CStone Pharmaceuticals Reports 2023 Interim Results and Updates

On August 15, 2023 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported 2023 interim results and recent business updates (Press release, CStone Pharmaceauticals, AUG 15, 2023, View Source [SID1234634974]).

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"In the first half of 2023, CStone delivered robust growth and positive results. Our three precision medicines achieved a 53% year-on-year increase in sales revenue with significant improvement of gross profit margin. Our cash reserves amount to RMB 1,005.4 million, and we significantly reduced our net losses." said Dr. Jason Yang, CEO of CStone.

"We made remarkable progress in our global product pipeline. We expanded the First-in-Human (FIH) global study of CS5001, a key product of our CStone Pipeline 2.0 Strategy, to China from the United States and Australia, accelerating its development. The phase I clinical trial completed safety evaluation of several dose levels. CS5001, one of the most advanced ROR1 ADCs in global clinical development, showed promising safety, stability, and preliminary anti-tumor activity in hematological and solid malignancies.

We are awaiting the approval of sugemalimab (PD-L1) as first-line treatment of Stage IV NSCLC in the UK and the EU, with the GCP inspection notification from the EMA received recently. We expect the approval in the first half of 2024. We are also actively looking for partners to develop and commercialize sugemalimab and nofazinlimab (PD-1) outside of the Greater China, to advance the global commercialization of these assets.

Going forward, we will continue to strengthen our research and development capabilities for innovative products, optimize the commercial potential of existing products, and improve our global strategic positioning, to create more growth opportunities for the company and more value for investors, partners, and stakeholders."

Interim Report on the First Six Months of 2023

On August 15, 2023 Stada reported its Interim Report on the First Six Months of 2023 (Presentation, Stada, AUG 15, 2023, View Source [SID1234634827]).

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Results Presentation for the full year ended 30 June 2023

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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Impilo Therapeutics Launches to Enable Nucleic Acid-Based Medicines to Effectively Treat Solid Tumor Cancers

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.

Legend Biotech Reports Second Quarter 2023 Results and Recent Highlights

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