On September 27, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal year ended June 30, 2022 and provided a corporate update (Press release, Kintara Therapeutics, SEP 27, 2022, View Source [SID1234621461]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

CORPORATE HIGHLIGHTS AND RECENT DEVELOPMENTS

Announced that three posters were accepted for data presentation at the 2022 Society for Neuro-Oncology ("SNO") Annual Meeting. The 2022 SNO Annual Meeting will be held from November 16 through November 20, 2022 in Tampa, Florida (September).
Received a Study May Proceed letter from the United States Food and Drug Administration ("FDA") to begin a 15-patient study evaluating REM-001 Photodynamic Therapy ("PDT") for the treatment of cutaneous metastatic breast cancer ("CMBC"). This study is intended to aid in the design of a planned Phase 3 registrational study (August).
Entered into a purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $20.0 million of shares of the Company’s common stock, subject to the satisfaction of the conditions contained in the agreement as well certain limitations contained therein (August).
Received notice from the FDA that the Company was granted Fast Track Designation for VAL-083 for the treatment of patients with newly-diagnosed, unmethylated glioblastoma ("GBM") (June).
Received written notification from the Listing Qualification Department of The Nasdaq Stock Market LLC ("Nasdaq") granting the Company’s request for a 180-day extension to regain compliance with Nasdaq’s minimum bid price requirement. The Company has until November 28, 2022 to meet the requirement (June).
Announced that the Company’s first European site, University Hospital Zurich in Zurich, Switzerland, had been activated for the VAL-083 treatment arm in the Global Coalition for Adaptive Research ("GCAR") registrational Phase 2/3 clinical trial for GBM, titled Glioblastoma Adaptive Global Innovative Learning Environment ("GBM AGILE Study") (May).
"This last quarter was a very productive quarter – on the financing side we put in place a $20.0 million equity facility with Lincoln Park to help bolster our balance sheet. On the regulatory front we received our second Fast Track Designation from the FDA for VAL-083 and the GBM-AGILE Study continues to exceed our expectations," commented Robert E. Hoffman, Kintara’s President and Chief Executive Officer. "Moving our REM-001 CMBC program back into the clinic is also an important step for us to deliver on our mission of serving cancer patients where there is a clear unmet medical need. We believe we remain on track to start enrolling patients in the CMBC study around the end of September 2022."

SUMMARY OF FINANCIAL RESULTS FOR FISCAL YEAR ENDED JUNE 30, 2022

At June 30, 2022, Kintara had cash and cash equivalents of approximately $11.8 million. During the year ended June 30, 2022, the Company completed two registered direct offerings for aggregate net proceeds to the Company of approximately $21.6 million.

For the year ended June 30, 2022, Kintara reported a net loss of approximately $22.7 million, or $0.52 per share, compared to a net loss of approximately $38.3 million, or $1.60 per share, for the year ended June 30, 2021. The decreased net loss for the year ended June 30, 2022 compared to the year ended June 30, 2021 was largely due to the recognition of $16.1 million of non-cash expenses related to the acquisition of in-process research and development costs associated with the Adgero transaction in August 2020.

On September 27, 2022 Ajinomoto Corporation ("Ajinomoto Co."), through its consolidated subsidiary, Ajinomoto Genexine Corporation ("AGX"), reported that it has reached an agreement with JSR Corporation ("JSR"), a leading materials company, to collaborate on the global expansion of its biopharmaceutical culture media business, adding new high-performance media developed by JSR, to Ajinomoto Co.’s product lineup. Sales are scheduled to begin in December 2022 (Press release, JSR, SEP 27, 2022, View Source [SID1234621460]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Image is for illustration purposes.

Currently, the global market for culture media, which is essential for cell culture in biopharmaceutical R&D and manufacturing, is growing at an annual rate of more than 10% due to the growing demand for antibody drugs and vaccines and the expansion of cell and gene therapies. Demand is forecast to grow to more than USD15 billion*1 by 2030. Accordingly, demand for CHO cell line culture medium, which has become a mainstream for biomedical use, is expected to increase further.

In this collaboration, Ajinomoto Co. will receive access to the composition of a high-performance culture medium (CELLiSTTM BASAL CHO MX) optimized for JSR’s CHO-M cell line*2, which will be commercialized and manufactured by AGX. AGX will undertake sales in the Asian markets, while JSR will retain exclusive rights to market and sell Basal CHO MX in the U.S. and European markets. In addition to the CHO-M cell line, this product has also been confirmed to exhibit higher antibody productivity in other CHO cell lines than products currently available on the market. (Ajinomoto Co. and JSR research).

Under the Ajinomoto Group Medium-Term Management Plan 2020-2025, the Group is focusing on the biopharmaceutical culture medium business. Ajinomoto Co. has been involved in the development, production, and sale of CHO and other culture media for biopharmaceuticals for more than 30 years. The company’s strengths include bioprocess technologies, which have been cultivated through the supply of amino acids for pharmaceutical and food applications, and the company’s global supply chain of amino acids, which are important raw materials for culture media. Since 2017, Ajinomoto Co. has been selling and marketing biopharmaceutical media under the CELLiSTTM brand, mainly in Asia.

CELLiST_220927.png

JSR, through its JSR Life Sciences division, provides materials for downstream bioprocessing including Amsphere A3 protein A resins and others and a full range of drug discovery and development support services.

Both companies will exhibit the CELLiSTTM BASAL CHO MX at BioProcess International 2022, which will be held from September 27-30, 2022 in Boston, Massachusetts, USA.

Michael Lish, General Manager of Amino Science Division, Ajinomoto Co., commented as follows: "Since 2014, we have been supplying high-quality culture media for biopharmaceuticals from our plant in South Korea. We are very honored to have the opportunity to meet the needs of our customers in Europe and the United States through this new market channel. This collaboration is an important measure to grow our culture media business into the second pillar of our amino acid business."

"Ajinomoto is a good fit to commercialize this culture media because of their advanced technology and high quality assurance systems," said Tim Lowery, Senior Officer, General Manager of Life Sciences Div. "JSR is a materials company at our core, and this collaboration expands our ability to bring our expertise to customers, so we are excited to bring the CELLiSTTM BASAL CHO MX to the North American and European markets."

Ajinomoto Co. and JSR will strengthen their biopharmaceutical culture media business through collaboration for global business development. Ajinomoto Co. will continue to contribute to the development of new medicines through the production and marketing of CELLiSTTM, a biomedical medium, with the aim of "solving food and health problems through the action of amino acids." As a state-of-the-art technology company, JSR Corporation promotes the advancement and practical application of science based on its corporate mission of Materials Innovation.

On September 27, 2022 Imunon, Inc. (NASDAQ: IMNN), a clinical-stage drug development company, reported that Dr. Corinne Le Goff, President and Chief Executive Officer will present a company overview and be available for 1×1 meetings at the upcoming Chardan 6th Annual Genetic Medicines Conference (Press release, IMUNON, SEP 27, 2022, View Source [SID1234621459]). The conference will be held on October 3-4 with in-person participation held at the Westin Grand Central Hotel in New York City.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Le Goff will present in person on Monday, October 3rd at 2:30 pm ET. The presentation will available live and on-demand here.

On September 27, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable FastPharming Manufacturing System, reported that preliminary unaudited financial results for the fiscal year ended June 30, 2022, and provides a corporate update (Press release, iBioPharma, SEP 27, 2022, View Source [SID1234621458]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have continued to take important steps toward achieving our strategic objective of becoming a leading biotechnology company with a focus on developing innovative immunotherapies," said Tom Isett, Chairman & CEO of iBio. "Chief among these was the RubrYc asset acquisition, which provides us with a differentiated, AI-powered drug discovery platform and four promising new candidates to go along with our lead asset, IBIO-101, an IL-2 sparing anti-CD25 antibody. With an expanded portfolio and increasing technical, regulatory, and market challenges for COVID-19 vaccine development, we have decided not to proceed with an IND submission for IBIO-202, our multi-variant COVID-19 vaccine candidate. We also continue to review options to extend our cash runway."

Recent Business Developments:

BIOPHARMACEUTICALS

Therapeutics

Last week, iBio acquired substantially all the assets of its partner, RubrYc Therapeutics, Inc. ("RubrYc"). The transaction included RubrYc’s artificial intelligence ("AI")-driven Discovery Engine; its proprietary humanized antibody library; all rights, with no future milestone payment or royalty obligations, to the two immuno-oncology assets previously licensed in the partnership; and four new immunotherapy candidates.

The AI Discovery Engine is unique as it is the only proprietary machine-learning platform of its kind to combine computational biology and 3D-modeling of epitopes for the identification and engineering of large-molecule drug candidates based upon subdominant, as well as conformational, epitopes that have proven hard to target using traditional ‘trial-and-error’ screening methods.

As part of the RubrYc transaction, the Company now wholly-owns, with no further financial commitments, its lead immune-oncology asset, IBIO-101; an IL-2 sparing anti-CD25 antibody aimed at depleting immunosuppressive regulatory T cells without interfering with T effector cell anti-tumor effects. As iBio evaluates its recently increased options for the molecule’s development, the Company now expects to file an Investigational New Drug ("IND") application for IBIO-101 with the U.S. Food and Drug Administration ("FDA") in the first half of calendar 2024.
Vaccines

As previously reported, preclinical studies of IBIO-202, the Company’s vaccine candidate that uses a nucleocapsid ("N") antigen rather than the more mutable spike ("S") protein of SARS-CoV-2, demonstrated a robust, antigen-specific, memory T-cell response. Nevertheless, data derived from recent IND-enabling challenge studies in immunologically naïve hamsters showed that IBIO-202 did not provide protective effect as an "N-only" vaccine. Accordingly, iBio has decided not to move forward with the IND submission for IBIO-202 in 2023.
A recent preclinical study published in the peer-reviewed journal, Science Translational Medicine, similarly demonstrated that N-only vaccination provided modest protection from SARS-CoV-2. However, the study also showed that combining N with S ("N+S") induced more robust protection against both Delta and Omicron variants than S-only vaccination.
In light of the challenge study data, the continuing need for a ‘last dose’, not a ‘next dose’ of a COVID-19 vaccine, and iBio’s prospects to secure non-dilutive funding and/or partnership opportunities for the program, iBio is evaluating next steps for its proprietary N-antigen drug substance.
Recent Corporate Developments:

At the Company’s Special Meeting of Stockholders held on June 30, 2022, iBio’s stockholders approved a proposal giving the Board of Directors (the "Board") the option to effect a one for twenty-five (1-for-25) reverse stock split of the Company’s shares of common stock in the event that it deemed it advisable.

iBio announced today the Board has approved a one for twenty-five (1-for-25) reverse stock split that will become effective Friday, October 7, 2022, upon the filing of a Certificate of Amendment to the Company’s Certificate of Incorporation, as amended, with the Secretary of the State of Delaware. On Monday, October 10, 2022, the Company’s common stock will begin trading on a post-reverse split basis on the NYSE American under the same symbol "IBIO," but with a new CUSIP number of 451033609.
"The importance of having flexibility to pursue our strategic objectives with the availability of additional issuable shares was underscored with the RubrYc transaction, financed upfront with iBio common stock," said Mr. Isett. "We are pleased that our shareholders voted in favor of the reverse stock split proposal that could provide the Company with strategic business management flexibility."

Preliminary Unaudited Financial Results:

Revenues for the fiscal year ended June 30, 2022, were approximately $2.4 million, an increase of 1% over fiscal 2021.

R&D and G&A expenses for fiscal 2022 increased $7.7 million and $12.1 million, respectively, over the comparable period in fiscal 2021. The growth in R&D and G&A reflects the Company’s growing investments in its pipeline, platform technologies, employees, and related infrastructure.

iBio’s consolidated net loss for the fiscal year ended June 30, 2022, was $50.3 million, an increased loss of $27.1 million compared to 2021 due to increased R&D and administrative expenses incurred to support the Company’s business strategy and $10.2 million in Fraunhofer USA settlement income in fiscal 2021 that did not recur in fiscal 2022 offset by $1.8 million in Fraunhofer USA license revenue in fiscal 2022.

iBio held cash, cash equivalents and investments in debt securities of $39.5 million as of June 30, 2022.

The Company has concluded there is substantial doubt about the Company’s ability to continue as a going concern. Accordingly, the Company has been informed by its registered public accounting firm that its audit opinion that will be included in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2022 to be filed with the Securities and Exchange Commission will include an explanatory paragraph related to the Company’s ability to continue as a going concern. This announcement is made pursuant to NYSE American LLC Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. iBio is evaluating a number of potential options to expand its cash runway, the implementation of which will impact its liquidity. Potential options being considered to increase liquidity include lowering our expenses through decreasing spending, such as with the IBIO-202 program, and focusing product development on a select number of product candidates. Additional options include the sale or out-licensing of certain product candidates or parts of the business, raising money from capital markets, grant revenue or collaborations, or a combination thereof.

Webcast and Conference Call

iBio management will host a webcast and conference call at 4:30 p.m. Eastern Time today, September 27, 2022, to discuss these results and provide additional updates.

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. To access the live call by phone, participants should go to this registration link, where they will be provided with the dial-in details.

On September 27, 2022 Galapagos NV (Euronext & NASDAQ: GLPG) reported a share capital increase arising from subscription right exercises (Press release, Galapagos, SEP 27, 2022, View Source [SID1234621457]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Galapagos issued 107,000 new ordinary shares on 27 September 2022, for a total capital increase (including issuance premium) of EUR 3,076,250.

Pursuant to the subscription right exercise program for Galapagos’ executive committee, the members of the executive committee automatically are committed to exercise a minimum number of subscription rights, subject to certain conditions. In accordance with the rules of this program, one executive committee member exercised 5,000 subscription rights.

In accordance with Belgian transparency legislation1, Galapagos also wishes to note that its total share capital currently amounts to EUR 356,111,899.01, the total number of securities conferring voting rights amounts to 65,835,511, which is also the total number of voting rights (the denominator), and all securities conferring voting rights and all voting rights are of the same category. The total number of rights (formerly known as ‘warrants’) to subscribe to not yet issued securities conferring voting rights is (i) 10,763,717 subscription rights under several outstanding personnel subscription right plans, which equals 10,763,717 voting rights that may result from the exercise of those subscription rights, and (ii) 1 subscription right issued to Gilead Therapeutics to subscribe for a maximum number of shares that is sufficient to bring the shareholding of Gilead (and its affiliated companies) to 29.9% of the actually issued and outstanding shares after the exercise of such subscription right. Galapagos does not have any convertible bonds or shares without voting rights outstanding.