On November 13, 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 third quarter ended September 30, 2023 (Press release, Centessa Pharmaceuticals, NOV 13, 2023, View Source [SID1234637531]).

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"We continue to execute and achieve key milestones across our pipeline of potential transformative medicines for patients with unmet needs," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "We’re making good progress enrolling our registrational studies for SerpinPC in hemophilia B, with or without inhibitors, and are excited to share new data from the ongoing Phase 2a study of SerpinPC during a poster presentation at ASH (Free ASH Whitepaper) in December. We also continue to advance our novel LockBody technology platform with LB101, a PD-L1xCD47 LockBody, which is in an ongoing Phase 1/2a clinical trial for the treatment of solid tumors."

Dr. Saha continued, "Momentum continues to build with our orexin agonist development program. The preclinical data we recently shared at the World Sleep Congress show that ORX750 is a highly potent and selective novel orexin receptor 2 (OX2R) agonist that closely mimics the function of the endogenous peptide. We believe these data support a potential best-in-class profile for ORX750 for the treatment of narcolepsy and other sleep-wake disorders. We are focused on rapidly moving ORX750 through IND-enabling studies, obtaining IND clearance and initiating clinical development with the goal of sharing clinical proof of concept data in sleep-deprived healthy volunteers in 2024. In addition, we are exploring follow-up molecules for potential expansion opportunities into a range of sleep-wake disorders and broader neurological indications."Recent Highlights
•In October, the Company announced a set of new preclinical data from in vivo and in vitro studies of its investigational, novel OX2R agonist, ORX750, that support a potential best-in-class profile for the treatment of narcolepsy and other sleep-wake disorders. The preclinical data were presented recently at the World Sleep Congress and are also available within a recorded webcast at View Source
•In November, the Company announced that new data from the third year (Part 5) of the ongoing Phase 2a study of SerpinPC, an investigational subcutaneously administered novel inhibitor of activated protein C (APC), for the treatment of hemophilia, has been accepted for a poster presentation at ASH (Free ASH Whitepaper) on December 10, 2023. The presentation will include efficacy and safety data from an additional 52-weeks of continuous treatment with a subcutaneous injection of SerpinPC in subjects with hemophilia.
•In October, the Company announced the dosing of the first subject in its registrational PRESent-3 clinical study of SerpinPC for the treatment of hemophilia B with inhibitors. The Company initiated dosing in its registrational PRESent-2 clinical study of SerpinPC for the treatment of hemophilia B without inhibitors in July.
•In August, the Company announced LB206, a PD-L1xCD3 LockBody, as a development candidate and shared preclinical data which demonstrated single agent regressions of large tumors in a difficult-to-treat mouse xenograft model.

Anticipated Upcoming Program Milestones
•Hemophilia (SerpinPC) – The registrational PRESent-2 and PRESent-3 studies are ongoing. Data from Part 5 of the ongoing Phase 2a study accepted for poster presentation at ASH (Free ASH Whitepaper) on December 10, 2023.
•Solid Tumors (LockBody Technology Platform)
◦PD-L1xCD47 LockBody LB101 – Phase 1/2a first-in-human clinical study is ongoing.
◦PD-L1xCD3 LockBody LB206 – LB206 is a development candidate.
•Narcolepsy and Other Sleep-Wake Disorders (ORX750) – The Company is focused on rapidly advancing ORX750 through IND-enabling studies, obtaining IND clearance and initiating clinical development with the goal of sharing clinical proof of concept data in sleep-deprived healthy volunteers in 2024.

Where applicable, the Company plans to provide updates on preclinical programs as they advance toward clinical studies.

Third Quarter 2023 Financial Results
•Cash, Cash Equivalents and Short-term Investments: $281.3 million as of September 30, 2023, which the Company expects will fund operations into 2026, without drawing on the remaining available tranches under the Oberland credit facility.
•Research & Development Expenses: $28.2 million for the third quarter ended September 30, 2023, compared to $36.7 million for the third quarter ended September 30, 2022.
•General & Administrative Expenses: $12.0 million for the third quarter ended September 30, 2023, compared to $12.3 million for the third quarter ended September 30, 2022.
•Net Loss Attributable to Ordinary Shareholders: $38.6 million for the third quarter ended September 30, 2023, compared to $53.9 million for the third quarter ended September 30, 2022.

On November 13, 2023 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported financial results for the third quarter ended September 30, 2023 and provided other recent corporate updates (Press release, Celcuity, NOV 13, 2023, View Source [SID1234637530]).

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"Despite the important role the PI3K/mTOR pathway plays in tumor types such as breast and prostate cancer, the available therapies that target this pathway have only reported limited improvements in outcomes for patients. Development of an optimized PI3K/mTOR inhibitor, like gedatolisib, thus represents, we believe, one of the most important opportunities to improve the standard of care in these cancers. With our Phase 3 program in HR+/HER2- advanced breast cancer, and our newly initiated Phase 1b/2 program in metastatic castration resistance prostate cancer, we are hoping to eventually impact over 200,000 patients globally," said Brian Sullivan, CEO and Co-Founder of Celcuity. "The equity financing we recently closed further supports these programs and extends our cash runway into mid-2026."

Third Quarter 2023 Business Highlights and Other Recent Developments

● The VIKTORIA-1 Phase 3 trial remains on track to provide initial data and analysis of the PIK3CA wild type patient sub-group in the second half of 2024 and data for the PIK3CA mutated patient sub-group in the first half of 2025.

○ The Phase 3 VIKTORIA-1 clinical trial is now recruiting patients at nearly 220 sites in 23 countries in North and South America, Europe, and Asia.

○ VIKTORIA-1 is evaluating gedatolisib in combination with fulvestrant, an endocrine therapy, with and without palbociclib, a CDK4/6 inhibitor, in adults with HR+, HER2- advanced breast cancer.

● The CELC-G-201 Phase 1b/2 clinical trial evaluating gedatolisib in combination with Nubeqa (darolutamide) for the treatment of metastatic castration resistant prostate cancer (mCRPC) is on track to activate trial sites in the first quarter of 2024 and to report initial data in the first half of 2025.

○ The U.S. Food and Drug Administration (FDA) cleared an Investigational New Drug (IND) submission that enables Celcuity to proceed with a trial to evaluate gedatolisib in combination with darolutamide in August 2023.

○ We entered into a clinical trial collaboration and supply agreement with Bayer AG in August 2023 to provide Nubeqa (darolutamide) at no cost.

○ The Phase 1b/2 trial will enroll up to 54 patients with mCRPC whose disease progressed after treatment with an androgen receptor inhibitor.

● Celcuity closed a private placement of equity that resulted in net proceeds of approximately $50 million in October 2023.

Third Quarter 2023 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2023, compared to the third quarter ended September 30, 2022.

Total operating expenses were $18.9 million for the third quarter of 2023, compared to $10.6 million for the third quarter of 2022. Research and development (R&D) expenses were $17.5 million for the third quarter of 2023, compared to $9.6 million for the third quarter of 2022. Of the approximately $7.9 million increase in R&D expenses, $7.5 million was due to an increase in expenses related to the VIKTORIA-1 Phase 3 clinical trial, and $0.4 million was related to increased employee-related expenses.

General and administrative expenses were $1.4 million for the third quarter of 2023, compared to $1.0 million for the third quarter of 2022. Employee-related expenses accounted for $0.3 million of the increase. The remaining $0.1 million increase resulted from professional fees and other expenses associated with being a public company.

Net loss for the third quarter of 2023 was $18.4 million, or $0.83 loss per share, compared to a net loss of $10.9 million, or $0.75 loss per share, for the third quarter of 2022. Non-GAAP adjusted net loss for the third quarter of 2023 was $17.3 million, or $0.78 loss per share, compared to non-GAAP adjusted net loss for the third quarter of 2022 of $9.5 million, or $0.63 loss per share. Non-GAAP adjusted net loss excludes stock-based compensation expense, non-cash interest expense, and non-cash interest income. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles in the United States (GAAP) to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2023 was $12.7 million, compared to $9.3 million for the third quarter of 2022. At September 30, 2023, Celcuity reported cash, cash equivalents and short-term investments of $133.9 million.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 8:00 a.m. ET today to discuss the third quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial 1-877-407-0784 or1-201-689-8560. A live webcast presentation can also be accessed using this weblink: View Source;tp_key=7d2827005c. A replay of the webcast will be available on the Celcuity website following the live event.

On November 13, 2023 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, reported financial results for the third quarter ended September 30, 2023, and provided a corporate update (Press release, ALX Oncology, NOV 13, 2023, View Source [SID1234637528]).

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Third Quarter 2023 Highlights and Recent Developments

Reported positive interim Phase 2 ASPEN-06 clinical trial results for evorpacept for the treatment of advanced HER2-positive gastric/gastroesophageal junction ("GEJ") cancer.
Completed public offering generating gross proceeds of approximately $63.2 million.
Realigned leadership team to match platform asset evorpacept’s maturing portfolio of programs and refined long-term development strategy.
Advanced pipeline of nine programs evaluating evorpacept in combination with anti-cancer antibodies, antibody-drug conjugates ("ADCs"), and PD-1/PD-L1 immune checkpoint inhibitors.
Commenced assessment of indications for future clinical studies where standard of care and market opportunities maximize evorpacept’s potential.
"This past quarter proved to be an important growth milestone for the Company highlighted by the outstanding interim results from the ASPEN-06 phase 2 clinical trial which again demonstrated evorpacept’s best-in-class safety profile and unique mechanism of action," commented Jason Lettmann, Chief Executive Officer of ALX Oncology. "With this additional clinical validation in gastric cancer and having completed an oversubscribed public offering, we are now accelerating our portfolio of clinical programs combining evorpacept with anti-cancer antibodies as well as with ADCs and PD-1/PD-L1 immune checkpoint inhibitors and are heading into the final months of 2023 with a great deal of momentum."

Evorpacept Pipeline Update

Throughout the third quarter, the Company continued to advance its pipeline of proprietary and partnered programs addressing multiple hematologic and solid malignancies. In October 2023, the Company reported positive interim Phase 2 data from the ASPEN-06 clinical trial, a randomized multi-center international study evaluating evorpacept in combination with trastuzumab, CYRAMZA (ramucirumab) and paclitaxel for the treatment of patients with HER2-positive gastric/GEJ cancer, which is the first randomized clinical trial to show activity in the solid tumor setting in the CD47 space. This prespecified interim analysis represented results from 54 randomized patients with second and third line gastric/GEJ cancer, including a meaningful number of patients previously treated with ENHERTU (trastuzumab deruxtecan) and checkpoint inhibitors. Patients were treated with evorpacept at 30 mg/kg every two weeks, mirroring the treatment cycle of trastuzumab, CYRAMZA and paclitaxel.

To summarize the key findings, a confirmed overall response rate ("ORR") of 52% was demonstrated for the evorpacept combination treatment arm compared to 22% for the control group of trastuzumab + CYRAMZA + paclitaxel; median duration of response ("mDOR") was not reached for the evorpacept combination treatment arm compared to 7.4 months for the control group; and the safety profile of evorpacept was consistent with the Company’s previous clinical trials and was well-tolerated. Furthermore, the interim results compare favorably to the efficacy reported for CYRAMZA + paclitaxel in the RAINBOW study (ORR of 28% and mDOR of 4.4 months), which is the regulatory benchmark and global standard of care for second line gastric/GEJ cancer.

Upcoming Clinical Milestones for Evorpacept’s Development Pipeline

1H 2024
Non-Hodgkin Lymphoma – Phase 1b investigator-sponsored trial with rituximab + lenalidomide top line results (Q1/Q2 2024)
Gastric/GEJ Cancer – Phase 2 ASPEN-06 randomized top line final results (Q2 2024)
2H 2024
Head and Neck Squamous Cell Carcinoma – Phase 2 ASPEN-03 with KEYTRUDA randomized top line results
Head and Neck Squamous Cell Carcinoma – Phase 2 ASPEN-04 with KEYTRUDA + chemotherapy randomized top line results
Gastric/GEJ Cancer – Phase 3 ASPEN-06 study initiation
Urothelial Carcinoma – Phase 1b ASPEN-07 with PADCEV (enfortumab vedotin-ejfv) top line results
Breast Cancer – Phase 1b I-SPY study with ENHERTU top line results
Corporate Update

ALX Oncology achieved a significant corporate development milestone during the third quarter with the realignment of the Company’s leadership team. Jason Lettmann, who has been involved with ALX Oncology for nearly a decade since its founding, having co-led the Company’s first institutional financing and serving as a member of its Board of Directors since 2015, was appointed Chief Executive Officer in September 2023. In turn, Dr. Jaume Pons who founded ALX Oncology and served as its Chief Executive Officer since inception, transitioned to the role of President and Chief Scientific Officer. This represents an important growth milestone for the Company as it signifies the clinical maturity of evorpacept’s portfolio of therapeutic candidates and enables Dr. Pons to focus on pipeline extension opportunities while continuing to generate scientific support for the platform asset.

An additional recent highlight was the closing of an underwritten public offering of common stock and pre-funded warrants in October 2023 which provided ALX Oncology with gross proceeds of approximately $63.2 million. The Company sold 8,663,793 shares of common stock, which included 1,293,103 shares of common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,250,000 shares of common stock in the offering. The shares of common stock were sold at a public offering price of $6.38 per share (the closing price on October 4, 2023), and the pre-funded warrants were sold at a public offering price of $6.379 per pre-funded warrant.

Third Quarter 2023 Financial Results:

Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of September 30, 2023, were $196.4 million. ALX Oncology believes its cash, cash equivalents, and investments along with the ability to draw down an additional $40 million of its term loan and the net proceeds from its recent public offering are sufficient to fund planned operations into early 2026.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended September 30, 2023, were $45.8 million, compared to $29.4 million for the prior-year period. The increase was primarily attributable to an increase of $16.4 million in clinical costs from an increase in the number of active trials and patient enrollment as well as manufacturing of clinical trial materials to support a higher number of active clinical trials and future expected patient enrollment related to the advancement of evorpacept.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended September 30, 2023, were $7.5 million, compared to $7.3 million for the prior year period.
Net loss: GAAP net loss was $51.0 million for the third quarter ended September 30, 2023, or $1.24 per basic and diluted share, as compared to a GAAP net loss of $35.3 million for the third quarter ended September 30, 2022, or $0.87 per basic and diluted share. Non-GAAP net loss was $44.0 million for the third quarter ended September 30, 2023, as compared to a non-GAAP net loss of $29.1 million for the third quarter ended September 30, 2022. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

On November 13, 2023 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, reported a business update and announced financial results for the third quarter ended September 30, 2023 (Press release, Allakos, NOV 13, 2023, View Source [SID1234637527]).

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Recent Allakos Events

•
Completed enrollment in both the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis and the Phase 2b study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria ("CSU").
•
Began dosing patients in the Phase 1 study of AK006. The Phase 1 study is a single and multiple ascending dose study of AK006 in healthy volunteers. In addition, the Phase 1 study will explore the activity of AK006 in a randomized, double-blind, placebo-controlled cohort of patients with CSU.
•
Appointed Neil Graham, M.D., Rand Sutherland, M.D., and Dolca Thomas, M.D. to the Allakos Board of Directors.

Upcoming Allakos Anticipated Milestones

•
Topline data expected from the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in late Q4 2023 to Q1 2024.
•
Topline data expected from the Phase 2b study of subcutaneous lirentelimab in patients with CSU in late Q4 2023 to Q1 2024.
•
Following the single and multiple ascending dose portions of the Phase 1 AK006 study in healthy volunteers, initiation of the randomized, double-blind, placebo-controlled cohort in patients with CSU is expected in Q2 2024.

Third Quarter 2023 Financial Results

Research and development expenses were $36.7 million in the third quarter of 2023 compared to $18.4 million in the third quarter of 2022, an increase of $18.3 million. The increase is primarily attributed to a $16.7 million increase in manufacturing costs as the third quarter of 2022 included a $12.2 million benefit from refunds for previously expensed R&D raw materials and the third quarter of 2023 included increased manufacturing costs associated with our lirentelimab (AK002) and AK006 programs, as well as a $1.6 million increase in other research and development expenses.

General and administrative expenses were $11.5 million for the third quarter of 2023 compared to $13.0 million for the third quarter of 2022, a decrease of $1.5 million. The decrease was due to decreases in professional expenses, employee compensation and other administrative expenses.

Allakos reported a net loss of $45.6 million in the third quarter of 2023 compared to $30.8 million in the third quarter of 2022. The third quarter of 2023 included noncash expenses for stock-based compensation of $10.5 million, compared to $10.7 million in the same period in 2022, and depreciation expense of $1.5 million in each of the third quarters of 2023 and 2022. Net loss per basic and diluted share was $0.52 for the third quarter of 2023 compared to $0.53 in the third quarter of 2022.

Allakos ended the third quarter of 2023 with $193.9 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $27.2 million during the third quarter of 2023.

On November 13, 2023 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported a business update and announced its financial results for the third quarter ended September 30, 2023 (Press release, Acorda Therapeutics, NOV 13, 2023, View Source [SID1234637526]).

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"We were pleased to see a 32% increase in new INBRIJA prescription requests in Q3 2023 over Q3 2022. New prescription requests have increased by 38% in the first three quarters of 2023 versus the same period in 2022. This is an encouraging sign for the long-term growth of the brand, and we are reiterating our 2023 INBRIJA guidance," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We are also delighted that Biopas has filed for the approval of INBRIJA in six countries in Latin America and expects to have up to five approvals in 2024. They also expect to file in Chile by the end of 2023 and in Brazil and Mexico in 2024."

Third Quarter 2023 Financial Results

For the quarter ended September 30, 2023, the Company reported INBRIJA worldwide net revenue of $9.5 million, a 7% increase, of which $8.1 million was derived from sales in the U.S., a 4% increase compared to the same quarter in 2022. The Company also reported ex-U.S. INBRIJA net revenue of $1.4 million in the third quarter related to sales in Spain.

For the quarter ended September 30, 2023, the Company reported AMPYRA net revenue of $15.7 million, a 26% decrease compared to $21.1 million for the same quarter in 2022. AMPYRA net revenue for the first three quarters of 2023 decreased by 17% over the same period in 2022. Additionally, for the quarter ended September 30, 2023, the Company reported FAMPYRA royalty revenues of $2.5 million, a 3% decrease compared to the same quarter in 2022. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018. The Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended September 30, 2023 were $1.2 million, compared to $1.4 million for the same quarter in 2022. Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2023 were $23.2 million, compared to $23 million for the same quarter in 2022.

Total operating expenses for the quarter ended September 30, 2023 was $30.2 million, compared to $38.5 million for the same quarter in 2022.

Non-GAAP adjusted operating expenses (adjusted OPEX) was $24.4 million for the quarters ended September 30, 2023 and September 30, 2022. This quarterly non-GAAP measure, more fully described below under "Non-GAAP Financial Measures," excludes costs of goods sold, amortization of intangible assets,

change in fair value of derivative liability, and change in fair value of acquired contingent liability. A reconciliation of the GAAP operating expenses to non-GAAP operating expenses is included with the attached financial statements.

Benefit from income taxes for the quarter ended September 30, 2023 was $1.1 million, compared to a provision for income taxes of $1.4 million for the same quarter in 2022.

The Company reported a GAAP net loss of $8.9 million for the quarter ended September 30, 2023, or a net loss of ($7.16) per share on both a basic and diluted basis. Net loss in the same quarter of 2022 was $13.9 million, or a net loss of ($11.17) per share on both a basic and diluted basis.

At September 30, 2023, the Company had cash, cash equivalents, and restricted cash of $33.6 million, compared to $44.7 million at year end 2022.

2023 Financial Guidance

For the full year 2023, the Company reaffirms INBRIJA U.S. net revenue guidance to be $34-$38 million, Adjusted OPEX guidance to be $93-$98 million, ending cash balance guidance to be $39-44 million, and AMPYRA net revenue guidance to be $65-$70 million.

Webcast and Conference Call

The Company will host a Webcast/Conference Call in conjunction with its third quarter update and financial results today at 4:30 p.m. ET.

To participate in the Webcast, please use the following registration link:

o
View Source

If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. After you have registered, you will receive a confirmation email with the Webcast details. On the day of the Webcast, you will receive an email 2 hours prior to the start of the Webcast with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 8:30 p.m. ET on November 13, 2023, until 11:59 p.m. ET on December 12, 2023. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); access code 197086. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.