On August 11, 2023 Kineta reported its corporate presentation (Presentation, Kineta, AUG 11, 2023, View Source [SID1234634285]).

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On August 11, 2023 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, reported its financial results for the second quarter of 2023 (Press release, Xenetic Biosciences, AUG 11, 2023, View Source [SID1234634284]).

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"Since the beginning of 2023, we have taken important, fundamental steps to further advance our DNase-based oncology platform. We have secured strategic collaborations, bolstered our team’s expertise and identified development and regulatory pathways that give us line of sight towards our first in human clinical study. Moving forward, we intend to establish additional strategic collaborations that we believe will enable us to expedite this pathway to the clinic and expand our opportunities and value proposition," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

Recent Highlights:

Executed the first Collaborator Statement of Work ("SOW") as part of the previously announced collaboration agreement with VolitionRx and CLS Therapeutics to develop NETs-targeted adoptive cell therapies for the treatment of cancer. The Company’s collaboration with Volition is an early exploratory program to evaluate the potential combination of Volition’s Nu.Q technology and Xenetic’s DNase-Armored CAR T platform to develop proprietary adoptive cell therapies potentially targeting multiple types of solid cancers for which current CAR T cell therapies have shown limited or no effect; and
Continued participation in conferences and investor-focused events. To watch the replay of the most recent event, click here.
Summary of Financial Results for Second Quarter 2023

Net loss for the quarter ended June 30, 2023 was approximately $1.1 million. Research & development expenses for the three months ended June 30, 2023 decreased by approximately $1.2 million, or 56.5%, to approximately $0.9 million from approximately $2.1 million in the comparable quarter in 2022. The decrease was primarily due to in-process research and development ("IPR&D") expense of $1.3 million associated with the Company’s licensing of the DNase oncology platform during the three months ended June 30, 2022. There was no similar expense in 2023. Excluding the $1.3 million of IPR&D expense from total R&D expense of $2.1 million for the three months ended June 30, 2022, R&D expense for the three months ended June 30, 2023 increased by $0.1 million, or 16.9%, primarily due to increased spending related to our pre-clinical development efforts associated with our DNase platform. Royalty payments of approximately $0.7 million were received from our sublicense with Takeda Pharmaceuticals Co. Ltd in the three months ended June 30, 2023, representing an approximate 56.2% increase over the same period in 2022. General and administrative expenses for the three months ended June 30, 2023 decreased by approximately $0.1 million, or 7.8%, to approximately $0.9 million from approximately $1.0 million in the comparable quarter in 2022. The decrease was primarily due to a decrease in legal fees and share-based expense during the three months ended June 30, 2023 compared to the same period in 2022.

The Company ended the quarter with approximately $10.7 million of cash and no debt.

On August 11, 2023 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), reported financial results for the second quarter ended June 30, 2023 and provided an update on recent corporate developments (Press release, vTv Therapeutics, AUG 11, 2023, View Source [SID1234634283]).

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"In the first half of 2023, we made further progress in the development of cadisegliatin as an adjunctive therapy to insulin for the treatment of type 1 diabetes," said Paul Sekhri, Chief Executive Officer of vTv. "The Breakthrough Therapy Designation granted to cadisegliatin has enabled us to actively engage with the FDA to align on the design and conduct of the planned Phase 3 study. Further, our partners at Cantex Pharmaceuticals have made exciting progress on the development of azeliragon, a small-molecule RAGE inhibitor discovered by vTv, as a potential treatment for a variety of oncology and related indications. Overall, we believe we are well positioned heading into the second half of the year and look forward to providing updates, as appropriate, on our partnered programs as well as cadisegliatin as we advance toward the initiation of Phase 3 study activities, which we continue to expect by year-end. The initial phase 3 study will test the FDA’s recommended primary endpoint, which is the reduction in the number of hypoglycemic events between placebo and cadisegliatin treated groups."

Recent Company Highlights

•On July 17, 2023, the Company received notice from Nasdaq that it had approved the Company’s request to extend the period for the Company to regain compliance with the Minimum Bid Requirement until December 18, 2023.
Second Quarter 2023 Financial Results

•Cash Position: The Company’s cash position as of June 30, 2023 was $12.6 million compared to $12.1 million as of December 31, 2022.

•Research & Development (R&D) Expenses: R&D expenses were $4.7 million and $2.2 million in each of the three months ended June 30, 2023 and 2022, respectively. The increase of $2.5 million is primarily attributable to higher spending on cadisegliatin, due to increases in drug product related costs, and an increase in indirect costs related to the development of cadisegliatin.
•General & Administrative (G&A) Expenses: G&A expenses were $3.3 million and $1.8 million for each of the three months ended June 30, 2023 and 2022, respectively. The increase of $1.5 million was primarily due to higher payroll cost and higher other G&A costs.
•Other Income (Expense): Other income for the three months ended June 30, 2023 was $0.6 million and was driven by an unrealized gain related to our investment in Reneo, as well as gains related to the change in the fair value of the outstanding warrants to purchase shares of our stock issued to related parties. Other expense for the three months ended June 30, 2022 was $0.1 million and was driven by an unrealized loss related to the investment in Reneo as well as the gains related to the change in the fair value of the outstanding warrants to purchase shares of our own stock issued to a related party.
•Net Loss: Net loss attributable to vTv shareholders for the three months ended June 30, 2023 was $5.6 million or $0.07 per basic share. Net loss attributable to vTv shareholders for the comparable period a year ago was $3.2 million or $0.04 per basic share.

On August 11, 2023 The Gray Foundation, a Midtown-based nonprofit that aims to expand BRCA-related cancer research, reported that it has awarded $25 million for seven research teams to study gene mutations that increase risk of cancer (Press release, The Gray Foundation, AUG 11, 2023, View Source [SID1234634282]).

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Women who have a BRCA1 or BRCA2 gene mutation are at increased risk of developing breast, ovarian and pancreatic cancers, and men with mutations are at higher risk of getting pancreatic, breast and prostate cancers. When the genes work properly, according to Memorial Sloan Kettering Cancer Center, they suppress cancer development–but mutations create heightened risk of developing cancer.

According to the foundation, the seven teams awarded were selected from 55 applications for the funding. Most teams are based at Massachusetts institutions including the Massachusetts Institute of Technology, Harvard Medical School and the Dana-Farber Cancer Institute. One team will work in New York, led by Kenneth Olive at Columbia University.

The teams, which are part of the Gray Foundations’ ongoing Team Science program, will work to discover new approaches for prevention, early detection and intervention for cancers related to BRCA mutations.

Dana Zucker, chief executive of the Gray Foundation, said a panel evaluated all of the applications in a first selection period and then independent reviewers assessed 12 applications to select seven winners. The goal of Kenneth Olive’s work is to determine whether BRCA2 mutations can impact inflammation of certain tissues and potentially induce cancer development, she said.

These grants bring the Gray Foundation’s total amount of BRCA-related funding to $187 million. The nonprofit’s funding has also supported research at Weill Cornell and Memorial Sloan Kettering.

"What’s so interesting about studying BRCA mutations is that you know, with certainty that a high percentage of people will end up developing cancer. So it’s just ripe for research," said foundation co-founder Mindy Gray, adding that the research could have broad implications for other types of cancer.

In addition to research funding, the foundation works to expand access to education and health care for young New Yorkers with lower income by providing scholarships and financial literacy initiatives. The foundation has committed a total of $375 million between its cancer research funding and youth programs.

On August 11, 2023 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported financial results for the second quarter and the six months ended June 30, 2023 (Press release, RAPT Therapeutics, AUG 11, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-reports-second-quarter-2023-financial-results [SID1234634280]).

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"We continue to remain focused on our Phase 2 trials for RPT193 in atopic dermatitis (AD) and asthma. We anticipate reporting top-line data from our Phase 2b trial in AD in mid-2024 and we continue to enroll our Phase 2a trial in asthma. These are the first two indications in what we believe will be a significant franchise for our promising oral small molecule drug in inflammatory diseases," said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. "Separately, our Phase 2 trial of FLX475 continues to progress and we anticipate providing an update later this year. With our current cash balance, we expect to be able to support our operations through mid-2025."

Financial Results for the Second Quarter and the Six Months Ended June 30, 2023

Second Quarter Ended June 30, 2023

Net loss for the second quarter of 2023 was $25.3 million, compared to $19.2 million for the second quarter of 2022.

Research and development expenses for the second quarter of 2023 were $21.6 million, compared to $14.4 million for the same period in 2022. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and early-stage programs, as well as increases in personnel expense, lab supplies, consulting expense, facilities and stock-based compensation expense, partially offset by lower development costs related to FLX475.

General and administrative expenses for the second quarter of 2023 were $6.7 million, compared to $5.4 million for the same period in 2022. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation and facilities.

Six Months Ended June 30, 2023

Net loss for the six months ended June 30, 2023 was $54.6 million, compared to $39.7 million for the same period in 2022.

Research and development expenses for the six months ended June 30, 2023 were $47.2 million, compared to $31.0 million for the same period in 2022. The increase in research and development expenses was primarily due to higher development costs related to RPT193 and early-stage programs, as well as increases in personnel expense, lab supplies, consulting expense, facilities and stock-based compensation expense, partially offset by lower development costs related to FLX475.

General and administrative expenses for the six months ended June 30, 2023 were $12.7 million, compared to $10.2 million for the same period of 2022. The increase in general and administrative expenses was primarily due to increases in expenses for personnel, stock-based compensation, facilities and professional services.

As of June 30, 2023, the Company had cash, cash equivalents and marketable securities of $205 million.