On August 3, 2017 CTI BioPharma Corp. (NASDAQ and MTA:CTIC) reported financial results for the second quarter ended June 30, 2017 (Press release, CTI BioPharma, AUG 3, 2017, View Source [SID1234520024]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Clinical / Regulatory

In July 2017, the first patient was enrolled in PAC203, a Phase 2 clinical trial of pacritinib in patients with primary myelofibrosis who have failed prior ruxolitinib therapy. PAC203 is designed to evaluate the dose response relationship for safety and efficacy (spleen volume reduction at 12 and 24 weeks) of three dose regimens: 100 mg once-daily, 100 mg twice-daily (BID) and 200 mg BID. The 200 mg BID dose regimen was used in the Phase 3 PERSIST-2 trial of pacritinib in patients with myelofibrosis. The trial is expected to enroll up to approximately 105 patients.
In July 2017, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for pacritinib for the treatment of patients with myelofibrosis who have thrombocytopenia (platelet counts less than 100,000 per microliter). Validation confirms that the submission is complete and initiates the centralized review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
In August 2017, enrollment was completed in the PIX306 Phase 3 trial of PIXUVRI (pixantrone). The PIX306 trial is evaluating PIXUVRI combined with rituximab in comparison to that of rituximab combined with gemcitabine in patients with aggressive B-cell non-Hodgkin lymphoma (NHL). PIXUVRI has previously been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The trial is being conducted as a post-authorization requirement of conditional marketing authorization. If positive, the results from this trial could support broader indications. Top-line results are event-driven and are expected in the first half of 2018.
Financing and Partnerships

In June 2017, received gross proceeds of $45 million through an underwritten public offering.
In April 2017, CTI BioPharma announced the expansion of the existing license and development collaboration agreement with Servier for PIXUVRI. Under the expanded agreement, Servier will have rights to PIXUVRI in all markets except in the U.S. where CTI BioPharma will retain the commercialization rights. In May 2017, CTI BioPharma received €12 million from Servier, which includes €2 million for a new milestone previously achieved, and Servier purchased a certain amount of PIXUVRI drug product for an additional €0.9 million. CTI BioPharma is eligible to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.
Board of Directors

In July 2017, Laurent Fischer, M.D. was appointed to the Board of Directors (BOD). Dr. Fischer has more than 20 years of experience in developing and commercializing novel medicines in the biopharmaceutical industry and currently serves as liver therapeutic area head at Allergan following its acquisition of Tobira Therapeutics in 2016.
In June 2017, David Parkinson, M.D. was appointed to the BOD. Dr. Parkinson has significant experience in oncology clinical development and currently is President and Chief Executive Officer of Essa Pharmaceuticals, Inc and has also served as a venture partner at New Enterprise Associates (NEA), Inc. since 2012 moving into the role of venture advisor to NEA in 2016.
"Over the last quarter we have worked hard to become a leaner, more focused company that is adequately financed to meet our objectives," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "The EMA validated the MAA for pacritinib which is now under review and the PAC203 trial is now enrolling. Our cash position has improved through an expanded partnership with Servier and the recent $45 million financing. Changes to the board have added three new independent board members with many years of experience in successfully developing and commercializing novel therapeutics."

Second Quarter Financial Results

Total revenues for the second quarter and six months ended June 30, 2017, were $22.2 million and 23.0 million, respectively, compared to $7.4 million and $43.8 million for the respective periods in 2016. The increase in total revenues for the second quarter compared to the same period in 2016 is primarily due to license and contract revenue that includes the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI with Servier and the receipt of a payment from Teva Pharmaceutical Industries Ltd. related to the achievement of sales milestones for TRISENOX (arsenic trioxide). The decrease in total revenues for the six months of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Net product sales of PIXUVRI for the second quarter and six months ended June 30, 2017, were $0.3 million and $1.0 million, respectively, compared to $1.1 million and $2.3 million for the respective periods in 2016

GAAP operating income for the second quarter was $5.3 million and GAAP operating loss for the six months was $14.0 million for the period ended June 30, 2017, compared to GAAP operating loss of $19.1 million and $14.9 million for the respective periods in 2016. Non-GAAP operating income, which excludes non-cash share-based compensation expense, for the second quarter was $6.4 million and non-GAAP operating loss for the six months was $11.1 million for the period ended June 30, 2017, compared to non-GAAP operating loss of $16.7 million and $8.8 million for the respective periods in 2016. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2017, was $1.1 million and $2.9 million, respectively, compared to $2.3 million and $6.2 million for the respective periods in 2016. Operating income in the second quarter of 2017 as compared to an operating loss for the same period in 2016 resulted primarily from the increase in license and contract revenue as mentioned above and decrease in research and development and selling, general and administrative expenses. For information on CTI BioPharma’s use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures."

Net income for the second quarter of 2017 was $1.0 million, or $0.03 per share, compared to a net loss of $19.8 million, or ($0.71) per share, for the same period in 2016. Net loss for six months ended June 30, 2017, was $18.8 million, or ($0.63) per share, compared to a net loss of $16.5 million, or ($0.59) per share, for the same period in 2016.

As of June 30, 2017, cash and cash equivalents totaled $74.7 million, compared to $44.0 million at December 31, 2016.

On August 3, 2017 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the second quarter ended June 30, 2017, and provided a business update (Press release, Corvus Pharmaceuticals, AUG 3, 2017, View Source [SID1234520021]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to make significant progress in advancing the clinical development of our lead product candidate, CPI-444, and other product candidates in our immuno-oncology pipeline," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We presented results from our ongoing Phase 1/1b study at the recent ASCO (Free ASCO Whitepaper) Annual Meeting, demonstrating promising clinical activity with CPI-444 in patients with non-small cell lung cancer and renal cell cancer who are resistant or refractory to prior anti-PD-(L)1 therapy. This is a difficult-to-treat and growing patient population, as there are very few treatment options for patients who have been given checkpoint inhibitor therapy, but whose disease has either continued to advance or has returned. With CPI-444 and other product candidates in our pipeline targeting the adenosine pathway, we now have several novel agents focused on this important new target in immuno-oncology."

RECENT ACHIEVEMENTS AND UPCOMING MILESTONES
Clinical and Preclinical

Continued enrolling patients in four expansion cohorts in the ongoing disease-specific expansion part of the Phase 1/1b clinical study of CPI-444, the Company’s lead oral checkpoint inhibitor. The expanded cohorts include treatment with CPI-444 both as a single agent and in combination with atezolizumab (Tecentriq), an anti-PD-L1 antibody, in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC). Corvus plans to present additional data from this study at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in November 2017.
Presented interim safety and efficacy data from 75 patients with RCC or NSCLC enrolled in the Phase 1/1b study in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2017 Annual Meeting. The data showed that treatment with CPI-444 both as a single agent and in combination with atezolizumab resulted in anti-tumor activity in patients resistant or refractory to prior treatment with anti-PD-(L)1 antibodies and in patients with PD-L1 negative tumors.
Entered into a second collaboration agreement with Genentech to evaluate CPI-444 in combination with atezolizumab in a Phase 1b/2 clinical study as second-line therapy in patients with NSCLC who are resistant/refractory to prior anti-PD-(L)1 antibody therapy. Genentech and Corvus will share the costs of the trial that is expected to be initiated in the fourth quarter of 2017.
Continued to progress the anti-CD73 antibody program toward Phase 1 study initiation in the first half of 2018.
Continued to progress both A2B receptor antagonist and ITK inhibitor programs. Preclinical findings with a candidate A2B receptor antagonist indicate that it may enhance immune responses to certain tumors. These findings, which suggest the possible use of A2A receptor and A2B receptor antagonists in combination therapy, may lead to selection of a lead clinical candidate A2B receptor antagonist in 2018.
Initiated development of an in-licensed antibody-based product candidate that inhibits a novel target in the adenosine pathway.
Corporate

Held an R&D Day titled "The Adenosine Pathway: Extending the Reach of Cancer Immunotherapy." An archive of the webcast is available in the "Investors" section of the Company’s website.
Licensed global rights to an undisclosed novel immuno-oncology program, which includes a lead product candidate, from Monash University.
FINANCIAL RESULTS
At June 30, 2017, Corvus had cash, cash equivalents and marketable securities totaling $110.3 million. This compared to cash, cash equivalents and marketable securities of $134.9 million at December 31, 2016.

Research and development expenses for the three months ended June 30, 2017, totaled $12.4 million compared to $7.1 million for the same period in 2016. The increase of $5.3 million was primarily due to an increase of $3.0 million in outside clinical trial and contracted research costs associated with the Phase 1/1b clinical trial for CPI-444, an increase of $1.2 million in drug manufacturing costs for the anti-CD73 antibody program, and an increase of $0.7 million in drug manufacturing costs for the ITK program.

General and administrative expenses for the three months ended June 30, 2017, totaled $2.8 million compared to $1.7 million for the same period in 2016. The increase of $1.1 million was primarily due to an increase of $0.4 million in personnel and associated costs, primarily due to an increase in headcount, a $0.3 million increase in legal and accounting costs, and an increase of $0.3 million in costs associated with being a public company.

The net loss for the three months ended June 30, 2017, was $15.0 million compared to $8.6 million for the same period in 2016. Total stock compensation expense for the three months ended June 30, 2017, was $1.5 million compared to $1.1 million for the same period in 2016.

On August 3, 2017 Bristol-Myers Squibb Company (NYSE:BMY) and IFM Therapeutics (IFM) reported that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders (Press release, Bristol-Myers Squibb, AUG 3, 2017, View Source [SID1234520020]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The acquisition will give Bristol-Myers Squibb full rights to IFM’s preclinical STING (stimulator of interferon genes) and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer, and is an example of Bristol-Myers Squibb’s continued focus on leveraging external innovation to expand and develop its portfolio of transformative medicines. IFM’s STING agonist program includes a lead asset that accelerates the company’s efforts against this target, while the NLRP3 agonist program includes a potential first-in-class pipeline candidate.

"Targeting innate immunity pathways represents a potentially differentiated approach in immuno-oncology designed to initiate and augment immune responses that may help the body’s natural defenses better recognize and attack tumors," said Thomas Lynch, Jr., M.D., executive vice president, chief scientific officer, Bristol-Myers Squibb. "The addition of STING and NLRP3 agonist programs broadens our ability to investigate additional pathways across the immune system and complements our immuno-oncology portfolio. We look forward to advancing the development of these important programs initiated by Gary Glick, his leadership team and leading academic and industry experts across immunology and oncology."

"A comprehensive body of preclinical data support the continued research of IFM’s NLRP3 and STING agonists with a goal of uncovering their potential benefit to patients, particularly those not served by currently available cancer immunotherapeutics. Based on its deep expertise and leadership positions in immunology, oncology, and immuno-oncology, Bristol-Myers Squibb is uniquely positioned to accelerate these programs and maximize their potential," said Gary D. Glick, Ph.D., CEO and co-founder of IFM Therapeutics.

"The company is delighted by the validation this deal brings to IFM’s technology, and under the stewardship of Bristol-Myers Squibb, researching the promise it holds for potentially improving the lives of patients," said Jean-François Formela, M.D., chair of the IFM board.

Under the terms of the agreement, Bristol-Myers Squibb will pay $300 million upon closing of the transaction. IFM stockholders also will be entitled to additional contingent payments of up to $1.01 billion for each of the first products from the two programs upon the achievement of certain development, regulatory and sales milestones. Also, IFM is eligible for additional contingent milestone payments for further products resulting from these programs. In connection with the acquisition, a newly formed entity will be established by the current shareholders of IFM – IFM Therapeutics LLC – and it will retain IFM’s current personnel and facilities, as well as its remaining research programs, which include an NLRP3 antagonist program focused on curbing immune responses that lead to inflammatory diseases and fibrosis. In consideration of an additional payment at closing and future investment, Bristol-Myers Squibb will be granted at closing certain rights against the newly formed entity’s NLRP3 antagonist program, including a right of first refusal.

The transaction has been approved by the boards of directors of both companies and by the stockholders of IFM.

Bristol-Myers Squibb and IFM anticipate the transaction will close during the third quarter of 2017. Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

On August 3, 2017 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported unaudited consolidated financial results for the quarter ended June 30, 2017 (Press release, AMAG Pharmaceuticals, AUG 3, 2017, View Source [SID1234520016]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Total GAAP revenue for the second quarter of 2017 increased to a record $158.4 million, 24% higher than the same period last year (and 14% higher than the first quarter of 2017). This increase was driven by sales growth across the product portfolio, particularly Makena (hydroxyprogesterone caproate injection), which grew 31%. The company reported operating income of $3.6 million in the second quarter of 2017, compared with $18.1 million in the same period last year. Non-GAAP adjusted EBITDA totaled $50.1 million in the second quarter of 2017, compared with $64.6 million in the second quarter of 2016.1

"AMAG delivered another quarter of record revenues and strong growth across our portfolio of products. That same commercial excellence is now being applied to the launch of Intrarosa, announced just last week," said William Heiden, president and chief executive officer. "We have already realized a number of significant milestones in 2017, and look forward to reaching many others in the second half of the year. The achievement of these goals is an important step on the path to building an even stronger company that develops and markets novel therapeutics to address significant unmet medical needs."

Second Quarter 2017 and Recent Business Highlights:
•
Hired and trained a new women’s health commercial team of approximately 150 people;
•
Launched Intrarosa, the first and only FDA-approved local non-estrogen product for the treatment of moderate-to-severe dyspareunia (pain during intercourse), a symptom of vulvar and vaginal atrophy (VVA), due to menopause;
•
Advanced bremelanotide development and regulatory activities to support the planned new drug application (NDA) submission in early 2018;
•
Received FDA acceptance for review of Makena subcutaneous auto-injector supplemental NDA (sNDA) and a PDUFA date of February 14, 2018;
•
Drove record quarterly sales of Makena to over $102 million;
•
Realized highest number of new family enrollments at Cord Blood Registry (CBR) since the fourth quarter of 2015;
•
Partner, Velo Bio, enrolled first patient in Phase 2b/3a study for the treatment of severe preeclampsia;
•
Achieved record quarterly sales of Feraheme and completed submission to FDA to broaden Feraheme’s label; and
•
Strengthened the balance sheet and ended the quarter with $399.2 million of cash and investments.


Second Quarter Ended June 30, 2017 (unaudited)
Financial Results (GAAP Basis)
Total revenues for the second quarter of 2017 were $158.4 million, compared with $127.4 million in the second quarter of 2016. Net product sales of Makena were $102.7 million in the second quarter of 2017, compared with $78.4 million in the same period last year. Sales of Feraheme and MuGard totaled $27.7 million in the second quarter of 2017, compared with $24.6 million in the second quarter of 2016. Service revenue from CBR totaled $28.0 million in the second quarter of 2017, compared with $24.4 million in the same period last year.

Costs and expenses, including costs of product sales and services, totaled $154.8 million in the second quarter of 2017, compared with $109.3 million for the same period in 2016. This increase was primarily due to (i) higher selling, general and administrative expenses of $29.1 million primarily related to commercial activities to support the launch of Intrarosa, including the addition of a new women’s health sales force, (ii) higher research and development expenses of $16.0 million, primarily due to development work performed by Palatin to support the NDA for bremelanotide, and (iii) higher cost of products sold of $10.2 million, of which $8.9 million was due to amortization expense related to the Makena intangible asset. Also recorded in the second quarter of 2017 was a charge of $5.8 million to acquired in-process research and development expense in connection with the closing of the company’s agreement with Endoceutics for the rights to Intrarosa.

The higher expenses in the second quarter of 2017 resulted in $3.6 million in operating income in the second quarter of 2017, a decrease of $14.4 million, as compared to $18.1 million in operating income for the same period last year. The company reported a net loss of $14.1 million, or $(0.40) per basic and diluted share, for the second quarter of 2017, compared with a net loss of $0.6 million, or $(0.02) per basic share and diluted share, for the same period in 2016. The increased net loss in the second quarter of 2017 includes a $9.5 million loss on the extinguishment of debt in connection with the early retirement of the company’s term loan and a portion of the convertible notes due in 2019.

Financial Results (Non-GAAP Basis)1
Non-GAAP revenue totaled $159.8 million in the second quarter of 2017, up from $132.5 million in the second quarter of 2016. Non-GAAP CBR service revenue totaled $29.4 million in each of the second quarters of 2017 and 2016. The difference between GAAP and non-GAAP revenue represents CBR purchase accounting adjustments related to deferred revenue.

Total costs and expenses on a non-GAAP basis totaled $109.7 million in the second quarter of 2017, compared with $67.8 million in the second quarter of 2016.

Non-GAAP adjusted EBITDA for the second quarter of 2017 was $50.1 million, resulting in an adjusted EBITDA margin of 31%. This compares to non-GAAP adjusted EBITDA of $64.6 million in the second quarter of 2016, with an adjusted EBITDA margin of 49%. The decline in adjusted EBITDA for the second quarter of 2017 is in line with the company’s expectations and stated plans to invest in the continued development of its current and future products in order to create long-term value.

Balance Sheet Highlights
As of June 30, 2017, the company’s cash and investments totaled $399.2 million and total debt (principal amount outstanding) was $861.1 million.

During the second quarter of 2017, the company issued $320 million of convertible senior notes due in 2022. The company also repurchased $158.9 million of its existing convertible senior notes due in 2019 for an aggregate purchase price of $171.3 million, including accrued interest. The company used proceeds from the convertible transactions, along with balance sheet cash, to repay the remaining balance of $321.8 million of its term loan, which was due in 2021.

"By extending our maturities and reducing our total debt by approximately $170 million, we have more financial flexibility to invest in our newest products — Intrarosa and bremelanotide, as well as continue to expand our

2

product portfolio through potential acquisitions and licensing transactions," stated Ted Myles, chief financial officer. "We are pleased with the strong second quarter and year-to-date 2017 financial performance reported today, and we are reaffirming our full year guidance."

Reaffirming 2017 Financial Guidance


2017 GAAP Guidance

2017 Non-GAAP Guidance
$ in millions




Makena sales

$410 – $440

$410 – $440
Feraheme and MuGard sales

$100 – $110

$100 – $110
CBR revenue

$110 – $120

$115 – $1253
Intrarosa

$5 – $15

$5 – $15
Total revenue

$625 – $685

$630 – $690





Net loss

($62) – ($31)2

N/A
Operating income (loss)

($23) – $272

N/A
Adjusted EBITDA

N/A

$210 – $260