulting in basic and diluted net loss per share of $1.83. Net loss was $1.7 million for the same period in 2020, resulting in basic and diluted net loss per share of $0.41.
About GTB-3550 TriKE

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

On May 17, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported the receipt of $4.5 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2020 (Press release, PDS Biotechnology, MAY 17, 2021, View Source [SID1234580192]).

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"We are pleased to receive an allocation from the New Jersey NOL program," said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "The funding will be beneficial to us as we continue to efficiently utilize our resources to advance our immuno-oncology pipeline through development."

The NOL program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 U.S. employees (including parent company and all subsidiaries) to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. PDS Biotech is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

On May 17, 2021 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported an exclusive license and collaboration agreement with Ji Xing Pharmaceuticals (Ji Xing) to develop and, if approved, commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China (Press release, Milestone Pharmaceuticals, MAY 17, 2021, View Source [SID1234580243]). Ji Xing is a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW) focused on advancing innovative medicines in China.

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"This agreement marks an important step toward realizing our vision for etripamil to benefit patients living with PSVT globally while strengthening our balance sheet and executional capabilities through partnership," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We look forward to partnering with the talented team at Ji Xing to develop and commercialize this promising therapy in the licensed regions."

"Etripamil has the potential to change the treatment paradigm for PSVT and could serve as a meaningful new therapeutic option for patients," said Peter Fong, Chief Executive Officer of Ji Xing and Head of Company Creation at RTW. "We are delighted to expand Ji Xing’s cardiovascular focus by partnering with Milestone and look forward to unlocking the full therapeutic potential of etripamil for patients with PSVT in China."

Under the terms of the agreement, Milestone will grant Ji Xing an exclusive license to develop and, if regulatory approval is obtained, commercialize etripamil in patients with PSVT in Greater China. Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment by RTW. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. Milestone will supply etripamil and delivery devices to Ji Xing. Ji Xing will be responsible for development and commercialization costs in Greater China.

About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning that affects approximately two million Americans. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. However, calcium channel blockers approved for the termination of SVT episodes must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, Milestone’s lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and a Phase 2 proof-of-concept trial is now underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).

On May 17 2021 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a biotech innovator and biologics contract manufacturing organization, reported its financial results for the fiscal quarter ended March 31, 2021 (Press release, iBioPharma, MAY 17, 2021, View Source [SID1234585484]).

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"Our focus on strategy execution was reflected in our third quarter results as we advanced our second-generation COVID-19 vaccine candidate, defended our intellectual property rights, and achieved strong year-over-year revenue growth while adding new development services clients," said Tom Isett, Chairman & CEO of iBio. "Also, more recently, we saw continued progress on new product and pipeline additions, including line extensions to our Bioanalytical Services offering, and a planned investment in the establishment of a new Drug Discovery team. Importantly, we believe that when our new discovery capabilities are installed, we will be able to more fully leverage the many ‘speed-to-clinic’ advantages conveyed by our proprietary FastPharming System."

Fiscal Third Quarter and Recent Business Developments:

Vaccines

In May 2021, iBio reported on development of IBIO-202, a subunit vaccine candidate that targets the nucleocapsid protein ("N protein") of SARS-CoV-2. Using its FastPharming System, iBio has successfully expressed N protein antigens and has initiated both intramuscular and intranasal preclinical studies to evaluate antigen-adjuvant combinations that may provide strong T-cell memory and immune responses. Initial results are expected in early Q1 FY2022.
The Company also announced that IBIO-201, its COVID-19 vaccine candidate combining antigens derived from the spike protein ("S protein") fused with its patented LicKM Immunostimulator, had completed IND-enabling toxicology studies, with no adverse effects observed at low or high doses.
In support of approval for production of its lead animal health product candidate, IBIO-400, the Company submitted an "Outline of Production" and facility documentation to the U.S. Department of Agriculture for review.
Therapeutics

Today, iBio announced its plans to establish drug discovery capabilities in the San Diego, CA, area, with an initial focus upon monoclonal antibodies for use in oncology.
The Company continued pre-clinical development of IBIO-100, with initiation of IND-enabling studies expected in FY 2022.
Contract Development and Manufacturing ("CDMO") Services

In May 2021, iBio announced that it concluded its lawsuit with Fraunhofer USA, Inc. ("Fraunhofer USA") as described in full detail in the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on May 4, 2021.
Today, iBio announced an expanded menu of Bioanalytical Services, including intact protein analysis, new proteomic assays and middle-down characterization for monoclonal antibodies. The Company’s Bioanalytical Services were previously available only to FastPharming Development and Manufacturing Services clients, but are now available to biologics developers using alternative protein expression systems.
Research & Bioprocess Products

iBio continues to make progress towards launching certain cytokines and growth factors as part of a new catalog of products for research and further manufacturing uses.
"We are excited about the advancement of a differentiated second-generation COVID-19 vaccine candidate," said Mr. Isett. "Additionally, we are pleased with the protection of – and compensation for – our IP in plant-based biologics, as we further develop our FastPharming Technologies. Moreover, we continue to see increased demand from new and existing customers for our CDMO Services, even while we are in the midst of our transformation."

With reference to the Company’s planned establishment of in-house drug discovery capabilities, Mr. Isett commented, "We believe that our investment in fast, translatable drug discovery activities will enable us to optimally leverage our FastPharming System to create a robust pipeline of truly innovative molecules and fast-followers, particularly in the field of oncology."

Fiscal Third Quarter and Recent Corporate Developments:

Fiscal year to-date, iBio increased staffing by approximately 21% to 57 employees.
During the fiscal third quarter, iBio further strengthened its leadership team with the additions of Dr. Martin B. Brenner as Chief Scientific Officer and Mr. Robert M. Lutz as Chief Financial & Business Officer, effective January 18 and March 4, 2021, respectively.
"The key additions of Martin and Rob – along with the recruitment of many talented new employees to our R&D and Operations functions – reflect the ongoing rapid and successful transformation of iBio," said Mr. Isett. "By further expanding the capabilities of our team this quarter, we delivered new pipeline candidates, new service products and continued to advance other key initiatives. Clearly, our ability to execute and deliver value to shareholders has been further elevated this quarter, and we expect that the investment in the new Drug Discovery Team will yield significant returns as we seek to make the FastPharming System the bioprocess platform-of-choice."

Financial Results:

For the fiscal quarter ended March 31, 2021, iBio reported revenues of approximately $0.8 million, an increase of $0.7 million from $0.1 million in the fiscal quarter ended March 31, 2020.

To further clarify the results of its operations for investors, from this quarter forward, iBio will include Cost of Goods Sold ("COGS") and Gross Profit line items in its financial statements. For the three-months ended March 31, 2021, iBio reported COGS of approximately $0.5 million and gross profit of $0.3 million, compared to COGS of $0.1 million and gross profit that was not significant for the three months ended March 31, 2020. Since iBio’s revenue is currently derived from a small number of contracts, and revenue recognition from development and manufacturing services is generally subject to volatility due to timing, the Company expects that gross profit and gross profit percentage may fluctuate significantly from quarter to quarter.

R&D expenses for the fiscal quarter ended March 31, 2021 were approximately $2.2 million, compared with approximately $1.1 million in the same period of 2020. The increase in R&D expense of approximately $1.1 million was primarily related to increases in personnel and other expenses to support the Company’s development of a portfolio of proprietary therapeutics and vaccines.

G&A expenses for the fiscal quarter ended March 31, 2021 were approximately $5.3 million, compared with approximately $3.0 million in the same period of 2020. The increase of approximately $2.3 million resulted primarily from increased headcount and increased operations to support the growth of the business.

Net loss attributable to iBio stockholders for the fiscal quarter ended March 31, 2021 was approximately $7.7 million, or $0.04 per share. This compared with a net loss of approximately $4.7 million, or $0.06 per share, in the same period of 2020.

iBio had $103.9 million in cash, cash equivalents and debt investments as of March 31, 2021. The Company further strengthened its financial position through the aforementioned settlement of litigation with Fraunhofer USA. The Company believes it will have sufficient resources to fund its planned operations at least through March 31, 2023, inclusive of its planned investment in the FastPharming Discovery Platform and potential in-licensing activities.

Webcast and Conference Call

iBio management will host a webcast and conference call at 8:00 a.m. Eastern Time today, May 17, 2021, to discuss these results and provide a corporate update.

The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference code: 3085726.