On August 14, 2023 Pfizer Inc. (NYSE:PFE) reported the U.S. Food and Drug Administration (FDA) has granted accelerated approval to ELREXFIO (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody (Press release, Pfizer, AUG 14, 2023, View Source [SID1234634407]). Approval was based on the results of the single-arm Phase 2 MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy that binds to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells.

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"ELREXFIO reflects our ongoing commitment to developing scientific breakthroughs that meaningfully improve outcomes for people with cancer. Discovered at Pfizer, we advanced this therapy from a first-in-patient trial to approval in less than five years, because we know that time is life for people living with multiple myeloma," said Angela Hwang, Chief Commercial Officer and President of Global Biopharmaceuticals Business, Pfizer. "With significant responses in a patient population with highly refractory disease, we believe ELREXFIO is poised to potentially become the new standard of care for multiple myeloma, as we plan to build upon this indication with continued development across the expansive MagnetisMM program."

The approval of ELREXFIO is based on data from response rates and duration of response. Data from cohort A (n=123) of the Phase 2 MagnetisMM-3 study (NCT04649359) showed meaningful responses among heavily pretreated RRMM patients who received ELREXFIO as their first BCMA-directed therapy. Among the patients in this study who received four or more lines of therapy prior to ELREXFIO (n=97), the overall response rate was 58%, with an estimated 82% maintaining the response for at least nine months. The median time to first response was 1.2 months. This study also established ELREXFIO as the first BCMA-directed therapy in the U.S. with once-every-other-week dosing for responding patients after 24 weeks of weekly therapy, which means less time at the clinic and potentially greater long-term treatment tolerability. The label also includes data from MagnetisMM-3 cohort B (n=64). Among the 63 patients in this cohort who received at least four prior lines of therapy, including a BCMA-directed therapy (CAR-T or antibody-drug conjugate), the overall response rate was 33% after a median follow-up of 10.2 months, with an estimated 84% maintaining the response for at least nine months.

In longer-term efficacy data for cohort A (n=123) presented at the 2023 European Hematology Association (EHA) (Free EHA Whitepaper) meeting, the objective response rate was 61%, and median duration of response, overall survival, and progression-free survival had not yet been reached at 14.7 months median follow-up. For the responding patients, the probability of maintaining a response at 15 months was 72%. Among responding patients who switched to every-other-week dosing at least six months prior to the data cut-off date (n=50), 80% maintained or improved their response after the switch, with 38% attaining a complete response or better after the switch.

"Most multiple myeloma patients will experience relapse or resistance of their disease to treatment, often facing increased symptom burden and lowering their chance of surviving longer with each attempted line of therapy," said MagnetisMM clinical trial investigator Ajay Nooka, MD, MPH, Director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University. "By offering durable clinical response with an established safety profile and the convenience of subcutaneous administration, ELREXFIO provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma."

ELREXFIO’s label contains a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity (NT), including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity. The most common adverse reactions to ELREXFIO (incidence ≥20%) are CRS, fatigue, injection site reaction, diarrhea, upper respiratory tract infection, musculoskeletal pain, pneumonia, decreased appetite, rash, cough, nausea, and fever (pyrexia). The most common Grade 3 to 4 laboratory abnormalities (≥20%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased white blood cells, and decreased platelets. The step-up dose regimen (12/32/76 mg), combined with acetaminophen, dexamethasone, and diphenhydramine pre-treatment, is intended to reduce the incidence and severity of CRS. As a precaution, patients should be hospitalized for 48 hours following the first step-up dose and for 24 hours following the second step-up dose. No hospitalization is required for the third step-up dose. Given the risk of CRS and NT, including ICANS, ELREXFIO is available only through a restricted program called the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS). A confirmatory trial (MagnetisMM-5) in the double-class exposed relapsed or refractory population involving 854 patients was initiated in 2022 to gather additional safety and efficacy data. Data will be shared as available.

"Accessibility is key to unlocking the potential impact of new treatment options. Unfortunately, novel therapies for triple-class-exposed multiple myeloma can be out of reach for medically underserved populations," said Jenny Ahlstrom, Founder and Chief Executive Officer of the HealthTree Foundation for Multiple Myeloma. "With the approval of ELREXFIO, patients have a new off-the-shelf treatment option that can be delivered on an ongoing basis in community clinics, where the majority of patients with multiple myeloma receive their care."

For patients who are prescribed ELREXFIO, Pfizer offers the support of Patient Access Navigators, through our Pfizer Oncology Together program, who provide personalized services for all aspects of treatment, including financial assistance resources, treatment support, and resources to navigate potential insurance and coverage issues.

ELREXFIO received Breakthrough Therapy Designation and Orphan Drug Designations and was approved under the FDA’s Accelerated Approval Program, which is designed to shorten the time of FDA review for drugs that treat serious conditions and fill an unmet medical need. The FDA review was also conducted under Project Orbis, a framework for the concurrent submission and review of oncology drugs among international partners to potentially expedite approvals. Currently, five countries (Switzerland, Brazil, Canada, Australia, and Singapore) are participating. A new drug application for ELREXFIO is being evaluated by the Japanese Ministry of Health, Labour and Welfare. Additionally, a marketing authorization application for ELREXFIO is currently being evaluated under the PRIME scheme by the European Medicines Agency (EMA).

The extensive MagnetisMM clinical development program is investigating ELREXFIO’s use across the entire spectrum of myeloma progression, from newly diagnosed multiple myeloma to RRMM. Ongoing registrational-intent trials are exploring ELREXFIO both as monotherapy and in combination with standard or novel therapies. These include the Phase 3 MagnetisMM-5 trial in the double-class exposed setting and MagnetisMM-7 with ELREXFIO as maintenance treatment in newly diagnosed patients after transplant.

View the full Prescribing Information, including the Boxed Warning and patient Medication Guide. If it is not currently available via this link, it will be visible as soon as possible as we work to finalize the document. Please check back for the full information shortly.

About Multiple Myeloma
Multiple myeloma (MM) is an aggressive and currently incurable blood cancer that affects plasma cells made in the bone marrow. Healthy plasma cells make antibodies that help the body fight infection.1 MM is the second most common type of blood cancer, with over 35,000 new cases of MM diagnosed annually in the U.S. and 176,000 globally.2,3 About half of those diagnosed with MM won’t survive beyond five years, and most will receive four or more lines of therapy due to relapse.4 While disease trajectory varies for each person, relapses are nearly inevitable.5 Real-world evidence shows that people with RRMM often become resistant to the three main classes of treatment – proteasome inhibitors, immunomodulatory agents and anti-CD38 monoclonal antibodies – after just a few rounds of therapy, and re-treating with these classes was common.6 The goal of therapy for people with RRMM is to achieve disease control with acceptable toxicity and improved quality of life.7

What is the most important information I should know about ELREXFIO?
ELREXFIO (elranatamab-bcmm) may cause side effects that are serious, life-threatening, or can lead to death, including cytokine release syndrome (CRS) and neurologic problems.

Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS or neurologic problems at any time during your treatment with ELREXFIO.

Cytokine release syndrome (CRS). Symptoms of CRS may include:

fever of 100.4°F (38ºC) or higher
trouble breathing
chills
dizziness or light-headedness
fast heartbeat
headache
increased liver enzymes in your blood
Due to the risk of CRS, you will receive ELREXFIO on a "step-up" dosing schedule and should be hospitalized for 48 hours after the first "step-up" dose and for 24 hours after the second "step-up" dose of ELREXFIO.

During the "step-up" dosing schedule:
For your first dose, you will receive a smaller "step-up" dose of ELREXFIO on day 1 of treatment
For your second dose, you will receive a larger "step-up" dose of ELREXFIO, which is usually given on day 4 of treatment
For your third dose, you will receive the first treatment dose of ELREXFIO, which is usually given on day 8 of treatment
If your dose of ELREXFIO is delayed for any reason, you may need to repeat the "step-up" dosing schedule
Before each dose of ELREXFIO you receive during the "step-up" dosing schedule, you will receive medications to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medications to help reduce your risk of CRS with future doses
Neurologic problems. Symptoms of neurologic problems may include:

headache
agitation, trouble staying awake, confusion or disorientation, or seeing or hearing things that are not real (hallucinations)
trouble speaking, thinking, remembering things, paying attention, or understanding things
problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms
numbness and tingling (feeling like "pins and needles")
burning, throbbing, or stabbing pain
changes in your handwriting
Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with ELREXFIO, as well as other side effects, and will treat you as needed. Your healthcare provider may temporarily stop or completely stop your treatment with ELREXFIO if you develop CRS, neurologic problems, or any other severe side effects.

If you have any questions about ELREXFIO, ask your healthcare provider.

See "What are the possible side effects of ELREXFIO?" section for more information about side effects.

ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) Program due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists signs and symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the signs and symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Before taking ELREXFIO, tell your healthcare provider about all of your medical conditions, including if you:

have an infection
are pregnant or plan to become pregnant. ELREXFIO may harm your unborn baby. Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with ELREXFIO
You should use effective birth control (contraception) during treatment and for 4 months after your last dose of ELREXFIO
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with ELREXFIO
are breastfeeding or plan to breastfeed. It is not known if ELREXFIO passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of ELREXFIO
Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.

What should I avoid while receiving ELREXFIO?
Do not drive or operate heavy or potentially dangerous machinery for 48 hours after completing each of the 2 doses of ELREXFIO that are part of the "step-up" dosing schedule and the first treatment dose and at any time during treatment with ELREXFIO if you develop any new neurologic symptoms until the symptoms go away.

What are the possible side effects of ELREXFIO?
ELREXFIO may cause serious side effects, including:

Infections. Upper respiratory tract infection and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death. Your healthcare provider will monitor you for symptoms of infection before and during treatment with ELREXFIO
Your healthcare provider may prescribe medications for you to help prevent infections and treat you as needed if you develop an infection during treatment with ELREXFIO
Tell your healthcare provider right away if you develop any signs or symptoms of an infection during treatment with ELREXFIO, including:
fever of 100.4°F (38ºC) or higher
chills
cough
shortness of breath
chest pain
sore throat
pain during urination
feeling weak or generally unwell
People with active infections should not start ELREXFIO
Decreased white blood cell counts. Decreased white blood cell counts are common during treatment with ELREXFIO and can also be severe. A fever can occur with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed
Liver problems. ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of a liver problem:
tiredness
loss of appetite
pain in your right upper stomach-area (abdomen)
dark urine
yellowing of your skin or the white part of your eyes
Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.

The most common side effects of ELREXFIO include:

tiredness
injection site reaction, such as redness, itching, pain, bruising, rash, swelling, and tenderness
diarrhea
muscle and bone pain decreased appetite rash
cough
nausea
fever
The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.

These are not all of the possible side effects of ELREXFIO.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is ELREXFIO?
ELREXFIO is a prescription medication used to treat adults with multiple myeloma who have already received at least four treatment regimens (including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody) to treat their multiple myeloma, and their cancer has come back or did not respond to prior treatment.

ELREXFIO is approved based on patient response. Data are not yet available to show if ELREXFIO improves survival or symptoms.

It is not known if ELREXFIO is safe and effective in children.

Please read full Prescribing Information, including BOXED WARNING, for ELREXFIO.

On August 14, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, reported financial results for the three and six months ended June 30, 2023, and provided a business update (Press release, BioAffinity Technologies, AUG 14, 2023, View Source [SID1234634406]).

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Highlights from the second quarter of 2023 and subsequent weeks included:

Corporate and Commercial Highlights

The American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code for use with CyPath Lung with an effective date of Oct. 1, 2023. CPT codes provide a uniform system to identify medical services and procedures and seek reimbursement from private payers and public health insurance programs, including Medicare and Medicaid.
The Department of Defense (DOD) purchased CyPath Lung tests for use in an observational study on active military personnel at high risk for developing lung cancer (NCT05870592) and for research on the use of bronchoalveolar lavage fluid to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.
Michael Dougherty joined the management team as Chief Financial Officer. Previously, he served as CFO of Amazon’s Alexa commercial domains with responsibility for financial strategy over Alexa’s multibillion-dollar investments in AI-generated customer experiences.
The Company launched a pilot marketing and sales program in select cities in Texas to provide insights and strategies for the successful product rollout for CyPath Lung.
Research and Development Highlights

Presented advancements in CyPath Lung at the Cleveland Clinic’s invitation-only fourth annual "Advances in Early Lung Cancer Detection" symposium, which focuses on accelerating the development and implementation of new technologies and methods for the early detection of lung cancer.
Presented a poster titled "Development of porphyrin-stained polystyrene compensation beads for use on an automated analysis platform" at CYTO 2023, the annual Congress for the International Society for the Advancement of Cytometry, that demonstrated the suitability of the Company’s proprietary compensation beads for commercial use with flow cytometry, including with CyPath Lung.
Presented a poster titled "Vitamin B12 deprivation does not phenocopy selective cytotoxicity of CD320 and LRP2 silencing" at the University of Massachusetts T.H. Chan Medical School’s fifth annual RNA Therapeutics Symposium demonstrating that deprivation of vitamin B12 does not play a role in the selective cytotoxicity of cancer cells observed after silencing the expression of CD320 and LRP2; this research follows the Company’s discovery that using small interfering RNA (siRNA) to knock down CD320 and LRP2 killed cancer cells in vitro without harming healthy cells.
Management Commentary

"Our sales team is implementing a test market pilot program of CyPath Lung across various target markets in Texas, and we are encouraged with their progress. The pilot program is a tactical program to test various marketing and selling approaches to accelerate the development of a successful regional and then national roll out of the CyPath Lung test. Issuance of a CPT code by the AMA specifically for CyPath Lung is another important milestone that we believe signals the value our diagnostic adds to the clinical care of patients at high risk for developing lung cancer," bioAffinity President and Chief Executive Officer Maria Zannes said.

"We are building brand awareness and finetuning our market positioning at the same time we are showcasing our innovation at prestigious medical and scientific conferences. The result is increased recognition and adoption of CyPath Lung, including interest by the DOD. We expect revenues from CyPath Lung to grow as we expand our geographic reach, add prescribing physicians and focus on larger medical systems," Ms. Zannes added.

Second Quarter Financial Results

Revenue for the second quarter of 2023 was $20,000, compared with $1,000 for the prior-year period. Revenue is generated from royalties from the Company’s licensee, Precision Pathology Services, from sales of CyPath Lung as a laboratory developed test, from clinical flow cytometry services provided to Precision Pathology Services related to CyPath Lung and from CyPath Lung tests purchased by the DOD. Sales to the DOD were $10,000 for the second quarter of 2023.

Research and development expenses were $335,000 for the second quarter of 2023, compared with $248,000 for the comparable period in 2022. The increase was primarily due to higher compensation costs from adding research personnel and higher costs for lab supplies and reagents.

Clinical development expenses were $35,000 for the second quarter of 2023, compared with $28,000 for the second quarter of 2022. The increase was primarily due to higher professional fees related to clinical strategy evaluation as the Company prepares to launch the CyPath Lung pivotal trial.

Selling, general and administrative expenses were $1.4 million for the second quarter of 2023, compared with $409,000 for the comparable period in 2022. The increase was primarily attributed to higher consulting, legal and professional fees related to being a publicly traded company, higher board compensation, and sales and marketing costs for commercialization of CyPath Lung.

Net loss for the second quarter of 2023 was $1.7 million, or $0.20 per share, compared with a net loss of $88,000, or $0.03 per share, for the comparable period in 2022.

Cash and cash equivalents were $8.3 million as of June 30, 2023, compared with $11.4 million as of December 31, 2022. bioAffinity Technologies believes that its available cash will be sufficient to fund planned operations for at least the next 12 months.

On August 14, 2023 XNK Therapeutics reported that it will participate at NK2023 in Oslo in September and present the latest research relating to the company’s leading natural killer (NK) cells therapies (Press release, XNK Therapeutics, AUG 14, 2023, View Source [SID1234634405]). Two abstracts have been accepted for presentation at the meeting.

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The data have been generated in collaboration with XNK’s external partners, Anders Ullén and Fernanda Costa Svedman at the Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden, for the bladder cancer abstract, and Abhishek Maiti and Naval Daver at The University of Texas MD Anderson Cancer Center in Houston, Texas, USA, for the AML abstract.

NK2023 is the 20th annual meeting arranged by the Society of Natural Immunity and takes place in Oslo, Norway, on September 26-29, 2023. The meeting will attract more than 450 participants and is focused entirely on NK cells, with a preceding day entirely focused on the development of NK cell-based immunotherapies.

"Discussing our pipeline with the world’s combined expertise really helps us moving forward and as one of the leading companies in the field we are pleased to contribute to this important meeting," said Anna-Karin Maltais, CSO of XNK Therapeutics.

On August 14, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the second quarter ended June 30, 2023 (Press release, Oncolytics Biotech, AUG 14, 2023, View Source [SID1234634404]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Matt Coffey, President and Chief Executive Officer. "Data reported at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from our BRACELET-1 randomized phase 2 trial demonstrated robust improvements in objective response rate (ORR) and progression-free survival (PFS) with a hazard ratio of 0.29 (95% CI: 0.09, 0.98). This has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout. At the same time, pelareorep was selected for inclusion in the ongoing Precision Promise pancreatic cancer platform trial. Precision Promise, created by the Pancreatic Cancer Action Network, provides us with the opportunity to reduce the time and costs needed for a potential approval, and we are honored to have been selected for participation in this novel and exclusive trial."

Second Quarter and Subsequent Highlights

Breast Cancer Program

BRACELET-1 data demonstrated a >50% improvement in progression-free survival and a nearly three-fold increase in confirmed overall response rate

An oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting featured results from a randomized trial of pelareorep in HR+/HER2- metastatic breast cancer. As of a March 3, 2023 cut-off date, BRACELET-1 data in the paclitaxel plus pelareorep cohort showed median PFS of 9.5 months, compared to 6.3 months in the paclitaxel monotherapy cohort. This resulted in a hazard ratio of 0.29 (95% CI: 0.09, 0.98), indicating the pelareorep-paclitaxel combination reduced the risk of disease progression by 71%. Confirmed ORR in these cohorts was 37.5% for paclitaxel plus pelareorep and 13.3% for paclitaxel. Overall survival data continues to mature as several patients are still on study. With these data, the HR+/HER2- metastatic breast cancer program is now phase 3-ready, and, with two randomized phase 2 trials showing meaningful benefits to patients, the focus is now on progressing to a registrational trial evaluating pelareorep-paclitaxel compared to paclitaxel alone.

Oncolytics hosted a key opinion leader (KOL) webinar on June 5, 2023 where breast cancer experts and the management team discussed recent data from the BRACELET-1 study. A link to the replay is available by clicking here.

Pancreatic Cancer Program

Pelareorep selected for inclusion in Precision Promise Pivotal Phase 3 Platform Trial

Pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise. Created by the Pancreatic Cancer Action Network (PanCAN), Precision Promise is an innovative adaptive phase 3 clinical trial designed to streamline registration pathways for promising pancreatic cancer therapies. Inclusion is expected to accelerate the registrational pathway and reduce by half the phase 3 costs compared to a traditional trial. The study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel in comparison to gemcitabine and nab-paclitaxel standard of care therapy. This clinical study is expected to support the approval of the pelareorep combination therapy as a treatment for first-line metastatic pancreatic ductal adenocarcinoma.

Additional Immunotherapeutic Opportunity

Preclinical pelareorep-chimeric antigen receptor (CAR) T cell therapy combination program

A poster presentation at ASCO (Free ASCO Whitepaper) showed preclinical results of pelareorep synergistically enhancing CAR T cell therapy efficacy in murine solid tumor models (link to the poster). The results suggest pelareorep could substantially expand the commercial potential of CAR T cell therapy beyond hematologic malignancies to include solid tumors, which represent the vast majority of cancer cases. Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep-CAR T cell combination therapies.

Financial Highlights

As of June 30, 2023, the Company reported $24.4 million in cash, cash equivalents, and marketable securities, then successfully closed a US$15 million public offering on August 8, 2023. On a pro forma basis, including the estimated US$13.6 million in net proceeds from the public offering, the Company’s cash, cash equivalents and marketable securities would have been approximately $42.7 million.
The net loss for the second quarter of 2023 was $7.4 million, compared to a net loss of $5.1 million for the second quarter of 2022. The basic and diluted loss per share was $0.12 in the second quarter of 2023, compared to a basic and diluted loss per share of $0.09 in the second quarter of 2022.
Net cash used in operating activities for the six months ended June 30, 2023 was $16.3 million, compared to $13.2 million for the six months ended June 30, 2022. The change reflected higher net operating activities and non-cash working capital changes.
General and administrative expenses for the second quarter of 2023 were $3.5 million, compared to $2.8 million for the second quarter of 2022. The increase was primarily due to higher investor relations activities and annual general meeting of shareholders costs.
Research and development expenses for the second quarter of 2023 were $3.7 million, compared to $3.2 million for the second quarter of 2022. The increase was primarily due to higher manufacturing expenses associated with an engineering production run along with process and analytical development activities and higher personnel-related expenses. The increase was partly offset by lower BRACELET-1 study costs.
Anticipated Milestones and Catalysts

Updated GOBLET study data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC): H2 2023
Update on GOBLET study’s metastatic colorectal and anal cancer cohorts: H2 2023
Guidance on both the HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC registration paths: H2 2023
BRACELET-1 phase 2 metastatic breast cancer study overall survival data
Webcast and Conference Call

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, August 14, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 5411-4798. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 114-798#.

On August 14, 2023 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal third quarter ended June 30, 2023 (Press release, Citius Pharmaceuticals, AUG 14, 2023, View Source [SID1234634403]).

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Fiscal Q3 2023 Business Highlights and Subsequent Developments

Achieved 92 required events for completion of the Mino-Lok Phase 3 trial, subject to confirmation by an independent review committee;
Mino-Lok trial to continue recruiting in the near term; additional patients in active treatment, which may result in additional events;
Citius to engage with the FDA to address enhanced product testing requirements identified in the complete response letter (CRL) for LYMPHIR, received July 28, 2023, in preparation for Resubmission; such efforts are not expected to impact Company’s cash runway, which extends to August 2024;
Citius preparing for an End of Phase 2 meeting with the FDA following positive topline results of Phase 2b trial of Halo-Lido for the treatment of hemorrhoids; and,
$15 million in capital raised through a registered direct offering of common stock and warrants at a purchase price of $1.20 per share on May 8, 2023.
Financial Highlights

Cash and cash equivalents of $33.3 million as of June 30, 2023
R&D expenses were $3.8 million and $11.9 million for the three and nine months ended June 30, 2023, respectively, compared to $4.9 million and $13.8 million for the three and nine months ended June 30, 2022, respectively;
G&A expenses were $3.7 million and $11.1 million for the three and nine months ended June 30, 2023, respectively, compared to $3.0 million and $9.0 million for the three and nine months ended June 30, 2022, respectively;
Stock-based compensation expense was $1.2 million and $3.5 million for the three and nine months ended June 30, 2023, respectively, compared to $1.0 million and $2.9 million for the three and nine months ended June 30, 2022, respectively; and,
Net loss was $8.5 million and $22.6 million, or ($0.06) and ($0.15) per share for the three and nine months ended June 30, 2023, respectively, compared to a net loss of $8.9 million and $25.6 million, or ($0.06) and ($0.18) per share for the three and nine months ended June 30, 2022, respectively.
"I am pleased to report significant progress in our pipeline and positive milestones on multiple fronts. We believe we have achieved the minimum 92-event threshold required to complete the Phase 3 Mino-Lok trial, pending confirmation by a committee of independent reviewers. We have also made progress in other areas of our business, including announcing positive topline results for the Phase 2b Halo-Lido trial, extending our financial runway through August 2024 with a $15 million capital raise, and clarifying our path toward approval for LYMPHIR (denileukin diftitox)," stated Leonard Mazur, Chairman and Chief Executive Officer of Citius.

"Although we were disappointed to receive the FDA’s complete response letter for LYMPHIR, we are encouraged that no clinical data issues related to safety or efficacy were noted. Rather, the FDA focused primarily on enhanced product testing, which we are already addressing. We plan to work closely with the FDA in preparation for a Resubmission package. The timing of our contemplated spin-off of LYMPHIR will be adjusted in accordance with the asset’s regulatory path. Coupled with our recent financing, we believe we have sufficient funds to advance our pipeline, including efforts to remediate the CRL, and continue to prepare our commercial infrastructure for the ultimate launch of LYMPHIR, if approved," added Mazur.

THIRD QUARTER 2023 FINANCIAL RESULTS:

Liquidity

As of June 30, 2023, the Company had $33.3 million in cash and cash equivalents.

As of June 30, 2023, the Company had 146,211,130 common shares outstanding.

On May 8, 2023, the Company closed a registered direct offering of 12,500,001 common shares and accompanying warrants to purchase up to an aggregate of 12,500,001 shares of its common stock, at a purchase price of $1.20 per share. The warrants have an exercise price of $1.50 per share, are exercisable six months from the date of issuance, and expire five years from the date of issuance. The Company also issued 875,000 warrants to the placement agent as part of the transaction. Net proceeds of the offering totaled $13.8 million.

The Company estimates that its available cash resources will be sufficient to fund its operations through August 2024. We anticipate the need to raise additional capital in the future to support our operations beyond August 2024.

Research and Development (R&D) Expenses

R&D expenses were $3.8 million and $11.9 million for the three and nine months ended June 30, 2023, respectively, compared to $4.9 million and $13.8 million for the comparable periods ended June 30, 2022. The decrease reflects lower Mino-Lok and LYMPHIR trial costs offset by higher Halo-Lido Phase 2b study costs as the trial was completed during the three months ended June 30, 2023. Additionally, a decrease of $1 million for the three months ended June 30, 2023, reflects NoveCite manufacturing startup costs incurred in the three months ended June 30, 2022, which are no longer realized.

We expect that research and development expenses will stabilize in fiscal 2023 as we focus on the commercialization of LYMPHIR and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.

General and Administrative (G&A) Expenses

G&A expenses were $3.7 million and $11.1 million for the three and nine months ended June 30, 2023, respectively, compared to $3.0 million and $9.0 million for the comparable periods ended June 30, 2022. The increase was primarily due to pre-launch and market research activities associated with LYMPHIR. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the fiscal quarter ended June 30, 2023, stock-based compensation expense was $1.2 million as compared to $1.0 million for the prior year period. For the nine months ended June 30, 2023, stock-based compensation expense was $3.5 million as compared to $2.9 million for the nine months ended June 30, 2022. The increase reflects expenses related to new grants made to employees (including new hires), directors and consultants.

Net loss

Net loss was $8.5 million, or ($0.06) per share for the three months ended June 30, 2023, compared to a net loss of $8.9 million, or ($0.06) per share for the three months ended June 30, 2022.

The decrease in the net loss was primarily due to a decrease in research and development offset by an increase in general and administrative expenses.

Net loss was $22.6 million, or ($0.15) per share for the nine months ended June 30, 2023, compared to a net loss of $25.6 million, or ($0.18) for the nine months ended June 30, 2022.

The decrease in net loss primarily reflects an increase in other income from the $3.6 million gain recognized in connection with the sale of certain New Jersey income tax net operating losses to a third party under the New Jersey Technology Business Tax Certificate Transfer Program offset by increased operating expenses during the period.