On August 3, 2023 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported financial results for the second quarter ended June 30, 2023 and provided a business update (Press release, Protara Therapeutics, AUG 3, 2023, View Source [SID1234633770]).

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"Following the positive preliminary data from the dose escalation portion of the ADVANCED-1 trial of TARA-002 in patients with high-grade non-muscle invasive bladder cancer (NMIBC), we have seen rapid enrollment in the expansion portion of the trial and anticipate sharing preliminary results in the first half of 2024," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We are building on this momentum, and plan to initiate two additional trials for TARA-002 later this year while continuing to maintain a disciplined approach to investments. We are in a solid financial position with cash runway into 2025."

Recent Highlights

TARA-002 in NMIBC

In April 2023 at the American Urological Association Annual Meeting, the Company announced positive preliminary results from the Phase 1a dose-escalation component of the ADVANCED-1 clinical trial of TARA-002, its investigational cell-based therapy, for the treatment of patients with high-grade NMIBC. The clinical data indicate that TARA-002 was generally well tolerated and anti-tumor activity was observed, including tumor regression in all three evaluable patients with carcinoma in situ (CIS), including one heavily pre-treated Bacillus Calmette-Guérin (BCG)-unresponsive patient who achieved a complete response (CR).

In May 2023, the Company dosed the first patients in its Phase 1b ADVANCED-1EXP study, an open-label expansion trial evaluating intravesical TARA-002 at the 40KE1 dose in 12 CIS patients, including BCG-naïve, BCG-unresponsive, and BCG-inadequately treated patients. Dosing continues to progress in the trial, with preliminary results expected in the first half of 2024. The primary endpoint of the trial is the CR rate at three months.

In the fourth quarter of 2023, the Company plans to initiate ADVANCED-2, a Phase 1b/2 open-label trial evaluating intravesical TARA-002 in up to 102 patients with high-grade CIS, including 27 patients with CIS (± Ta/T1), BCG-Naïve, or BCG-experienced, who have not received intravesical BCG for at least 24 months prior to CIS diagnosis, and 75 patients with BCG-unresponsive CIS (± Ta/T1).
TARA-002 in Lymphatic Malformations (LMs)

In April 2023, the Company received regulatory clearance from the U.S. Food and Drug Administration (FDA) to commence STARBORN-1, a Phase 2 clinical trial of TARA-002 in pediatric patients with macrocystic and mixed-cystic LMs. Trial start-up activities are well underway at the ten pediatric centers of excellence participating in the trial, and initiation is expected in the fourth quarter of 2023.
IV Choline Chloride Program

Protara is concluding its prospective prevalence study to enhance understanding of the incidence of choline deficiency in patients dependent on parenteral nutrition. The Company continues to engage with the FDA and plans to use both regulatory feedback and results from the prospective study to inform next steps for the IV Choline Chloride development program.
Second Quarter 2023 Financial Results

As of June 30, 2023, cash, cash equivalents and restricted cash were $80.4 million. The Company expects its current cash and cash equivalents will be sufficient to fund its planned operations into 2025.
Research and development expenses for the second quarter of 2023 increased to $7.2 million from $3.1 million during the second quarter of 2022, primarily reflecting an increase in expenses related to clinical and non-clinical trial activities for TARA-002.
General and administrative expenses for the second quarter of 2023 decreased to $4.9 million from $5.6 million for the prior year period, primarily due to lower employee related expenses.
For the second quarter of 2023, Protara reported a net loss of $11.3 million, or $1.00 per share, compared with a net loss of $8.5 million, or $0.76 per share, for the same period in 2022. Net loss for the second quarter of 2023 included approximately $1.6 million of stock-based compensation expenses.
About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan and approved in Taiwan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a strong immune cascade. Neutrophils, monocytes, and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha are secreted by immune cells to induce a strong inflammatory reaction and destroy the abnormal cells.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

About Lymphatic Malformations (LMs)

LMs are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth, with more than 50% detected at birth and 90% diagnosed before the age of 3 years. The most common morbidities and serious manifestations of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and cosmetic and other functional disabilities.

About IV Choline Chloride

IV Choline Chloride is an investigational, intravenous (IV) phospholipid substrate replacement therapy initially in development for patients receiving parenteral nutrition (PN). Choline is a known important substrate for phospholipids that are critical for healthy liver function. Because PN patients cannot sufficiently absorb adequate levels of choline and no available PN formulations contain sufficient amounts of choline to correct this deficiency, PN patients often experience a prolonged progression to hepatic failure and death, with the only known intervention being a dual small bowel/liver transplant. IV Choline Chloride has been granted Orphan Drug Designation by the FDA for the prevention of choline deficiency in PN patients.

On August 3, 2023 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Protagonist, AUG 3, 2023, View Source [SID1234633768]).

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"The second quarter of 2023 was transformative for Protagonist, marked by the disclosure of strongly positive data from FRONTIER 1, a Phase 2b study of JNJ-2113, at the World Congress of Dermatology, and the decision by our partner, Janssen, to move forward into a Phase 3 clinical program in psoriasis and a Phase 2b study in ulcerative colitis," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist. "JNJ-2113 is a first-in-class and only oral IL-23 receptor antagonist peptide that has the potential to lead the field of oral therapy for psoriasis. Today, a significant number of people living with moderate-to-severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies, and JNJ-2113 can potentially offer a highly convenient, effective and safe solution to a broad category of eligible individuals."

"We have also made impressive strides forward in the clinical development of our fully owned asset, rusfertide, in polycythemia vera," Dr. Patel continued. "The Phase 2 REVIVE study results were presented to a large audience as a late breaker at EHA (Free EHA Whitepaper)2023. The Phase 3 VERIFY clinical trial is continuing to enroll study participants at sites globally, with enrollment completion projected by the end of the first quarter of 2024. Our cash position remains strong, with estimated cash runway through end of 2025. This estimate does not include the potential $200 million in milestones associated with a successful Phase 3 study, NDA filing, and approval of JNJ-2113 in psoriasis."

Q2 and Recent Corporate Highlights

· Positive Phase 2b FRONTIER 1 topline results were presented at the World Congress of Dermatology in Singapore in July 2023. All primary and secondary efficacy endpoints were achieved in the study, which evaluated five different dosing regimens of JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis.

· JNJ-2113 is a novel oral IL-23R antagonist peptide which binds with high affinity to the IL-23 receptor.

· In the FRONTIER 1 study, a greater proportion of patients who received JNJ-2113 achieved Psoriasis Area and Severity Index (PASI) 75 (primary endpoint), as well as PASI 90 and PASI 100 (75, 90 and 100 percent improvement in skin lesions as measured by PASI, respectively), compared to placebo, at week 16.

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· 78.6 percent, 59.5 percent and 40.5 percent of adult patients who received JNJ-2113 at 100 mg twice daily achieved PASI 75, 90 and 100, respectively, at week 16.

· Five treatment groups were evaluated in the study, ranging from 25 mg once daily to 100 mg twice daily.

· Treatment was generally well tolerated, and the proportions of patients with adverse events were comparable between patient groups.

· The proportion of participants experiencing one or more adverse events was 52.4 percent in the combined JNJ-2113 group and 51.2 percent in the placebo group.

· JNJ-2113 is advancing into Phase 3 development for moderate-to-severe plaque psoriasis and in a Phase 2b clinical trial for adults living with ulcerative colitis.

· Pre-clinical and Phase 1 data for JNJ-2113 were presented at the International Societies for Investigative Dermatology meeting in Tokyo, Japan in May 2023, showing selective systemic IL-23 pathway inhibition in pre-clinical rat models and systemic pharmacodynamic activity in healthy human volunteers in a Phase 1 trial.

· Positive topline results from the blinded, placebo-controlled, randomized withdrawal portion of the Phase 2 REVIVE study of rusfertide in polycythemia vera were presented in Frankfurt, Germany in June 2023 at EHA (Free EHA Whitepaper)2023.

· The Company completed a $115 million equity financing in April 2023.

Second Quarter 2023 Financial Results

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of June 30, 2023, were $313.4 million.

· License and Collaboration Revenue: License and collaboration revenue was zero for the three and six months ended June 30, 2023 as we completed our performance obligation associated with the Janssen License and Collaboration Agreement as of June 30, 2022. License and collaboration revenue for the three and six months ended June 30, 2022 was $0.9 million and $26.6 million, respectively. The six months to June 30, 2022 included a one-time $25.0 million milestone earned by the Company following the dosing of the third patient in the Janssen Phase 2b FRONTIER 1 clinical trial of JNJ-2113.

· Research and Development ("R&D") Expenses: R&D expenses were $33.2 million and $60.6 million for the three and six months ended June 30, 2023, respectively, as compared to $34.6 million and $70.9 million for the same periods in 2022. The decreases in R&D expenses from prior year periods was primarily due to decreases in PN-943 expenses and costs related to the completion of PN-232 Phase 1 trials, partially offset by an increase in rusfertide expenses related primarily to the Phase 3 VERIFY clinical trial.

· General and Administrative ("G&A") Expenses: G&A expenses were $9.2 million and $17.8 million for the three and six months ended June 30, 2023, respectively, as compared to $7.7 million and $18.2 million for the same periods in 2022. The increase in G&A expenses from the prior year quarter was primarily due to increases in payroll and stock-based compensation and general expenses. The decrease in G&A expenses from the prior year was primarily due to one-time costs incurred in the first quarter of 2022.

· Net Loss: Net loss was $38.5 million, or $0.68 per share, for the three months ended June 30, 2023 as compared to a net loss of $41.0 million, or $0.84 per share, for the three months ended June 30, 2022. Net loss was $72.2 million, or $1.34 per share, for the six months ended June 30, 2023 as compared to a net loss of $62.0 million, or $1.27 per share, for the six months ended June 30, 2022.

On August 3, 2023 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Prelude Therapeutics, AUG 3, 2023, View Source [SID1234633766]).

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Kris Vaddi, Ph.D., Chief Executive Officer of Prelude stated, "With the recent financing that extended our cash runway into 2026, we are in a strong position to advance our diverse pipeline of potentially best and/or first-in-class compounds to address the needs of patients with certain underserved cancers. Our focus remains on generating critical data for each of our molecules to make key strategic decisions. As disclosed recently, and based on additional data generated in this quarter, PRT2527 (CDK9 inhibitor) and PRT1419 (MCL1 inhibitor) demonstrated differentiated clinical safety profiles and strong target inhibition and are continuing to enroll patients with hematological malignancies, which is where we see the best opportunities for these molecules."

"Our first-in-class selective SMARCA2 degrader, PRT3789, and next generation CDK4/6 inhibitor, PRT3645, are progressing well in Phase 1 and are on track to reach confirmation doses in the first half of 2024 and by year end 2023, respectively," added Dr. Vaddi. "Based on meaningful progress made in the first half of the year, we look forward to sharing updates and clarity around strategic prioritization of our pipeline in the coming months."

Pipeline Updates

PRT2527- CDK9 Inhibitor Program

The Company believes its highly selective CDK9 inhibitor, PRT2527, has the potential to avoid off-target toxicities, achieve substantial clinical activity and become the best-in-class CDK9 inhibitor, making it amenable for combination with other therapies.

PRT2527 has completed a Phase 1 multi-dose escalation study (NCT05159518) in patients with solid tumors. In this trial, PRT2527 was shown to achieve high levels of target inhibition and the potential to be better tolerated than existing CDK9 inhibitors, specifically, manageable neutropenia and an absence of meaningful gastrointestinal events or hepatotoxicity. *

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AACR2023 Poster Presentation

A Phase 1 multi-dose escalation study (NCT05665530) is currently ongoing in hematologic malignancies. Patient recruitment for hematological clinical trials in the US is highly competitive and this trial has recently been expanded to include global sites to support patient recruitment.

The Company’s objective is to establish a biologically active confirmation dose by Q1 2024. As part of this Phase 1 multi-dose escalation trial, the Company intends to expand the Phase 1 clinical trial and evaluate PRT2527 in combination with zanubrutinib.

Potential indications for PRT2527 include aggressive B-cell lymphoma subtypes, mantle cell lymphoma (MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) including Richter syndrome, and T-cell lymphoma subtypes.

The Company intends to provide a program update by year end on the CDK9 inhibitor program and present initial results at a future scientific meeting.

PRT1419- MCL1 Inhibitor Program

PRT1419 is a potent and selective MCL1 inhibitor. With its optimized PK/PD profile, the Company believes PRT1419 has the potential to achieve greater target engagement and provide patients with better clinical outcomes as well as improved safety and tolerability, as compared to other MCL1 inhibitors in development.

PRT1419 has completed a Phase 1 multi-dose escalation study (NCT04837677) in patients with solid tumors. In this study, PRT1419 demonstrated an acceptable safety and tolerability profile in patients with advanced and metastatic solid tumors. No cardiac toxicity was observed. Pharmacokinetics/pharmacodynamics and safety data in the 80 mg/m2 QW dose cohort support further evaluation of this dose in future studies.

A Phase 1 multi-dose escalation clinical trial of PRT1419 in patients with hematologic malignancies is ongoing (NCT05107856). In this trial, PRT1419 is being evaluated as monotherapy for myeloid malignancies and in combination with azacitidine or venetoclax for patients with relapsed/refractory myeloid or B-cell malignancies.

The Company will provide a clinical update on PRT1419 by year end.

PRT3645- Next Generation CDK4/6 Inhibitor Program

PRT3645 is a highly potent and selective next generation CDK4/6 inhibitor with the potential to provide improved safety and tolerability outcomes and higher, more effective brain and tissue penetration than current CDK4/6 inhibitors.

In preclinical models in vivo, PRT3645 has been shown to be efficacious in multiple cancers as monotherapy as well as when combined with KRAS inhibitors, MEK inhibitors and with a brain penetrant HER2 receptor kinase inhibitor. Additionally, oral administration of PRT3645 has been shown to induce tumor regressions in preclinical models that are resistant to currently approved CDK4/6 inhibitors. Together, these data suggest that PRT3645 may extend the benefit of CDK4/6 inhibition beyond HR+ breast cancer.

A Phase 1 multi-dose escalation clinical trial of PRT3645 (NCT05538572) is underway and the Company expects to reach a biologically active dose confirmation in Q4 2023.

Potential indications for PRT3645 in combination with other therapies, in addition to breast cancer with or without brain metastases, include endometrial, sarcomas, glioblastomas, non-small cell lung cancer, head and neck cancers.

The Company intends to provide a program update by year end and present initial results at a future scientific meeting.

PRT3789- SMARCA2 Targeted Protein Degrader Program

PRT3789 is a first-in-class highly selective degrader of SMARCA2 protein, which along with SMARCA4 controls gene regulation through chromatin remodeling. Cancer cells with SMARCA4 mutations are dependent on SMARCA2 for their growth and survival and selectively degrading SMARCA2 induces cell death in cancer cells while sparing normal cells. PRT3789 is efficacious and well tolerated in preclinical models of SMARCA4 deleted/mutated cancers as monotherapy and in combination with standards of care. The Company believes a selective SMARCA2 degrader has the potential to be of benefit in up to 70,000 US/EU cancer patients with the SMARCA4 mutation.

Patients with SMARCA4 mutations or deletions may have poor clinical outcomes and limited treatment options. Therefore, mutated, or deleted SMARCA4 cancers provides a potential biomarker to select those patients most likely to respond to treatment with a highly selective SMARCA2 degrader.

A Phase 1 multi-dose escalation clinical trial of PRT3789 is ongoing (NCT05639751) in biomarker selected SMARCA4 mutated cancers. The Company intends to evaluate PRT3789 as monotherapy as well as in combination.

The Company intends to provide a program update by year end and expects to reach confirmation dose in the first half of 2024.

SMARCA2- Oral Program

The Company has also recently nominated a new chemical entity as a potent, orally bioavailable and highly selective SMARCA2 degrader candidate (>1000x over SMARCA4) and intends to file an IND early in 2024.

Second Quarter 2023 Financial Results

Cash, Cash Equivalents and Marketable Securities: In May 2023, the Company completed a public offering of common stock, raising gross proceeds of $113.0 million before deducting underwriting discounts, commissions and offering expenses. Net proceeds received, $110.4 million, will be focused on the continued development and expansion of the Company’s product pipeline.

Cash, cash equivalents, and marketable securities as of June 30, 2023, were $255.0 million. Prelude anticipates that its existing cash, cash equivalents and marketable securities will fund the Company’s operations into 2026.

Research and Development (R&D) Expenses: For the second quarter of 2023, R&D expense increased to $25.0 million from $21.3 million for the prior year period. Research and development expenses increased primarily due to the timing of our clinical research programs. We expect our R&D expenses to vary from quarter to quarter, primarily due to the timing of our clinical development activities.

General and Administrative (G&A) Expenses: For the second quarter of 2023, G&A expenses decreased to $7.4 million from $8.2 million for the prior year period. General and administrative expenses decreased reflecting the Company’s careful management of its G&A expenses.

Net Loss: For the three months ended June 30, 2023, net loss was $30.4 million, or $0.54 per share compared to $27.4 million, or $0.58 per share, for the prior year period. Included in the net loss for the quarter ended June 30, 2023, was $6.7 million of non-cash expense related to the impact of expensing share-based payments, including employee stock options, as compared to $6.0 million for the same period in 2022.

On August 3, 2023 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three and six months ended June 30, 2023 (Press release, Opko Health, AUG 3, 2023, View Source [SID1234633765]).

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Second quarter business highlights included the following:

U.S. FDA approved NGENLA for pediatric growth hormone deficiency; OPKO earned a $90 million milestone payment from its commercial partner, Pfizer. In June 2023, the U.S. Food and Drug Administration (FDA) approved NGENLA (somatrogon), a once-weekly, human growth hormone analog indicated for the treatment of pediatric patients aged three years and older with impaired growth due to insufficient growth hormone. Pfizer, OPKO’s commercial partner, expects NGENLA to become available for U.S. prescribing this month. In addition to the $90 million milestone payment earned upon receipt of FDA approval, OPKO is entitled to profit sharing based on regional, tiered gross profit for both NGENLA and Genotropin, Pfizer’s daily human growth hormone.
NGENLA has now been approved in 44 markets including the U.S., Japan, EU Member States, Canada and Australia; sales are underway by Pfizer in over 18 countries with expectations to launch in all priority international markets by year-end. NGENLA is the first once-weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, the United Kingdom, Taiwan, United Arab Emirates and Brazil. OPKO is entitled to gross profit sharing in all global markets based on regional, tiered gross profit for both NGENLA and Genotropin, with the U.S. region commencing gross profit sharing in August 2023.
OPKO Health’s ModeX Therapeutics, Inc. (ModeX) advanced its antiviral and immune-oncology product pipeline. ModeX continued to advance its pipeline of antiviral and immune-oncology programs utilizing its next-generation multispecific antibodies, and anticipates initiating a Phase 1 clinical trial for certain cancers next year. In addition, ModeX’s collaboration with Merck to develop MDX-2201, its vaccine for Epstein-Barr virus, is progressing. As part of its ongoing business strategy, ModeX is pursuing additional licensing and collaboration opportunities with strategic partners for certain other pipeline candidates.

BioReference Health continued on its path to profitability with cost reductions, improved operational efficiencies and enhanced productivity. BioReference continued to implement initiatives to reduce costs and rationalize its business in line with current testing volumes. Additionally, BioReference is focused on improving productivity and enhancing innovation of its higher value specialty testing segments. Other efforts to return this business to profitability include expanding into new market segments, such as providing information for the pharmaceutical market.
Second Quarter Financial Results

Pharmaceuticals: Revenue from products in the second quarter of 2023 increased to $43.5 million from $35.9 million in the second quarter of 2022, driven by sales in OPKO’s international operating companies and an increase in sales of Rayaldee to $7.7 million from $6.2 million in the prior-year period. Revenue from the transfer of intellectual property was $94.9 million in the second quarter of 2023, reflecting revenue of $90.0 million triggered by the FDA approval of NGENLA, compared with $87.2 million in the 2022 period, which included an $85.0 million milestone payment related to the commencement of NGENLA sales in Europe and Japan. Total costs and expenses were $74.7 million in the second quarter of 2023, up from $67.7 million in the prior-year period. The increase was mainly due to an increase in cost of revenue and a full quarter of research expenses at ModeX, which was acquired in May 2022. Operating income was $63.6 million in the second quarter of 2023, compared with $55.4 million in the second quarter of 2022.

Diagnostics: Revenue from services in the second quarter of 2023 was $127.0 million compared with $186.8 million in the prior-year period. Revenue decreased due to lower COVID-19 testing volume and reimbursement. BioReference processed approximately 33,000 COVID-19 PCR tests in the second quarter of 2023, representing 1.5% of total testing volume, versus 874,000 tests in the second quarter of 2022, representing 31% of total testing volume. Furthermore, revenue during the 2022 period included $12.1 million from GeneDx, which was sold in April 2022. Total costs and expenses were $171.3 million in the second quarter of 2023 compared with $244.3 million in the second quarter of 2022, resulting in an operating loss of $44.3 million compared with an operating loss of $57.5 million in the 2022 period. The 2022 period included a $15.4 million gain on the sale of GeneDx offset by $5.8 million of operating losses prior to closing in April 2022. BioReference continues to implement cost-reduction initiatives as it works toward profitability.

Consolidated: Consolidated total revenues for the second quarter of 2023 were $265.4 million compared with $309.9 million for the comparable period of 2022. Operating income for the second quarter of 2023 was $7.0 million compared with an operating loss of $10.7 million for the 2022 quarter. Net loss for the second quarter of 2023 included a mark-to-market adjustment of $19.9 million compared to $71.2 million in the 2022 period related to the decrease in share price of GeneDx, resulting in a net loss of $19.6 million, or $0.03 per share, compared with a net loss of $101.7 million, or $0.14 per share, for the 2022 quarter.

Cash and cash equivalents: Cash and cash equivalents were $108.1 million as of June 30, 2023, which does not include the $90.0 million milestone payment from Pfizer that is expected to be received in August 2023.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss second quarter financial results, provide financial guidance and answer questions during a conference call and audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until August 10, 2023 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 7009686. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On August 3, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported the receipt of a Study May Proceed letter from the U.S. Food and Drug Administration (FDA), for a Phase 1/2 dose escalation study of ONCT-534, a novel dual-action androgen receptor inhibitor (DAARI), in patients with metastatic castration-resistant prostate cancer (mCRPC) who have relapsed or are refractory to approved androgen receptor signaling inhibitors (ARSIs) (Press release, Oncternal Therapeutics, AUG 3, 2023, View Source [SID1234633764]). The letter was received prior to the 30-day review date.

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"We are very pleased with the FDA’s authorization to proceed with our Phase 1/2 clinical trial of ONCT-534," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Many men suffering from prostate cancer that has relapsed or is refractory after treatment with standard of care ARSI therapy, such as enzalutamide or abiraterone, need additional treatment alternatives. We believe that ONCT-534’s novel mechanism of action may help address key tumor escape mechanisms that cause such resistance. Preclinical studies suggest that ONCT-534 binds to both the ligand-binding domain (LBD) and N-terminal domain of the androgen receptor (AR), inhibiting AR function and triggering AR protein degradation, even in the presence of ligand-binding domain alterations including mutations and splice variants such as AR-V7. Clinical sites that will conduct the initial dose finding study for ONCT-534 have been selected and we expect to report preliminary data in the first half of 2024".