On May 13, 2024 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported financial results for the third quarter ended March 31, 2024 and provided a corporate update (Press release, iBioPharma, MAY 13, 2024, View Source [SID1234643142]).

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"In our third fiscal quarter, we continued to advance toward our goal of becoming a leading antibody discovery company with a differentiated machine-learning platform," said Dr. Martin Brenner, CEO and Chief Scientific Officer. "Along with our recent equity financing, we secured a transformative partnership with AstralBio to discover and develop novel antibodies to treat obesity and other cardiometabolic diseases, with a lead program focused on targeting the transforming growth factor beta (TGFb) superfamily for treating muscle wasting and obesity. Our enhanced financial position has permitted us to accelerate the AstralBio collaboration, and we’ve already begun recruiting for key positions to support the process of identifying new molecules that are expected to simultaneously expand and diversify our pipeline. We believe we are well-positioned to advance our internal pipeline priorities in immuno-oncology and cardiometabolics, and drive partnerships in new therapeutic areas."

Fiscal Third Quarter 2024 & Recent Corporate Updates:

Entered into a securities purchase agreement for a fully subscribed private investment in public equity ("PIPE") financing with several institutional investors and an accredited investor in March, and consummated the financing in April for gross proceeds of approximately $15.0M before deducting placement agent fees and offering expenses.
Entered into a collaboration with AstralBio, Inc. to provide an exclusive license in the cardiometabolic and obesity space. iBio will develop four targets of interest, with the Company having the rights to license up to three of these targets prior to entering the clinic.
In February, iBio closed the sale of its early-stage PD-1 asset to Otsuka Pharmaceutical Co., Ltd. ("Otsuka") for $1M in upfront cash with contingent downstream payments of up to $52.5M, a pivotal moment that showcased the power of iBio’s platform to discover best-in-class assets.
Strengthened iBio’s cash position after previously issued warrants were exercised for proceeds of approximately $4.3M.
Appointed iBio’s CEO and Chief Scientific Officer, Dr. Martin Brenner, to the Board of Directors, effective June 1, 2024.
Presented data on the company’s technology stack, demonstrating how its machine learning (ML)-driven epitope steering and mammalian-display antibody libraries efficiently discover diverse T-cell engager arms tuned for potency, toxicity, developability, and cyno cross-reactivity at the 24th annual PepTalk conference.
Fiscal Third Quarter 2024 Financial Results:

No revenue was reported for the third quarter ended March 31, 2024.
R&D and G&A expenses for the third quarter of fiscal 2024 decreased approximately 66% and 23%, respectively, over the comparable period in fiscal 2023, reflecting the Company’s cash preservation strategy and focus on collaboration partnerships. Net loss from continuing operations for the third quarter ended March 31, 2024, was approximately $2.6 million, or $0.71 per share, compared to a net loss of approximately $6.3 million, or $9.53 per share, in the same period of 2023.
Cash, cash equivalents and restricted cash as of March 31, 2024 was approximately $6.4 million, inclusive of $1.1 million of restricted cash. On April 1, 2024, iBio received net proceeds of approximately $14.1 million after consummation of the PIPE financing. As of today’s filing, the Company has approximately $17.9 million in cash, cash equivalents and restricted cash.

On May 13, 2024 Genmab A/S (Nasdaq: GMAB). On March 15, 2024, Genmab reported the initiation of a share buy-back program to repurchase up to DKK 3.5 billion worth of shares (Press release, Genmab, MAY 13, 2024, View Source [SID1234643141]).
The share buy-back program is expected to be completed no later than December 16, 2024.

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The following transactions were executed under the program from May 6, 2024 to May 10, 2024:

Trading Platform No. of shares Average price (DKK) Total value (DKK)
Accumulated through
last announcement 689,510 1,393,154,997.08
May 6, 2024 XCSE
CEUX
AQEU
TQEX
Total 0 0.00 0.00
May 7, 2024 XCSE 0 0
CEUX 35 1,998.00
AQEU 0 0
TQEX 0 0
Total 35 1,998.00 69,930.00
May 8, 2024 XCSE 28 2,013.00
CEUX 55 2,015.45
AQEU 0 0
TQEX 37 2,002.00
Total 120 2,010.73 241,288.00
May 9, 2024 XCSE
CEUX
AQEU
TQEX
Total 0 0.00 0.00
May 10, 2024 XCSE
CEUX
AQEU
TQEX
Total 0 0.00 0.00
Total 155 311,218.00
Accumulated under the program 689,665 1,393,466,215.08

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 1,538,803 shares as treasury shares, corresponding to 2.33% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated March 15, 2024.

On May 13, 2024 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the first quarter ended March 31, 2024, and provided recent corporate updates (Press release, Galera Therapeutics, MAY 13, 2024, View Source [SID1234643140]).

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"Our review of strategic options continues, as we strive to maximize value for our stockholders," said Mel Sorensen, M.D., Galera’s President and CEO. "Potential options may include mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions and may encompass a potential development path for avasopasem. The process could ultimately culminate in the dissolution of the Company."

General Corporate Updates

Galera remains actively engaged with Stifel, Nicolaus & Company, Inc. to undertake a comprehensive review of strategic alternatives for both the Company and its portfolio of dismutase mimetics. The Company has not set a fixed timeline for completing this evaluation process and does not intend to disclose further updates unless and until it is determined that further disclosure is appropriate or necessary.
On May 3, 2024, the Company announced that its Board of Directors (the "Board") unanimously resolved to adopt a limited duration stockholder rights agreement (the "Rights Agreement") to protect stockholder interests. The Board resolved to adopt the Rights Agreement in response to recent accumulations of the Company’s common stock, and the Rights Agreement is intended to enable all Galera stockholders to realize the full potential value of their investment in Galera and to protect the interests of the Company and its stockholders by reducing the likelihood that any person or group gains control of Galera without paying an appropriate control premium. In addition, the Rights Agreement provides the Board with time to make informed decisions that are in the best long-term interests of Galera and its stockholders. It does not deter the Board from considering any offer or proposal that is fair and otherwise in the best interest of Galera stockholders.
First Quarter 2024 Financial Highlights

Research and development expenses were $1.5 million in the first quarter of 2024, compared to $7.3 million for the same period in 2023. The decrease was primarily attributable to a decrease in avasopasem and rucosopasem development costs. The Company has ceased all clinical trial activity and suspended the clinical development of its product candidates as it explores potential strategic alternatives.
General and administrative expenses were $3.1 million in the first quarter of 2024, compared to $6.6 million for the same period in 2023. The decrease was primarily attributable to the cessation of avasopasem commercial preparations and medical affairs activities and reduced personnel-related expenses due to the workforce reduction announced in August 2023.
Galera reported a net loss of $(4.4) million, or $(0.08) per share, for the first quarter of 2024, compared to a net loss of $(17.7) million, or $(0.50) per share, for the same period in 2023.
As of March 31, 2024, Galera had cash and cash equivalents of $13.5 million. Galera expects that its existing cash and cash equivalents will enable Galera to fund its operating expenses and capital expenditure requirements into the third quarter of 2025.

On May 13, 2024 Circio Holding ASA (OSE: CRNA), a biotechnology company developing circular RNA-based gene therapy, reported that it has presented two posters that demonstrate in vivo proof-of-concept for its powerful and differentiated circVec platform approach to gene therapy (Press release, Circio, MAY 13, 2024, View Source [SID1234643139]). The two posters were presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 annual meeting 7-11 May in Baltimore, USA

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"Circio has generated results demonstrating that the circVec 2.1 design performs very well in vitro. We have now confirmed this in vivo with statistically significant higher expression level and durability for circVec 2.1 DNA vectors compared to standard linear mRNA-based expression. These results provide an important technical proof-of-concept for Circio´s technology platform in an animal model. We now have confirmation for our expectation that this could translate into improved gene therapies for patients in the future," said Dr. Thomas B Hansen, CTO at Circio. "In recent experiments, Circio has observed up to four months circVec durability in vivo. This substantially outperforms mRNA vector expression. Following these results, we can rapidly advance to design and test circVec in several AAV and DNA-based vectors. This will validate these very promising data in therapeutically relevant formats."

At ASGCT (Free ASGCT Whitepaper), Circio also presented the dual-function ‘remove-&-replace’ concept for Alpha-1-antitrypsin deficiency (AATD). This genetic disease causes severe symptoms in the lung and liver. There are currently no satisfactory therapeutic options available for this indication and AATD still represents a major unmet medical need. There are over 200,000 AATD patients affected in the USA and EU alone. With the technologically differentiated circVec remove-&-replace format, Circio has developed a unique gene therapy concept that can deal with both the lung and liver-associated symptoms in one single therapeutic.

"AATD is a challenging genetic disease to treat. This is in part due to the two distinct pathologies in the liver and lung," said Dr. Victor Levitsky, CSO at Circio. "We have now established and technically validated circVec constructs that can both replenish functional wild-type AAT and specifically remove more than 90% of the mutated protein. This is challenging to achieve because the functional and mutant forms are very similar. By using circular RNA-based AAT expression, Circio is uniquely able to separate the two species for mutant-specific knockdown, thereby solving two problems with one single product."

Optimization and In Vivo Performance of circVec, a Vector-Based Circular RNA Expression Platform; O´Leary et al. ASGCT (Free ASGCT Whitepaper) 2024

Expressing AAT from circular RNA-encoding vectors as a promising gene therapy approach for Alpha 1-antitrypsin deficiency; O´Leary et al. ASGCT (Free ASGCT Whitepaper) 2024

On May 13, 2024 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported that James Oliviero, President and Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ, taking place on Monday, May 20, 2024, at 12:30 p.m. ET (Press release, Checkpoint Therapeutics, MAY 13, 2024, View Source [SID1234643138]). Checkpoint will also attend in-person one-on-one meetings during the conference.

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A webcast of the fireside chat will be available on the News & Events page, located within the Investors section of Checkpoint’s website, View Source, for approximately 30 days after the meeting.