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

On August 3, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the second quarter 2017 (Filing, Q2, Mirati, 2017, AUG 3, 2017, View Source [SID1234520040]).

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"The second half of 2017 remains on track to be a significant time for all of Mirati’s programs," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Our team continues to work diligently to deliver the anticipated data for each program this year."

Mirati expects to present data on the following programs in the second half of 2017:
•
Glesatinib, single agent, Phase 2 trial in Non-Small Cell Lung Cancer (NSCLC)
•
Sitravatinib, single agent, Phase 1b trial in NSCLC
•
Sitravatinib and nivolumab combination, Phase 2 trial in NSCLC
•
Mocetinostat and durvalumab combination, Phase 2 trial in NSCLC


Second Quarter 2017 Financial Results

Cash, cash equivalents, and short-term investments were $87.8 million at June 30, 2017, compared to $56.7 million at December 31, 2016.

Research and development expenses for the second quarter of 2017 were $15.0 million, compared to $18.4 million for the same period in 2016. Research and development expenses for the six months ended June 30, 2017 were $29.4 million, compared to $36.4 million for the same period in 2016. The decrease in research and development expenses for both the three and six months ended June 30, 2017 is primarily due a decrease in third party research and development expense, including a reduction in glesatinib manufacturing expenses, as well as expense associated with a one-time license fee incurred in 2016 related to an early stage discovery project. In addition, share-based compensation expense decreased in the six months ended June 30, 2017 compared to the same period of 2016 due to lower exercise prices for options granted during the last half of 2016 and first half of 2017. These decreases in expenses are partially offset by an increase in expenses associated with our ongoing sitravatinib Phase 1b clinical trial.

General and administrative expenses for the second quarter of 2017 were largely unchanged compared to the same period of 2016 and were $3.7 million and $3.8 million, respectively. General and administrative expenses for the six months ended June 30, 2017 were $7.3 million, compared to $7.9 million for the same period in 2016. The decrease in general and administrative expense is primarily due to a decrease in share-based compensation expense, which is due to lower exercise prices for options granted during the last half of 2016 and the first half of 2017.

Net loss for the second quarter of 2017 was $18.3 million, or $0.74 per share basic and diluted, compared to net loss of $22.1 million, or $1.11 per share basic and diluted for the same period in 2016. Net loss for the six months ended June 30, 2017 was $36.2 million, or, $1.47 per share basic and diluted, compared to net loss of $44.0 million, or $2.24 per share basic and diluted for the same period in 2016.

On August 3, 2017 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported financial results and business highlights for the second quarter 2017 (Press release, Juno, AUG 3, 2017, View Source [SID1234520038]).

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"It has been a historic last several months for the CAR T field, highlighting the potential of these therapies for patients. Juno is well-positioned to make a major impact, particularly with the potential best-in-class profile emerging for JCAR017," said Hans Bishop, Juno’s President and Chief Executive Officer. "We look forward to starting the pivotal cohort for JCAR017 this quarter as well as expanding the use of this drug into broader populations over the coming year."

Second Quarter 2017 Highlights
Clinical Update:
JCAR017 in DLBCL – Investigators presented interim results at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and International Conference of Malignant Lymphoma meetings in June 2017 from the Phase I TRANSCEND study in patients with r/r diffuse large B cell lymphoma (DLBCL) who were treated with fludarabine/cyclophosphamide (flu/cy) lymphodepletion and JCAR017. The core group (N=44) includes patients that represent the population that Juno plans to move forward with for the pivotal cohort. The core group includes patients with DLBCL (de novo and transformed from follicular lymphoma) that are ECOG Performance Status 0-1. Topline results for both dose levels for the core group as of a data cutoff date of May 4, 2017 included:
Overall response rate (ORR) was 86% (38/44) and the complete response (CR) was 59% (26/44).
Three-month ORR was 66% (21/32) and CR was 50% (16/32). Of patients in response at three months, 90% (9/10) continued in response at six months.

Early data suggested a dose response relationship at three months with dose level 2 (100 million cells) ORR of 78% (7/9) and CR of 56% (5/9) as compared to dose level 1 (50 million cells) ORR of 58% (11/19) and CR of 42% (8/19).

97% (37/38) of responding patients were alive and in follow-up as of data cutoff date.

2% (1/44) experienced severe CRS and 18% (8/44) experienced severe NT.

66% (29/44) did not experience any CRS or NT. No deaths were reported from CRS or NT.

Corporate News:
Hired key talent to our leadership team, including the appointment of Sunil Agarwal, M.D. as President of Research & Development. Dr. Agarwal is responsible for the execution of Juno’s drug development pipeline, integration of translational insights into ongoing programs, and the prioritization of research and development initiatives.

Appointments to Board of Directors of Jay Flatley, Executive Chairman of Illumina, Inc. and Rupert Vessey, MA, BM BCh, FRCP, DPhil, Celgene Corporation’s President of Research and Early Development.

Second Quarter 2017 Financial Results
Cash Position: Cash, cash equivalents, and marketable securities as of June 30, 2017 were $801.8 million compared to $850.7 million as of March 31, 2017 and $922.3 million as of December 31, 2016.

Cash Used in Operating Activities and Capital Expenditures: For the second quarter of 2017 cash used in operating activities was $38.0 million and cash used for capital expenditures was $21.8 million, compared to $2.2 million provided by operating activities and $7.4 million used for capital expenditures for the same period in 2016.

Cash Burn: Cash burn, which is cash used in operating activities and capital expenditures, excluding cash inflows and outflows from upfront payments related to business development activities, was $59.8 million in the second quarter of 2017, of which $56.9 million was operating cash burn and $2.9 million was cash burn for capital expenditures, compared to cash burn of $5.2 million, of which $2.2 million was an operating cash inflow and $7.4 million was cash burn for capital expenditures for the same period in 2016. For purposes of comparing the operating cash burn and cash burn for capital expenditures to the Company’s financial guidance, a cash inflow of $18.9 million for a tenant improvement allowance was reclassified from operating activities to capital expenditures. The increase in cash burn of $54.6 million was primarily driven by the $50.0 million cash inflow from Celgene in the second quarter of 2016 related to the CD19 License.

Revenue: Revenue for the three and six months ended June 30, 2017 was $21.3 million and $40.6 million, respectively, compared to $27.6 million and $37.4 million for the three and six months ended June 30, 2016, respectively. The decrease in the three months ended June 30, 2017 compared to the prior year period was due to milestone revenue recognized in the second quarter of 2016 in connection with the Novartis sublicense agreement.

The increase in the six months ended June 30, 2017 compared to the prior year period was primarily due to revenue recognized under our Celgene Collaboration Agreement and Celgene CD19 License for the upfront license fee and partial reimbursement by Celgene of research and development costs incurred by us in the first and second quarters of 2017, offset by milestone revenue recognized in the six months ended June 30, 2016 related to the Novartis sublicense agreement.

R&D Expenses: Research and development expenses for the three and six months ended June 30, 2017, inclusive of non-cash expenses and computed in accordance with GAAP, were $101.1 million and $184.0 million, respectively, compared to $72.3 million and $146.0 million for the three and six months ended June 30, 2016, respectively. The increases in 2017 compared to 2016 were primarily due to increased costs to manufacture Juno’s product candidates, execute on Juno’s clinical development strategy, and expand its overall research and development capabilities, an increase in expense related to its success payment and contingent consideration obligations, expense incurred for the amortization of the intangible asset associated with the AbVitro, Inc. ("AbVitro") acquisition, and an increase in non-cash stock-based compensation expense. These increases were offset by a decrease in milestone expense.

Non-GAAP R&D Expenses: Non-GAAP research and development expenses for the three and six months ended June 30, 2017 were $77.8 million and $152.2 million, respectively, and include $10.1 million and $19.8 million of stock-based compensation expense, respectively. Non-GAAP research and development expenses for the three and six months ended June 30, 2016 were $72.1 million and $152.3 million, respectively, and include $8.9 million and $18.0 million of stock-based compensation expense, respectively. Non-GAAP research and development expenses for the first half of 2017 exclude the following:

An expense of $17.2 million and $24.6 million for the three and six months ended June 30, 2017, respectively, associated with the change in the estimated fair value and elapsed service period for Juno’s potential success payment liabilities to Fred Hutchinson Cancer Research Center ("FHCRC") and Memorial Sloan Kettering Cancer Center ("MSK").

Non-cash stock-based compensation expense of $0.9 million and $1.6 million for the three and six months ended June 30, 2017, respectively, related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.

An expense of $2.4 million for the three and six months ended June 30, 2017 associated with amortization of the intangible asset recorded in connection with the AbVitro acquisition.

An expense of $2.7 million and $3.2 million for the three and six months ended June 30, 2017, respectively, associated with the change in the estimated fair value of the contingent consideration liabilities recorded in connection with the Stage and X-Body acquisitions.

Non-GAAP research and development expenses for the first half of 2016 exclude the following:
An expense of $3.5 million for the three months ended June 30, 2016 and a gain of $3.1 million for the six months ended June 30, 2016 associated with the change in the estimated value and elapsed service period for Juno’s potential success payment liabilities to FHCRC and MSK.

Non-cash stock-based compensation expense of $1.2 million and $2.4 million for the three and six months ended June 30, 2016, respectively, related to a 2013 restricted stock award to a co-founding director that became a consultant upon his departure from Juno’s board of directors in 2014.

A gain of $4.5 million and $5.5 million for the three and six months ended June 30, 2016, respectively, associated with the change in the estimated fair value of the contingent consideration liabilities recorded in connection with the Stage and X-Body acquisitions.

G&A Expenses: General and administrative expenses on a GAAP basis for the three and six months ended June 30, 2017 were $23.6 million and $44.3 million, respectively, compared to $16.8 million and $32.8 million for the same periods in 2016. The increases in 2017 compared to 2016 were primarily due to an increase in consulting and other expenses to support the growing organization including costs related to commercial readiness, increased personnel expenses primarily related to increased headcount to support the business, and an increase in stock-based non-cash compensation expense. The increases in the six month period were partially offset by decreased business development expenses. General and administrative expenses include $6.9 million and $13.0 million of non-cash stock-based compensation expense for the three and six months ended June 30, 2017, respectively, compared to $5.5 million and $10.4 million for the three and six months ended June 30, 2016.

GAAP Net Loss: Net loss for the three and six months ended June 30, 2017 was $100.7 million, or $0.96 per share, and $182.9 million, or $1.76 per share, respectively, compared to $64.8 million, or $0.64 per share and $135.9 million, or $1.35 per share, for the three and six months ended June 30, 2016, respectively.

Non-GAAP Net Loss: Non-GAAP net loss, which incorporates the non-GAAP R&D expense, for the three and six months ended June 30, 2017 was $77.5 million, or $0.74 per share, and $151.1 million, or $1.45 per share, respectively, compared to $64.6 million, or $0.64 per share, and $142.1 million, or $1.41 per share for the three and six months ended June 30, 2016, respectively.

Reconciliations of cash burn to GAAP cash used in operating activities and capital expenditures, non-GAAP net loss to GAAP net loss, and non-GAAP R&D expense to GAAP R&D expense are presented below under "Non-GAAP Financial Measures."

2017 Financial Guidance
Juno reaffirms 2017 cash burn, which is cash used in operating activities and capital expenditures, excluding cash inflows or outflows from upfront payments related to business development activities, of between $270 million and $300 million.

Operating burn estimated to be between $245 million and $275 million.

Capital expenditures, net of tenant improvement allowances, estimated to be between $22 million and $27 million, the majority of which are related to one-time infrastructure build-outs.

On August 3, 2017 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported financial results for the second quarter ended June 30, 2017 and provided a business update (Press release, Insys Therapeutics, AUG 3, 2017, View Source [SID1234520036]).

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Business Update

On track to report top-line results from phase 3 CONVERT study in September plus or minus one month. The CONVERT study, or INS-212, is evaluating amikacin liposome inhalation suspension (ALIS) in treatment refractory NTM lung disease caused by MAC. The primary efficacy endpoint is the proportion of subjects who achieve culture conversion at Month 6 in the ALIS plus multi-drug regimen arm compared to the multi-drug regimen without ALIS arm. The Company reported that the last patient in the study has progressed beyond the Month 6 measure. Additionally, Insmed reported that the dropout rate observed in the study was lower than the initially assumed dropout rate.

Plan to initiate enrollment of phase 2 dose-ranging study of INS1007 in non-cystic fibrosis (non-CF) bronchiectasis in the second half of 2017. INS1007 is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase I (DPP1), an enzyme responsible for activating neutrophil serine proteases in neutrophils when they are formed in the bone marrow. Pending dialogue with the FDA, Insmed plans to evaluate two doses of INS1007 (10mg and 25mg) vs. placebo over 24 weeks. The primary endpoint is expected to evaluate time to first exacerbation while secondary endpoints are expected to evaluate mechanistic, clinical and outcomes-based measures. Insmed is also evaluating the potential of INS1007 in other indications.

The FDA provides established name for lead development program. The FDA recently advised Insmed that the established name for its phase 3 product candidate in development for the treatment of refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC) will be amikacin liposome inhalation suspension, or ALIS.

Enhanced management team with appointment of chief financial officer, chief medical officer and chief product strategy officer. During the second quarter the company announced changes to its senior leadership team with the appointment of Paolo Tombesi as chief financial officer and Paul Streck, M.D., as chief medical officer. Additionally, Eugene Sullivan, M.D., assumed the newly created role of chief product strategy officer.
"Throughout 2017 we have remained committed to our mission of transforming the lives of patients with rare diseases. We continue to focus on the execution and evaluation of our phase 3 CONVERT study for which we continue to anticipate top-line results in September plus or minus one month. If the study meets the primary endpoint, we intend to complete preparation for a U.S. regulatory filing with the FDA, under Subpart H, for the treatment of patients with refractory NTM," said Will Lewis, president and chief executive officer of Insmed. "Our pre-commercialization activities are also accelerating, as is our assessment of the regulatory pathway beyond the U.S. with a particular focus on Japan. We are also moving ahead with our planning for life cycle management for ALIS and advancing our pipeline."

Second Quarter Financial Results

For the second quarter of 2017, Insmed reported a net loss of $44.7 million, or $0.72 per share, compared with a net loss of $36.6 million, or $0.59 per share, for the second quarter of 2016.

Research and development expenses were $26.9 million for the second quarter of 2017, compared with $23.9 million for the second quarter of 2016. The increase was primarily due to an increase in expenses related to INS1007 and higher compensation and related expenses due to an increase in headcount partially offset by decreases in ALIS manufacturing expenses.

General and administrative expenses for the second quarter of 2017 were $16.6 million, compared with $12.3 million for the second quarter of 2016. The increase was primarily due to higher expenses related to our pre-commercial planning activities for ALIS and higher compensation and related expenses due to an increase in headcount, as compared to the prior year period.

Balance Sheet and Other Financial Highlights

As of June 30, 2017, Insmed had cash and cash equivalents of approximately $91 million. The Company’s operating expenses for the second quarter of 2017 were approximately $44 million, and its cash-based operating expenses (as defined below) for the second quarter of 2017 were approximately $38 million. Insmed ended the second quarter of 2017 with approximately $55 million in debt.