OPKO Health Reports 2021 Third Quarter Business Highlights and Financial Results

On October 28, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that business highlights and financial results for the three months ended September 30, 2021 (Press release, Opko Health, OCT 28, 2021, View Source [SID1234592113]).

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Business Highlights

Health Canada approved NGENLA (somatrogon) injection for pediatric growth hormone deficiency. NGENLA is a once-weekly, long-acting recombinant human growth hormone, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency, or GHD). Please click here to view Pfizer Canada’s news release issued earlier today. Global regulatory applications for somatrogon continue to advance with action dates in the U.S., Europe and Japan expected during the first half of 2022.

BioReference Laboratories (BRL) processed approximately 2.2 million COVID-19 PCR tests in the third quarter of 2021. In addition, during the quarter BRL performed approximately 158,100 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity. In August 2021 Rite Aid, the U.S. Department of Health and Human Services, and BRL announced a "Back to School" COVID-19 testing program offering students at New York State public schools the opportunity for free COVID-19 testing prior to or at the start of the 2021-2022 school year. Students will be tested using highly accurate RT-PCR laboratory-based COVID-19 tests.

BRL acquired the U.S. Ariosa centralized laboratory prenatal testing business from Roche. Ariosa’s noninvasive prenatal screening (NIPS) test, the Harmony Prenatal Test, is one of the most widely studied tests utilized in prenatal screening. This test has been performed in more than 1.5 million patients. The acquisition of Ariosa will complement the current NIPS offering at GenPath, BRL’s specialty health division.

Completed enrollment in Phase 2 trial evaluating RAYALDEE as a treatment for symptomatic COVID-19 outpatients. The U.S. trial, "A Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of RAYALDEE (calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected with SARS-CoV-2," completed final enrollment with 171 subjects, including some with stage 3 or 4 chronic kidney disease who are at higher risk for developing more severe illness. Topline data are expected later this year.

Formed a joint venture with LeaderMed Group to develop, manufacture and commercialize oxyntomodulin and Factor VIIa-CTP in China and other Asian territories. Under the terms of the agreements, OPKO granted the joint venture exclusive rights to develop, manufacture and commercialize OPK88003, an oxyntomodulin analog being developed for the treatment of obesity and diabetes, and Factor VIIa-CTP, a novel long-acting coagulation factor being developed to treat hemophilia, in exchange for a 47% ownership interest in the joint venture. LeaderMed will be responsible for funding the joint venture’s operations, development and commercialization efforts. OPKO retains full rights to oxyntomodulin and Factor VIIa-CTP in all other geographies.

Executed exclusive worldwide agreement with CAMP4 Therapeutics Corporation (CAMP4) for the development, manufacture and commercialization of therapeutics utilizing the AntagoNAT technology. This technology is an oligonucleotide platform developed under OPKO CURNA. CAMP4 has prioritized OPKO’s lead AntagoNAT compound to progress into clinical trials for the treatment of Dravet syndrome. Under the terms of the agreement, OPKO received an upfront payment and shares of privately held CAMP4. In addition, OPKO will be eligible to receive up to $93.5 million and additional shares upon the achievement of certain development and sales milestones for products developed from this technology and associated intellectual property. CAMP4 will also pay OPKO double-digit royalties on product sales.
Third Quarter Financial Results

Consolidated: Consolidated total revenues for the third quarter of 2021 were $385.8 million compared with $428.1 million for the comparable period of 2020. Operating income for the third quarter of 2021 increased 72% to $37.8 million compared with $21.9 million, for the comparable period of 2020. Net income for the third quarter of 2021 was $28.7 million, or $0.04 per diluted share, compared with $23.7 million, or $0.04 per diluted share, for the comparable period of 2020.

Diagnostics: Revenue from services in the third quarter of 2021 decreased to $340.1 million from $382.5 million in the prior-year period, primarily due to a decrease in COVID-19 testing volume, which was partially offset by an improvement in COVID-19 test reimbursement and an increase in clinical and genomic test revenue. Total costs and expenses were $320.5 million in the third quarter of 2021 compared with $346.4 million in the third quarter of 2020, resulting in operating income of $19.7 million compared with $46.2 million in the 2020 period. The decrease in operating income is primarily due to a decline in COVID-19 test volume and an increased level of investment in our commercial organization for our base business and digital health activities resulting in increased professional fees and personnel expenses. During the third quarter of 2020, BioReference received a $10.0 million non-recurring grant under the CARES Act.

Pharmaceuticals: Revenue from products in the third quarter of 2021 increased almost 29% to $36.9 million compared with $28.7 million in the third quarter of 2020, with the increase primarily attributable to accelerating growth within OPKO’s international pharmaceutical businesses. Total prescriptions for RAYALDEE in the third quarter of 2021 decreased to approximately 11,500 from approximately 16,700 in the third quarter of 2020. Revenue from sales of RAYALDEE in the third quarter of 2021 was $8.5 million compared with $8.1 million in the prior-year period, with the increase reflecting a higher net realized price as a result of lower Medicare Part D rebates. Revenue from the transfer of intellectual property was $8.8 million in the third quarter of 2021 compared with $6.8 million for the 2020 period. The increase reflects the CAMP4 and LeaderMed agreements partially offset by a decrease in revenue related to the Pfizer transaction. Total costs and expenses were $17.0 million in the third quarter of 2021 compared with $49.9 million in the prior-year period, primarily due to a $31.5 million gain on the sale of assets to Horizon Therapeutics plc for OPKO’s sterile-fill-finish manufacturing facility in Ireland. Operating income was $28.6 million in the third quarter of 2021 compared with an operating loss of $14.4 million in the third quarter of 2020.

Cash and equivalents: Cash, cash equivalents and marketable securities were $148.6 million as of September 30, 2021. In addition, the Company has $64.3 million availability under its line of credit with JP Morgan.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss third quarter financial results and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are requested to pre-register for the conference call using the link here. Upon pre-registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. Alternatively, please dial (888) 869-1189 or (706) 643-5902 and use conference ID 6958207

To access the live call via webcast, please click on the link OPKO 3Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 3Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 6958207.

CohBar Announces Pricing of $15.0 Million Public Offering of Common Stock and Warrants

On October 28, 2021 CohBar, Inc. (NASDAQ: CWBR) (the "Company"), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported the pricing of an underwritten public offering of 20,833,334 shares of the Company’s common stock and accompanying warrants to purchase 20,833,334 shares of common stock at a price to the public of $0.72 per share and accompanying warrant (Press release, CohBar, OCT 28, 2021, View Source [SID1234592130]). Each warrant will have an exercise price of $0.72 per share and be exercisable for 5 years from the closing date of the offering. The aggregate gross proceeds from this offering are expected to be approximately $15.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering is expected to close on or about November 1, 2021, subject to customary closing conditions.

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Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as co-manager.

CohBar intends to use the net proceeds from the offering, together with its existing cash resources, for general corporate purposes, which may include funding preclinical and clinical development of its peptides, increasing working capital, operating expenses and capital expenditures.

The securities will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on August 24, 2020. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

Gilead Announces Clinical Trial Collaboration With Merck to Evaluate Trodelvy® (sacituzumab govitecan-hziy) in Combination With KEYTRUDA® (pembrolizumab) in Patients With First-Line Metastatic Triple-Negative Breast Cancer

On October 28, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) to evaluate the efficacy of Gilead’s Trop-2 targeting antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as a first-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (TNBC) (Press release, Gilead Sciences, OCT 28, 2021, View Source [SID1234592146]).

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Under the terms of the agreement, Gilead will sponsor a global Phase 3 clinical trial to evaluate Trodelvy in combination with KEYTRUDA compared to standard of care KEYTRUDA in combination with chemotherapy in first-line patients with locally advanced or metastatic TNBC.

"Trodelvy has already been established as a preferred treatment option in second-line metastatic TNBC," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Looking ahead, we are excited about the opportunity to advance Trodelvy as a potential treatment for first-line metastatic TNBC. This helps further our ambition of displacing chemotherapy with Trodelvy to improve outcomes for people living with cancer."

Metastatic TNBC has the worst survival rate among breast cancer subtypes, and there is an urgent need for new therapies that improve patient outcomes. Trodelvy is an antibody-drug conjugate that specifically targets Trop-2 expressing cells to enable local delivery of a cytotoxic payload that selectively kills the targeted cells. The combination of Trodelvy with an immune-stimulating agent such as KEYTRUDA could provide a novel regimen in first-line metastatic TNBC.

The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.

The combination of Trodelvy and KEYTRUDA has not been approved by any regulatory agency in any treatment setting. The safety and efficacy of this combination is under investigation and has not been established.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About Triple-Negative Breast Cancer (TNBC)

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Beyond the approvals of Trodelvy in the United States, it is also approved in Australia, Canada, Great Britain and Switzerland for adults with metastatic TNBC. Trodelvy is also under multiple regulatory reviews worldwide, including the EU, as well as in Singapore and China through our partner Everest Medicines. Trodelvy continues to be developed for potential use in other TNBC and metastatic UC populations and is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumors is also underway.

In the United States, Trodelvy is indicated for the treatment of:

Adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
U.S. Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

Severe or life-threatening neutropenia may occur. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold Trodelvy until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to Trodelvy.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 61% of patients treated with Trodelvy. Grade 3-4 neutropenia occurred in 47% of patients. Febrile neutropenia occurred in 7%. Withhold Trodelvy for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold Trodelvy for neutropenic fever.

Diarrhea: Diarrhea occurred in 65% of all patients treated with Trodelvy. Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal perforation following diarrhea. Neutropenic colitis occurred in 0.5% of patients. Withhold Trodelvy for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with Trodelvy. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of Trodelvy was 0.3%. The incidence of anaphylactic reactions was 0.3%. Pre-infusion medication is recommended. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use. Permanently discontinue Trodelvy for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 66% of all patients treated with Trodelvy and Grade 3 nausea occurred in 4% of these patients. Vomiting occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold Trodelvy doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with Trodelvy. The incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28, 46% in patients heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue Trodelvy based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, Trodelvy can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. Trodelvy contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Trodelvy and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Trodelvy and for 3 months after the last dose.

ADVERSE REACTIONS

In the ASCENT study (IMMU-132-05), the most common adverse reactions (incidence ≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPHY study (IMMU-132-06), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite, constipation, vomiting, abdominal pain, and rash. The most frequent serious adverse reactions (SAR) (≥5%) were infection (18%), neutropenia (12%, including febrile neutropenia in 10%), acute kidney injury (6%), urinary tract infection (6%), and sepsis or bacteremia (5%). SAR were reported in 44% of patients, and 10% discontinued due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPHY study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of Trodelvy with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with Trodelvy.

UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with Trodelvy.

Aligos Therapeutics to Announce Third Quarter 2021 Results November 4, 2021

On October 28, 2021 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that it will report the company’s third quarter 2021 financial results on Thursday, November 4, 2021 after the close of U.S. financial markets (Press release, Aligos Therapeutics, OCT 28, 2021, View Source [SID1234592165]).

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Pan Cancer T Extends Seed Financing Round with Additional Funding from Existing Shareholders and New Investor Thuja Capital

On October 28, 2021 Pan Cancer T B.V., a biotech spin-off from the Erasmus MC dedicated to the discovery and development of novel TCR-T therapies against solid tumors, reported the closing of an extended seed investment round (Press release, Pan Cancer T, OCT 28, 2021, https://pancancer-t.com/2021/10/28/pan-cancer-t-extends-seed-financing-round-with-additional-funding-from-existing-shareholders-and-new-investor-thuja-capital/ [SID1234592114]). All current shareholders participated in the round, with Thuja Capital joining as a new investor. The undisclosed proceeds add to the initial seed capital financing announced earlier this year. The Company’s syndicate of experienced life science venture capital investors now includes Van Herk Ventures, Swanbridge Capital, and Thuja Capital as well as founding shareholder Erasmus MC.

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Katrien Reynders-Frederix, CEO of Pan Cancer T, said: "Despite certain successes of adoptive cell therapies like the Chimeric Antigen Receptor (CAR) T cell therapy, the vast majority of solid cancers remains refractory to such treatments. TCR-T cell therapy is a novel, promising option that has demonstrated significant clinical benefits in patients with various solid tumors. Thanks to the extended seed round and the continuous support of our investors we will be able to further advance our lead program and strengthen our pre-clinical assets. Next, we will be preparing to raise a Series A financing round to advance our lead program into the clinic."

Michel Briejer, Investment Manager at Thuja Capital added: "Since we identified Pan Cancer T as an investment opportunity, we have been deeply impressed by the quality of the science, the team and its advisers. We are thrilled to join the shareholder base and take a seat on the Supervisory Board to help and support Pan Cancer T towards the success it is bound for."

Dharminder Chahal, Investment Manager at Van Herk and Swanbridge Capital, said: "I am pleased to see that Pan Cancer T made such a progress within only one year after its foundation. I am convinced that the company will continue this high pace of development through this additional investment."

Prof. Chris Bangma, Professor of the Department of Urology at Erasmus University Medical Centre in Rotterdam, stated: "Erasmus MC valorizes the development of novel therapeutic treatment options for its patients. The results of immune therapy in various tumors are beyond expectations. Many patients may benefit from the carefully designed new immunologic approaches and evaluation in the clinic. Hence, Erasmus MC is pleased to support Pan Cancer T on this journey."