On August 1, 2019 Geron Corporation (Nasdaq: GERN) reported financial results for the second quarter ended June 30, 2019, and recent events (Press release, Geron, AUG 1, 2019, View Source [SID1234538010]). The Company ended the second quarter with $162.3 million in cash and marketable securities.

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During the second quarter, data from the Phase 2 portion of IMerge was reported at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress that further support Geron’s late-stage development plans for the imetelstat program. Geron continues to plan to open the Phase 3 portion of IMerge in lower risk myelodysplastic syndromes (MDS) for screening and enrollment in August 2019.

"This past quarter, data presented at EHA (Free EHA Whitepaper) for the Phase 2 portion of IMerge reported higher efficacy responses from prior reported data for both 8-week and 24-week RBC-TI rates, highlighting the meaningful and durable transfusion independence potentially achievable with imetelstat treatment in heavily transfusion dependent lower risk MDS patients. Accordingly, we’re very much looking forward to the Phase 3 portion of IMerge opening for screening and enrollment later this month," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "In addition, a second EHA (Free EHA Whitepaper) presentation reported results of statistical analyses in which the months of median overall survival were more than double for imetelstat-treated relapsed/refractory MF patients in IMbark, compared to real-world data from closely matched patients treated with best available therapy. This provides additional support for our ongoing strategic evaluation of potential late-stage development approaches and regulatory scenarios in relapsed/refractory MF as we prepare for an End of Phase 2 meeting with the FDA, which we’re planning to conduct by the end of the first quarter of 2020."

Phase 3 Portion of IMerge Phase 2/3 Clinical Trial – Initial Site Initiations Complete and Trial to Open for Patient Screening and Enrollment in August 2019

In May, Geron completed the transfer of the imetelstat investigational new drug (IND) sponsorship from Janssen Biotech, Inc. (Janssen), and assumed complete development responsibility for imetelstat. Site initiations for the Phase 3 portion of IMerge were completed for several clinical sites in July 2019. Geron is planning for the trial to open for patient screening and enrollment later this month.

IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed/refractory to erythroid stimulating agents (ESAs). The primary efficacy endpoint is the rate of red blood cell transfusion independence (RBC-TI) lasting at least eight weeks, or 8-week RBC-TI rate, which is defined as the proportion of patients achieving RBC-TI during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, durability of transfusion independence and the amount and relative change in RBC transfusions.

The Phase 3 portion of IMerge is designed as a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of RBC-TI compared to placebo.

Approximately 170 patients are planned to be enrolled and randomized in a 2:1 ratio to receive either imetelstat or placebo. Many key aspects from the Phase 2 portion of IMerge remain the same for the Phase 3 portion. A target patient population of non-del(5q) lower risk MDS patients who were naïve to treatment with hypomethylating agents (HMAs) and lenalidomide was identified from the Phase 2 portion and will be enrolled in the Phase 3. In addition, the primary and secondary endpoints, the dose and schedule of imetelstat administration and many of the clinical sites remain the same as in the Phase 2. The Company is planning for the trial to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia.

Second Quarter and Year-to-Date 2019 Results

For the second quarter of 2019, the Company reported a net loss of $14.2 million, or $0.08 per share, compared to $6.9 million, or $0.04 per share, for the comparable 2018 period. Net loss for the first six months of 2019 was $24.3 million, or $0.13 per share, compared to $14.1 million, or $0.08 per share, for the comparable 2018 period.

Revenues for the three and six months ended June 30, 2019 were $101,000 and $158,000, respectively, compared to $208,000 and $526,000 for the comparable 2018 periods. Revenues for the three and six months ended June 30, 2019 and 2018 included royalty and license fee revenues under various non-imetelstat license agreements. The decline in revenues reflects a reduction in the number of active research license agreements in 2019 related to the Company’s human telomerase reverse transcriptase, or hTERT, technology as a result of patent expirations on the underlying technology.

Total operating expenses for the three and six months ended June 30, 2019 were $15.3 million and $26.7 million, respectively, compared to $7.5 million and $15.2 million for the comparable 2018 periods. Research and development expenses for the three and six months ended June 30, 2019 were $10.1 million and $16.0 million, respectively, compared to $3.2 million and $5.6 million for the comparable 2018 periods. The increase in research and development expenses, compared to the same periods in 2018, primarily reflects costs for the transition of the imetelstat program, including resuming sponsorship of the ongoing imetelstat clinical trials; expenses for start-up activities for the Phase 3 portion of IMerge; and higher personnel-related costs for the expanding development team. General and administrative expenses for the three and six months ended June 30, 2019 were $5.2 million and $10.6 million, respectively, compared to $4.2 million and $9.6 million for the comparable 2018 periods. The increase in general and administrative expenses, compared to the same periods in 2018, primarily reflects higher corporate and patent legal costs and increased personnel-related expenses for additional headcount to support the development organization.

Interest and other income for the three and six months ended June 30, 2019 was $1.1 million and $2.3 million, respectively, compared to $717,000 and $1.1 million for the comparable 2018 periods. The increase in interest and other income, compared to the same periods in 2018, primarily reflects higher yields on the Company’s increased marketable securities portfolio.

The Company ended the second quarter of 2019 with $162.3 million in cash and marketable securities. Since May 2019, the Company has raised cumulative net cash proceeds of approximately $2.6 million from the sales of an aggregate of 1,893,091 shares of common stock under an At Market Issuance Sales Agreement, after deducting sales commissions and other offering expenses payable by Geron. The Company expects these net cash proceeds to provide additional financial flexibility as it advances the imetelstat development program. The funds will support future development costs, including conducting the Phase 3 portion of IMerge.

2019 Financial Guidance Reaffirmed

For fiscal year 2019, the Company expects total operating expenses to range from $80 to $85 million, of which approximately $20 to $25 million represents one-time costs that include imetelstat program transition activities from Janssen to Geron and purchase of drug product, drug substance and raw materials from Janssen to supply the Phase 3 portion of IMerge and prepare for new drug manufacturing. The Company continues to expect transition of the imetelstat program from Janssen to be completed by the end of the third quarter of 2019.

As of July 31, 2019, the Company had 38 employees, and plans to grow to a total of approximately 45 to 50 employees by year-end 2019, of whom half will be research and development personnel.

Conference Call

Geron will host a conference call to discuss second quarter and year-to-date financial results and recent events at 4:30 p.m. ET on Thursday, August 1, 2019.

Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The conference ID is 2379646. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS) and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion dependent anemia due to non-del(5q) lower risk MDS who are refractory or resistant to an erythroid stimulating agent.

On August 1, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the second quarter ended June 30, 2019 (Press release, Corvus Pharmaceuticals, AUG 1, 2019, View Source [SID1234538009]).

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"Corvus continues to be a leader in the field of drug development targeting the adenosine pathway, with complementary lead programs – ciforadenant and CPI-006 – that have shown promising activity in a range of solid tumors. We also have a third program in the clinic, CPI-818, which is an ITK inhibitor for the treatment of patients with advanced T-cell lymphomas. Together, I believe these three programs position Corvus as a leader in the development of second-generation immuno-oncology agents," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "At ASCO (Free ASCO Whitepaper) this year, initial clinical data on CPI-006 was presented in an oral session and subsequently selected for the Highlight of the Day session. The data demonstrated activity as a monotherapy and in combination with ciforadenant and that CPI-006 represents a potential novel immuno-oncology approach via activation of immune cells and the inhibition of adenosine production. We plan to continue presenting new data on our programs at the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting and other meetings over the remainder of the year."

Recent Achievements
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Continued enrollment of patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The RCC patients in the trial have failed treatments with anti-PD-(L)1 antibodies and tyrosine kinase inhibitors. This trial is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy.
Amending our ongoing Phase 1b/2 study to include an arm evaluating ciforadenant in combination with Tecentriq in patients with prostate cancer. This arm will also evaluate the use of the Adenosine Signature.
Continued follow-up in a Phase 1b/2 trial of ciforadenant and Tecentriq being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating this combination in patients who have failed no more than two prior regimens.
CPI-006: Immunomodulatory Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either ciforadenant or pembrolizumab. The trial is currently enrolling patients in the dose escalation phase for CPI-006 administered as a monotherapy and in combination with ciforadenant.
Initial clinical data covering 20 patients with advanced, refractory cancer from the Phase 1/1b trial was delivered in an oral presentation at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. The initial data showed a trend toward longer disease control with higher doses of CPI-006, and enhanced disease control with CPI-006 in combination with ciforadenant compared with monotherapy. Additional highlights from the presentation:
Clinical and laboratory results demonstrated potential for a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
Dose-dependent disease control when administered as a monotherapy and in combination with ciforadenant.
CPI-006 was well tolerated at all dose levels, with no dose-limiting toxicities. Grade 1 infusion reactions were detected (N=3 patients) and mitigated with premedication with acetaminophen and antihistamine. Grade 3 or 4 toxicities included a grade 3 anemia (N=1).
CPI-818: A small molecule ITK inhibitor

Continued enrolling patients with T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others, in a Phase 1/1b study with CPI-818, an ITK inhibitor.
Anticipated Events in 2H 2019

Updated clinical and immunologic data from the Phase 1/1b clinical trial of CPI-006 monotherapy and combination with ciforadenant is expected to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in November 2019.
Presentation on identification and role of biomarkers in adenosine pathway therapies is expected to be presented at SITC (Free SITC Whitepaper).
Preclinical and early clinical data regarding CPI-818 is expected to be presented in late 2019 or early 2020.
Financial Results

At June 30, 2019, Corvus had cash, cash equivalents and marketable securities totaling $96.8 million, as compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018. Corvus expects full-year 2019 net cash used in operating activities to be between $38 and $42 million and estimates ending 2019 with cash, cash equivalents and marketable securities of between $73 and $77 million.

Research and development expenses for the three months ended June 30, 2019 totaled $10.6 million, as compared to $9.7 million for the same period in 2018. The increase of $0.9 million was primarily due to an increase in CPI-006 program costs.

The net loss for the three months ended June 30, 2019 was $13.0 million, compared to a net loss of $11.6 million for the same period in 2018. Total stock compensation expense for the three months ended June 30, 2019 was $1.9 million, as compared to $1.7 million for the same period in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, August 1, 2019, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2019 financial results. The conference call can be accessed by dialing 1-888-599-8686 (toll-free domestic) or 1-720-543-0302 (international) and using the conference ID 2091306. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days following the call.

On August 1, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended June 30, 2019 (Press release, Corcept Therapeutics, AUG 1, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-2019-financial [SID1234538008]).

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Financial Highlights

Revenue of $72.3 million, a 16 percent increase from second quarter 2018
GAAP net income of $0.17 per share, compared to $0.14 per share in second quarter 2018
Non-GAAP net income of $0.25 per share, compared to $0.20 per share in second quarter 2018
Cash and investments of $225.7 million, compared to $215.7 million at March 31, 2019
Reaffirmed 2019 revenue guidance of $285 – $315 million
Corcept reported quarterly revenue of $72.3 million, compared to $62.3 million in the second quarter of 2018. Second quarter GAAP net income was $20.2 million, compared to $18.2 million in the same period last year. Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the second quarter was $31.0 million, compared to $25.4 million in the second quarter of 2018. A reconciliation of GAAP to non-GAAP net income is included below.

The company reaffirmed its 2019 revenue guidance of $285 – $315 million.

Second quarter operating expenses were $47.6 million, compared to $41.7 million in the second quarter of 2018, primarily due to growth in the number of research and development personnel, increased spending to advance new compounds, and increased spending to formulate and manufacture the selective cortisol modulators relacorilant, exicorilant and miricorilant.

Cash and investments were $225.7 million at June 30, 2019, an increase of $10.0 million from March 31, 2019. This increase was after the expenditure of $17.4 million in the second quarter to repurchase 1.6 million shares of common stock pursuant to Corcept’s stock repurchase program.

"Our Cushing’s franchise had a strong quarter," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "As they have every year, patients taking Korlym successfully overcame the insurance reauthorization hurdles many of them face in the first quarter. These obstacles do not interrupt their care, because we provide them with free Korlym. They do, however, temporarily reduce our revenue. Meanwhile, our business grew as the number of patients receiving Korlym and the number of physicians prescribing the medication continued to increase."

Clinical Highlights

"It is gratifying to work on development programs that may benefit so many patients," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "We are advancing our proprietary, selective cortisol modulators in Cushing’s syndrome, solid tumors and metabolic diseases. Our clinical trials in these areas are progressing and we plan to start important new trials later this year and in 2020."

Cushing’s Syndrome

Dosing continues in Phase 3 trial ("GRACE") of relacorilant in patients with Cushing’s syndrome
Placebo-controlled trial of relacorilant to treat patients with less severe Cushing’s syndrome
to begin late this year
GRACE seeks to confirm relacorilant’s positive Phase 2 results and to provide the basis for its approval in the United States and Europe as a treatment for Cushing’s syndrome.1 Patients in relacorilant’s Phase 2 trial exhibited meaningful improvements in glucose control and hypertension – two of Cushing’s syndrome’s most common and pernicious manifestations. The trial also met a wide range of secondary endpoints, including weight loss, liver function, coagulopathy, insulin resistance, cognitive function, mood and quality of life. These results were achieved without instances of Korlym’s significant off-target effects – vaginal bleeding, endometrial thickening and low potassium.2

In the fourth quarter, Corcept plans to start a double-blind, placebo-controlled trial of relacorilant in patients whose Cushing’s syndrome is caused by an adrenal adenoma – an etiology where the effect of medical treatment has not been extensively studied. A controlled study is possible in these patients because their symptoms, while serious, are usually less severe than those experienced by patients with other etiologies of the disorder. The trial will enroll approximately the same number of patients as the GRACE trial at sites in the United States and Europe. Most of these sites are also participating in GRACE.

Metabolic Disease

Phase 1b trial underway in reduction of antipsychotic-induced weight gain; results expected late this year
Phase 2 trial in reversal of recent antipsychotic-induced weight gain planned to start late this year
Corcept’s Phase 1b trial in the reduction of weight-gain caused by antipsychotic medication is on track to produce results late this year. Approximately 60 healthy subjects will receive olanzapine (Eli Lily’s Zyprexa) and either miricorilant or placebo for two weeks, with the primary endpoint being change in weight. "We modeled this trial on the successful placebo-controlled studies3 we conducted with Korlym," said Dr. Grauer. "Unfortunately, Korlym’s off-target effects preclude its development for such a common disorder. Miricorilant is a better potential medication because it does not bind to the progesterone receptor. Activity at the progesterone receptor is what causes Korlym’s off-target effects. We look forward to completing this trial and starting one double-blind, placebo-controlled Phase 2 trial in patients later this year and another in 2020."

Corcept is also advancing miricorilant as a treatment for NASH, a serious and widespread liver disorder, and plans to start a double-blind, placebo-controlled Phase 2 trial in 2020.

Solid Tumors

Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer planned
to start late this year
European Medicines Agency Committee for Orphan Medicinal Products (COMP) recommends orphan drug designation for relacorilant to treat metastatic pancreatic cancer
"At the American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) meeting this June, we presented data from our Phase 1/2 study of relacorilant plus the taxane nab-paclitaxel (Celgene’s Abraxane)," said Dr. Grauer. "Seven of 25 patients with metastatic, pancreatic cancer and five of 11 patients with advanced ovarian cancer achieved "durable disease control," meaning their tumors either shrank or ceased growing for a period of 16 weeks or longer. Tumor response in two patients with pancreatic disease persisted for more than 50 weeks. One patient’s ovarian tumor disappeared completely; another’s responded for 65 weeks.4Any response to treatment in patients with such advanced disease is surprising. That is especially true in these patients, whose tumors had progressed during multiple lines of prior therapy, including treatments with nab-paclitaxel or another taxane.

"We hope to confirm these findings in larger, more definitive studies. Our 180-patient, placebo-controlled Phase 2 trial in ovarian cancer is enrolling patients. We plan to start a Phase 3 trial in metastatic pancreatic cancer later this year and are seeking FDA guidance regarding the fastest path to approval in that indication. Relacorilant’s designation as an orphan drug for pancreatic cancer in the United States and the European Union will be helpful as our program advances."

On July 18, 2019, the COMP recommended orphan designation of relacorilant for the treatment of pancreatic cancer. The COMP’s letter stated that "relacorilant has the potential to restore tumour sensitivity to taxane therapy. This was demonstrated by non-clinical and clinical results, i.e. the achievement of durable partial responses or disease control in some patients, despite previously failed treatment regimens. The COMP considered that the preliminary clinical data submitted by the sponsor supported the claim [of] significant benefit for the purpose of an initial orphan designation."

The European Commission is expected to adopt the COMP’s recommendation later this year. The FDA designated relacorilant an orphan drug for the treatment of pancreatic cancer in September 2018.

Conference Call

We will hold a conference call on August 1, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-888-394-8218 from the United States or 1-323-794-2590 internationally approximately ten minutes before the start of the call (passcode 9712194). A replay will be available through August 15, 2019 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 9712194).

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most people with Cushing’s syndrome experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated effectively.

On August 1, 2019 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), corporate highlights and reported financial results for the quarter ended June 30, 2019 (Press release, Coherus Biosciences, AUG 1, 2019, View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-reports-corporate-highlights-and-second-0" rel="nofollow">View Source [SID1234538007]).

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Second Quarter 2019 Company Highlights

Net product revenue for the second quarter of 2019 was $83.4 million and net income was $23.6 million, or $0.32 per share on a fully diluted basis. Net income was $3.6 million or $0.05 per share on a fully diluted basis for the first half of 2019. Cash flow from operations for the quarter was also positive at $12.7 million.
Uptake of UDENYCA (pegfilgrastim-cbqv) is progressing strongly across all segments (340B hospitals, non-340B hospitals and community oncology clinics), with increased uptake in the 340B segment after receiving transitional pass-through status from Centers for Medicare & Medicaid Services on April 1, 2019.
After just two quarters on the market, UDENYCA is the U.S. market leading pegfilgrastim biosimilar with greater than approximately 13% of unit market share at the end of June 2019, and it is anticipated to reach over 20% of unit market share by the end of 2019.
Second Quarter 2019 Financial Results

Net product revenue for the second quarter of 2019 was $83.4 million. Cost of goods sold for the second quarter of 2019 was $0.6 million, resulting in a gross profit margin of 99 percent for the second quarter of 2019, up from 94 percent in the first quarter of 2019.
Research and development (R&D) expense for the second quarter of 2019 was $18.9 million, as compared to $26.5 million for the same period in 2018. R&D expense for the six months ended June 30, 2019 was $37.7 million, as compared to $52.0 million for the same period in 2018. The decrease in R&D expense in both periods was primarily due to the capitalization of UDENYCA manufacturing costs in the first quarter of 2019 and a decrease in CHS-0214 development costs.
Selling, general and administrative (SG&A) expense for the second quarter of 2019 was $36.5 million, as compared to $18.4 million for the same period in 2018. SG&A expense for the six months ended June 30, 2019 was $69.1 million, as compared to $35.0 million for the same period in 2018. The increase in SG&A expense in 2019 was primarily attributable to the costs related to commercializing UDENYCA in the United States, which included personnel and third-party services costs for commercial and marketing initiatives, as well as legal costs in support of litigations.
Cash, cash equivalents and investments in marketable securities for the second quarter totaled $111.9 million at June 30, 2019, as compared to $96.4 million at March 31, 2019 and $72.4 million at December 31, 2018. Cash flow from operations was $12.7 million for the second quarter of 2019.
Net income attributable to the Company for the second quarter of 2019 was a 23.6 million, or $0.32 per share on a fully diluted basis, compared to a net loss of ($43.6) million, or ($0.68) per share on a basic and fully diluted basis for the same period in 2018.
Guidance for the Next Six Months from June 30, 2019

UDENYCA (pegfilgrastim-cbqv) biosimilar to Neulasta (pegfilgrastim)
• Continue as market leading pegfilgrastim biosimilar of choice.
• Achieve 2019 exit unit market share of 20% or greater.
• Increase penetration into all Neulasta dosage forms.
CHS-1420, biosimilar candidate to Humira (adalimumab)
• Complete certain development objectives to support BLA filing in 2020.
CHS-0214, biosimilar candidate to Enbrel (etanercept)
• Prepare for BLA supporting activities, pending legal developments.
CHS-3351, biosimilar candidate to Lucentis (ranibizumab) and CHS-2020, biosimilar candidate to Eylea (aflibercept)
• Advance the development of the ophthalmology pipeline.
CHS-131, small molecule, PPAR-g modulator drug candidate in nonalcoholic steatohepatitis ("NASH")
• Initiate clinical phase program in NASH.
Conference Call Information

When: Thursday, August 1, 2019 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9268814
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About UDENYCA

UDENYCA (pegfilgrastim-cbqv) is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

Indication

UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use

UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Contraindication

Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

Warnings and Precautions

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCA in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCA in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCA if causality is likely.
Adverse Reactions

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences, Inc. at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On August 1, 2019 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2019, and provided an update on Clovis’ clinical development programs and regulatory and commercial outlook for the second half of 2019 (Press release, Clovis Oncology, AUG 1, 2019, View Source [SID1234538006]).

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"We continue to make progress in the second-line ovarian cancer maintenance indication in the U.S., and we look forward to the potential prostate indication in the U.S. and launches in additional EU countries to support top-line growth in 2020," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "In addition, we are extremely pleased to have begun our combination studies of lucitanib plus Rubraca and lucitanib plus Opdivo, and we look forward to sharing initial data from these studies at medical meetings next year. We believe these combinations have significant potential and in almost every case, will study unselected or all-comer populations."

Second Quarter 2019 Financial Results

Clovis reported net product revenue for Rubraca of $33.0 million for Q2 2019, which included U.S. net product revenue of $32.7 million and ex-U.S. net product revenue of $0.3 million, compared to net product revenue for Q2 2018 of $23.8 million. U.S. net product revenue increased three percent sequentially from Q1 2019 to Q2 2019. Ex-US net product revenues were lower sequentially in Q2 2019 than Q1 2019, as initial launch stocking shipments were made in March and reported in Q1 product revenue. Clovis expects ex-U.S. net product revenues to increase in Q3 compared to Q2 2019.

Clovis expects global net product revenue to be in the range of $137 million to $147 million for the full year.

The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for Q2 2019 was marginally higher at approximately 22 percent of the overall commercial supply, compared to 21 percent in Q1 2019 and lower than the 25 percent reported in Q2 2018. This represented $9.3 million in commercial value for Q2 2019 compared to $8.4 million in Q1 2019 and $7.9 million in Q2 2018.

Net product revenue for the first half of 2019 was $66.1 million, as compared to net product revenue of $42.3 million for the first half of 2018. The Rubraca label was expanded to include the broader and earlier-line maintenance treatment indication in the U.S. in April 2018 and in the EU in January 2019. For the first half of 2019, the supply of free drug distributed to eligible patients was an additional approximately 21 percent of the overall commercial supply compared to 24 percent in the first half of 2018. This represented $17.7 million in commercial value for the first half of 2019 compared to $13.4 million in the first half of 2018.

Clovis had $315.9 million in cash, cash equivalents and available-for-sale securities as of June 30, 2019. Cash used in operating activities was $98.9 million for Q2 2019 and $197.4 million for the first half of 2019, compared with $110.2 million for Q2 2018 and $210.8 million for the first half of 2018. For the first half of 2019, total cash used included product supply costs of $42.5 million and a $15.75 million milestone payment to Pfizer related to the second European product approval in Q1 2019. For the first half of 2018, total cash used included product supply costs of $76.1 million and milestone payments to Pfizer of $58.0 million in Q2 2018 related to U.S. product approvals in December 2016 and April 2018 and European product approval in May 2018.

The amount spent on product supply costs and milestone payments is expected to decrease substantially in the second half of 2019 and in 2020. These reduced costs, combined with anticipated net product revenue growth in the global ovarian indications and the potential U.S. prostate indication in 2020, will significantly reduce our cash burn in the second half of 2019 and 2020. This will be additionally supported by the quarterly cash payments provided by the ATHENA clinical trial financing.

Clovis reported a net loss for Q2 2019 of $120.4 million, or ($2.27) per share, and $206.9 million, or a net loss of ($3.91) per share for the first half of 2019. Net loss for Q2 2018 was $101.2 million, or ($1.94) per share, and $178.9 million, or a net loss of ($3.48) per share, for the first half of 2018. Net loss for Q2 and first half of 2019 included share-based compensation expense of $14.1 million and $27.8 million, compared to $14.9 million and $26.8 million for the comparable periods of 2018.

Research and development expenses totaled $70.7 million for Q2 2019 and $132.8 million for the first half of 2019, compared to $52.7 million and $96.3 million for the comparable periods in 2018. The increase is primarily due to higher research and development costs for rucaparib clinical trials. Clovis expects research and development costs to be higher for the full year 2019 compared to 2018. Thereafter, we expect research and development costs to flatten, and then trend lower in the following years, as the largest of the Clovis’ sponsored clinical trials near completion.

Selling, general and administrative expenses totaled $48.0 million for Q2 2019 and $95.8 million for the first half of 2019, compared to $44.9 million and $84.1 million for the comparable periods in 2018. The increase year over year is primarily due to higher selling, general and administrative expenses related to the commercialization of Rubraca in the U.S. and EU. Clovis also expects selling, general and administrative costs to be higher for the full year 2019 compared to 2018, however, these costs will continue to increase modestly as Clovis prepares for anticipated product launches in a greater number of countries outside of the U.S. and launch activities for the anticipated prostate indication approval in 2020.

In May 2019, Clovis entered into an agreement for up to $175.0 million in non-dilutive clinical trial financing with certain affiliates of TPG Sixth Street Partners to reimburse Clovis’ quarterly costs and expenses related to the ATHENA clinical trial. ATHENA is Clovis’ largest clinical trial, with a planned target enrollment of 1,000 patients across more than 270 sites in at least 25 countries. Clovis plans to borrow amounts required to reimburse actual costs and expenses incurred during each quarter, beginning in Q2 2019, and repayment is anticipated to begin in 2022, the approximate anticipated timing of a potential Rubraca first-line maintenance approval in advanced ovarian cancer. The financing is secured by Rubraca assets, and Clovis maintains worldwide rights to Rubraca.

Rubraca in BRCA-mutant Advanced Prostate Cancer

Initial data from Clovis’ ongoing TRITON studies of Rubraca in metastatic castrate-resistant prostate cancer (mCRPC) were presented at the ESMO (Free ESMO Whitepaper) 2018 Congress (European Society for Medical Oncology) in October 2018. The initial TRITON2 data showed a 44 percent confirmed objective response rate (ORR) by investigator assessment in 25 RECIST1/PCWG3** response-evaluable patients with a BRCA1/2 mutation and results by independent assessment were consistent. The median duration of response in these patients had not yet been reached. In addition, a 51 percent confirmed prostate specific antigen (PSA) response rate was observed in 45 PSA response-evaluable patients with a BRCA1/2 mutation. Preliminary safety data for Rubraca in men with mCRPC were consistent with those observed in patients with ovarian cancer and other solid tumors.

The TRITON2 results were the basis for Breakthrough Therapy designation for Rubraca as a monotherapy treatment of adult patients with BRCA1/2 mutant mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy, which was granted on October 1, 2018 by the U.S. Food and Drug Administration (FDA). Both studies in the TRITON program, TRITON2 and TRITON3, continue to enroll patients.

As a result of Rubraca’s breakthrough therapy status, Clovis agreed to provide updates to FDA on Clovis’ advanced prostate cancer development program on a regular basis. Later this month, Clovis intends to provide an update to FDA on the TRITON2 data for patients with BRCA-mutant mCRPC. These data will show RECIST and PSA response rates consistent with the data presented at ESMO (Free ESMO Whitepaper) 2018. Clovis will present the TRITON2 data in a poster discussion session at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Barcelona in late September. Clovis intends to file the planned supplemental New Drug Application (sNDA) during the fourth quarter of 2019.

Rubraca Clinical Development

Clovis has a robust clinical development program underway in multiple tumor types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials. The following Clovis-sponsored clinical studies are open for enrollment or are anticipated to open during the next several months:

ARIEL4, a confirmatory study in the ovarian cancer treatment setting, is a Phase 3 multicenter, randomized study of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. This study is currently enrolling patients.
ATHENA is a Phase 3 study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating Rubraca plus Opdivo (PD-1 inhibitor), Rubraca, Opdivo and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. This study, as part of a broad clinical collaboration with Bristol-Myers Squibb, is currently enrolling patients.
TRITON3 is a Phase 3 comparative study in mCRPCenrolling BRCA-mutant and ATM-mutant (both inclusive of germline and somatic) patients who have progressed on androgen-receptor (AR)-targeted therapy and who have not yet received chemotherapy in the castration-resistant setting. TRITON3 compares Rubraca to physician’s choice of AR-targeted therapy or chemotherapy in these patients. This study is currently enrolling patients.
TRITON2 is a Phase 2 single-arm study in mCRPC in patients with BRCA mutations (inclusive of germline and somatic), which is also enrolling patients with deleterious mutations of other homologous recombination (HR) repair genes. All patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of AR-targeted therapy. This study is currently enrolling patients.
ARIES is a Phase 2, open-label, multi-cohort study evaluating the combination of Rubraca and Opdivo in patients with relapsed ovarian cancer. This study is currently enrolling patients.
SEASTAR is a Phase 1b/2 study comprised of multiple single-arm rucaparib combination studies, which currently includes the following planned combinations:
Rubraca and lucitanib, Clovis’ investigational inhibitor of multiple tyrosine kinases including VEGFR, for the treatment of ovarian cancer, is currently enrolling patients with locally advanced or metastatic solid tumors into the Phase 1b portion;
Rubraca and sacituzumab govitecan, an antibody drug conjugate, for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum-resistant ovarian cancer and advanced metastatic urothelial cancers, is expected to begin enrolling patients by year-end;
And a planned Phase 2 pan-tumor study in patients with solid tumors associated with deleterious mutations in homologous recombination repair genes, which is expected to begin by year-end 2019.
Also, a Phase 2 combination study of Opdivo with Rubraca for the treatment of mCRPC is underway. This study, sponsored by Bristol-Myers Squibb, is being conducted as an arm in the CHECKMATE 9KD prostate cancer study, and is currently enrolling patients. In addition, a new Phase 2 combination study of Opdivo and Yervoy with Rubraca for the treatment of advanced gastric cancer is planned to initiate in Q4 2019 and will be sponsored by Bristol-Myers Squibb.

Exploratory studies in other solid tumors are also underway, as well as active discussions with Bristol-Myers Squibb regarding additional potential combination studies.

Lucitanib Clinical Development

Lucitanib is an investigational, oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Clovis has global rights (excluding China) for lucitanib.

Recent data for a drug that inhibits these same three pathways – when combined with a PD-1 inhibitor – are extremely encouraging and represent a scientific rationale for the development of lucitanib in combination with a PD-1 inhibitor, and a Clovis-sponsored study of lucitanib in combination with Opdivo is underway in advanced gynecologic cancers and other solid tumors. Based on encouraging data of VEGF and PARP inhibitors in combination, a study of lucitanib in combination with rucaparib in advanced ovarian cancer is also underway as an arm of the SEASTAR study. Each of these Phase 1b/2 studies is currently enrolling patients.

As previously announced, Clovis and Alkermes have initiated a preclinical research collaboration to evaluate ALKS 4230, Alkermes’ investigational engineered interleukin-2 (IL-2) variant immunotherapy, in combinations with rucaparib and lucitanib.

Conference Call Details

Clovis will hold a conference call to discuss Q2 2019 results this morning, August 1, at 8:30am ET. The conference call will be simultaneously webcast on the Clovis Oncology web site www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 877.698.7048, International participants 647.689.5448, conference ID: 5192422.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

In the EU, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. This expands rucaparib’s indication beyond its initial marketing authorization in the EU granted in May 2018 and with this label expansion, rucaparib is now available to patients regardless of their BRCA mutation status. Rubraca is also approved in the EU for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and the EU.

About Lucitanib

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDFGRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3). Emerging clinical data support the combination of angiogenesis inhibitors and immunotherapy to increase effectiveness in multiple cancer indications. Angiogenic factors, such as vascular endothelial growth factor (VEGF), are frequently up-regulated in tumors and create an immunosuppressive tumor microenvironment. Use of antiangiogenic drugs reverses this immunosuppression and can augment response to immunotherapy.

Lucitanib is an unlicensed medical product.