iBio Reports Fiscal Third Quarter 2025 Financial Results

On May 2, 2025 iBio, Inc. (Nasdaq:IBIO), reported financial results for the third quarter ended March 31, 2025, and provided a corporate update on its progress (Press release, iBioPharma, MAY 2, 2025, View Source [SID1234652478]).

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"During the third quarter we were able to broaden our access to investors given our move to Nasdaq and subsequently in April, strengthened our financial position with a $6.2 million warrant-inducement equity raise, positioning us for continued growth and keeping us on track for regulatory submission of IBIO-600 in 2026," said Martin Brenner, Ph.D., DVM, iBio’s Chief Executive Officer and Chief Scientific Officer. "At the same time, we made significant strides in our pipeline, with promising non-human primate data for IBIO-600 and the in-licensing of a first-in-class Activin E antibody, two antibodies we truly believe are bringing us closer to fulfilling our mission of delivering transformative therapies to patients suffering from cardiometabolic diseases and obesity."

Fiscal Third Quarter 2025 & Recent Corporate Updates:

Began trading on the Nasdaq Stock Exchange under the ticker symbol "IBIO," marking a significant corporate milestone that enhances visibility, improves trading liquidity, and aligns with the company’s strategy to attract long-term institutional investors.
Reported non-human primate data for IBIO-600, a potentially best-in-class long-acting anti-myostatin antibody, demonstrating extended half-life and dose dependent muscle growth. Simultaneously, iBio announced interim in vivo results for a first-in-class Activin E antibody showing fat-selective weight loss alone and in combination with semaglutide.
In-licensed the aforementioned first-in-class Activin E-targeting antibody from AstralBio, expanding iBio’s cardiometabolic and obesity pipeline.
Raised $6.2 million in gross proceeds through a warrant inducement transaction with institutional investors, strengthening our balance sheet and providing additional working capital to support advancements in our pipeline.
Fiscal Third Quarter 2025 Financial Results:

R&D expenses for the three months ending March 31, 2025 and 2024 were $1.9 million and $0.9 million, respectively, an increase of approximately $1.0 million. The growth in R&D expenses is mainly due to increased spending on consultants and outside services, consumable supplies, and personnel-related costs as a result of advancing research activities to support our IBIO-600 and Activin E programs.
G&A expenses for the three months ending March 31, 2025 and 2024 were approximately $3.0 million and $2.7 million, respectively, an increase of $0.3 million. The increase is primarily attributable to growth in IT related costs, consulting fees and franchise taxes, partially offset by lower professional service fees.
Net loss from continuing operations for the three months ending March 31, 2025 was approximately $4.9 million, or $0.49 per share, compared to a net loss from continuing operations of approximately $2.6 million, or $0.71 per share, in the same period of fiscal 2024.
Cash, cash equivalents and restricted cash as of March 31, 2025, was approximately $5.2 million, inclusive of $0.2 million of restricted cash. Subsequent to the warrant inducement transaction in April, cash, cash equivalents and restricted cash was approximately $10.5 million as of May 1, 2025.

Exact Sciences to Participate in May Investor Conference

On May 2, 2025 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conference and invited investors to participate by webcast (Press release, Exact Sciences, MAY 2, 2025, View Source [SID1234652477]).

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BofA Securities Health Care Conference, Las Vegas
Fireside chat on Wednesday, May 14, 2025 at 1:40 p.m. ET (10:40 a.m. PT)
The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Lilly to participate in Bank of America Securities 2025 Healthcare Conference

On May 2, 2025 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Bank of America Securities 2025 Healthcare Conference, May 15, 2025. Lucas Montarce, Lilly executive vice president and chief financial officer, will take part in a fireside chat at 11:40 a.m., Eastern time (Press release, Eli Lilly, MAY 2, 2025, View Source [SID1234652476]).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

Agios to Present at the BofA Securities 2025 Health Care Conference on May 14, 2025

On May 2, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that its management team is scheduled to present at the BofA Securities 2025 Health Care Conference on Wednesday, May 14, 2025, at 8:00 am PT/11:00 am ET (Press release, Agios Pharmaceuticals, MAY 2, 2025, View Source [SID1234652475]).

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The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

Genmab to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed/Refractory Follicular Lymphoma (FL)

On May 2, 2025 Genmab A/S (Nasdaq: GMAB) reported its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), following at least one prior systemic therapy (Press release, Genmab, MAY 2, 2025, View Source [SID1234652444]).

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The decision to submit the sBLA is supported by positive topline results from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab plus R2 versus R2 alone in adult patients with R/R FL. Based on an interim analysis conducted by an Independent Data Monitoring Committee (IDMC) review, the study met one of its dual primary endpoints of ORR (Complete Response plus Partial Response, p-value < 0.0001). The safety profile of epcoritamab plus R2 in adult patients with R/R FL was consistent with the known safety profiles of the individual regimens (epcoritamab and R2) and as presented in the U.S. prescribing information for epcoritamab. No new safety signals were observed. The full results will be submitted later this year for presentation at an upcoming medical congress and discussed with global regulatory authorities.

"We are pleased with the strength of the data that allows us to submit a supplemental Biologics License Application in accordance with the U.S. FDA’s Project Frontrunner, which supports our commitment to advance novel medicines to patients who need them. The interim topline results demonstrate the potential of this investigational epcoritamab combination regimen to treat relapsed or refractory follicular lymphoma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. "This milestone represents our commitment to the ongoing development of epcoritamab, with our partner AbbVie, and we look forward to seeing the full results from the study."

Use of epcoritamab plus R2 in R/R FL is not approved in the U.S., in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in FL have not been established. Epcoritamab is currently approved by the FDA under Accelerated Approval as a monotherapy for the treatment of adults with R/R FL after two or more lines of systemic therapy.

About Follicular Lymphoma (FL)
FL is typically an indolent (or slow-growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20-30 percent of all cases.i About 15,000 people develop FL each year in the U.S.ii and it is considered incurable with current standard of care therapies.iii Patients often relapse and, with each relapse the remission and time to next treatment is shorter.iv Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25 percent of FL patients.v

About the EPCORE FL-1 Trial
EPCORE FL-1 (NCT05409066) is a Phase 3 open-label interventional trial to evaluate the safety and efficacy of epcoritamab plus rituximab and lenalidomide (R2) versus R2 alone in patients with relapsed/refractory (R/R) follicular lymphoma (FL). The dual primary endpoints are ORR and progression-free survival assessed by independent review committee (IRC) per Lugano criteria.

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.vi

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744), and a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.