On August 14, 2023 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported financial results and provided a business update for the three months ended June 30, 2023 (Press release, Galectin Therapeutics, AUG 14, 2023, View Source [SID1234634380]). These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.

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Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said:
"We are increasingly optimistic as we oversee and manage our adaptively designed Phase 2b/3 NAVIGATE trial for the prevention of esophageal varices in patients with NASH cirrhosis, which completed randomization of 357 patients in February 2023. To help manage NAVIGATE and prepare for the interim analysis from the phase 2b portion, which is expected in the fourth quarter of 2024, we have added several key staff members over the past few months in the areas of biostatistics, quality assurance and clinical operations. The Company’s results will be the first, and as of now, the only data generated from a late-stage trial focusing on compensated cirrhosis caused by NASH that has progressed to portal hypertension. Currently, this patient population has no curative option, other than a liver transplantation.

Additionally, we are continuing to evaluate options and develop plans for a potential Phase 2 clinical trial of belapectin in combination with Keytruda© in patients with advanced head and neck cancers. Our team is fully committed to maximizing the value of our company for the stockholders by advancing our programs for patients."

Dr. Pol Boudes, Chief Medical Officer stated: "Compared to pre-cirrhotic NASH stages, cirrhosis of the liver is characterized by a distinct pathophysiology, with activated macrophages, the target of belapectin, playing a central role in the progression of the disease to portal hypertension and, ultimately, liver failure. We are pleased by the continued apparent safety and tolerance profile of belapectin in the NAVIGATE patient population, and we remain encouraged that the NAVIGATE results can one day bring a therapy to patients with NASH cirrhosis that currently can only contemplate liver transplantation as a therapeutic option."

Financial Results

For the three months ended June 30, 2023, the Company reported a net loss applicable to common stockholders of $9.2 million, or ($0.15) per share, compared to a net loss applicable to common stockholders of $9.7 million, or ($0.16) per share for the three months ended June 30, 2022. The decrease is largely due to a decrease in 2023 research and development expenses related to the timing of certain costs related to the Company’s NAVIGATE trial.

Research and development expenses for the three months ended June 30, 2023, were $7.4 million compared with $8.1 million for the three months ended June 30, 2022. The decrease was primarily due to timing of certain costs related to our NAVIGATE clinical trial and other supportive activities. General and administrative expenses for the three months ended June 30, 2023, were $1.6 million, compared to $1.6 million for the three months ended June 30, 2022.

As of June 30, 2023, the Company had $18.0 million of cash and cash equivalents. Additionally, the Company has $30 million remaining available under a $60 million line of credit provided by its chairman to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through at least December 31, 2024.

The Company expects that it will require more cash to fund operations after December 31, 2024, and believes it will be able to obtain additional financing as needed. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH when it has progressed to the liver cirrhosis stage as well as advanced cancers. Galectin-3 is produced by activated macrophages, a key inflammatory cell, and plays a major role in diseases that involve scarring of organs, including fibrotic disorders of the liver, lung, kidney, heart, as well as in the cancerous tumor microenvironment. Belapectin binds to galectin-3 and disrupts its function. Belapectin, because of its unique structure, is also captured by activated macrophages and exerts its activity directly at the source of galectin-3 production. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis associated with liver cirrhosis, a disease that is characterized by an invasion of activated macrophages into the liver parenchyma. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (www.NAVIGATEnash.com), titled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis," completed randomization of 357 patients in February 2023 with top-line data expected from the Phase 2b portion in the fourth quarter of 2024, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, in making the tumor microenvironment resistant to immunological treatment, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and Keytruda in advanced melanoma and in head and neck cancers. This trial provided a strong rationale for moving forward into a Company-sponsored Phase 2 development program, which the company is exploring.

On August 14, 2023 Roivant (Nasdaq: ROIV) reported its financial results for the first quarter ended June 30, 2023, and provided an update on the business (Press release, Roivant Sciences, AUG 14, 2023, View Source [SID1234634379]).

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"This was an incredibly busy quarter with multiple clinical readouts and trial initiations. We reported positive data from the chronic period of the Phase 2b study of RVT-3101 in ulcerative colitis, in addition to positive data from the ADORING 1 trial evaluating VTAMA in patients as young as 2 years old with moderate-to-severe atopic dermatitis. We also initiated two separate trials, the TAHOE Phase 2 study of RVT-3101 in Crohn’s disease and the Phase 1 study of IMVT-1402 in healthy volunteers. We’re incredibly excited about the progress we’ve made in this quarter alone and look forward to announcing additional clinical results in the upcoming months," said Matt Gline, CEO of Roivant. "On the commercial side, we saw another three months of continued product revenue growth for the company from VTAMA sales."

Recent Developments

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Telavant: In June 2023, Telavant reported positive data from the chronic period of TUSCANY-2, a large, global Phase 2b study evaluating RVT-3101 for the treatment of ulcerative colitis. Outcomes were measured at week 56 for the chronic period (vs. week 14 from the previously reported induction period). At the expected Phase 3 dose in the overall population and in the biomarker positive populations, RVT-3101 treatment produced clinically meaningful efficacy results with improved Clinical Remission, Endoscopic Improvement, and Endoscopic Remission at week 56. In July 2023, Telavant announced the first patient was dosed in the TAHOE study, a global Phase 2 trial of RVT-3101 in patients with moderate to severe Crohn’s disease.

•
Immunovant: In August 2023, Immunovant reported that initial data from the Phase 1 clinical trial of IMVT-1402 remains on track for September 2023 (single-ascending dose) and October / November 2023 (multiple-ascending dose).

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Dermavant: For the first quarter ended June 30, 2023, Roivant reported VTAMA net product revenue of $16.7M, representing a 26% gross-to-net yield for the quarter. As of August 2023, nearly 200,000 VTAMA prescriptions have been written by approximately 11,500 unique prescribers for psoriasis, based on IQVIA data. Coverage has been expanded to 129 million US commercial lives and 87 million government lives and includes coverage by all three of the top pharmacy benefit managers. In May 2023, VTAMA met the primary and all secondary endpoints in ADORING 1, the second of two replicate Phase 3 studies in patients with moderate-to-severe atopic dermatitis. Importantly, no new safety or tolerability signals were observed in this population, which included children as young as 2 years old.

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Priovant: In August 2023, Priovant announced the sixth positive Phase 2 study of oral brepocitinib, out of six conducted, with statistically significant, positive results from the 12-week induction period of Pfizer’s Phase 2 study of brepocitinib in adult patients with moderate to severe Crohn’s disease. The primary and key secondary endpoints were met with safety and tolerability generally consistent with prior brepocitinib studies, further validating TYK2/JAK1 inhibition activity in highly inflammatory autoimmune diseases.

•
Roivant: Roivant reported its consolidated cash, cash equivalents and restricted cash of $1.4B at June 30, 2023, supporting cash runway into the second half of calendar year 2025.

Major Upcoming Milestones

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Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.

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Immunovant expects IMVT-1402 Phase 1 initial data from single-ascending dose cohorts in September 2023 and initial data from multiple-ascending dose cohorts in October or November 2023. Additionally, for batoclimab: top-line results from the ongoing myasthenia gravis (MG) trial are expected in the second half of calendar year 2024. Top-line results from the Phase 3 thyroid eye disease (TED) program, consisting of two Phase 3 clinical trials, are expected in the first half of calendar year 2025. Immunovant also expects to have initial results from period 1 of the Phase 2B clinical trial in chronic inflammatory demyelinating polyneuropathy (CIDP) in the first half of calendar year 2024. Initial results from the Phase 2 proof-of-concept trial in Graves’ disease (GD) are expected in the fourth quarter of calendar year 2023.

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Telavant has initiated a Phase 2 dose-ranging study of RVT-3101 in Crohn’s disease with data from the induction portion expected in the fourth quarter of calendar year 2024.

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Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with systemic lupus erythematosus (SLE) in the fourth quarter of calendar year 2023. Priovant also expects to announce topline results from the Phase 2 POC study in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.

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Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndromes (MDS) patients in the second half of calendar year 2023.

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Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.

First Quarter Ended June 30, 2023, Financial Summary

Cash Position

As of June 30, 2023, the company had consolidated cash, cash equivalents and restricted cash of $1.4 billion.

Research and Development Expenses

Research and development (R&D) expenses decreased by $10.7 million to $125.1 million for the three months ended June 30, 2023, compared to $135.8 million for the three months ended June 30, 2022, primarily due to decreases in program-specific costs of $7.8 million and share-based compensation of $4.3 million, partially offset by an increase in other expenses of $2.2 million.

The decrease of $7.8 million in program-specific costs largely reflects the discontinued development of several programs, including ARU-1801, LSVT-1701 and CVT-TCR-01, as well as our reprioritization of drug discovery efforts. These decreases were partially offset by increases reflecting the progression of our programs, including Immunovant’s anti-FcRn franchise, RVT-3101, and namilumab. The asset acquisition of RVT-3101 was completed in November 2022.

Non-GAAP R&D expenses were $115.7 million for the three months ended June 30, 2023, compared to $122.5 million for the three months ended June 30, 2022.

Acquired In-Process Research and Development Expenses

Acquired in-process research and development was $12.5 million for the three months ended June 30, 2023, relating to the achievement of development and regulatory milestones for batoclimab.

Selling, General and Administrative Expenses

Selling, general and administrative expenses (SG&A) increased by $7.1 million to $156.2 million for the three months ended June 30, 2023, compared to $149.1 million for the three months ended June 30, 2022, primarily due to a decrease of $19.4 million of share-based compensation expense partially offset by an increase in selling, general and administrative expenses of $27.1 million at Dermavant as a result of the commercial launch of VTAMA.

Non-GAAP SG&A expenses were $113.0 million for the three months ended June 30, 2023, compared to $87.7 million for the three months ended June 30, 2022. The majority of non-GAAP SG&A expenses were related to Dermavant’s SG&A and ongoing VTAMA commercial launch activities.

Net Loss

Net loss was $327.8 million for the three months ended June 30, 2023, compared to $353.8 million for the three months ended June 30, 2022. On a per common share basis, net loss was $0.38 for the three months ended June 30, 2023, and $0.48 for the three months ended June 30, 2022. Non-GAAP net loss was $211.5 million for the three months ended June 30, 2023, compared to $210.7 million for the three months ended June 30, 2022.

On August 14, 2023 Eli Lilly and Company (NYSE: LLY) reported the successful completion of its acquisition of Sigilon Therapeutics, Inc. (NASDAQ: SGTX) (Press release, Eli Lilly, AUG 14, 2023, View Source [SID1234634378]). The acquisition allows Lilly to continue researching and developing encapsulated cell therapies, including SIG-002, for the treatment of type 1 diabetes.

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"Make life better – that’s the phrase that guides everything we do at Lilly," said Ruth Gimeno, Ph.D., group vice president, diabetes, obesity and cardiometabolic research at Lilly. "We are excited to welcome our new colleagues from Sigilon to Lilly; together, we will strive to provide solutions for people living with type 1 diabetes that absolves them of constant disease management, and advance Sigilon’s technology for patients."

The Offer and the Merger

As previously announced, Lilly and Sigilon entered into a Merger Agreement dated as of June 28, 2023, and pursuant thereto, on July 13, 2023, Lilly and a wholly owned subsidiary ("Purchaser") commenced a tender offer (the "Offer") to purchase all of the issued and outstanding shares ("Shares") of Sigilon’s common stock in exchange for (a) $14.92 per Share, net to the stockholder in cash, without interest (the "Cash Consideration") and less any applicable tax withholding, plus (b) one non-tradable contingent value right ("CVR" and, together with the Cash Consideration, the "Offer Price") per Share, which represents the contractual right to receive contingent payments of up to $111.64 per Share in cash, net to the stockholder in cash, without interest and less any applicable tax withholding, upon the achievement of certain specified milestones. There can be no assurance that any payments will be made with respect to the CVRs. The Offer expired as scheduled on Aug. 9, 2023, with 1,718,493 Shares validly tendered and not validly withdrawn, which together with Shares previously owned by Lilly, represented 76.61% of the issued and outstanding Shares. In accordance with the terms of the Offer, Purchaser accepted for payment all such validly tendered and not validly withdrawn Shares.

Following consummation of the Offer, on Aug. 11, 2023, Lilly completed its acquisition of Sigilon through the merger of Purchaser with and into Sigilon in accordance with Section 251(h) of the General Corporation Law of the State of Delaware), with Sigilon surviving such merger as a wholly owned subsidiary of Lilly. In connection with the merger, each Share issued and outstanding immediately prior to the effective time of the merger (other than (i) Shares held in Sigilon’s treasury or owned by Sigilon, or owned by Lilly, Purchaser or any direct or indirect wholly-owned subsidiary of Lilly or Purchaser or (ii) Shares held by any stockholder of Sigilon who was entitled to demand and properly demanded appraisal for such Shares in accordance with Section 262 of the DGCL), including each Share that was subject to vesting or forfeiture restrictions granted pursuant to a Sigilon equity incentive plan, program or arrangement, was canceled and converted into the right to receive the Offer Price, without interest, less any applicable tax withholding. Sigilon’s common stock has been delisted from the NASDAQ Global Select Market and will be deregistered under the Securities Exchange Act of 1934, as amended.

For Lilly, Morgan, Lewis & Bockius LLP is acting as legal counsel. For Sigilon, Lazard is acting as lead financial advisor and Ropes & Gray LLP is acting as legal counsel. Canaccord Genuity also acted as financial advisor to Sigilon.

On August 14, 2023 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for second quarter ended June 30, 2023 (Press release, Leap Therapeutics, AUG 14, 2023, View Source [SID1234634377]).

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Leap Highlights:

· Announced that initial data from Part A of the Phase 2 DeFianCe study of DKN-01 in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC) exceeded a twenty percent (20%) overall response rate (ORR) with a high disease control rate, leading to the initiation of the 130-patient randomized controlled Part B of the study

· Presented new long-term follow-up data from Part A of the Phase 2 DisTinGuish study of DKN-01 plus tislelizumab and chemotherapy demonstrating 19.5 months median overall survival (OS) in first-line patients with advanced gastroesophageal adenocarcinoma (GEA) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

"The Company made important progress on our DKN-01 program during the second quarter. Based on Part A of the DeFianCe study exceeding our threshold of a 20% ORR, all of which are now confirmed responses, we initiated Part B, our second randomized controlled trial," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We also presented new long-term follow-up data from Part A of the DisTinGuish study at ASCO (Free ASCO Whitepaper), demonstrating 19.5 months median overall survival which exceeds current benchmarks. Additionally, enrollment continues to be strong in the 160 patient randomized controlled Part C of the DisTinGuish study, and we expect to complete enrollment in the fourth quarter of this year."

DKN-01 Development Update

· Announced initial results from Part A of the DeFianCe Study of DKN-01 for the treatment of colorectal cancer patients and initiation of the randomized controlled Part B of the study. The DeFianCe study (NCT05480306) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with standard of care bevacizumab and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. The study began with an initial Part A cohort that enrolled 33 patients, including significant numbers of patients who had early progression on first-line therapy, previous exposure to bevacizumab, tumors with Ras mutations, or liver metastases. Initial results indicated an ORR above twenty percent (20%) with a high disease control rate, which exceeds the benchmarks expected for this population. The study has expanded into a 130-patient Part B randomized controlled trial. The primary endpoint of the randomized study is progression free survival. Secondary objectives include overall response rate, duration of response, and overall survival. Leap expects to be able to enroll Part B in approximately 12 months.

· Presented updated data from Part A of the DisTinGuish Study of DKN-01 plus tislelizumab and chemotherapy in gastric cancer patients at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. The Company presented new long-term follow-up data in first-line patients with advanced GEA from Part A of the DisTinGuish study (NCT0436380), a Phase 2 clinical trial evaluating Leap’s anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with tislelizumab and chemotherapy. Highlights from the data include:

o At two years follow up, DKN-01 plus tislelizumab and chemotherapy demonstrated an ORR of 73% in the modified intent-to-treat (mITT) population and 86% in the PD-L1 low-subgroup

o Median OS of 19.5 months and median progression-free survival (PFS) of 11.3 months exceeds benchmark results in the overall population

o Combination was well tolerated with manageable toxicity, with most adverse events related to DKN-01 being low-grade

Selected Second Quarter 2023 Financial Results

Net Loss was $13.4 million for the second quarter 2023, compared to $17.0 million for the same period in 2022. The decrease was primarily due to decreased research and development expenses and increased interest income.

Research and development expenses were $11.1 million for the second quarter 2023, compared to $14.0 million for the same period in 2022. The decrease in research and development expenses was primarily due to a decrease of $4.5 million in manufacturing costs related to clinical trial material, partially offset by an increase of $0.8 million in clinical trial costs and an increase of $0.8 million in payroll and other related expenses due to an increase in headcount of our research and development full-time employees.

General and administrative expenses were $3.6 million for the second quarter 2023, compared to $2.9 million for the same period in 2022. The increase in general and administrative expenses was primarily due to an increase of $0.6 million in professional fees due to higher finance and legal costs associated with our business development activities and a $0.3 million increase in payroll and other related expenses due to an increase in headcount of our general and administrative full-time employees, partially offset by a decrease of $0.2 million in insurance costs.

Interest income was $1.2 million for the second quarter 2023, compared to an immaterial amount for the same period in 2022. The increase reflects the increased interest rate environment applicable to the Company’s cash balance.

Cash and cash equivalents totaled $91.4 million at June 30, 2023. Research and development incentive receivables totaled $2.6 million at June 30, 2023.

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.