On August 14, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company focused on discovering and developing medicines that are transformational for patients, reported financial results and business highlights for the second quarter ended June 30, 2023 (Press release, Centessa Pharmaceuticals, AUG 14, 2023, View Source [SID1234634376]).

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"This is an exciting time for Centessa as we continue to execute across our portfolio with the goal of bringing transformative medicines to patients with unmet needs," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We recently commenced dosing in our registrational PRESent-2 study of SerpinPC for the treatment of hemophilia B without inhibitors and are now enrolling subjects across multiple global sites. To date, clinical data support SerpinPC’s potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with hemophilia B. In the months ahead, we plan to share new data from subjects with approximately 3 years of continuous treatment with SerpinPC from the ongoing Phase 2a study."

"We are also making great progress with our LockBody technology platform, enrolling and dosing subjects in the ongoing Phase 1/2a clinical trial of LB101, a PD-L1xCD47 LockBody molecule for the treatment of solid tumors. In addition, we are excited to announce LB206, a conditionally bivalent PD-L1xCD3 bispecific monoclonal antibody, as our second LockBody development candidate for the treatment of solid tumors, and share encouraging preclinical data for LB206 which demonstrated the potential of our LockBody technology to selectively drive potent CD3 activity within solid tumors in a difficult-to-treat mouse xenograft model with no apparent observed toxicity. We believe this progress marks an important milestone in advancing our novel LockBody technology platform," said Dr. Saha.

"In parallel with progress on our two clinical programs, we are advancing ORX750, our first oral selective orexin receptor 2 (OX2R) agonist development candidate, through IND enabling studies for the treatment of narcolepsy, and are thrilled to present preclinical data for ORX750 at the World Sleep Congress in October 2023," said Dr. Saha. "We are also excited to be exploring follow-up orexin agonists for potential expansion opportunities into a range of high value sleep disorders and broader neurological indications. With a team comprised of experienced and insightful scientists in the orexin field, we believe Centessa is well-positioned to play a leading role in orexin agonist development."

Dr. Saha concluded, "We have line of sight to multiple potential clinical milestones expected over the next several quarters and with a cash runway into 2026, we believe we are well positioned to advance our pipeline of potentially transformative medicines and deliver value for our stakeholders."

Recent Highlights
•Today, the Company shared new preclinical data for LB206, a PD-L1xCD3 LockBody development candidate, which demonstrated single agent regressions of large tumors in a difficult-to-treat mouse xenograft model. The preclinical data is shown in the Company’s corporate overview for August 2023 which is available at View Source
•In July, the Company announced the dosing of the first subject in its registrational PRESent-2 clinical study of SerpinPC for the treatment of hemophilia B without inhibitors. SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC).
•In May, the Company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to SerpinPC for the treatment of hemophilia B, with or without inhibitors.

Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC) – The global registrational program for hemophilia B is ongoing. PRESent-5, an observational feeder study, continues enrolling subjects and the Company has commenced dosing in the registrational PRESent-2 clinical study of hemophilia B without inhibitors. Dosing in the registrational PRESent-3 clinical study of hemophilia B with inhibitors, is expected to begin this year. In addition, the Company expects to share data from Part 5 of the ongoing Phase 2a study of SerpinPC at a scientific meeting later this year.
•Solid Tumors
▪PD-L1xCD47 LockBody (LB101) – The Phase 1/2a first-in-human clinical study is ongoing.
▪PD-L1xCD3 LockBody (LB206) – LB206 has been named as a development candidate.

•Narcolepsy and Other Sleep Disorders (ORX750) – ORX750 is undergoing IND-enabling activities. The Company plans to share preclinical data on ORX750 at the World Sleep Congress taking place from October 20-25, 2023, in Rio de Janeiro, Brazil.

The Company has multiple earlier-stage preclinical assets including additional orexin agonists and discovery-stage programs. Where applicable, the Company plans to provide updates on preclinical programs as they advance toward clinical studies.

Second Quarter 2023 Financial Results
•Cash, Cash Equivalents and Short-term Investments: $303.6 million as of June 30, 2023. In addition, the Company received approximately $15.0 million in gross proceeds through ATM sales in August 2023. The Company expects its current cash, cash equivalents and short-term investments will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $33.7 million for the second quarter ended June 30, 2023, compared to $53.7 million for the second quarter ended June 30, 2022.
•General & Administrative Expenses: $13.3 million for the second quarter ended June 30, 2023, compared to $14.8 million the second quarter ended June 30, 2022.
•Net Loss Attributable to Ordinary Shareholders: $24.9 million for the second quarter ended June 30, 2023, compared to $64.7 million for the second quarter ended June 30, 2022. The net loss for the second quarter of 2023 included a tax benefit of $24.1 million, which primarily relates to a release of a valuation allowance on certain U.S. deferred tax assets in the quarter.