On August 15, 2023 CSL reported its Results Presentation for the full year ended 30 June 2023 (Presentation, CSL, AUG 15, 2023, View Source [SID1234634666]).

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On August 15, 2023 Impilo Therapeutics, Inc. ("Impilo"), a privately held drug discovery and development company, reported that it has launched with the mission to enable nucleic acid-based medicines to effectively treat solid tumor cancers (Press release, Impilo Therapeutics, AUG 15, 2023, View Source [SID1234634442]). The Company’s technology is derived from an agreement with Lisata Therapeutics, Inc. (NASDAQ: LSTA) ("Lisata") for the targeted delivery of nucleic acid-based medicines. Impilo is advancing its Tumor-Penetrating Nanocomplex, or TPN Platform, to provide a targeted delivery approach for a wide range of nucleic acid treatment modalities including antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), messenger RNAs (mRNAs), and in vivo gene editing, and is advancing an internal pipeline of programs for solid tumor cancer indications.

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Nucleic acid-based medicines have been approved for a range of diseases, but none for the treatment of cancer. In spite of the potential to provide precision medicines that target the genetic basis of disease, early promise for this class of drugs in pre-clinical and early clinical development failed to translate into commercial success. The tumor stroma, composed of non-cancerous cells and extracellular matrix surrounding cancer cells, is a primary impediment to effective drug delivery to treat solid tumor cancers and a particular challenge for nucleic acid-based drugs.

"It is clear to everyone involved in launching Impilo that there is enormous potential to translate the promise of nucleic acid-based medicines in treating cancer. We have assembled the right team and the right technology to rapidly advance exciting product opportunities enabled by the TPN Platform to benefit cancer patients," said David Slack, CEO of Impilo. "Our platform provides a targeted approach to enable nucleic acid-based drugs to penetrate the layers of the stroma and has shown encouraging results in animal models for many solid tumor types. Importantly, the key tumor-targeted tissue-penetrating technology component of the Platform has demonstrated encouraging activity and favorable safety profile in clinical trials conducted by our partners at Lisata with their investigational drug, LSTA1, in combination with a range of agents across a range of solid tumor types."

Impilo is led by CEO David Slack, an industry veteran with 30 years of experience leading biotech companies, including numerous financings, strategic partnerships, mergers and acquisitions. David was previously CEO at Lisata’s predecessor, Cend Therapeutics. He has also played senior roles at Viracta Therapeutics, Ionis Pharmaceuticals, Aventis Pharma (now Sanofi), Rhone-Poulenc Rorer and RPR Gencell. David is supported by a world-class executive and scientific team with extensive R&D expertise across multiple RNA modalities. John S. Grundy, Ph.D., Chief Development Officer, joins after previously co-founding and serving on the board of DTx Pharma and with a deep background on leading preclinical development and clinical pharmacology at Ionis, Regulus Therapeutics, and Arena Pharmaceuticals.

"I am thrilled by the team and focus that David has brought together to form Impilo," commented Impilo’s scientific founder, Erkki Ruoslahti, MD, PhD. "Coming from backgrounds at companies that originated multiple nucleic acid drug technologies, they have an appreciation for the challenges in applying this class of drugs for anticancer applications and a solid plan to exploit the broad potential of the TPN Platform to address these challenges."

About our TPN Platform

Key components that differentiate the TPN Platform technology include a proprietary tumor-targeted tissue penetrating peptide discovered by Dr. Ruoslahti and colleagues. The internalizing RGD or iRGD peptide targets tumors via affinity for integrins that are selectively expressed on tumor vasculature and key cell types within the tumor stroma, including cancer cells themselves. Once bound to these integrins at the tumor, the peptide is cleaved to release a cryptic peptide fragment that initiates an active transport pathway to enable the peptide, peptide fragment, and tethered nucleic acid-based drugs, to penetrate the layers of the stroma to enable more effective treatment of solid tumor cancers. The Platform also includes peptides targeting additional cell types, such as tumor-associated macrophages. It further incorporates a range of different carrier formats and additional technologies to optimize application across a broad range of nucleic acid-based treatment modalities.

About the Impilo-Lisata Transaction

Lisata granted Impilo exclusive rights to iRGD for nucleic acid-based drug applications and assigned rights to other technologies in exchange for equity in Impilo. Lisata also received right of first negotiation for an Impilo-generated TPN drug development candidate. David Mazzo, PhD, CEO of Lisata, will join Impilo’s Board of Directors alongside Dr. Ruoslahti and David Slack.

On August 15, 2023 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported its unaudited financial results for the three and six months ended June 30, 2023 (Press release, Legend Biotech, AUG 15, 2023, View Source [SID1234634440]).

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In addition to financial performance, Legend Biotech reported on the success of its portfolio and pipeline, including the CARTITUDE clinical development program for CARVYKTI, in collaboration with the Janssen Biotech, Inc. (Janssen).

Initial data from the CARTITUDE-4 study presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) supported recent submissions to U.S. and E.U. regulatory agencies by Janssen to expand the indication of CARVYKTI into earlier treatment of patients (1-3 prior lines of therapy) with relapsed or refractory multiple myeloma.

"We remain committed to exploring the full potential of CARVYKTI and are pleased with the continued growth of our development program, including two regulatory submissions made during the second quarter," said Ying Huang, Chief Executive Officer of Legend Biotech. "Following our most recent fundraising, we are well positioned to advance our pipeline and portfolio. We remain grateful to the investors who support our endeavors."

Financial Results for Quarter Ended June 30, 2023

Cash and Cash Equivalents, Time Deposits, and Short-Term Investments

As of June 30, 2023, after giving effect to the registered direct offering, private placements or warrant exercise noted above, Legend Biotech had approximately $1.5 billion of cash and cash equivalents, time deposits, and short-term investments.

Revenue

License Revenue

License revenue for the three months ended June 30, 2023 was $15.1 million due to the achievement of a milestone during the quarter, compared to no milestones achieved during the three months ended June 30, 2022. License revenue for the six months ended June 30, 2023 was $15.1 million, compared to $50 million for the six months ended June 30, 2022. This decrease of $34.9 million was primarily driven by the nature and timing of milestones achieved as outlined in the Global Development Plan under the Janssen Agreement for cilta-cel six months ended June 30, 2023.

Collaboration Revenue

Collaboration revenue for the three and six months ended June 30, 2023 was $58.2 million and $94.4 million, respectively, compared to $11.9 million for the three and six months ended June 30, 2022. The increases of $46.3 million and $82.5 million for the three and six-month periods, respectively, were due to an increase in revenue generated from sales of CARVYKTI in connection with the Janssen Agreement.

Operating Expenses

Collaboration cost of revenue

Collaboration cost of revenue for the three and six months ended June 30, 2023 was $32.7 million and $68.3 million, respectively, compared to $16.9 million for the three and six months ended June 30, 2022. The increases of $15.7 million and $51.3 million for the three and six months ended, respectively were a combination of Legend’s portion of collaboration cost of sales in connection with collaboration revenue under the Janssen Agreement along with expenditures to support the manufacturing capacity expansion which cannot be capitalized.

Research and Development Expenses

Research and development expenses for the three and six months ended June 30, 2023 were $95.8 million and $180.7 million, respectively, compared to $68.8 million and $150.4 million for the three and six months ended June 30, 2022, respectively. The increases of $27.0 million and $30.3 million for the three and six-month periods, respectively, were primarily due to continuous research and development activities in cilta-cel, including higher patient enrollment for Phase 3 clinical trials for cilta-cel, and an increase in research and development activities for other pipeline items. The other pipeline expenses include continued investment in our solid tumor programs, which include two IND approvals that advanced into phase 1 development.

Administrative Expenses

Administrative expenses for the three and six months ended June 30, 2023 were $27.8 million and $50 million, respectively, compared to $18.1 million and $30.7 million for the three and six months ended June 30, 2022, respectively. The increases of $9.7 million and $19.3 million for the three and six-month periods, respectively, were primarily due to the expansion of supporting administrative functions to facilitate continuous business growth and continued investment in building global information technology infrastructure.

Selling and Distribution Expenses

Selling and distribution expenses for the three and six months ended June 30, 2023 were $21.4 million and $39.4 million, respectively, compared to $27.4 million and $48.7 million for the three and six months ended June 30, 2022. The decrease of $6 million and $9.4 million were primarily due to non-recurring launch expenses incurred in the first half of 2022 to support the commercialization in the U.S market.

Other Income and Gains

Other income and gains for the three and six months ended June 30, 2023 were $16.4 million and $21 million, respectively, compared to $1.9 million and $2.9 million for the three and six months ended June 30, 2022, respectively. The increase of $14.5 million in the three months ended June 30, 2023 compared to the three months ended June 30, 2022 was primarily attributable to approximately a $10.9 million increase in interest income and gain on investment, as well an increase of approximately $3.6 million in foreign currency exchange gain. The increase of $18.1 million for the six month period ended June 30, 2023 compared to the six months ended June 30, 2022 was primarily due to an increase in interest income and gain on investments.

Other Expenses

Other expenses for the three and six months ended June 30, 2023 were $0.02 million and $7.1 million, respectively, compared to $8.1 million and $9.6 million for the three and six months ended June 30, 2022. The decrease in both comparative periods was primarily due to a decrease in foreign currency exchange loss.

Finance Costs

Finance costs for the three and six months ended June 30, 2023 were $5.2 million and $10.3 million, respectively, compared to $1.6 million and $2.7 million for the three and six months ended June 30, 2022. The increase in both comparative periods was primarily due to interest on advance funding, which is interest-bearing borrowings funded by Janssen under the Janssen Agreement and constituted of principal and applicable interests upon such principal.

Fair Value Loss of Warrant Liability

Fair value loss of warrant liability for the six months ended June 30, 2023 was $85.8 million, compared to a fair value loss of $31 million for the six months ended June 30, 2022. The increase was due to the fair value loss recorded on the full exercise of the warrant, which took place on May 11, 2023.

Loss for the Period

For the three months ended June 30, 2023, net loss was $199.1 million, or $0.57 per share, compared to net loss of $193.2 million, or $0.62 per share, for the three months ended June 30, 2022. For the six months ended June 30, 2023, net loss was $311.2 million, or $0.91 per share, compared to a net loss of $225.5 million, or $0.73 per share, for the six months ended June 30, 2022.

Webcast/Conference Call Details:

Legend Biotech will host its quarterly earnings call and webcast today at 8:00am ET. To access the webcast, please visit this weblink.

A replay of the webcast will be available on Legend Biotech’s website at View Source

On August 15, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), reported a corporate update in connection with the filing of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 (Press release, Shuttle Pharmaceuticals, AUG 15, 2023, View Source [SID1234634438]).

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Recent Highlights

On track to commence Phase II clinical study in the fourth quarter of 2023 for Ropidoxuridine, Shuttle Pharma’s lead clinical sensitizer drug candidate.
Successfully completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine for use in the Shuttle Pharma’s upcoming Phase II clinical trial.
Received approval for a Type B pre-IND meeting with the FDA for guidance on the proposed Phase II clinical trial with a goal of receiving written responses from the FDA by September 18, 2023.
Moved into new laboratory and office space to assist in furthering the development Shuttle Pharma’s lead drug candidates and accelerate broader diagnostic capabilities on predictive biomarkers.
Q2 2023 operating expenses (excluding non-cash items) totaled $1.5 million.
At June 30, 2023, Shuttle Pharma’s cash balance was $8.4 million (including cash, cash equivalents and marketable securities).

"We are making significant progress in the advancement of Ropidoxuridine, our lead clinical sensitizer drug candidate, for treatment in brain cancer patients undergoing radiation therapy. During the last few months, we successfully completed the initial manufacturing campaign for the API to be used in the upcoming Phase II clinical trial and received approval from the FDA for a Type B pre-IND meeting to receive guidance on the trial design," commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. "We expect to receive comments from the FDA by mid-September which would put us in position to initiate the clinical trial in the fourth quarter of this year — a significant inflection point in the development of Ropidoxuridine."

"The move into our new laboratory will accommodate not only our Ropidoxuridine research efforts, but also enhance our ability to establish a CLIA laboratory to advance our diagnostic intellectual property that has been developed with funding from NIH small business innovative (SBIR) research contracts over the past several years, particularly for our predictive biomarker capabilities for prostate cancer patients. We are eligible for NIH SBIR ‘bridge’ support to assist in funding the advancements of these efforts. Our recently published work in premier cancer journals provides insight into the immune response taking place in patients after radiation therapy for cancer and informs therapeutic strategies for sequencing radiation and immune therapy modalities for cancer treatment," Dr. Dritschilo concluded.

On August 15, 2023 YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, reported its unaudited financial results for the first quarter of the fiscal year ended March 31, 2024 (the "first quarter of fiscal year 2024") (Press release, Yisheng Biopharma, AUG 15, 2023, View Source [SID1234634437]).

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Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, "During the first quarter of fiscal year 2024, our top-line came under pressure from tight inventory levels of finished products available for sale, caused by the lingering impacts of COVID-related disruptions at our YSJA rabies vaccine manufacturing facilities. While these disruptions occurred in late 2022 and early 2023, the long and complex nature of the vaccine manufacturing process means that we are experiencing the impact at present. In the first quarter, we took several steps to enhance our operations and ensure future stability, including boosting manufacturing productivity, building out our sales network, and streamlining research and development efforts. Demand for our YSJA rabies vaccine remains robust, and we continue to bring our pipeline of promising product candidates, including our next generation PIKA rabies vaccine, towards commercialization. We are confident that we will overcome the near-term difficulties we have faced, and we believe we are well-positioned for sustainable, long-term success."

Ms. Brenda Wu, CFO of YS Biopharma, added, "In the first quarter of fiscal year 2024, our total revenues were RMB176.3 million, as we continued to deal with the fallout of COVID-related disruptions on our supply chains and manufacturing operations. Our gross profit for the quarter was RMB141.6 million, and we recorded a solid gross profit margin of 80.3%. As of the end of the first quarter, our balance sheet remains strong, and we plan to diligently monitor our expenses in order to create a stable foundation for our long-term growth. We are confident in our business model and excited for the opportunities the future holds."

Business Updates

YSJA Rabies Vaccine

YS Biopharma’s marketed vaccine product, YSJA rabies vaccine, was the first aluminum-free lyophilized rabies vaccine launched in China. Since the Company commenced production at its current GMP-compliant facilities in February 2020, and, since it commenced the product’s commercialization in late 2020, market intake of the Company’s YSJA rabies vaccine has been consistent and strong. As of June 30, 2023, YS Biopharma had sold more than 22.2 million doses of YSJA rabies vaccines to approximately 1,725 CDC customers, which represents over 60% of CDC customers in China.

Clinical Pipeline

YS Biopharma continues to advance its portfolio of innovative product candidates under various clinical development stages, including PIKA rabies vaccine, PIKA recombinant COVID-19 vaccine, and PIKA YS-ON-001.

PIKA Rabies Vaccine

As of June 1, 2023, the Company had been granted approval by regulatory bodies in the Philippines, Singapore, and Pakistan to undertake Phase III clinical trials of the vaccine. This multi-country Phase III study is a registration trial and will evaluate the vaccine’s ability to induce an immune response and its safety profile.
The Company intends to include a total of 4,500 participants in the Phase III trial, with the recruitment process projected to commence in the fourth quarter of 2023. The Company aims to obtain interim results by early 2024.
PIKA Recombinant COVID-19 Vaccine

In March 2023, the Company reported positive interim safety and immunogenicity data for the PIKA recombinant COVID-19 vaccine from Phase II of the Phase II/III clinical studies which were completed in the Philippines and the UAE. The safety and efficacy of the Company’s PIKA adjuvant technology was validated in the Phase II/III trial, which involved roughly 6,000 participants. The Company anticipates the findings from the Phase III clinical trials will be released before the end of 2023.
The Company will continue to monitor the evolving global situation surrounding COVID-19, and will utilize appropriate commercialization strategies for the PIKA recombinant COVID-19 vaccine accordingly.
PIKA YS-ON-001

PIKA YS-ON-001 is designed as an immunological therapeutical agent against cancers. The Company has completed the enrollment of cancer patients for the Phase I clinical trial of PIKA YS-ON-001 in China. The Company expects the Phase I clinical trial will be completed by December 31, 2023.
First Quarter of Fiscal Year 2024 Financial Results

Total Revenues

Total revenues were RMB176.3 million (US$24.4 million) in the first quarter of fiscal year 2024, compared to RMB205.5 million in the same period of fiscal year 2023, representing a change of 14.2%. This was primarily due to COVID-related disruptions affecting raw material supply chains, manufacturing operations, and production output at the Company’s YSJA rabies vaccine production facilities, which negatively impacted batch approvals and doses available for sale.

Gross Profit

Gross profit was RMB141.6 million (US$19.6 million), representing an 80.3% gross margin, compared to RMB154.3 million, or a 75.1% gross margin, in the same period of fiscal year 2023.

Selling and Marketing Expenses

Selling and marketing expenses in the first quarter of fiscal year 2024 were RMB79.2 million (US$11.0 million), compared to RMB70.5 million in the same period of fiscal year 2023. The increase in selling and marketing expenses reflects the Company’s ongoing long-term strategies to enhance promotional and marketing services in order to expand and strengthen its distribution network of district- and county-level CDCs and hospitals. This targeted expansion aligns with the Company’s commitment to driving growth in key markets.

General and Administrative Expenses

General and administrative expenses in the first quarter of fiscal year 2024 were RMB31.8 million (US$4.4 million), compared to RMB25.5 million in the same period of 2023. This change was primarily attributable to higher professional service fees associated with the Company’s status as a publicly-listed entity.

Research and Development Expenses

Research and development expenses were RMB100.6 million (US$13.9 million) in the first quarter of fiscal year 2024, compared to RMB70.3 million in the same period of 2023. The change was primarily driven by an increase in preclinical and clinical development costs associated with the Company’s rabies vaccine pipeline. This increase reflects the Company’s targeted allocation of resources to advance its promising rabies vaccine candidates through various stages of development, in line with the Company’s commitment to innovation and addressing unmet medical needs.

Net Loss

Net loss for the first quarter of fiscal year 2024 was RMB69.5 million (US$9.6 million), compared with RMB19.6 million in the same period of 2023.

Balance Sheet

As of June 30, 2023, the Company had cash and cash equivalents of RMB311.8 million (US$43.1 million), compared with RMB370.4 million as of March 31, 2023.

Corporate Update

As part of its strategy to unlock the commercial potential of its vaccine franchise in underserved markets in Southeast Asia, the Company recently set up a new subsidiary in the Philippines to focus on clinical and regulatory efforts and product commercialization.

Conference Call Information

The Company’s management will hold an earnings conference call on Tuesday, August 15, 2023 at 8:00 P.M. Eastern Time to discuss the financial results. Listeners may access the call by dialing the following numbers:

United States Toll Free: 1-888-346-8982
International: 1-412-902-4272
Mainland China Toll Free: 4001-201203
Canada Toll Free: 1-855-669-9657
Hong Kong: 852-301-84992

The replay will be accessible through August 22, 2023 by dialing the following numbers:

United States Toll Free: 1-877-344-7529
International: 1-412-317-0088
Canada Toll Free: 855-669-9658
Access Code: 8167733

A live and archived webcast of the conference call will also be available at the Company’s investor relations website at View Source