On May 9, 2023 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, reported that the Company’s product portfolio of FDA-approved brands delivered combined revenues of $9.2 million during the first quarter of 2023 (Press release, Cumberland Pharmaceuticals, MAY 9, 2023, View Source [SID1234631271]). Net income for the period was $0.2 million, or $0.01 a share, resulting in adjusted earnings of $1.7 million, or $0.11 a share. The Company ended the first quarter with $89 million in total assets, $53 million in total liabilities, and $36 million of shareholders’ equity.

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Cumberland will report its first quarter 2023 financial results and provide a company update via a conference call and live internet webcast today at 4:30 p.m. Eastern Time.

"We are pleased to announce a steady start to 2023," said Cumberland’s CEO, A.J. Kazimi. "As we continue to navigate through the many issues in our operating environment – supporting our patients and their quality of life is a top priority, as our team remains dedicated to delivering and developing high-quality medicines."

RECENT COMPANY DEVELOPMENTS:
Federal NOPAIN Act
In April 2023, Cumberland announced that it expects its Caldolor product will be eligible for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation Act (the "NOPAIN Act"), which was enacted as part of the Consolidated Appropriations Act of 2023.
The NOPAIN Act requires Medicare to provide separate reimbursement for non-opioid products that are used to manage pain during surgeries, conducted in outpatient hospital departments or in ambulatory surgical centers. The NOPAIN Act applies to products that are indicated to provide analgesia without acting upon the body’s opioid receptors. As a result, Cumberland expects that the NOPAIN Act will affect Medicare reimbursement for Caldolor, the Company’s non-opioid analgesic injection brand.
FDA Fee Waiver
In March 2023, the FDA informed Cumberland that it had granted a barrier-to-innovation waiver, which will result in a refund of nearly $2 million that the Company had previously paid for prescription drug program fees associated with its RediTrex product line.
The FDA granted the barrier-to-innovation waiver after concluding that Cumberland met the statutory criteria, based on the innovation associated with Cumberland’s ifetroban clinical development programs. Cumberland’s request for the waiver provided the rationale that the funds could be better used to advance its clinical programs, which are designed to address a series of unmet medical needs.

New Office Headquarters

Cumberland has relocated its international headquarters to the Broadwest campus in the Vanderbilt/West End corridor of Nashville. The new location allows Cumberland to maintain a strong presence in the Nashville healthcare community, which represents the nation’s largest concentration of healthcare companies.
International Updates
During the first quarter of 2023, the Company continued to support its international partners in their efforts to register Cumberland products in their countries:
•PiSA Pharmaceutical is preparing its submission for distribution of Caldolor in Mexico.
•Tabuk Pharmaceutical is updating the approval in Saudi Arabia in order to begin introducing Vibativ into the Middle East.
•SciClone Pharmaceuticals continues to address regulatory inquiries, as it seeks approval for Vibativ in China.
•DB Pharm Korea Co. Ltd. is working towards approval of Vibativ in South Korea, where it also distribute Caldolor.
Nordic Pharma RediTrex Agreement Restructured
In 2022, Cumberland restructured its agreement with Nordic Pharma, who previously provided Cumberland with the license for the U.S. rights associated with the RediTrex product line. Nordic will assume the responsibility for the product in the U.S. after June 30, 2023.
Sancuso Acquisition
During 2022, Cumberland announced its acquisition of the U.S. rights to oncology-supportive drug Sancuso from the U.S. subsidiary of Kyowa Kirin, Inc., a Japan-based specialty pharmaceutical company. Sancuso is the first and only FDA-approved prescription patch that prevents nausea and vomiting in cancer patients receiving certain types of chemotherapy treatment. Through the acquisition, Cumberland obtained full commercial responsibility for Sancuso in the U.S., including its marketing, promotion, distribution and manufacturing. In late 2022, the FDA approved moving the product’s manufacturer to a new facility, which will be the source of future product supplies. The product continues to be a significant contributor to Cumberland’s business.
Clinical Development Program
Cumberland continues to sponsor and progress three Phase II clinical programs featuring the Company’s ifetroban product candidate. These studies involve patients with:
a.Aspirin-Exacerbated Respiratory Disease, or AERD, a severe form of asthma;
b.Systemic Sclerosis, a debilitating autoimmune disorder; and
c.Duchenne Muscular Dystrophy, a genetic neuromuscular disease.
In addition, Cumberland has been designing a fourth Phase II clinical program, which will evaluate the use of ifetroban to treat patients with Progressive Fibrosing Interstitial Lung Diseases.

FINANCIAL RESULTS:

Net Revenue: For the three months ended March 31, 2023, net revenues were $9.2 million.
Net revenue by product for the first quarter of 2023, included $4.3 million for Kristalose, $1.9 million for Sancuso, $1.8 million for Vibativ and $0.9 million for Caldolor.
Operating Expenses: Total operating expenses for the first quarter of 2023 were $10.8 million.
Net Income: The Net Income for the first quarter of 2023 was $0.2 million or $0.01 a share.
Adjusted earnings: Adjusted earnings for the first quarter of 2023 were $1.7 million, or 0.11 per share.
The adjusted earnings calculation does not include the benefit of the $0.2 million of Vibativ cost of goods, which were received with the product acquisition. It also does not include the benefit of the $0.3 million of Sancuso cost of goods, which were received with that product’s acquisition.
Balance Sheet: At March 31, 2023, Cumberland had $89 million in total assets, including $16 million in cash and cash equivalents.
Total liabilities were $53 million, including $16 million outstanding on the Company’s revolving line of credit. Total shareholders’ equity was $36 million.
EARNINGS REPORT CALL:
A conference call will be held on May 9 at 4:30 p.m. Eastern Time, to discuss the results.
To participate in the call, please register at:
https://register.vevent.com/register/BI723fac45344448bbb1833dbb8fa667f3.
Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.
A replay of the call will be available for one year and can be accessed via Cumberland’s website or by visiting View Source

On May 9, 2023 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported its financial results for the first quarter of 2023 and reviewed recent pipeline progress (Press release, Caribou Biosciences, MAY 9, 2023, View Source [SID1234631270]).

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"We are driving important progress this year across our pipeline of allogeneic CAR-T cell therapies," said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. "Notably, we are advancing the ongoing ANTLER trial for our lead program CB-010, the first allogeneic cell therapy to be evaluated clinically in the second-line LBCL setting. Our goal is to provide access to a greater number of patients and potentially improve outcomes earlier in the disease course. Additionally, we are excited that the FDA granted CB-011 Fast Track designation for the treatment of relapsed or refractory multiple myeloma and that we have initiated patient dosing in our CaMMouflage trial. The momentum continues as we prepare CB-012, our third CAR-T cell program, for an IND application submission for relapsed or refractory acute myeloid leukemia in the second half of this year."
Accomplishments and Highlights

Pipeline and Technology
•CB-010: Caribou successfully completed dose escalation and has entered the dose expansion portion of the ongoing ANTLER Phase 1 clinical trial of CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).
◦Caribou currently is enrolling second-line patients with large B cell lymphoma (LBCL) in the dose expansion portion of the ANTLER trial in which two different CB-010 dose levels (80×106 CAR-T cells and 120×106 CAR-T cells) are being evaluated, each as a single-dose regimen, in approximately 30 second-line patients (approximately 15 patients per dose level) to determine the recommended Phase 2 dose (RP2D). Once the RP2D is determined, Caribou may enroll additional patients in the ANTLER trial.
◦The FDA has granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations.
•CB-011: Caribou has initiated patient dosing at dose level 1 (50×106 CAR-T cells) in the CaMMouflage Phase 1 trial for relapsed or refractory multiple myeloma (r/r MM).
◦The FDA recently granted CB-011 Fast Track designation for r/r MM.
•CB-012: Caribou is advancing IND-enabling activities for CB-012, an allogeneic anti-CLL-1 CAR-T cell therapy, to support a planned IND application submission for relapsed or refractory acute myeloid leukemia (r/r AML).
1

img25401123_0.jpg
◦Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting (View Source) demonstrated in preclinical AML models that CB-012 significantly reduced tumor burden and increased overall survival compared to controls.

Anticipated 2023 Milestones
•CB-010: Caribou plans to provide a safety and efficacy update in H2 2023 from the ongoing ANTLER Phase 1 clinical trial in r/r B-NHL, including data from at least 15 patients from dose escalation with a minimum of six months follow up.
•CB-011: Caribou plans to provide updates on dose escalation as the CaMMouflage Phase 1 clinical trial in r/r MM advances.
•CB-012: Caribou plans to submit an IND application for r/r AML in H2 2023.

First Quarter 2023 Financial Results

Cash, cash equivalents, and marketable securities: Caribou had $291.0 million in cash, cash equivalents, and marketable securities as of March 31, 2023, compared to $317.0 million as of December 31, 2022. Caribou expects its cash, cash equivalents, and marketable securities will be sufficient to fund its current operating plan into 2025.

Licensing and collaboration revenue: Revenue from Caribou’s licensing and collaboration agreements was $3.5 million for the three months ended March 31, 2023, compared to $2.7 million for the same period 2022. The increase was primarily due to revenue recognized under the Collaboration and License Agreement with AbbVie and other license agreements.
R&D expenses: Research and development expenses were $25.7 million for the three months ended March 31, 2023, compared to $13.9 million for the same period in 2022. The increase was primarily due to costs to advance pipeline programs, including the ANTLER and CaMMouflage Phase 1 trials; increased personnel-related expenses, including stock-based compensation; and facilities and other allocated expenses.

G&A expenses: General and administrative expenses were $8.9 million for the three months ended March 31, 2023, compared to $9.6 million for the same period in 2022. The decrease was primarily due to lower director and officer insurance, legal, and patent prosecution and maintenance costs. This decrease was partially offset by increased personnel-related expenses due to increased headcount.
Net loss: Caribou reported a net loss of $28.0 million for the three months ended March 31, 2023, compared to a net loss of $19.1 million for the same period in 2022.

About CB-010
CB-010 is the lead product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). In the ongoing ANTLER Phase 1 trial, Caribou is enrolling second-line patients with large B cell lymphoma (LBCL) comprising four different subtypes of aggressive r/r B-NHL (DLBCL NOS, PMBCL, HGBL, and tFL). CB-010 is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR

hybrid RNA-DNA (chRDNA) technology. CB-010 is the first allogeneic CAR-T cell therapy in the clinic, to Caribou’s knowledge, with a PD-1 knockout, a genome-editing strategy designed to improve antitumor activity by limiting premature CAR-T cell exhaustion. CB-010 is also the first anti-CD19 allogeneic CAR-T cell therapy, to Caribou’s knowledge, to be evaluated clinically in the second-line setting and has been granted Regenerative Medicine Advanced Therapy (RMAT), Fast Track, and Orphan Drug designations by the FDA. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011
CB-011 is the second product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. CB-011 is an allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology. CB-011 is the first allogeneic CAR-T cell therapy in the clinic, to Caribou’s knowledge, that is engineered to improve antitumor activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track designation by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.

About CB-012
CB-012 is the third product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in investigational new drug (IND)-enabling studies. CB-012 is the first allogeneic CAR-T cell therapy, to Caribou’s knowledge, with both checkpoint disruption, through a PD-1 knockout, and immune cloaking, through a B2M knockout and B2M–HLA-E fusion protein insertion; both armoring strategies are designed to improve antitumor activity. CB-012 is engineered with five genome edits, enabled by Caribou’s patented next-generation CRISPR technology platform, which uses Cas12a chRDNA genome editing to significantly improve the specificity of genome edits.

About Caribou’s Novel Next-Generation CRISPR Platform
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems have exhibited editing at unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced "chardonnays") that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies.

On May 9, 2023 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, reported financial results for the first quarter ended March 31, 2023, and provided a pipeline update on its clinical-stage investigational molecules – targeting TIGIT, the adenosine axis (CD73 and A2a/A2b receptors), HIF-2a and PD-1 – across multiple common cancers (Press release, Arcus Biosciences, MAY 9, 2023, View Source [SID1234631269]).

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"Together with our partner Gilead, we continue to execute on our four Phase 3 studies evaluating domvanalimab-based combinations versus standard of care in lung and gastrointestinal cancers. We are also making great progress on our earlier-stage pipeline. Specifically, we plan to initiate a Phase 2 combination study for AB521, our potential best-in-class HIF-2a inhibitor, in the second half of this year, while also advancing two additional molecules into the clinic in 2023," said Terry Rosen, Ph.D., chief executive officer of Arcus. "Meanwhile, we are leveraging our deep immunology and small-molecule expertise to diversify our portfolio into inflammatory disease with the advancement of our KIT inhibitor program. With $1.0 billion in cash and investments and runway into 2026, we are in an extremely strong position to advance our diverse portfolio of innovative therapies."

Pipeline Highlights:

Domvanalimab (Fc-silent anti-TIGIT monoclonal antibody)

•
Data from the ARC-7 study will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023, which will include updated data for all 150 patients in the trial.
•
Initial ORR data from the ongoing EDGE-Gastric (ARC-21) Phase 2 study of domvanalimab plus zimberelimab in first- and second-line upper GI cancers are expected in the second half of 2023. These data will be from the cohort that reflects the same patient population and dosing regimen as the ongoing Phase 3 study, STAR-221.
AB521 (HIF-2a inhibitor)

•
Arcus is enrolling the third dose-escalation cohort of ARC-20, a Phase 1/1b study of AB521 in cancer patients, evaluating a 100-mg daily dose, which Arcus believes has the potential to achieve at least 3 times greater HIF-2a inhibition than that of the approved dose of the marketed competitor.
o
Upon completion of this cohort, Arcus expects to advance ARC-20 into the dose-expansion stage of the study.
o
Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data, along with any preliminary signs of anti-tumor activity from the dose-escalation phase of ARC-20, are anticipated in late 2023 or early 2024.
•
A Phase 2 study evaluating AB521 in combination with other agents is anticipated to begin in the third quarter of 2023.

Quemliclustat (small-molecule CD73 inhibitor)

•
Arcus and Gilead expect mature overall survival (OS) data from the ongoing Phase 1/1b ARC-8 trial evaluating quemliclustat plus chemotherapy with or without zimberelimab in first-line pancreatic cancer in the second half of 2023; these data will inform next steps for quemliclustat in pancreatic cancer.
Etrumadenant (A2a/A2b adenosine receptor antagonist)

•
Updated analysis from the ARC-7 study will be presented at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2023, including more mature data for the etrumadenant plus domvanalimab plus zimberelimab arm.
•
Data from the randomized cohort of ARC-6, a Phase 1b/2 study evaluating etrumadenant plus zimberelimab and docetaxel versus docetaxel in metastatic castrate-resistant prostate cancer (mCRPCs), are expected in the second half of 2023.
•
Data from ARC-9, a Phase 1b/2 study evaluating etrumadenant plus zimberelimab plus chemotherapy in second-line and third-line metastatic colorectal cancer (mCRC), are expected in the second half of 2023.

Preclinical Programs

•
The IND for AB598, Arcus’s anti-CD39 antibody, has been cleared by the FDA, and Arcus is on track to initiate a Phase 1 trial in cancer patients in the second quarter of 2023.
•
Arcus expects to initiate a Phase 1 study for AB801, a potent and highly selective Axl inhibitor, in the second half of 2023.
o
Arcus presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023 demonstrating high potency and selectivity of AB801 for Axl over other kinases in multiple assays; the data also showed that AB801 significantly decreased tumor volume and increased survival in mouse tumor models.
o
The early development plan is expected to focus on treatment-resistant tumor types, such as STK11-mutant NSCLC.
•
Arcus expects to advance its first candidate against an inflammation target, AB375, a highly selective KIT inhibitor, into the clinic in early 2024.

Financial Results for First Quarter 2023:

•
Cash, cash equivalents and marketable securities were $1.0 billion as of March 31, 2023, compared to $1.1 billion as of December 31, 2022. The decrease during the period is primarily due to the use of cash in research and development activities. Cash, cash equivalents and marketable securities on-hand are expected to be sufficient to fund operations into 2026.
•
Revenues were $25 million for first quarter 2023, compared to $18 million for the same period in 2022. In first quarter 2023, Arcus recognized $17 million in license and development service revenues for programs optioned by Gilead. Arcus further recognized $8 million in collaboration revenue related to Gilead’s ongoing rights to access Arcus’s research and development pipeline in accordance with the Gilead collaboration agreement.
•
Research and Development (R&D) Expenses were $81 million for first quarter 2023, compared to $61 million for the same period in 2022. Arcus’s expanding clinical and development activities increased costs by $31 million, partially offset by $11 million in higher reimbursements for shared expenses from Arcus’s collaborations, primarily the Gilead collaboration, which was expanded in December 2021. The $20 million increase in R&D costs net of reimbursements was driven by Arcus’s expanding clinical and development activities as Arcus enrolled more patients in its existing and new studies. Non-cash stock-based compensation expense was $9 million for both periods. For first-quarter 2023 and 2022, Arcus recognized reimbursements of $42 million and $31 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration.
•
General and Administrative (G&A) Expenses were $30 million for first quarter 2023, compared to $24 million for the same period in 2022. The increase was driven by the increased complexity of supporting Arcus’s expanding clinical pipeline and partnership obligations. Non-cash stock-based compensation expense was $10 million for first quarter 2023, compared to $8 million for the same period in 2022.

•
Net Loss was $80 million for first quarter 2023, compared to $68 million for the same period in 2022.
Arcus Ongoing and Announced Clinical Studies

Trial Name

Arms

Setting

Status

NCT No.

Lung Cancer

ARC-7

zim vs. dom + zim vs. etruma + dom + zim

1L NSCLC (PD-L1 ≥ 50%)

Ongoing Randomized Phase 2

NCT04262856

PACIFIC-8

(Operationalized by AZ)

dom + durva vs. durva

Curative-Intent Stage 3 NSCLC

Ongoing Registrational Phase 3

NCT05211895

ARC-10

dom + zim vs. pembro

1L NSCLC (PD-L1 ≥ 50%)

Ongoing Registrational Phase 3

NCT04736173

STAR-121

(Operationalized by Gilead)

dom + zim + chemo vs. pembro + chemo

1L NSCLC (PD-L1 all-comers)

Ongoing Registrational Phase 3

NCT05502237

EDGE-Lung

dom +/- zim +/- quemli +/- chemo

1L/2L NSCLC (lung cancer platform study)

Ongoing Randomized Phase 2

NCT05676931

VELOCITY-Lung

(Operationalized by Gilead)

dom +/- zim +/- etruma +/- sacituzumab govitecan-hziy or other combos

1L/2L NSCLC (lung cancer platform study)

Ongoing Randomized Phase 2

NCT05633667

Gastrointestinal Cancers

ARC-9

etruma + zim + mFOLFOX vs. SOC

2L/3L/3L+ CRC

Ongoing

Randomized Phase 2

NCT04660812

EDGE-Gastric

(ARC-21)

dom +/- zim +/- quemli

+/- chemo

1L/2L Upper GI Malignancies

Ongoing

Randomized Phase 2

NCT05329766

STAR-221

dom + zim + chemo vs. nivo + chemo

1L Gastric, Gastroesophageal Junction (GEJ), and Esophageal Adenocarcinoma (EAC)

Ongoing Registrational Phase 3

NCT05568095

Pancreatic Cancer

ARC-8

quemli + zim + gem/nab-pac vs. quemli + gem/nab-pac

1L, 2L PDAC

Ongoing Randomized Phase 1/1b

NCT04104672

Prostate Cancer

ARC-6

etruma + zim + SOC vs. SOC (also enrolling sacituzumab govitecan-hziy combination cohorts)

2L/3L CRPC

Ongoing Randomized Phase 2

NCT04381832

Various

ARC-12

AB308 + zim

Advanced Malignancies

Ongoing

Phase 1/1b

NCT04772989

ARC-14

AB521

Healthy Volunteers

Ongoing

NCT05117554

ARC-20

AB521

Cancer Patients / ccRCC

Ongoing Phase 1/1b

NCT05536141

dom: domvanalimab; durva: durvalumab; etruma: etrumadenant; gem/nab-pac: gemcitabine/nab-paclitaxel; nivo: nivolumab; pembro: pembrolizumab; quemli: quemliclustat; SOC: standard of care; zim: zimberelimab

ccRCC: clear-cell renal cell carcinoma; CRC: colorectal cancer; CRPC: castrate-resistant prostate cancer; GI: gastrointestinal; NSCLC: non-small cell lung cancer; PDAC: pancreatic ductal adenocarcinoma

On May 9, 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 provided financial results for the first quarter ended March 31, 2023 (Press release, Allakos, MAY 9, 2023, View Source [SID1234631268]).

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Recent Allakos Events

Continued enrollment of a Phase 2 randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with moderate-to-severe atopic dermatitis during the first quarter of 2023.
Continued enrollment of a Phase 2b randomized, double-blind, placebo-controlled study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria (CSU) during the first quarter of 2023.
Upcoming Allakos Anticipated Milestones

Initiate the first-in-human study with AK006 in the first half of 2023.
Report topline data from the Phase 2 study of subcutaneous lirentelimab in patients with atopic dermatitis in the second half of 2023.
Report topline data from the Phase 2b study of subcutaneous lirentelimab in patients with chronic spontaneous urticaria in the second half of 2023.
First Quarter 2023 Financial Results

Research and development expenses were $33.1 million in the first quarter of 2023 compared to $176.8 million in the first quarter of 2022. First quarter of 2023 research and development expenses were significantly lower compared to the same period in the prior year as a result of the cost reduction efforts and reorganization plan implemented in the first quarter of 2022. The first quarter of 2022 research and development expenses included $130.5 million related to contract terminations and $4.6 million of employee related costs due to the reorganization plan.

General and administrative expenses were $12.0 million for the three months ended March 31, 2023 compared to $18.8 million for the three months ended March 31, 2022, a decrease of $6.9 million. The first quarter of 2022 general and administrative expenses included $4.3 million of costs as a result of the reorganization plan. The remaining decrease in general and administrative expenses from the prior year first quarter was primarily due to decreases in stock-based compensation expense and other general and administrative expenses.

Allakos reported a net loss of $42.4 million in the first quarter of 2023 compared to $197.0 million in the first quarter of 2022. Additionally, the first quarter of 2023 included non-cash expenses for stock-based compensation of $10.7 million, compared to $11.4 million in the same period in 2022, and depreciation of $1.5 million, compared to $2.1 million in the same period in 2022. Net loss per basic and diluted share was $0.49 for the first quarter of 2023 compared to $3.60 in the first quarter of 2022.

Allakos ended the first quarter of 2023 with $252.6 million in cash, cash equivalents and investments resulting in a net decrease in cash and investments of $27.2 million during the first quarter of 2023.

On May 9, 2023 Interius BioTherapeutics, a preclinical stage gene therapy company developing novel methods for in vivo cell-specific gene delivery, reported a manufacturing partnership with WuXi Advanced Therapies (WuXi ATU), a global Contract Testing, Development and Manufacturing Organization (CTDMO) (Press release, Interius BioTherapeutics, MAY 9, 2023, View Source [SID1234631249]). Interius has developed a process to manufacture INT-2104, an off the shelf lentivector product designed to create autologous chimeric antigen receptor (CAR) T cells directly in vivo in a patient’s body for the treatment of B cell malignancies. Through this partnership, Interius will leverage WuXi ATU’s CTDMO platform for Good Manufacturing Process (GMP) manufacturing of Phase I clinical product.

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"The Interius process leverages existing standard industry manufacturing processes and enables seamless transfer into cGMP settings for the manufacture of Phase I clinical material. Our process lends itself to scale up compatible with late-stage trials and commercial scale," said Tim Culp, Vice President of Research and Development of Interius. "We are delighted to work with WuXi ATU, a partner with integrated plasmid and vector manufacturing expertise."

Lentivirus vectors are typically used during the manufacturing of cell therapy products for allogeneic and autologous ex vivo CAR cell therapies. "The proprietary and novel nature of our platform necessitated the development of our own process at Interius. WuXi ATU has successfully scaled the process to 200L, and our partnership is an important step toward fulfilling the vision of Interius to enable broad patient access to CAR T therapies," said Dr. Phil Johnson, Chief Executive Officer of Interius.