On February 10, 2021 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, reported that net revenues increased 38% and gross profit rose 49% for its fiscal 2021 first quarter ended December 31, 2020, setting new quarterly records for its second consecutive quarter and entering its fourth year of revenue growth (Press release, Veru, FEB 10, 2021, View Source [SID1234574855]).

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First-Quarter Financial Highlights: Fiscal 2021 vs Fiscal 2020

Net revenues increased 38% to $14.6 million from $10.6 million
FC2 prescription net revenues climbed 50% to $9.1 million from $6.1 million
Gross profit rose 49% to $10.8 million from $7.3 million
Gross margin increased to 74% of net revenues from 69% of net revenues
Operating income was $19.2 million, which includes an $18.4 million gain on sale of the PREBOOST business. Adjusted operating income, which excludes the gain on sale of PREBOOST, was $0.8 million versus an operating loss of $1.8 million
Net income, which includes the gain on sale of PREBOOST, was $17.2 million and diluted EPS was $0.23. Adjusted net loss, which excludes the gain on sale of PREBOOST, was $1.2 million compared with $3.3 million and adjusted diluted loss per share was $0.02, compared with $0.05 per share.
Balance Sheet Information

Cash and cash equivalents were $30.9 million as of December 31, 2020 versus $13.6 million as of September 30, 2020
Net accounts receivable were $4.2 million as of December 31, 2020 versus $5.2 million as of September 30, 2020
"During this quarter we reported another consecutive quarterly record both in net revenues and in gross profit driven primarily by the 50% growth in prescription sales of FC2," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "We plan to submit the TADFIN NDA next week which, if approved by the FDA, will add to the already significant cash being generated by the FC2 business to invest in the clinical development of our late-stage prostate and breast cancer drug pipeline. We are off to a great start for fiscal 2021."

"Furthermore, I could not be more pleased with Veru’s progress in developing new and novel oral therapies to treat both prostate and breast advanced cancers that have become resistant to current endocrine therapies, but prior to proceeding to IV chemotherapy. We are excited to be driving our prostate cancer drug candidates, VERU-111 and VERU-100, as well as our breast cancer drug candidates, Enobosarm and VERU-111 for triple negative breast cancer, into registration clinical studies. Now with the positive clinical efficacy and safety results from the Phase 2 clinical study that evaluated VERU-111 treatment in hospitalized patients with COVID-19 and at high risk for ARDS, Veru anticipates the potential for five registration clinical trials for one COVID-19 and four oncology indications to commence in calendar year 2021."

Pharmaceutical Pipeline Highlights:

TADFIN (Tadalafil 5mg and Finasteride 5mg Combination Capsule) for the Treatment of Lower Urinary Tract Symptoms Caused by Benign Prostatic Hyperplasia (BPH)

We expect to submit the NDA for TADFIN next week. We received a waiver of the FDA NDA PDUFA filing fees as a first-time filer worth approximately $2.4 million in cost savings. We plan to launch TADFIN, which contains finasteride (approved for BPH) and tadalafil (approved for BPH and erectile dysfunction), for the indication to treat BPH, if approved by FDA. We intend to launch TADFIN through third-party telemedicine sales channels and not have to invest in our own TADFIN sales organization. This is the same sales model that has been successful for FC2, and previously, for PREBOOST.

VERU-111, a Novel, Oral, Targeted Cytoskeleton Disruptor, for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer

The Phase 2 clinical trial of VERU-111 for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer is fully enrolled. Although the study is still ongoing, daily chronic drug administration continues to appear feasible and safe. At 63mg daily continuous oral once-a-day dosing, there were no reports of neutropenia, a single report of minor neurotoxicity, and manageable and fewer cases of low-grade diarrhea. Like the Phase 1b, we have observed efficacy results including PSA declines as well as objective and durable tumor responses including complete and partial responses. We will be presenting updated clinical results for the Phase 1b and as well as an update on the Phase 2 clinical trials at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium: "Abstract 325053: Clinical study of VERU-111, an oral cytoskeletal disruptor, in metastatic castration-resistant prostate cancer who failed an androgen receptor targeting agent" by Dr. Mark Markowski, Assistant Professor of Oncology, Johns Hopkins Kimmel Comprehensive Cancer Center, taking place February 11th-13th, 2021.

The Company has submitted its Phase 3 clinical registration protocol to evaluate VERU-111 for the treatment of men with metastatic castration resistant prostate cancer who have failed one androgen receptor targeting agent, but prior to IV chemotherapy. The Company anticipates starting the VERACITY Phase 3 study in the first quarter of calendar year 2021.

VERU-100, a Novel, Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide, 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy (ADT) for Advanced Prostate Cancer

VERU-100 is designed to address the current limitations of commercially available androgen deprivation therapies. ADT is currently the mainstay of advanced prostate cancer treatment and used as a foundation of treatment throughout the course of the disease. Furthermore, ADT is continued even as other endocrine, chemotherapy, and/or radiation treatments are added or stopped. The specific target product profile for VERU-100 is a chronic, long-acting GnRH antagonist peptide administered as a small volume, three-month depot subcutaneous injection without a loading dose. VERU-100 is expected to immediately suppress testosterone with no testosterone surge upon initial or repeated administration, a concern that occurs with currently approved luteinizing hormone-releasing hormone agonists used for ADT. There are no GnRH antagonist depot injectable formulations commercially approved for treatment beyond a one-month duration. A Phase 2 study to evaluate VERU-100 dosing is anticipated to begin the first half of calendar year 2021 and the Phase 3 registration study in approximately 100 men is anticipated to start in the second half of calendar year 2021.

Enobosarm, Selective AR Targeted Agent, to Treat Estrogen Receptor Targeted Agent and CDK4/6 Inhibitor Resistant AR+/ ER+/HER2- Metastatic Breast Cancer

Enobosarm, our oral, first-in-class, new chemical entity, is a selective androgen receptor targeted activating agent that is being developed for the treatment of AR+/ER+/HER2- metastatic breast cancer, that has become resistant to estrogen endocrine therapy and CDK 4/6 inhibitors, but prior to IV chemotherapy. Enobosarm, by targeting and activating the AR which is present in up to 85% of advanced ER+ positive breast cancers, represents the first new class of targeting endocrine therapy in advanced breast cancer in decades. The androgen receptor acts as a tumor suppressor in ER+ breast cancer. Enobosarm activates the AR in breast cancer to inhibit AR+ ER+ breast cancer cell proliferation and tumor growth including when ER+ breast cancer has become resistant to estrogen receptor targeting agents and CDK 4/6 inhibitors. Enobosarm could have additional beneficial clinical properties. For example, preclinical studies have shown that enobosarm builds and heals cortical and trabecular bone with the potential to treat osteoporosis and skeletal related cancer events. Enobosarm has also been shown to build muscle, to reduce fat, and to improve physical function in clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer. Furthermore, the tissue selectivity of enobosarm also results in a favorable side effect profile with no masculinization (facial hair and acne), no increase in hematocrit, and no liver toxicity. Two positive Phase 2 studies involving approximately 150 women with AR+/ER+ metastatic breast cancer have been conducted. Enobosarm AR targeted treatment demonstrated favorable clinical benefit rates, objective and durable tumor responses in women with heavily pretreated estrogen receptor targeted resistant AR+ ER+ metastatic breast cancer. Quality of life measurements demonstrated overall improvement including mobility, anxiety/depression and pain. Enobosarm appears safe and well tolerated without virilizing effects, increase in hematocrit, or liver toxicity.

FDA agreed to our enobosarm Phase 3 registration clinical trial to evaluate the efficacy and safety of enobosarm 9mg versus an active control (either exemestane or tamoxifen) 2:1 randomization for the treatment of metastatic AR+/ER+/HER2- breast cancer in approximately 240 patients who have failed a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor. The Phase 3 study will be called the ARTEST study. The primary endpoint is radiographic progression-free survival. Our enobosarm key opinion leaders have been particularly intrigued by the preclinical data that showed that the combination of enobosarm and a CDK4/6 inhibitor restored CDK4/6 sensitivity in AR+/ER+ metastatic breast cancer that was resistant to both estrogen receptor targeted agents and CDK4/6 inhibitors, which is the target patient population in our planned Phase 3 ARTEST clinical study. Consequently, we plan to add a third arm to our Phase 3 trial which would be a combination of enobosarm plus a CDK 4/6 inhibitor. The Phase 3 ARTEST trial will now have three treatment arms: enobosarm alone, enobosarm in combination with a CDK4/6 inhibitor, and active control of either exemestane or tamoxifen. The trial sample size will remain the same at approximately 240 women but randomized 1:1:1 instead of the 2:1 in the previous Phase 2 clinical trial design. The pivotal Phase 3, open label, randomized, active control ARTEST study is anticipated to commence next quarter.

VERU-111 for Taxane Resistant Metastatic Triple Negative Breast Cancer

Metastatic triple negative breast cancer (TNBC) is an aggressive form of breast cancer that is present in approximately 15% of all breast cancers. This form of breast cancer does not express ER, PR or HER2 and is resistant to endocrine therapies. The first line of treatment usually includes IV taxane chemotherapy. Almost all these women will develop taxane resistance and could be a candidate for VERU-111. Preclinical studies in human triple negative breast cancer grown in animal models demonstrate that VERU-111 significantly inhibits cancer proliferation, migration, metastases, and invasion of triple negative breast cancer cells and tumors that have become resistant to paclitaxel, which is a taxane.

Using the safety information from the Phase 1b and Phase 2 VERU-111 prostate cancer clinical studies in a total of approximately 80 men, we will meet with FDA in the first half of calendar year 2021 to discuss Phase 2b clinical trial design for possible accelerated approval for VERU-111 versus active control Trodelvy for patients with taxane resistant triple negative breast cancer, making the proposed trial a potential registration trial. The Phase 2b clinical study is planned to commence in the second half of calendar year 2021.

VERU-111 for COVID-19

This past Monday we announced positive results from the Phase 2 clinical trial evaluating VERU-111 for the treatment of hospitalized patients with COVID-19 who were at high risk for acute respiratory distress syndrome (ARDS). VERU-111 is a novel once a day orally dosed small molecule that has both broad antiviral and anti-inflammatory activities which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death. We conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating daily oral once a day dosing of VERU-111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for ARDS. This trial was conducted in 5 sites across the United States. Patients that were hospitalized with documented evidence of COVID-19 infection with symptoms and who were at high risk for ARDS were enrolled. Subjects received either VERU-111 18mg or placebo as well as standard of care for 21 days or until released from hospital. The primary efficacy endpoint was the proportion of patients that were alive without respiratory failure at Day 29.

For the primary endpoint in hospitalized patients that had >1 dose of study drug, VERU-111 for COVID-19 treatment compared to placebo had a statistically significant and clinically meaningful 81% relative reduction in death or respiratory failure at Day 29. With respect to secondary endpoints, VERU-111 had a statistically significant 82% relative reduction in patient mortality and statistically significant reduction in days in ICU; there was also a decrease in days on mechanical ventilation versus placebo. Furthermore, VERU-111 was well tolerated with a good safety profile.

The Company has been granted an expedited End of Phase 2 meeting with the FDA to discuss next steps including a Phase 3 clinical registration trial design for the VERU-111 COVID-19 program. The Company expects that this confirmatory study will have a similar trial design as the Phase 2 study to evaluate daily oral doses of VERU-111 versus placebo with the primary efficacy endpoint of proportion of patients that are alive without respiratory failure at Day 29. We expect the Phase 3 clinical trial will be conducted in approximately 200 hospitalized patients who have COVID-19 and are at high risk for ARDS. The Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services (BARDA) has granted Veru a meeting to discuss possible grant funding for the Phase 3 study and manufacturing scale up. We plan to commence the VERU-111 for COVID-19 Phase 3 study in April 2021.

Non-GAAP Financial Information

Certain financial results for fiscal years 2021 and 2020 are presented on both a reported and a non-GAAP, adjusted basis. Reported results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The non-GAAP results are adjusted to exclude the one-time gain on sale of PREBOOST in the first quarter of fiscal year 2021. Management believes non-GAAP financial measures provide useful information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the Company’s business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The Company has reconciled these non-GAAP financial measures to the nearest reported GAAP measures in the reconciliation table below.

Event Details
Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10151507, for one week.

On February 10, 2021 Kite, a Gilead Company (Nasdaq: GILD), reported findings from a new analysis of the ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) (Press release, Kite Pharma, FEB 10, 2021, https://www.businesswire.com/news/home/20210210005173/en/Kite-Announces-New-ZUMA-1-Cohort-Analysis-Evaluating-Prophylactic-Corticosteroid-Use-With-Yescarta%C2%AE-in-Patients-With-Relapsed-or-Refractory-Large-B-cell-lymphoma [SID1234574872]). Results were presented today in an oral session at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and Center for International Blood & Marrow Transplant Research (CIBMTR) (Abstract #70).

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In a new ZUMA-1 safety management cohort (Cohort 6), the primary objective was to assess the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and/or tocilizumab on the incidence and severity of cytokine release syndrome (CRS) and neurologic events. Patients with relapsed or refractory LBCL received dexamethasone 10 mg orally on the day of Yescarta infusion and each of the two following days. Corticosteroids and tocilizumab were started earlier, at lower grades of CRS and neurologic events, in Cohort 6 than in the ZUMA-1 pivotal cohorts (Cohorts 1 and 2). All 40 patients enrolled in Cohort 6 received at least one dose of corticosteroids.

In the Cohort 6 primary analysis, no Grade ≥3 CRS occurred. Grade ≥3 neurologic events occurred in 13 percent of patients and no patients experienced Grade 5 neurologic events at the time of data cut-off. Median time to onset of any grade CRS was five days and any grade neurologic events was six days. Sixty-eight percent of patients had no CRS or neurologic events within 72 hours of Yescarta infusion. Ninety-five percent of patients in Cohort 6 responded to Yescarta, including 80 percent of patients who achieved a complete response; 63 percent of patients were in an ongoing response at the time of the data cut-off (median study follow-up of 8.9 months). The median duration of response has not yet been reached.

A post-hoc propensity score-matching analysis was performed by selecting closely matched subgroups from Cohort 6 and pivotal cohorts based on pre-specified prognostic factors for patients with LBCL. This analysis provided a more robust comparison of the safety, efficacy and pharmacokinetic/pharmacodynamic profiles of Cohort 6 with pivotal cohorts. In this propensity score-matched subset, incidence of Grade ≥3 CRS was lower in Cohort 6 (0 percent) than in matched patients from the pivotal cohorts (13 percent) and median time to CRS onset was delayed (5 days versus 2 days). Severity and onset of neurologic events were generally similar between cohorts after propensity score-matching. The propensity score-matching analysis suggested that response rates in Cohort 6 were comparable to those observed in the pivotal cohorts.

"While previous analyses demonstrated a decrease in severity of CRS and neurologic events with earlier steroid intervention, this study suggests that prophylactic corticosteroids may also provide a benefit without compromising efficacy," said Olalekan O. Oluwole, MBBS, MPH, ZUMA-1 Cohort 6 lead investigator and Associate Professor of Medicine, Vanderbilt University Medical Center. "With two-thirds of patients experiencing no CRS or neurologic events up to three days after Yescarta and a five day time to onset of CRS, it is highly encouraging that use of prophylactic steroids may play a significant role in reducing the severe side effects of CAR T."

"As we work to bring the benefits of Yescarta to more patients, these results provide important insights into the use of Yescarta in LBCL, and for safety management protocols for trials with our CAR T-cell therapies," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development.

Yescarta was the first CAR T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, and high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

Prophylactic use of corticosteroids has not been approved by any regulatory agency in conjunction with Yescarta therapy. The safety and efficacy of this prophylactic adverse event management protocol requires further clinical investigation.

U.S. Important Safety Information for Yescarta

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving Yescarta. Do not administer Yescarta to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving Yescarta, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Yescarta. Provide supportive care and/or corticosteroids as needed.
Yescarta is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program.
CYTOKINE RELEASE SYNDROME (CRS) occurred in 94% of patients, with 13% ≥ Grade 3. Among patients who died after receiving Yescarta, 4 had ongoing CRS at death. The median time to onset was 2 days (range: 1-12 days) and median duration was 7 days (range: 2-58 days). Key manifestations include fever (78%), hypotension (41%), tachycardia (28%), hypoxia (22%), and chills (20%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome. Ensure that 2 doses of tocilizumab are available prior to Yescarta infusion. Following infusion, monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES occurred in 87% of patients, 98% of which occurred within the first 8 weeks with a median time to onset of 4 days (range: 1-43 days) and a median duration of 17 days. Grade ≥3 occurred in 31% of patients. The most common neurologic toxicities included encephalopathy (57%), headache (44%), tremor (31%), dizziness (21%), aphasia (18%), delirium (17%), insomnia (9%), and anxiety (9%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events including leukoencephalopathy and seizures, as well as fatal and serious cases of cerebral edema have occurred. Following Yescarta infusion, monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS: Because of the risk of CRS and neurologic toxicities, Yescarta is available only through a restricted program called the Yescarta and Tecartus REMS Program which requires that: Healthcare facilities that dispense and administer Yescarta must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after Yescarta infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Yescarta are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS: Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of Yescarta.

SERIOUS INFECTIONS: Severe or life-threatening infections occurred. Infections (all grades) occurred in 38% of patients. Grade ≥3 infections occurred in 23% of patients; those due to an unspecified pathogen occurred in 16% of patients, bacterial infections in 9%, and viral infections in 4%. Yescarta should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic anti-microbials according to local guidelines. Febrile neutropenia was observed in 36% of patients and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated. In immunosuppressed patients, including those who have received Yescarta, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Yescarta infusion. Grade ≥3 cytopenias not resolved by Day 30 following Yescarta infusion occurred in 28% of patients and included thrombocytopenia (18%), neutropenia (15%), and anemia (3%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA and B-cell aplasia can occur. Hypogammaglobulinemia occurred in 15% of patients. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following Yescarta treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Yescarta treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Yescarta infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS: The most common (incidence ≥20%) include CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections-pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

On February 10, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that it will release its full financial results for the fourth quarter and full-year 2020 after the close of market on Wednesday, February 17 (Press release, Veracyte, FEB 10, 2021, View Source [SID1234574839]). Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 4:30 p.m. Eastern Time on the same day.

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The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following conclusion of the live broadcast and will be accessible on the company’s website at View Source

On February 10, 2021 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, reported an exclusive collaboration and license agreement for the development and commercialization of tegavivint in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China (Press release, Apollomics, FEB 10, 2021, View Source [SID1234574856]).

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Tegavivint is a potent and selective inhibitor of nuclear β-catenin that works through binding to TBL1 (Transducin Beta-like Protein One), a downstream target in the Wnt-signaling pathway. Iterion is pursuing the development of Tegavivint for the treatment of cancers where nuclear ß-catenin signaling is known to play a role. Tegavivint is currently the subject of a Phase 1/2a clinical trial in patients with progressive desmoid tumors.

"As a potent and selective small molecule targeting the Wnt-signaling pathway, Tegavivint is an ideal addition to our clinical development pipeline," said Guo-Liang Yu, Ph.D., Chief Executive Officer of Apollomics. "The preclinical work has demonstrated that the differentiated mechanism of action may be applicable in several indications as both a monotherapy and a combination treatment. We look forward to working with the Iterion team to expand development in Greater China."

Under the terms of the agreement, Apollomics will be responsible for clinical development and commercialization in Greater China. Apollomics and Iterion will form a joint development committee to ensure ongoing collaboration of Tegavivint across indications and geographies. Iterion has received an initial cash payment for ongoing research and development costs in connection with the company’s global development of Tegavivint. Iterion is also eligible to receive potential development and sales milestone payments, as well as tiered royalties on net sales. Apollomics will be responsible for all costs related to development and commercialization activities for Tegavivint in Greater China.

Rahul Aras, Ph.D., President and Chief Executive Officer, Iterion Therapeutics, added, "As we explore multiple indications for Tegavivint in the U.S., including desmoid tumors, acute myeloid leukemia, non-small cell lung cancer, and pediatric cancers, we are excited to partner with Apollomics to expand its development and potential commercialization in Greater China. With Apollomics’ oncology focus and growing footprint in China, they are the partner of choice to successfully advance Tegavivint for cancer patients in this region."

About Tegavivint

Tegavivint is a potent and selective inhibitor of nuclear β-catenin that binds to TBL1 (Transducin βeta-like Protein One), a downstream target in the Wnt-signaling pathway. Targeting TBL1 may enable specific silencing of Wnt-pathway oncogenic gene expression without affecting other necessary cellular functions that are disrupted when targeting higher up the Wnt-pathway. This avoids toxicity issues common to other drugs in this pathway.

Tegavivint has the potential for clinical utility in multiple cancer types. Tegavivint is currently the subject of a Phase 1/2a clinical trial in progressive desmoid tumors. Desmoid tumors, a rare type of sarcoma for which there is no currently approved therapy, are driven primarily by nuclear β-catenin signaling and, thus, present an optimal indication for demonstrating the drug’s mechanism of action as the company pursues additional clinical programs. Tegavivint has also demonstrated anti-tumor activity in multiple pre-clinical models, including acute myeloid leukemia (AML) and non-small cell lung cancer (NSCLC).

On February 10, 2021 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (NASDAQ: IPA / TSX VENTURE: IPA) a leader in full-service, therapeutic antibody discovery and development, reported that the over-allotment option (the "Option") granted in connection with its previously announced bought deal offering of 1,616,293 common shares (the "Common Shares") in the capital of the Company (the "Offering"), has been fully exercised. H.C. Wainwright & Co. has purchased additional 242,443 shares of the Company (the "Additional Shares") at the public offering price of $13.45 per Additional Share for additional aggregate gross proceeds to the Company of approximately $3.3 million, less underwriting discounts and commissions (Press release, ImmunoPrecise Antibodies, FEB 10, 2021, View Source [SID1234574873]).

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H.C. Wainwright & Co. acted as sole book-running manager for the Offering.

The Company intends to use the net proceeds from the Offering and the issuance and sale of the Additional Shares for (i) pursuing the Company’s objective of expanding its operations into Good Laboratory Practice and Good Manufacturing Practice-certified; (ii) the development and commercialization of Talem Therapeutics, LLC’s, a wholly owned subsidiary of the Company, internal and partnered therapeutic discovery programs; (iii) investments in employees, partnerships, cloud computing, data curation and analysis to enable further work toward the development of custom algorithms, cloud computing, large-scale sequence data analysis, and expanded access to next-generation sequencing technologies; (iv) the development of its PolyTopeTM approach to the development of innovative therapeutics and vaccines against the COVID-19; and (v) general corporate and working capital purposes.

In connection with the Offering, the Company filed with the securities regulatory authorities in each of the provinces of Canada (except Quebec), a short form base shelf prospectus dated December 11, 2020. The short form base shelf prospectus was filed on Form F-10 with the U.S. Securities and Exchange Commission ("SEC"). The Company also filed a preliminary prospectus supplement to the short form base shelf prospectus with the securities regulatory authority in the Province of British Columbia as well as with the SEC as part of a registration statement on Form F-10 under the U.S.-Canada multijurisdictional disclosure system ("MJDS"). The Common Shares were only offered and sold in the United States either directly or through duly registered U.S. broker dealers. No Common Shares were offered or sold to Canadian purchasers.

The Offering was made in the United States only by means of the registration statement, including the base shelf prospectus and applicable prospectus supplement. Such documents contain important information about the Offering. A short form base shelf prospectus and accompanying preliminary prospectus supplement have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Copies of the short form base shelf prospectus and accompanying final prospectus supplement have been filed with the SEC and are available for free on the SEC’s website at www.sec.gov and on the SEDAR website at www.sedar.com. Electronic copies of the final prospectus supplement and registration statement may also be obtained from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd Floor, New York, NY 10022, or by calling (646) 975-6996 or by emailing [email protected].

No securities regulatory authority has either approved or disapproved the contents of this news release. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.