On May 10, 2023 Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing AI-powered precision T cell therapies targeting clonal neoantigens to treat solid tumors, reported its financial results for the first quarter ended March 31, 2023, and recent business highlights (Press release, Achilles Therapeutics, MAY 10, 2023, View Source [SID1234631340]).

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"We continue to make progress in our ongoing Phase I/IIa clinical trials evaluating our clonal neoantigen-reactive T cell (cNeT) therapy for the treatment of advanced NSCLC (CHIRON) and metastatic malignant melanoma (THETIS). Additionally, we continue to further develop PELEUS, our patented AI-driven bioinformatics platform, that uses multi-region sequencing analysis to provide what we believe is the best method to accurately identify clonal neoantigens," said Dr Iraj Ali, Chief Executive Officer of Achilles Therapeutics. "We are excited about the new AI immunogenicity prediction capability of the PELEUS platform and are very pleased with the recent grants of a US patent and MHRA Innovation Passport. We look forward to sharing more about the PELEUS platform at an upcoming scientific meeting and reporting additional clinical and translational science data in the fourth quarter of this year, which builds on the encouraging clinical results observed so far."

Business Highlights

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Announced that the new neoantigen immunogenicity prediction application of the PELEUS platform can uniquely identify the most potent clonal neoantigens for personalized cancer therapies, supporting potential implementation into the Company’s ongoing TIL-based clinical programs in advanced non-small cell lung cancer (NSCLC) and melanoma, and into other modalities including clonal neoantigen cancer vaccines
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US patent number 11,634,773 granted covering the treatment of patients with an immunotherapy targeting neoantigens based on tumor HLA status
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Innovation Passport granted for the treatment of NSCLC under the Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory body of the United Kingdom (UK), which aims to accelerate time to market and facilitate patient access to medicines in the UK for

life-threatening or seriously debilitating conditions by providing the opportunity for enhanced regulatory and other stakeholder input during development

Financial Highlights

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Cash and cash equivalents: Cash and cash equivalents were $158.5 million as of March 31, 2023, as compared to $173.3 million as of December 31, 2022. The Company anticipates that its cash and cash equivalents are sufficient to fund its planned operations into the middle of 2025.
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Research and development (R&D) expenses: R&D expenses were $13.9 million for the first quarter ended March 31, 2023, an increase of $0.9 million compared to $13.0 million for the first quarter ended March 31, 2022. The increase was primarily driven by increased activity related to our ongoing clinical trials, as well as spend associated with expansion of our manufacturing capacity and enhancements to PELEUSTM and VELOSTM.
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General and administrative (G&A) expenses: G&A expenses were $4.7 million for the first quarter ended March 31, 2023, a decrease of $1.3 million compared to $6.0 million for the first quarter ended March 31, 2022. This decrease was primarily driven by lower personnel costs.
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Net loss: Net loss for the first quarter ended March 31, 2023 was $17.5 million or $0.44 per share compared to $17.4 million or $0.45 per share for the first quarter ended March 31, 2022.

2023 Focus

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Clinical Data: Report clinical and translational science data from 15 to 20 additional patients treated with cNeT monotherapy in NSCLC and melanoma, and with a cNeT/anti-PD-1 checkpoint inhibitor combination in melanoma, in the fourth quarter of the year
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Translational Science: Leverage the Company’s world-class translational science platform to define the cNeT product features associated with clinical responses
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Clinical Activity: Drive the potential for additional confirmed responses in CHIRON and THETIS patients by delivering higher cNeT doses and improved product design
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Manufacturing Development: Continue VELOS and PELEUS development to optimize cNeT dose and functionality

On May 10, 2023 CTI BioPharma (Nasdaq: CTIC) ("CTI"), a commercial biopharmaceutical company focused on the development and commercialization of novel targeted therapies for blood-related cancers, reported that it has entered into a definitive agreement under which Swedish Orphan Biovitrum AB (STO: SOBI) ("Sobi"), a global healthcare leader in hematology, immunology and specialty care, will acquire CTI for $9.10 per share of common stock in an all-cash transaction, representing an implied equity value of approximately $1.7 billion (Press release, CTI BioPharma, MAY 10, 2023, View Source [SID1234631306]).

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The transaction will diversify Sobi’s portfolio of leading hematology medicines through CTI’s lead product, VONJO (pacritinib), which is FDA-approved for the treatment of adult myelofibrosis patients with a platelet count below 50 x109/L. Bringing together Sobi and CTI is expected to enhance Sobi’s commercial footprint in the U.S., and CTI will benefit from Sobi’s resources, scale and strong international presence as it continues to grow and explore new indications and development opportunities for VONJO. Following the completion of the transaction, CTI will become a wholly owned subsidiary of Sobi. Together, Sobi and CTI expect to advance their shared mission to change the treatment paradigm for underserved patient communities suffering from rare diseases through new, innovative and effective medicines and therapies.

"We are delighted to announce this transaction, which delivers a compelling all-cash premium to our shareholders, while positioning CTI to unlock the full potential of VONJO in treating myeloproliferative disease," said Adam Craig, M.D., Ph.D., M.B.A., President, Chief Executive Officer and Interim Chief Medical Officer of CTI BioPharma. "In Sobi, we’ve found a global partner whose mission, culture and strategic business priorities are aligned with ours, and by joining forces, we have access to additional financial and development resources to drive and enhance the growth of VONJO. As we enter CTI’s next chapter with the support of Sobi, we’d like to recognize the extraordinary work of our talented employees, who will play a key role in the success of the combined company."

Transaction Details and Closing

The transaction price represents an 89% premium to CTI’s closing share price on May 9, 2023, as well as a 95% premium to its 30 trading day volume-weighted average price of $4.67. The transaction, which was unanimously approved by CTI’s Board of Directors, is expected to close in the third quarter of 2023.

Under the terms of the merger agreement, Sobi, through a wholly owned, indirect subsidiary, will commence a tender offer to acquire all outstanding shares of CTI for $9.10 per share of common stock in cash. Sobi has received an irrevocable undertaking from certain entities affiliated with BVF Partners L.P. (BVF) to tender all of their shares of common stock, representing 6.7% of all outstanding shares of CTI common stock.

The closing of the tender offer will be subject to certain conditions, including the tender of shares in the tender offer representing at least a majority of the total number of CTI’s shares of common stock outstanding and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. Upon the successful completion of the tender offer, Sobi’s acquisition subsidiary will be merged into CTI, and any remaining shares of common stock of CTI will be cancelled and converted into the right to receive the same $9.10 per share in cash.

First Quarter 2023 Earnings Results

Given the transaction announcement, CTI does not intend to issue an earnings release for its first quarter 2023 financial results and will not host an earnings conference call.

Advisors

Centerview Partners LLC and MTS Health Partners are serving as CTI’s financial advisors and Skadden, Arps, Slate, Meagher & Flom LLP and Gibson, Dunn & Crutcher, LLP are serving as legal counsel.

On May 9, 2023 CStone Pharmaceuticals, a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, reported that CStone will regain rights for the development and commercialization of sugemalimab (anti-PD-L1 monoclonal antibody) and nofazinlimab (anti-PD-1 monoclonal antibody) outside of Greater China, upon the termination of the License Agreement for sugemalimab and nofazinlimab between CStone and EQRx (Press release, CStone Pharmaceauticals, MAY 9, 2023, View Source [SID1234644746]). Both parties are committed to ensuring a smooth transition. The termination of this License Agreement will not affect the upfront and milestone payments previously received from EQRx.

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The marketing authorization applications (MAAs) with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for sugemalimab as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) are under review. Upon transition completion, CStone will lead the regulatory process for sugemalimab MAA reviews by the EMA and the U.K. MHRA.

CStone strongly believes that there are significant market opportunities for sugemalimab and nofazinlimab and is delighted to take back the development and commercialization rights outside of Greater China for the two assets. Sugemalimab has achieved success in five registrational clinical trials, covering indications of stage III NSCLC, stage IV NSCLC, lymphoma, gastric cancer, and esophageal cancer. The multi-regional, Phase 3 registrational trial of nofazinlimab in combination with lenvatinib as a first-line treatment for advanced hepatocellular carcinoma is ongoing, to support the new drug applications globally. The clinical data of sugemalimab and nofazinlimab have been presented at international academic conferences. The results from multiple studies of sugemalimab have been published in journals such as The Lancet Oncology and Journal of Clinical Oncology.

Given the promising results from multiple clinical trials of these two assets, CStone remains confident in global market for sugemalimab and nofazinlimab, and continues to engage health authorities, such as the U.S. Food and Drug Administration (FDA), the EMA and the U.K. MHRA.

In the meantime, CStone will actively explore partnership for the development and commercialization of sugemalimab and nofazinlimab outside of Greater China.

Conference Call Information

CStone will host a live conference call in Mandarin for investors at 9:00 a.m. Beijing time on May 9th, 2023. The conference call may be accessed via View Source

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was discovered by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

Currently, sugemalimab is approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy and in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC.

The China’s NMPA accepted the supplemental biologics license applications for sugemalimab for the treatment of patients with relapsed/refractory extranodal NK/T-cell lymphoma, as well as in combination with chemotherapy for first-line treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma, and in combination with chemotherapy for first-line treatment of unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

About Nofazinlimab

Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting human programmed cell death protein 1 (PD-1) being developed in solid tumors. Nofazinlimab shows comparable high binding affinities to the PD-1 of humans, cynomolgus monkey, and mouse, and can block the interaction of PD-1 with its ligands PD-L1 and PD-L2.

The U.S. Food and Drug Administration has granted nofazinlimab Orphan Drug Designation in July 2020 for the treatment of patients with hepatocellular carcinoma.

In March 2022, the global multi-regional phase 3 registrational trial of nofazinlimab in combination with lenvatinib as first-line treatment for patients with advanced hepatocellular carcinoma, CS1003-305, has successfully reached its prespecified enrollment target.

On May 09, 2023 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), a specialty pharmaceutical company offering differentiated products to patients, reported financial results for the first quarter ended March 31, 2023 (Press release, Assertio Holdings, MAY 9, 2023, View Source [SID1234634950]).

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"Since becoming CEO a little over two years ago, we adopted a strategy to increase profitability, improve our balance sheet, reduce our cost of capital, diversify our business and create internal and external opportunities for growth," said Dan Peisert, President and Chief Executive Officer of Assertio. "Through the adoption of our innovative digital non-personal sales model, significant growth and cash flow, the refinancing of our indebtedness and our most recent completed acquisition of Sympazan, we have achieved most of what we set out to do and put Assertio on a pathway for significant and sustainable growth over the coming years."

First quarter net product sales performed above internal expectations in what is typically a seasonally low quarter, delivering 18% growth in net product sales, more than $25 million of adjusted EBITDA and almost $23 million in cash flow from operations. Results were driven by continued growth of Indocin and the first full quarter of sales for Sympazan. As a result, the Company is raising its full-year net product sales and adjusted EBITDA outlook

On May 09, 2023 ADC Therapeutics reported financial results for the first quarter 2023 and provided an updated corporate strategy (Press release, ADC Therapeutics, MAY 9, 2023, View Source,the%20same%20quarter%20in%202022. [SID1234632922]).

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"2023 is a pivotal year for positioning ADC Therapeutics to capture the full potential value of our assets. Our later-stage pipeline programs continue to progress, with several initial data readouts expected in the next 12-15 months. Following a comprehensive review of the business by our executive team, we are implementing a new corporate and capital allocation strategy which we believe will allow the Company to focus on the most advanced and highest-potential clinical value drivers," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics.

"After a comprehensive DLBCL market review including interactions with top academic and community centers, we are implementing a new commercial go-to-market model to better align with the market construct. Through our new strategy, we expect to optimize our commercial execution against ZYNLONTA’s unique and valuable market opportunity," said Kristen Harrington-Smith, Chief Commercial Officer of ADC Therapeutics.

"By focusing our resources and executing on our new portfolio and commercial strategy, I am confident that we will deliver on our objectives and unlock value for all of our stakeholders," added Mr. Mallik.