On November 2, 2017 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported third quarter financial results (Press release, OncoMed, NOV 2, 2017, View Source [SID1234521520]). As of September 30, 2017, cash, cash equivalents and short-term investments totaled $113.6 million.

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“OncoMed remains committed to developing novel anti-cancer therapeutics to improve the lives of patients. With four clinical programs progressing, including the newly initiated Phase 1a study of GITRL-Fc (OMP-336B11), OncoMed is positioned to deliver value for both patients and our shareholders,” commented Sunil Patel, Executive Vice President and Chief Financial Officer. “We look forward to upcoming clinical updates from our navicixizumab, rosmantuzumab and anti-TIGIT programs in 2018.”

Pipeline Highlights

GITRL-Fc (OMP-336B11)

In September, OncoMed dosed the first patient in a Phase 1a single agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.
Anti-TIGIT (OMP-313M32)

OncoMed now plans to initiate the Phase 1b portion of its anti-TIGIT trial to study anti-TIGIT in combination with anti-PD1 in the first half of 2018. The Phase 1b portion of the anti-TIGIT trial will be designed to assess safety and tolerability of escalating doses of the combination treatment.
OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses, and interim data from this trial are expected to be reported by year-end 2018.
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.
To date, OncoMed has enrolled over 80 patients across the Phase 1a and Phase 1b trials. Interim data are expected to be reported in 2018.
Rosmantuzumab (anti-RSPO3; OMP-131R10)

The Phase 1a/b multi-center, open-label, dose escalation and expansion study of OncoMed’s anti-RSPO3 antibody in patients with advanced solid tumors (Phase 1a) and in patients with previously treated metastatic colorectal or gastric cancer (Phase 1b; in combination with FOLFIRI) continues. As previously announced, enrollment in the study has recently been limited to patients that harbor an RSPO3 gene fusion.
Vantictumab (anti-Fzd; OMP-18R5) and Ipafricept (Fzd8-Fc; OMP-54F28)

OncoMed continues to evaluate potential partnering opportunities for Wnt/IO combinations.
Data were presented at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) demonstrating that a 6-gene breast cancer signature significantly correlated with PFS and OS outcomes in OncoMed’s completed Phase 1b trial in 40 patients with baseline tumor assessments.
Third Quarter 2017 Financial Results

Cash, cash equivalents and short-term investments totaled $113.6 million as of September 30, 2017, compared to $184.6 million as of December 31, 2016.

Revenues were $5.1 million for the third quarter of 2017, a decrease of $0.8 million, compared to $5.9 million for the same period in 2016. The decrease in revenue was primarily due to lower revenue recognized from reimbursement of research and development costs for services performed in the third quarter of 2017.

Research and development (R&D) expenses were $12.2 million for the third quarter 2017, a decrease of $15.2 million, compared to $27.4 million for the same period in 2016. The decrease was primarily due to lower external research and development costs attributable to the decrease in Phase 2 clinical trial costs of demcizumab and tarextumab programs as a result of our discontinuation of the dosing of all patients of these programs, and a decrease in internal program costs due to reduced headcount as a result of the restructuring actions implemented in April 2017.

General and administrative (G&A) expenses were $3.9 million for the third quarter of 2017, a decrease of $0.6 million, compared to $4.5 million for the same period in 2016. The decrease was primarily attributable to a decrease in personnel costs, including stock-based compensation expenses, due to a decrease in headcount as a result of the restructuring actions implemented in April 2017.

Net loss for the third quarter of 2017 was $10.7 million ($0.28 per share), compared to $25.9 million ($0.77 per share) for the same period of 2016. The change in net loss from the prior year quarter was due to lower R&D and G&A expenses.

2017 Financial Guidance

OncoMed anticipates 2017 full-year cash utilization will be approximately $90 million. Based on the current plan, OncoMed anticipates that its current cash balance is sufficient to fund pipeline development and company operations through the third quarter of 2019, before considering potential opt-in milestones.

Corporate Updates

OncoMed Chairman and CEO, Paul Hastings, on Medical Leave: Mr. Hastings continues a personal leave of absence for medical reasons. As previously announced, Mr. Hastings will continue to be the Chief Executive Officer and Chairman of the Board of Directors during his leave of absence. In Mr. Hastings’ absence, OncoMed is led by the Office of the President consisting of Executive Vice President, Research and Development, John Lewicki, and Executive Vice President and Chief Financial Officer, Sunil Patel. In addition, OncoMed’s Board of Directors has appointed a special committee of the Board, consisting of Jack Lasersohn, lead director of the Board, Perry Karsen, Deepa Pakianathan and Rick Winningham, to work closely with Dr. Lewicki and Mr. Patel during Mr. Hastings’ medical leave.

Conference Call Today

OncoMed management will host a conference call today beginning at 4:30 p.m. ET / 1:30 p.m. PT to review third quarter 2017 financial results and corporate updates.

Analysts and investors can participate in the conference call by dialing 1 (855)-859-2056 (domestic) and 1(484) 756-4194 (international) using the conference ID# 4699289. The webcast of the conference call can be accessed live on the Investor Relations section of the OncoMed website, View Source

An audio replay of the conference call can be accessed by dialing 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) utilizing the conference ID number listed above. The web broadcast of the conference call will be available for replay through the OncoMed website.

On November 2, 2017 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported financial results for the third quarter ended September 30, 2017 including (Press release, PDL BioPharma, NOV 2, 2017, View Source [SID1234521521]):

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Total revenues of $62.7 million and $252.0 million for the three and nine months ended September 30, 2017, respectively.
GAAP diluted EPS of $0.14 and $0.56 for the three and nine months ended September 30, 2017, respectively.
GAAP net income attributable to PDL’s shareholders of $20.7 million and $88.4 million for the three and nine months ended September 30, 2017, respectively.
Non-GAAP net income attributable to PDL’s shareholders of $21.7 million and $73.7 million for the three and nine months ended September 30, 2017. A full reconciliation of all components of the GAAP to non-GAAP financial results can be found in Table 4 at the end of the release.
Revenue Highlights

Total revenues of $62.7 million for the three months ended September 30, 2017 included:
Royalties from PDL’s licensees to the Queen et al. patents of $1.4 million, which consisted of royalties earned on sales of Tysabri under a license agreement;
Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $35.4 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to Depomed, Inc.;
Interest revenue from notes receivable financings to kaléo and CareView Communications of $6.1 million; and
Product revenues of $20.1 million, which consisted of $15.1 million from sales of Tekturna and Tekturna HCT in the United States, Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products) and $5.0 million for sales and leasing of the LENSAR Laser System.
Total revenues increased by 17 percent for the three months ended September 30, 2017, when compared to the same period in 2016.
Royalties from PDL’s licensees to the Queen et al. patents were lower due to reduced sales of Tysabri that was manufactured prior to the patent expiry date;
The increase in royalty rights – change in fair value was primarily due to the current period increase in fair value of the Depomed, Inc. royalty asset by $22.0 million.
PDL received $26.3 million in net cash royalties from its royalty rights in the third quarter of 2017, compared to $15.3 million for the same period of 2016. The increase in cash royalties is mainly due to the launch of the authorized generic for Glumetza sold by Valeant Pharmaceuticals International, Inc. (Valeant) subsidiary, Oceanside Pharmaceuticals, Inc. PDL received royalties on the authorized generic equivalents under the same terms as the branded Glumetza.
The decrease in interest revenues was primarily due to the early repayment of the Paradigm Spine, LLC note receivable investment.
The increase in product revenues were derived from the sale and lease of the LENSAR Laser System, which PDL did not begin to recognize until May 11, 2017.
Total revenues increased by 42 percent for the nine months ended September 30, 2017, when compared to the same period in 2016.
The decrease in royalties from PDL’s licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc. and reduced royalties on Tysabri.
The increase in royalty rights – change in fair value was primarily due to the year-to-date increase in fair value of the Depomed, Inc. royalty asset by $144.3 million.
PDL received $74.4 million in net cash royalties from its royalty rights in the nine months ended September 30, 2017, compared to $47.2 million for the same period of 2016.
The decrease in interest revenues was primarily due to the early repayment of the Paradigm Spine, LLC note receivable investment and ceasing to recognize interest from the LENSAR note receivable.
Product revenue increased due to sales of the Noden Products, which PDL did not begin to recognize until the third quarter of 2016 and the sale and lease of the LENSAR Laser System, which PDL did not begin to recognize until May 11, 2017.
License and other revenue increased by $19.5 million primarily due to a $19.5 million payment from Merck as part of the previously announced settlement agreement to resolve the patent infringement lawsuits related to Keytruda.
Operating Expense Highlights

Operating expenses were $30.1 million for the three months ended September 30, 2017, compared to $21.0 million for the same period of 2016. The increase in operating expenses for the three months ended September 30, 2017, as compared to the same period in 2016, was primarily a result of the $5.6 million increase in costs of Noden and LENSAR product revenues, $5.0 million increase in Noden and LENSAR sales and marketing costs due to the increase in sales force headcount, and increase general and administrative expenses, partially offset by the $1.4 million decrease in amortization of the Novartis anniversary payment and contingent consideration.
Operating expenses were $88.1 million for the nine months ended September 30, 2017, compared to $40.7 million for the same period of 2016. The increase in operating expenses for the nine months ended September 30, 2017, as compared to the same period in 2016, was primarily a result of the $12.6 million increase in costs of Noden and LENSAR product revenues, the $12.4 million increase in amortization of intangible assets, the $11.2 million increase in Noden and LENSAR sales and marketing costs due to a increase in sales force headcount, the $8.7 million increase general and administrative expenses related to the Noden and LENSAR businesses being acquired by PDL in the prior year, and $4.7 million increase in research and development, partially offset by the $3.5 million decrease in acquisition related expenses related to the Noden acquisition in 2016.
Recent Developments

On October 27, 2017, PDL and Depomed, Inc. entered into a settlement agreement with Valeant Pharmaceuticals International, Inc. to resolve all matters addressed in the lawsuit filed by Depomed on September 7, 2017 relating to underpayment of royalties by Valeant. Under the terms of the Settlement Agreement, the litigation will be dismissed, with prejudice, and Valeant paid a one-time, lump-sum payment of $13.0 million, which will be transferred to PDL pursuant to the terms of the Depomed Royalty Agreement. The cash from the settlement agreement is expected to be received in Q4 2017 and has been reflected in the Depomed royalty rights asset discounted cashflow valuation as of September 30, 2017.
On October 26, 2017, PDL submitted a proposal to acquire Neos Therapeutics, Inc. for $10.25 per share in cash, which represented a premium of 40 percent to the closing price of Neos shares on October 25, 2017 and a premium of 41 percent to Neos’ share price prior to PDL’s initial proposal on June 23, 2017. The acquisition of Neos is consistent with PDL’s stated strategy for growth and is a logical next step in the execution of its strategic plan. In particular, the Company believes that this acquisition would create an attractive pediatric platform and foundation for future growth. Subsequently, Neos’ Board of Directors rejected PDL’s proposal and refuses to engage in a constructive dialogue with PDL management on behalf of Neos’ shareholders. PDL has a number of investment opportunities before it, of which Neos is only one. PDL’s proposal remains outstanding through November 8, 2017. PDL will evaluate all of its options in the interim.
On October 26, 2017, Biogen sent to PDL a notice of overpayment related to royalties on Tysabri on sales in the US, Spain, Italy and South Africa for $13.5 million through the period ending September 30, 2017. The notice states that the overpayment was the result of royalties being paid on product manufactured after the expiration of the Queen et al. patents. PDL received cash payments of $14.9 million during the third quarter of 2017. As a result of the receipt of this overpayment notice, royalty revenue from the Queen et al. patents was $1.4 million, in the third quarter of 2017, which was the net amount of $14.9 million cash received and the potential overpayment of $13.5 million. PDL recorded a refund liability for the potential overpayment amount of $13.5 million at September 30, 2017. Biogen indicated to us that royalty payment for Tysabri in the fourth quarter of 2017 will be $4.5 million leaving a net potential overpayment of $9.0 million. PDL is currently working with Biogen to resolve this issue.
In October 2017, PDL received a royalty payment from Valeant in the amount of $6.9 million for royalties earned on sales of Glumetza for the month of September. The royalty payment included royalties related to the authorized generic version of Glumetza.
On September 21, 2017, PDL entered into an agreement with a third-party purchaser, pursuant to which PDL sold its entire interest in the kaléo, Inc note. Pursuant to the agreement, the purchaser paid PDL an amount equal to 100% of the then outstanding principal plus a premium of 1% of the principal amount and accrued interest, for an aggregate cash purchase price of $141.7 million, subject to an 18-month escrow holdback of $1.4 million against certain potential contingencies.
Other Financial Highlights

PDL had cash, cash equivalents, short-term investments and other investments of $516.5 million at September 30, 2017, compared to $242.1 million at December 31, 2016.
Net cash provided by operating activities in the nine months ended September 30, 2017 was $58.1 million, compared with $86.1 million in the same period in 2016. The decrease was as a result of the fair value changes of PDL’s royalty rights.
PDL anticipates an estimated cash tax rate of 22% as the company begins to utilize available tax operating loss carry forwards and credits and expects an effective tax rate of approximately 41% in fiscal 2017, which is dependent on the mix and timing of income.
Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results at 4:30 p.m. Eastern Time today, November 2, 2017.

To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 internationally. The conference ID is 8794857. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through one week following the call, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 8794857.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at View Source and go to “Events & Presentations.” Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On November 2, 2017 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the third quarter ending September 30, 2017 (Press release, PTC Therapeutics, NOV 2, 2017, View Source [SID1234521522]).

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“Our performance this quarter combined with our commercial, financial and R&D advancements should allow us to end 2017 in a strong position,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. “Our commercial success is driven by our mission of improving the lives of patients with Duchenne.”

Third Quarter Financial Highlights:

Translarna net product sales were $32.0 million for the third quarter of 2017, representing 45% growth over $22.0 million reported in the third quarter of 2016.
EMFLAZA net product sales were $9.8 million for the third quarter of 2017.
Total revenues for the third quarter of 2017 were $41.9 million compared to $23.0 million in the same period of 2016. The change in total revenue was a result of the expanded commercial launch of Translarna and the successful U.S. EMFLAZA launch.
GAAP R&D expenses were $30.0 million for the third quarter of 2017 compared to $31.4 million for the same period in 2016. Non-GAAP R&D expenses were $26.4 million for the third quarter of 2017, excluding $3.6 million in non-cash, stock-based compensation expense, compared to $27.1 million for the same period in 2016, excluding $4.3 million in non-cash, stock-based compensation expense. The decrease in R&D expense for the third quarter of 2017 as compared to the prior year period was primarily due to the completion of our Phase 3 Translarna trials at the end of 2016 partially offset by start-up clinical activities and regulatory spend.
GAAP SG&A expenses were $31.4 million for the third quarter of 2017 compared to $23.7 million for the same period in 2016. Non-GAAP SG&A expenses were $27.9 million for the third quarter of 2017, excluding $3.5 million in non-cash, stock-based compensation expense, compared to $19.0 million for the same period in 2016, excluding $4.6 million in non-cash, stock-based compensation expense. The increase in SG&A expenses primarily related to the expansion of the U.S. commercial sales team in support of the launch of EMFLAZA.
Net interest expense for the third quarter of 2017 was $3.4 million compared to net interest expense of $2.1 million in the same period in 2016. The increase in net interest expense is primarily a result of increased interest expense related to the $40 million secured loan facility which we closed during the second quarter of 2017 partially offset by reduced interest income from investments.
Net loss for the third quarter of 2017 was $33.7 million compared to a net loss of $35.2 million for the same period in 2016.
Cash, cash equivalents, and marketable securities totaled approximately $169.3 million at September 30, 2017 compared to approximately $231.7 million at December 31, 2016.
Shares issued and outstanding as of September 30, 2017, were 41.5 million, which includes 0.1 million shares of unvested restricted stock awards.
2017 Guidance:

Translarna net sales guidance for 2017 is anticipated to be between $120 and $140 million. We now anticipate EMFLAZA net sales for 2017 to be between $20 and $25 million, an increase from our prior guidance of $15 to $20 million. This brings 2017 full year revenue guidance between $160 and $185 million, an increase from our prior guidance of $155 million to $180 million, including a $20 million milestone we achieved in mid-October, under our SMA program.
GAAP R&D and SG&A expense for the full year 2017 are now anticipated to be between $250 to $260 million. Excluding estimated non-cash, stock-based compensation expense of approximately $40 million, full year 2017 non-GAAP R&D and SG&A expense are now anticipated to be between $210 million and $220 million. These expenses will be primarily in support of the commercial availability of Translarna globally, the commercial launch of EMFLAZA in the U.S. and the continued research and clinical development of other product pipeline candidates.
We now expect to end 2017 with over $150 million of cash and cash equivalents, an increase from prior guidance of $120 million.
Key Third Quarter and other Corporate Highlights:

Filed Formal Dispute Resolution Request with U.S. FDA to appeal Complete Response Letter for ataluren. PTC received a Complete Response Letter from the Office of Drug Evaluation I of the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of the investigational medicine ataluren for the treatment of nonsense mutation dystrophinopathies. The letter stated that it is unable to approve the application in its current form. PTC has filed a formal dispute resolution request challenging this decision.
EMFLAZA revenue grew to $9.8M in third quarter. PTC is committed to enabling access to EMFLAZA for all patients in need, regardless of financial situation or insurance status. We demonstrated an increase in EMFLAZA prescriptions over the past quarter. There are currently over 1,500 patients on EMFLAZA and we estimate that there are approximately 9,000 Duchenne patients in the U.S. over the age of five who are eligible to be prescribed EMFLAZA.
Continued global expansion of Translarna results in revenue of $32.0M in third quarter. PTC continues to expand its strong global footprint, with sales generated in over 25 countries. This strong performance reflects continued uptake, sustainable pricing levels, and high ( > 90%) compliance to treatment.
SMA clinical program advanced into the pivotal portion of the study. In mid-October, the SUNFISH trial transitioned into the pivotal portion of the study which triggered a $20M milestone to PTC from Roche. Data from the SUNFISH trial was presented at the International Congress of the World Muscle Society. An interim analysis of the five cohorts treated with RG7916 for 28 days demonstrates an exposure-dependent increase in SMN protein.
Non-GAAP Financial Measures:
In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial measures exclude stock-based compensation expense and one-time restructuring expenses relating to the reorganization of operations intended to improve efficiency and better align costs and employment structure with PTC’s strategic plans. These non-GAAP financial measures are provided as a complement to results reported in GAAP because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management’s opinion, these non-GAAP financial measures are useful to investors and other users of PTC’s financial statements by providing greater transparency into the operating performance at PTC and the company’s future outlook. Quantitative reconciliations of GAAP financial measures are included in the tables below

On November 2, 2017 Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq:RDUS), reported its financial results for the third quarter ended September 30, 2017, and provided a business update (Press release, Radius, NOV 2, 2017, View Source [SID1234521524]).

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“It is very encouraging for Radius to see TYMLOS gaining traction in the market,” said Jesper Høiland, President and CEO of Radius. “In addition to our stated goal of gaining market leadership for TYMLOS, we are excited by the positive response to the product by physicians, payors and patients. With the recent capital raise, we are also well funded to start investing in expanding the TYMLOS label and advancing the development of our other therapeutic candidates in the pipeline.”

“TYMLOS is proving itself to be an important treatment for a high unmet medical need, as demonstrated by the continued increase in lives covered through managed care contracts,” said David Snow, Chief Commercial Officer of Radius. “Postmenopausal women with osteoporosis at high risk for fractures deserve to have therapies that safely and effectively reduce that risk, with lower out of pocket costs. Our sales team is achieving strong reach and call frequency and we are continuing to expand payer acceptance while we see anabolic class volume stabilizing.”

TYMLOS (abaloparatide injection)

Third quarter reported sales of TYMLOS in the U.S. (the first full quarter since its launch) were approximately $3.5 million. 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 September 2017, Radius presented results from the completed ACTIVExtend study in an abstract titled “Sustained Fracture Risk Reduction with Sequential Abaloparatide/Alendronate: Results of ACTIVExtend” at the ASBMR 2017 Annual Meeting in Denver, Colorado. In ACTIVExtend, patients who had completed 18 months of TYMLOS or placebo in the ACTIVE Phase 3 trial were transitioned to receive 24 additional months of open-label alendronate. Patients who received a sequential therapy of TYMLOS followed by alendronate demonstrated statistically significant fracture risk reductions through 3.5 years. At the 43-month timepoint, the previous TYMLOS-treated patients had a significant 84 percent relative risk reduction (p<0.0001) in the incidence of new vertebral fractures compared with women who received placebo followed by alendronate. Additionally, TYMLOS followed by alendronate demonstrated a 39 percent relative risk reduction in nonvertebral fractures (p=0.038), compared with women who received placebo followed by alendronate.

The Company expects to submit a labeling supplement to the FDA in connection with the ACTIVExtend results by the end of 2017.
Pipeline Updates

Abaloparatide — Subcutaneous (SC)

European MAA
Radius’ European Marketing Authorisation Application (MAA) for 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 issued a second Day-180 List of Outstanding Issues. Radius is working with the CHMP to address these issues, and discussed preliminary responses with the Rapporteurs in a formal Clarification Meeting. We expect an opinion from the CHMP regarding the MAA prior to the end of 2017.
Male Osteoporosis Trial
We recently gained agreement with the FDA on the design of a clinical trial in men with osteoporosis, which, if successful, will form the basis of an sNDA seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture. The study will be a randomized, double-blind, placebo-controlled trial that will enroll approximately 225 men with osteoporosis.
The primary endpoint is change in spine bone mineral density (“BMD”) at 12 months compared with placebo. TYMLOS has demonstrated in previous clinical trials that it increases BMD in postmenopausal women. The study will include specialized high-resolution imaging of bone structure in a subset of the study participants. We expect to initiate the trial in the first quarter of 2018.
Abaloparatide-Transdermal Patch (TD)

We have scheduled a meeting with the FDA in January 2018 to align on a regulatory pathway for a pivotal study (e.g. bioequivalence or BMD) for abaloparatide-TD and we are also discussing manufacturing arrangements with 3M Company related to potential commercial supplies of abaloparatide-TD. We are on track to complete manufacturing scale-up, production, and other required activities needed to initiate a pivotal study. The pharmacokinetic profile of an optimized abaloparatide-TD patch was successfully modified so as to improve comparability to abaloparatide-SC. We believe that the transdermal patch program, if approved, will offer patients who suffer from osteoporosis a convenient alternative.
Elacestrant (RAD1901)

In a meeting to discuss the elacestrant breast cancer development program, the FDA indicated that, depending on the study results, which must demonstrate an improvement over then available therapies, the planned single-arm Phase 2 trial could be considered a pivotal study for accelerated approval as long as a confirmatory study is ongoing by the time of the NDA submission. We will provide further study details when the Phase 2 study is initiated, which we expect will be in early 2018. In October, elacestrant received FDA Fast Track designation supporting a rapid speed to market strategy.
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 are currently reviewing our elacestrant vasomotor development program and plan to provide an update by the end of 2017.
RAD140

In September 2017, the Company announced that the first patient had been enrolled in the Company’s Phase 1 study of RAD140, a nonsteroidal selective androgen receptor modulator (SARM) undergoing clinical evaluation for the treatment of hormone receptor positive breast cancer. The clinical trial is designed to evaluate the safety and maximum tolerated dose of RAD140 in approximately 40 patients.
Radius Anticipates the Following Milestones

Abaloparatide
Receive Committee for Medicinal Products for Human Use (CHMP) opinion regarding the EMA’s review of the abaloparatide-SC MAA before the end of 2017
Submit a labeling supplement in connection with the ACTIVExtend data to the FDA by 2017 year end
Provide updates on the potential regulatory pathway for an abaloparatide-transdermal patch (TD) pivotal study following a scheduled meeting with the FDA in January 2018 and discussions with 3M Company for potential commercial supplies of abaloparatide-TD
Initiate a male osteoporosis study in the first quarter of 2018
Enter into a partnership for the potential commercialization of abaloparatide-SC outside the US and Japan prior to commercial launch in the European Union
Elacestrant
Initiate Phase 2 single-arm monotherapy clinical trial in metastatic breast cancer patients in early 2018
Complete review of the elacestrant vasomotor development program and provide an update by the end of 2017
RAD140
Continue enrollment in the Phase 1 study
Corporate Update

The Company also announced today that Ansbert Gadicke, M.D., has resigned from the Board of Directors of the Company effective November 8, 2017, after having served on the Board of the Company and its predecessor since 2003. Following Dr. Gadicke’s resignation, the Company expects to reduce the size of the Board from 10 to 9 members.

Radius Expects to Make Presentations at the Following Upcoming Conferences

On December 5-9, 2017, Gary Hattersley, PhD, Chief Scientific Officer, will present at the San Antonio Breast Cancer Symposium and Radius will host one-on-one meetings
On January 8-11, 2018, Jesper Høiland, Radius President and CEO, will present and host one-on-one meetings at the 36th JP Morgan Annual Healthcare Conference in San Francisco
On March 12-14, 2018, Jesper Høiland, Radius President and CEO, will present and host one-on-one meetings at the 38th Cowen Annual Healthcare Conference
Third Quarter 2017 Financial Results

Three Months Ended September 30, 2017
For the three months ended September 30, 2017, Radius reported a net loss of $57.8 million, or $1.31 per share, compared to a net loss of $46.2 million, or $1.07 per share, for the three months ended September 30, 2016.

For the three months ended September 30, 2017, Radius reported TYMLOS net product revenues of about $3.5 million, which reflects the first full quarter of recorded sales. Radius had no revenue in the three months ended September 30, 2016 as the FDA approved TYMLOS on April 28, 2017.

Research and development expense for the three months ended September 30, 2017, was $21.0 million compared to $27.5 million for the three months ended September 30, 2016, a decrease of $6.5 million, or 24%. This decrease was primarily driven by a $3.4 million decrease in vasomotor project related spending, a $2.0 million decrease in abaloparatide-SC project costs, and a $1.1 million decrease in RAD1901 oncology project costs.

Selling, general, and administrative expense for the three months ended September 30, 2017, was $47.7 million compared to $19.2 million for the three months ended September 30, 2016, an increase of $28.5 million, or 148%. This increase was primarily the result of an increase of approximately $10.1 million in professional fees and support costs, 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 $15.2 million increase in compensation expense, including stock-based compensation, due to the increase in headcount.

Nine Months Ended September 30, 2017
For the nine months ended September 30, 2017, Radius reported a net loss of $183.2 million, or $4.21 per share, compared to a net loss of $130.1 million, or $3.02 per share, for the nine months ended September 30, 2016.

For the nine months ended September 30, 2017 Radius reported TYMLOS net product revenues of about $4.4 million, which reflects the first full quarter of reported sales. Radius had no revenue in the nine months ended September 30, 2016 as the FDA approved TYMLOS on April 28, 2017.

Research and development expense for the nine months ended September 30, 2017, was $60.2 million compared to $81.8 million for the nine months ended September 30, 2016, a decrease of $21.6 million, or 26%. This decrease was primarily driven by a $14.9 million decrease in RAD1901 project costs, a $14.1 million decrease in abaloparatide-SC project costs, and a $2.2 million decrease in development costs associated with abaloparatide-TD. This decrease was partially offset by a $9.7 million increase in compensation expense, including stock-based compensation, due to an increase in headcount.

Selling, general, and administrative expense for the nine months ended September 30, 2017, was $135.9 million compared to $50.1 million for the nine months ended September 30, 2016, an increase of $85.8 million, or 171%. This increase was primarily the result of an increase of approximately $27.9 million in professional fees and support costs during the nine months ended September 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 $49.4 million increase in compensation expense, including stock-based compensation, due to an increase in headcount.

As of September 30, 2017, Radius had $468.1 million in cash, cash equivalents and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of September 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 November2, 2017 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that will host a Q3 2017 Investor Call on Thursday, November 9, 2017 at 10:00 AM (EST) to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, NOV 2, 2017, View Source [SID1234521487]).

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