On August 3, 2017 Takeda Pharmaceutical Company Limited (TSE: 4502) and Molecular Templates, Inc. reported a collaboration agreement for oncology drug discovery programs (Press release, Takeda, AUG 3, 2017, View Source [SID1234520052]). The collaboration will apply Molecular Templates’ engineered toxin bodies (ETB) technology platform to potential therapeutic targets provided by Takeda through a joint scientific committee of both companies.

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"Over the past year, Takeda has expanded its collaborations in the Oncology space with the aim of accessing highly-innovative platforms to target specific tumor antigens using novel payloads and modality approaches," said Christopher Arendt, Ph.D., Head, Oncology DDU & Immunology Unit, Takeda. "In fact, we had already been working with the Molecular Templates team on a program that we have the option to in-license. The announcement of today’s collaboration with Molecular Templates allows us to extend this partnership and leverage their potentially groundbreaking approach to address additional tumors types, including solid tumors. The Molecular Templates team is outstanding, and we look forward to expanding our partnership."

Under the terms of the agreement, Takeda will make an equity investment and Molecular Templates is eligible to receive upfront payments, development and commercial milestone payments, Takeda has agreed to royalties on the sales of commercial products developed through the collaboration. Under the agreement, Takeda will also appoint a Director to Molecular Templates’ board of directors.

"This collaboration is an exciting opportunity to develop a new class of oncology therapeutics by applying our modified Shiga-like toxin fusion proteins to Takeda’s world-class oncology target portfolio," said Eric Poma, Ph.D., Molecular Templates’ Chief Executive and Scientific Officer. "Takeda’s oncology expertise and drug development capabilities represent unique assets for combination with our approach to targeting and destroying cancer cells, and we look forward to developing products via this new avenue of oncology research."

Takeda will have the right to exercise exclusive options to obtain license rights to products resulting from the collaboration. Molecular Templates would be responsible for manufacturing and supply of products licensed for development by Takeda through Phase I clinical development. Additional terms of the agreement are not being disclosed.

Takeda signed this agreement through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc.

About Molecular Templates
Molecular Templates is focused on the discovery, development and commercialization of next-generation immunotoxins called Engineered Toxin Bodies (ETBs) for the treatment of cancers and other serious diseases. For additional information, please visit the Company’s website at View Source;.

On August 3, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2017 and provided a business update (Press release, Regeneron, AUG 3, 2017, View Source [SID1234520050]).

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Financial Highlights

($ in millions, except per share data)

Three Months Ended
June 30,


2017

2016

% Change
EYLEA U.S. net product sales

$
919


$
831


11%
Total revenues

$
1,470


$
1,213


21%
GAAP net income

$
388


$
196


98%
GAAP net income per share – diluted

$
3.34


$
1.69


98%
Non-GAAP net income(2)

$
487


$
329


48%
Non-GAAP net income per share – diluted(2)

$
4.17


$
2.82


48%
"In the first half of 2017, we continued to bring our market-leading therapy EYLEA to more patients with retinal diseases, resulting in strong global sales. We also markedly expanded our positive impact on patient lives with two important new product launches for serious diseases, Dupixent for moderate-to-severe atopic dermatitis and Kevzara for moderately to severely active rheumatoid arthritis," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "The Dupixent U.S. launch in moderate-to-severe atopic dermatitis is proceeding well, with a very positive reception in the physician and patient community and strong commercial execution. In the second half of the year, we anticipate EU approval for Dupixent in atopic dermatitis, as well as Phase 3 study results and a potential U.S. regulatory submission for Dupixent in uncontrolled asthma."

Business Highlights

Marketed Product Update

EYLEA (aflibercept) Injection for Intravitreal Injection

In the second quarter of 2017, net sales of EYLEA in the United States increased 11% to $919 million from $831 million in the second quarter of 2016. Overall distributor inventory levels remained within the Company’s one- to two-week targeted range.
Bayer commercializes EYLEA outside the United States. In the second quarter of 2017, net sales of EYLEA outside of the United States(1) were $542 million, compared to $486 million in the second quarter of 2016. In the second quarter of 2017, Regeneron recognized $191 million from its share of net profit from EYLEA sales outside the United States, compared to $167 million in the second quarter of 2016.
Dupixent (dupilumab) Injection

Dupilumab, an antibody that blocks signaling of IL-4 and IL-13, is currently being studied in asthma, children with atopic dermatitis, nasal polyps, and eosinophilic esophagitis.
In the second quarter of 2017, global net sales of Dupixent were $29 million. Product sales for Dupixent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Dupixent. Sales of Dupixent in the second quarter largely reflect end-user demand and negligible contribution from inventory build.
In July 2017, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the marketing authorization of Dupixent, recommending its approval for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.
In the second quarter of 2017, a Phase 3 study of dupilumab in pediatric patients (6-11 years of age) with uncontrolled persistent asthma was initiated.
Praluent (alirocumab) Injection for the Treatment of Elevated Low-Density Lipoprotein (LDL) Cholesterol

In the second quarter of 2017, global net sales of Praluent were $46 million, compared to $24 million in the second quarter of 2016. Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent.
In April 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for a once-monthly (every four weeks), 300 mg dose of Praluent.
In the second quarter of 2017, the FDA granted orphan drug designation for the treatment of homozygous familial hypercholesterolemia (HoFH).
In June 2017, the Company and Sanofi announced that two Phase 3b/4 ODYSSEY-DM trials in patients with diabetes met their primary endpoints.
The ODYSSEY OUTCOMES trial, which is assessing the potential of Praluent to demonstrate cardiovascular benefit, remains ongoing.
Kevzara (sarilumab) Injection

In May 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response or intolerance to one or more disease modifying anti-rheumatic drugs (DMARDs).
In June 2017, the European Commission granted marketing authorization for Kevzara in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; Kevzara may be used as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate.
Pipeline Progress

Regeneron has seventeen product candidates in clinical development, which consist of EYLEA and fully human monoclonal antibodies generated using the Company’s VelocImmune technology, including six in collaboration with Sanofi. In addition to EYLEA, Dupixent (dupilumab), Praluent, and Kevzara (sarilumab) discussed above, updates from the clinical pipeline include:

REGN2810, an antibody to programmed cell death protein 1 (PD-1), is being studied in patients with cancer.

In June 2017, the Company and Sanofi presented, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, positive preliminary results from data in patients with advanced cutaneous squamous cell carcinoma (CSCC) pooled from two expansion cohorts of the REGN2810 Phase 1 trial. A pivotal Phase 2 study in CSCC is ongoing.
A Phase 3 study in first-line treatment for non-small cell lung cancer was initiated in the second quarter of 2017.
A potentially pivotal Phase 2 study in basal cell carcinoma was initiated in the second quarter of 2017.
Fasinumab is an antibody targeting Nerve Growth Factor (NGF). A Phase 3 efficacy study in patients with pain due to osteoarthritis of the knee or hip was initiated in the second quarter of 2017.

Evinacumab, an antibody to Angptl-3, is in clinical development for the treatment of HoFH and severe forms of hyperlipidemia.

In May 2017, the Company announced that the Phase 2 study in patients with HoFH met its primary endpoint.
In May 2017, an analysis published in the New England Journal of Medicine showed that people with inactivating mutations of the ANGPTL3 gene have significantly reduced risk of coronary artery disease and significantly lower levels of key blood lipids including triglycerides and low-density lipoprotein cholesterol (LDL-C, or "bad cholesterol").
REGN1979, a bispecific antibody to CD20 and CD3, received orphan drug designation from the FDA in diffuse large B-cell lymphoma.

REGN2477, an antibody to Activin A, received Fast Track designation from the FDA for the prevention and treatment of heterotopic ossification in patients with Fibrodysplasia Ossificans Progressiva (FOP) in the second quarter of 2017.

REGN3918, an antibody to complement 5 (C5), is being developed for paroxysmal nocturnal hemoglobinuria (PNH). A Phase 1 clinical study in healthy volunteers was initiated in the second quarter of 2017.

Select Upcoming 2017 Milestones

Programs

Milestones
EYLEA
•
Submit sBLA to FDA for every 12-week dosing interval in neovascular age-related macular degeneration (wet AMD)
Dupixent
•
Submission for additional regulatory approvals in atopic dermatitis outside of the United States
•
Regulatory agency decision on atopic dermatitis in the European Union
•
Report results from Phase 3 asthma program in adults and adolescents
•
Submit sBLA for asthma in adult/adolescent patients
•
Initiate Phase 3 studies in pediatric patients in atopic dermatitis
Praluent
•
Complete ODYSSEY OUTCOMES study (with data expected in early 2018)
Kevzara
•
Submission for additional regulatory approvals and regulatory agency decisions on applications outside of the United States
Suptavumab (REGN2222; RSV-F Antibody)
•
Report results from Phase 3 study
REGN2810 (PD-1 Antibody)
•
Initiate Phase 3 study in cervical cancer
Fasinumab (NGF Antibody)
•
Initiate Phase 3 study in chronic low back pain
Nesvacumab/aflibercept (Ang2 Antibody co-formulated with aflibercept)
•
Report data from Phase 2 studies in DME (RUBY) and wet AMD (ONYX)
REGN2477 (Activin A Antibody)
•
Initiate Phase 2 study in patients with FOP
Business Development Update

In the second quarter of 2017, the Company entered into clinical study agreements with Inovio Pharmaceuticals, Inc. and SillaJen, Inc. to evaluate REGN2810 in combination with their respective product candidates.
The Company’s Antibody Discovery Agreement with Sanofi will end on December 31, 2017 without any extension. Praluent (anti-PCSK9), Dupixent (anti-IL-4R), Kevzara (anti-IL-6R), REGN2810 (anti-PD-1), REGN3500 (anti-IL-33), and REGN3767 (anti-LAG-3) were discovered and initially developed under the Antibody Discovery Agreement. Praluent, Dupixent, Kevzara, and REGN3500 will continue to be developed, and commercialized as applicable, with Sanofi under the Antibody License and Collaboration Agreement. REGN2810 and REGN3767 will continue to be developed with Sanofi under the immuno-oncology collaboration. Upon expiration of the Antibody Discovery Agreement, Regeneron has the right to develop or continue to develop other product candidates discovered under this agreement independently or with other collaborators. The $130 million of 2017 annual funding from Sanofi under the Antibody Discovery Agreement is expected to be fully utilized by the end of the third quarter of 2017.
Second Quarter 2017 Financial Results

Product Revenues: Net product sales were $924 million in the second quarter of 2017, compared to $834 million in the second quarter of 2016. EYLEA net product sales in the United States were $919 million in the second quarter of 2017, compared to $831 million in the second quarter of 2016.

Total Revenues: Total revenues, which include product revenues described above, increased by 21% to $1.470 billion in the second quarter of 2017, compared to $1.213 billion in the second quarter of 2016. Total revenues include Sanofi and Bayer collaboration revenues of $432 million in the second quarter of 2017, compared to $355 million in the second quarter of 2016. Sanofi collaboration revenue in the second quarter of 2017 increased primarily due to Sanofi’s reimbursement of immuno-oncology research and development costs in connection with the advancement of REGN2810 and other product candidates. Total revenues in the second quarter of 2017 also include (i) reimbursement of the Company’s research and development expenses in connection with its collaboration agreement with Teva that was entered into in September 2016, and (ii) the recognition of two development milestones in connection with fasinumab of $25.0 million and $30.0 million from Teva and Mitsubishi Tanabe Pharma, respectively.

Refer to Table 4 for a summary of collaboration and other revenue.

Research and Development (R&D) Expenses: GAAP R&D expenses were $510 million in the second quarter of 2017, compared to $560 million in the second quarter of 2016. The lower R&D expenses in the second quarter of 2017 were principally due to a $75 million up-front payment made in connection with the license and collaboration agreement with Intellia in the second quarter of 2016, partly offset by an increase in REGN2810 clinical trial costs. In addition, in the second quarter of 2017, R&D-related non-cash share-based compensation expense was $70 million, compared to $79 million in the second quarter of 2016.

Selling, General, and Administrative (SG&A) Expenses: GAAP SG&A expenses were $307 million in the second quarter of 2017, compared to $292 million in the second quarter of 2016. In the second quarter of 2017, SG&A-related non-cash share-based compensation expense was $45 million, compared to $48 million in the second quarter of 2016.

Cost of Collaboration and Contract Manufacturing (COCM): GAAP COCM was $61 million in the second quarter of 2017, compared to $28 million in the second quarter of 2016. COCM includes costs incurred in connection with producing commercial drug supplies and validating the Company’s commercial facilities in connection with its Sanofi and Bayer collaborations. COCM also included inventory write-offs and reserves totaling $31 million in the second quarter of 2017.

Other (Expense) Income, Net: Other expense in the second quarter of 2017 included an out-of-period adjustment which resulted in the recognition of a non-cash, loss on debt extinguishment charge of $30.1 million in connection with the Company’s March 2017 Tarrytown lease transaction.

Income Tax Expense: In the second quarter of 2017, GAAP income tax expense was $138 million and the effective tax rate was 26.3%, compared to $96 million and 32.9% in the second quarter of 2016. The effective tax rate for the second quarter of 2017 was positively impacted, compared to the U.S. federal statutory rate, by the tax benefit associated with stock-based compensation, the domestic manufacturing deduction, and the federal tax credit for research activities, partly offset by losses incurred in foreign jurisdictions with rates lower than the federal statutory rate and the non-tax deductible Branded Prescription Drug Fee.

GAAP and Non-GAAP Net Income(2): The Company reported GAAP net income of $388 million, or $3.66 per basic share and $3.34 per diluted share, in the second quarter of 2017, compared to GAAP net income of $196 million, or $1.88 per basic share and $1.69 per diluted share, in the second quarter of 2016.

The Company reported non-GAAP net income of $487 million, or $4.59 per basic share and $4.17 per diluted share, in the second quarter of 2017, compared to non-GAAP net income of $329 million, or $3.15 per basic share and $2.82 per diluted share, in the second quarter of 2016.

A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

2017 Financial Guidance(3)

The Company’s updated full year 2017 financial guidance consists of the following components:

EYLEA U.S. net product sales
Approximately 10% growth over 2016
(previously single digit percentage growth over 2016)
Sanofi reimbursement of Regeneron commercialization-related expenses
$370 million – $400 million
(previously $385 million – $425 million)
Non-GAAP unreimbursed R&D(2)(4)
$925 million – $965 million
(previously $950 million – $1.025 billion)
Non-GAAP SG&A(2)(4)
$1.12 billion – $1.16 billion
(previously $1.14 billion – $1.20 billion)
Effective tax rate
27% – 31%
(previously 32% – 38%)
Capital expenditures
$250 million – $285 million
(previously $300 million – $350 million)


(1)
Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with an affiliate of Bayer. The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within "Bayer collaboration revenue" in its Statements of Operations.


(2)
This press release uses non-GAAP net income, non-GAAP net income per share, non-GAAP unreimbursed R&D, and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the income tax effect of reconciling items.



The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control, such as the Company’s stock price on the dates share-based grants are issued. Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company’s historical GAAP to non-GAAP results is included in Table 3 of this press release.


(3)
The Company’s 2017 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release and assumes that Praluent will remain on the market throughout 2017.


(4)
A reconciliation of full year 2017 non-GAAP to GAAP financial guidance is included below:






Projected Range


(In millions)

Low

High


GAAP unreimbursed R&D (5)

$
1,205


$
1,265



R&D: Non-cash share-based compensation expense

(280)


(300)



Non-GAAP unreimbursed R&D

$
925


$
965










GAAP SG&A

$
1,325


$
1,395



SG&A: Non-cash share-based compensation expense

(205)


(235)



Non-GAAP SG&A

$
1,120


$
1,160



(5)
Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company’s collaborators and/or customers.

On August 3, 2017 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported financial results for the three-month period ended June 30, 2017 (Press release, Spectrum Pharmaceuticals, AUG 3, 2017, View Source [SID1234520048]).

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"During the second quarter we made significant progress in our highest priority clinical programs and achieved solid performance across our commercial business," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We completed enrollment in ROLONTIS’s ADVANCE registrational Phase 3 study ahead of schedule and enrollment in a second international study RECOVER is well under way in Europe and U.S. We are also very excited about the prospects of poziotinib in cancer patients with exon 20 insertion mutations and expect interim results from the Phase 2 lung cancer study before the end of the year. We are driven to bring our novel drugs to patients with unmet medical needs and look forward to multiple near-term development catalysts that could shape the Company’s future."

Pipeline Update:

ROLONTIS (eflapegrastim), a novel long-acting GCSF: A registrational Phase 3 study ADVANCE was initiated under an SPA with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. The Company has completed enrollment in the ADVANCE study with 405 patients randomized and expects to report topline data in Q1 2018. To strengthen the regulatory package in the Europe and U.S., the Company is currently enrolling the 218-patient international RECOVER study. The Company continues to expect to file the BLA next year.
Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: An investigator sponsored trial is currently enrolling at the University of Texas MD Anderson Cancer Center in non-small cell lung cancer patients with exon 20 insertion mutations in EGFR or HER2. The study is expected to yield interim results before year end. Following discussions with the FDA, the Company is initiating an additional multicenter study in a similar patient population. Spectrum is also conducting a Phase 2 breast cancer study in the third-line setting in the U.S., based on promising Phase 1 study efficacy data in breast cancer patients who had failed multiple HER2-directed therapies. The Company is in discussions with the FDA about a combination trial of poziotinib and standard of care therapy in HER2+ breast cancer patients in the second-line setting.
QAPZOLA, a potent tumor-activated drug for bladder cancer is being investigated for low and intermediate risk non-muscle invasive bladder cancer: The Company has an SPA from the FDA for a new Phase 3 study incorporating learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous program, this new Phase 3 study will include fewer evaluable patients (n=425 versus 1,557 patients), use a higher dosage of QAPZOLA (8 mg versus 4 mg), and will evaluate time-to-recurrence as the primary endpoint. Approximately 50 sites have been selected thus far for enrolling patients in the Phase 3 study and patients are currently being screened.
Three-Month Period Ended June 30, 2017 (All numbers are approximate)

GAAP Results

Total product sales were $31.2 million in the second quarter of 2017. Product sales in the second quarter included: FUSILEV (levoleucovorin) net sales of $2.1 million, FOLOTYN (pralatrexate injection) net sales of $11.2 million, ZEVALIN (ibritumomab tiuxetan) net sales of $2.3 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.2 million, BELEODAQ (belinostat) for injection net sales of $3.4 million, and EVOMELA (melphalan) for injection net sales of $10.1 million.

Spectrum recorded a net loss of $20.5 million, or $0.26 per basic and diluted share in the three-month period ended June 30, 2017, compared to a net loss of $24.3 million, or $0.35 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $15.1 million in the quarter, as compared to $14.3 million in the same period in 2016. Selling, general and administrative expenses were $17.1 million in the quarter, compared to $27.6 million in the same period in 2016.

Our June 30, 2017 cash and equivalents balance is $138.6 million. In July 2017, we sold and issued 3.2 million shares of our common stock for net proceeds of $23.7 million under our ATM. These shares and proceeds are not included in our June 30, 2017 financial statements. We have now fully utilized the ATM facility.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $8.6 million, or $0.11 per basic and diluted share in the three-month period ended June 30, 2017, compared to non-GAAP net loss of $3.7 million, or $0.05 per basic share and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $14.6 million, as compared to $12.9 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $14.5 million, as compared to $16.1 million in the same period in 2016.

On August 3, 2017 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a fully integrated science-driven biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported its financial results for the second quarter ended June 30, 2017, and provided a business update (Press release, Radius, AUG 3, 2017, View Source [SID1234520046]). As of June 30, 2017, Radius had $215 million in cash, cash equivalents and marketable securities.

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"This is a very exciting time for Radius, as the company builds out its commercial organization and launches TYMLOS, the first new bone building anabolic approved by the FDA in 15 years. There is a high unmet medical need among postmenopausal women with osteoporosis at high risk for fractures for therapies which can safely and effectively reduce that risk," said Jesper Høiland, President and CEO of Radius. "I am confident that we have the leadership and resources to build this important brand globally and to continue to advance our strong pipeline assets, including elacestrant."

"While early in the launch of TYMLOS, we are extremely pleased with the substantial progress we have made and the strong support we have received from payors, physicians, and patients," said David Snow, Chief Commercial Officer of Radius. "We are already ahead of plan in contracting with managed care organizations with access to over 133 million covered lives across Commercial and Medicare Part D plans, and highly gratified that Express Scripts has aligned with us on TYMLOS to assure that appropriate patients have access to therapy with lower out of pocket costs."

TYMLOS (abaloparatide)

Radius received FDA approval for TYMLOS on April 28, 2017, for the treatment of postmenopausal women with osteoporosis at high risk of fracture, and began shipments to wholesalers at the end of May 2017. In the second quarter of 2017, we reported sales of TYMLOS from the first four weeks of launch of approximately $1.0 million.

In May 2017, Radius announced positive top-line results from the completed 24-month ACTIVExtend clinical trial of TYMLOS, which met all of its primary and secondary endpoints. In ACTIVExtend, patients who had completed 18 months of TYMLOS (abaloparatide) injections or placebo in the ACTIVE Phase 3 trial were transitioned to received 24 additional months of open-label alendronate. For the subset of ACTIVE trial patients that enrolled in the ACTIVExtend trial, the previous TYMLOS-treated patients had a significant 84% relative risk reduction in the incidence of new vertebral fractures compared with women who received placebo followed by alendronate. They also demonstrated a 39% risk reduction in nonvertebral fractures, a 34% risk reduction in clinical fractures and a 50% risk reduction in major osteoporotic fractures compared with women who received placebo followed by alendronate. At the 43-month time point, for all patients that enrolled in the ACTIVE trial, TYMLOS-treated patients had a statistically significant risk reduction in new vertebral fractures, nonvertebral fractures, clinical fractures, and major osteoporotic fractures. While not a pre-specified endpoint, there was also a statistically significant risk reduction in hip fractures in the TYMLOS-treated patient group compared with women who received placebo followed by alendronate at the 43-month time point. The adverse events reported during the alendronate treatment period were similar between the previous TYMLOS-treated patients and the previous placebo group. The incidences of cardiovascular adverse events including serious adverse events were similar between groups. There have been no cases of osteonecrosis of the jaw (ONJ) or atypical femoral fracture (AFF) in the entire TYMLOS development program. Additional results from the completed ACTIVExtend trial will be presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting September 8-11, 2017 in Denver, Colorado.

We plan to submit an sNDA to the FDA in connection with the ACTIVExtend results by year end.

On July 13, 2017, Radius announced that it had entered into a license and development agreement with Teijin Limited in Japan for abaloparatide-SC, which combined with the U.S., provides Radius with access to the largest two markets for bone anabolics, which account for approximately 80% of global sales. Teijin is developing abaloparatide-SC in Japan under an agreement with Ipsen Pharma S.A.S. and has initiated a Phase 3 trial in Japanese patients with osteoporosis. The license agreement provides Teijin with the right to manufacture abaloparatide-SC for commercial supply in Japan, as well as the right to reference Radius’ NDA and MAA and regulatory data to support its marketing application in Japan and to use Radius intellectual property, and provides Radius with an option to negotiate a co-promotion agreement for abaloparatide-SC in Japan. Radius will also receive upfront and milestone payments and royalties for the rights granted to Teijin. Teijin is conducting and funding its Japanese Phase 3 development program and the parties may further collaborate in the future in new indications for abaloparatide-SC. Radius maintains full global rights to its development program for abaloparatide-transdermal (abaloparatide-TD), which is not part of the agreement with Teijin.
Pipeline Updates

Eladynos (abaloparatide-SC)

Radius’ European Marketing Authorisation Application (MAA) for Eladynos (abaloparatide-SC) for the treatment of postmenopausal women with osteoporosis is under review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). On July 21, 2017, the CHMP, the scientific committee of the EMA, issued a second Day-180 List of Outstanding Issues. Radius is working with the CHMP to address these issues, and we expect an opinion from the CHMP regarding the MAA for Eladynos prior to the end of 2017.
Elacestrant (RAD1901)

In June 2017, Radius reported additional positive data from the ongoing Phase 1 dose-escalation and expansion study at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) in Chicago. As of the study cut-off date of April 28, 2017, the elacestrant single agent objective response rate was 23% in heavily pre-treated patients with advanced ER-positive breast cancer. In the 400 mg patient group of 26 patients with mature data, the median progression free survival was 4.5 months and there were five confirmed partial responses. These results showed that elacestrant was well-tolerated with the most commonly reported adverse events being low grade nausea and dyspepsia. To date, no dose limiting toxicities have been reported in the elacestrant program. We recently completed patient enrollment in both of our ongoing elacestrant Phase 1 breast cancer trials.

In June 2017, we discussed the data from the ongoing Phase 1 studies with the FDA to gain alignment on defining the next steps for our elacestrant breast cancer program, including the design of a Phase 2 trial. Following this discussion, the FDA agreed that a single-arm monotherapy Phase 2 study of under 200 patients is appropriate and provided additional feedback on the proposed clinical protocol, including confirmation that the primary endpoint will be objective response rate ("ORR"), coupled with durability of response ("DOR"). The FDA indicated that, depending on the study results, which must demonstrate superiority to then available therapies, the single-arm Phase 2 trial could be considered a pivotal study for accelerated approval as long as we have commenced a confirmatory study by the time of our NDA submission. We will provide further study details when the Phase 2 study is started and will continue to pursue additional pathways to accelerated approval.

Elacestrant is also being evaluated at low doses as an estrogen receptor ligand for the potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. We expect to report results from our Phase 2b clinical study of elacestrant for the potential treatment of postmenopausal vasomotor symptoms in the second half of 2017.
Abaloparatide-TD

We are focused on completing the manufacturing, scale-up, production, and other required activities needed to initiate a pivotal study to evaluate bioequivalence to TYMLOS. We believe that the transdermal patch program has the potential to allow physicians who treat osteoporosis, but rarely use injectable drugs, an opportunity to expand their practices to include the use of anabolic therapy. We will provide an update on these activities before the end of 2017.
RAD140

An investigational new drug application, or IND, submitted to the FDA for RAD140, a selective androgen receptor modulator, has been accepted. We expect to initiate a first-in-human Phase 1 clinical trial in women with hormone receptor positive breast cancer in the second half of 2017.
Radius Anticipates the Following Milestones

Abaloparatide-SC
Receive a CHMP opinion regarding the EMA’s review of the abaloparatide-SC MAA prior to the end of 2017
Enter into a partnership for the potential commercialization of abaloparatide-SC outside the U.S. and Japan prior to commercial launch in the European Union
Report additional clinical results from the recently completed 24-month ACTIVExtend clinical trial at the ASBMR Annual Meeting in September 2017
Submit an sNDA in connection with the ACTIVExtend data to FDA by year end
Elacestrant
Complete ongoing Phase 1 breast cancer clinical trials
Initiate a Phase 2 single-arm monotherapy clinical trial in metastatic breast cancer patients in early 2018 with a goal of accelerated approval
Complete and report results from our ongoing Phase 2b vasomotor trial in the second half of 2017
RAD140
Initiate a first-in-human Phase 1 study in the second half of 2017 in women with hormone receptor positive breast cancer
Radius Expects To Make Presentations at the Following Upcoming Conferences

On August 10, 2017, Radius President and CEO, Jesper Høiland, will make a presentation and host one-on-one meetings at the Canaccord Genuity Growth Conference in Boston.
On September 6, 2017, Dr. Alison O’Neill, V.P., Clinical Development, will present on a Breast Cancer panel and host one-on-one meetings at the Citi 12th Annual Biotech Conference in Boston.
On September 8-11, 2017 Radius will be present 7 abstracts regarding abaloparatide-SC at the ASBMR Annual Meeting in Denver, Colorado, including an oral plenary presentation.
On September 13, 2017, Jesper Høiland, Radius President and CEO, will participate in a fireside chat and host one-on-one meetings at the Morgan Stanley 15th Annual Global Healthcare Conference in New York.
On September 25, 2017, Jesper Høiland, Radius President and CEO, will present and host one-on-one meetings at the Cantor Fitzgerald Global Healthcare Conference in New York.
Second Quarter 2017 Financial Results

Three Months Ended June 30, 2017

For the three months ended June 30, 2017, Radius reported a net loss of $68.4 million, or $1.58 per share, compared to a net loss of $43.4 million, or $1.01 per share, for the three months ended June 30, 2016, for an increase of 58%.

For the three months ended June 30, 2017, Radius reported TYMLOS net revenues of about $1.0 million, which reflects the first four weeks of sales. Radius had no revenues in the three months ended June 30, 2016 as the FDA approved TYMLOS on April 28, 2017.

Research and development expense for the three months ended June 30, 2017, was $19.7 million compared to $26.9 million for the three months ended June 30, 2016, a decrease of $7.2 million, or 27%. This decrease was primarily driven by a $5.3 million decrease in regulatory and professional fees associated with abaloparatide-SC regulatory applications, a $5.1 million decrease in elacestrant (RAD1901) project costs, and a $1.2 million decrease in development costs associated with abaloparatide-TD. This decrease was partially offset by a $4.5 million increase in compensation expense, including stock-based compensation, due to the increase in headcount, including the medical science liaisons to support the TYMLOS launch.

Selling, general, and administrative expense for the three months ended June 30, 2017, was $50.1 million compared to $17.2 million for the three months ended June 30, 2016, an increase of $32.9 million, or 192%. This increase was primarily the result of an increase of approximately $9.5 million in professional fees and support costs during the three months ended June 30, 2017, including the costs associated with increasing headcount and preparing for the commercialization of TYMLOS in the United States. This increase was also driven by a $19.6 million increase in compensation expense, including stock-based compensation, due to an increase in headcount, due largely to the hiring of the U.S. sales force and other functions to support the launch of TYMLOS and general purposes.

Six Months Ended June 30, 2017

For the six months ended June 30, 2017, Radius reported a net loss of $125.4 million, or $2.90 per share, compared to a net loss of $83.9 million, or $1.95 per share, for the six months ended June 30, 2016, for an increase of 49%.

For the six months ended June 30, 2017 Radius reported TYMLOS net revenues of about $1.0 million, which reflects the first four weeks of sales. Radius had no revenues in the six months ended June 30, 2016 as the FDA approved TYMLOS on April 28, 2017.

Research and development expense for the six months ended June 30, 2017, was $39.2 million compared to $54.4 million for the six months ended June 30, 2016, for a decrease of $15.2 million, or 28%. This decrease was primarily driven by a $12.1 million decrease in abaloparatide-SC project costs, a $10.4 million decrease in elacestrant (RAD1901) project costs, and a $2.7 million decrease in development costs associated with abaloparatide-TD. This decrease was partially offset by a $9.1 million increase in compensation expense, including stock-based compensation, due to an increase in headcount, including the hiring of the medical science liaisons to support the U.S. launch of TYMLOS.

Selling, general, and administrative expense for the six months ended June 30, 2017, was $88.2 million compared to $30.8 million for the six months ended June 30, 2016, an increase of $57.4 million, or 186%. This increase was primarily the result of an increase of approximately $17.9 million in professional fees and support costs during the six months ended June 30, 2017, including the costs associated with increasing headcount and preparing for the commercialization of TYMLOS in the United States. This increase was also driven by a $34.2 million increase in compensation expense, including stock-based compensation, due to an increase in headcount, particularly the sales force and other support functions necessary to launch TYMLOS in the U.S. and for general purposes.

As of June 30, 2017, Radius had $215 million in cash, cash equivalents and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of June 30, 2017, we believe that, prior to the consideration of proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for not less than twelve months from the date of this press release.

On August 3, 2017 Oncolytics Biotech Inc. (Oncolytics or the Company) (TSX:ONC) (OTCQX:ONCYF) reported its financial results and operational highlights for the quarter ended June 30, 2017 (Press release, Oncolytics Biotech, AUG 3, 2017, View Source [SID1234520044]).

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"After selecting metastatic breast cancer as our registration pathway for REOLYSIN and announcing statistically significant clinical data in this indication in the second quarter, obtaining Fast Track designation was a key development as we prepare for our End-of-Phase 2 meeting with the FDA," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "We expect to receive guidance from the FDA that will help form the basis of our Phase 3 registration study and expect to announce the outcome of our filings in the fourth quarter. In parallel, we will continue to pursue additional clinical collaborations to study REOLYSIN’s therapeutic potential in combination with other immunotherapies as part of our previously announced clinical development plan."

Selected Highlights from Q2 and through the end of July 2017

Clinical Updates

· Announced that the United States Food and Drug Administration (FDA) granted Fast Track designation for REOLYSIN, also known as pelareorep, for the treatment of metastatic breast cancer (mBC). The designation is based on the data from IND 213, an open-label, randomized, phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN and paclitaxel. Results showed a statistically significant improvement in median overall survival (OS) from 10.4 months in the control arm to 17.4 months in the test arm.
· Announced a registration pathway and clinical development plan with the primary objective of obtaining regulatory approval for REOLYSIN based on compelling mBC survival data from IND 213. The plan’s secondary objective is expanding REOLYSIN into commercially valuable new treatment areas, including immunotherapy and immunomodulatory (IMiD) agents, in collaboration with pharmaceutical partners.
· Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting preliminary results of REO 024, an open-label phase 1b trial of patients with histologically confirmed metastatic adenocarcinoma of the pancreas (MAP) who have failed, or did not tolerate, first-line treatment. The study was designed to assess the safety (primary endpoint) and dose-limiting toxicity of REOLYSIN in combination with pembrolizumab (KEYTRUDA) and chemotherapy. Investigators concluded that the combination therapy showed manageable safety profiles and anti-tumour activity in previously treated MAP patients.
Corporate Updates

· Closed an underwritten public share offering of 16,445,000 units at a purchase price of $0.70 for gross proceeds of approximately $11.5 million ($10.4 million net). Proceeds are to be used to prepare for a Phase 3 registration study in mBC, to expand partnering activities and for general corporate purposes.
· Appointed Andrew de Guttadauro as President of its US subsidiary, Oncolytics Biotech (U.S.) Inc., who will primarily be responsible for pursuing both global and regional licensing, partnership and commercialization opportunities for REOLYSIN.
· Opened San Diego office to support business development, clinical operations and investor relations activities.
Anticipated Milestones

· Summer 2017: End-of-Phase 2 meeting in August
· Third quarter 2017: First patient enrollment in our multiple myeloma collaboration with Celgene and Myeloma UK
· Fourth quarter 2017: Results from regulatory filings
· First half of 2018: Update on our exploration of strategic and regional alliances
Q2 2017 Financial Results

· At June 30, 2017, the Company reported $16.7 million in cash and cash equivalents. Cash runway expected to the end of 2018.
· As at August 2, 2017, the Company had an unlimited number of authorized common shares with 139,426,222 common shares issued and outstanding, 7,532,827 options outstanding (with exercise prices ranging between $0.26 and $6.72 and expiry dates ranging from 2017 to 2027), 16,445,000 warrants outstanding (with a $0.95 strike price expiring in June 2022) and 2,370,388 RSU’s and PSU’s outstanding.


ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)

June 30,
2017
$ December 31,
2016
$
Assets
Current assets
Cash and cash equivalents 16,676,298 12,034,282
Short-term investments — 2,088,800
Accounts receivable 62,109 54,406
Prepaid expenses 485,075 260,841
Total current assets 17,223,482 14,438,329

Non-current assets
Property and equipment 355,309 319,955
Total non-current assets 355,309 319,955

Total assets 17,578,791 14,758,284

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 3,310,948 4,068,664
Total current liabilities 3,310,948 4,068,664

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
June 30, 2017 – 139,231,722
December 31, 2016 – 121,258,222 270,091,373 262,321,825
Warrants 3,617,900 —
Contributed surplus 26,766,168 26,643,044
Accumulated other comprehensive loss 488,572 554,060
Accumulated deficit (286,696,170) (278,829,309)
Total shareholders’ equity 14,267,843 10,689,620
Total liabilities and equity 17,578,791 14,758,284




ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)

Three
Month
Period
Ending
June 30,
2017
$ Three
Month
Period
Ending
June 30,
2016
$ Six Month
Period
Ending
June 30,
2017
$ Six Month
Period
Ending
June 30,
2016
$
Expenses
Research and development 2,918,673 1,490,956 5,186,744 4,217,085
Operating 1,444,543 1,125,458 2,744,843 2,485,870
Operating loss (4,363,216) (2,616,414) (7,931,587) (6,702,955)
Interest income 14,163 35,537 64,878 105,158
Loss before income taxes (4,349,053) (2,580,877) (7,866,709) (6,597,797)
Income tax (recovery) expense (89) 169 (152) 314
Net loss (4,349,142) (2,580,708) (7,866,861) (6,597,483)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment (44,740) (130,827) (65,488) (300,886)

Net comprehensive loss (4,393,882) (2,711,535) (7,932,349) (6,898,369)
Basic and diluted loss per common share (0.03) (0.02) (0.06) (0.06)
Weighted average number of shares (basic and diluted) 127,349,643 119,601,638 124,320,760 118,900,812




ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)


Share Capital
$
Warrants
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2015 261,324,692 — 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and comprehensive loss — — — (300,886) (6,597,483) (6,898,369)
Issued pursuant to "At the Market" Agreement 1,078,193 — — — — 1,078,193
Issued pursuant to incentive share award plan 41,000 — (41,000) — — —
Share issue costs (468,363) — — — — (468,363)
Share based compensation — — 201,266 — — 201,266
As at June 30, 2016 261,975,522 — 26,438,232 460,092 (270,286,813) 18,587,033


Share Capital
$
Warrants
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
Accumulated
Deficit
$
Total
$
As at December 31, 2016 262,321,825 — 26,643,044 554,060 (278,829,309) 10,689,620
Net loss and comprehensive loss — — — (65,488) (7,866,861) (7,932,349)
Issued pursuant to "At the Market" agreement 668,648 — — — — 668,648
Issued pursuant to public offering 7,893,600 3,617,900 — — — 11,511,500
Issued pursuant to stock option plan 461,823 — (166,473) — — 295,350
Share issue costs (1,254,523) — — — — (1,254,523)
Share based compensation — — 289,597 — — 289,597
As at June 30, 2017 270,091,373 3,617,900 26,766,168 488,572 (286,696,170) 14,267,843




ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)

Three Month
Period Ending
June 30,
2017
$ Three Month
Period Ending
June 30,
2016
$ Six Month
Period Ending
June 30,
2017
$ Six Month
Period Ending
June 30,
2016
$

Operating Activities
Net loss for the period (4,349,142) (2,580,708) (7,866,861) (6,597,483)
Amortization – property and equipment 25,688 44,675 49,724 90,617
Share based compensation 155,708 119,626 289,597 201,266
Unrealized foreign exchange gain (164,676) (243,914) (112,644) (102,619)
Net change in non-cash working capital (216,906) 37,581 (854,552) 762,236
Cash used in operating activities (4,549,328) (2,622,740) (8,494,736) (5,645,983)
Investing Activities
Acquisition of property and equipment (80,050) (5,702) (85,886) (5,702)
Redemption (purchase) of short-term
investments — — 2,088,800 (27,823)
Cash used in investing activities (80,050) (5,702) 2,002,914 (33,525)
Financing Activities
Proceeds from "At the Market" equity
distribution agreement 570,027 710,374 559,527 609,830
Proceeds from public offering 10,366,098 — 10,366,098 —
Proceeds from exercise of options 295,350 — 295,350 —
Cash provided by financing activities 11,231,475 710,374 11,220,975 609,830
Increase (decrease) in cash 6,602,097 (1,918,068) 4,729,153 (5,069,678)
Cash and cash equivalents, beginning of period 10,102,393 20,233,408 12,034,282 24,016,275
Impact of foreign exchange on cash and cash
equivalents (28,192) 5,641 (87,137) (625,616)
Cash and cash equivalents, end of period 16,676,298 18,320,981 16,676,298 18,320,981


To view the Company’s Fiscal 2017 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s annual filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source