On October 29, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported a corporate update and reported financial results for the third quarter ending September 30, 2019 (Press release, PTC Therapeutics, OCT 29, 2019, View Source [SID1234549998]).

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"We are following through on our commitment to build an innovative, diversified rare disorders company," said Stuart Peltz, Ph.D., CEO of PTC Therapeutics. "This quarter, we completed a successful financing to continue to drive our internal programs while continuing to evaluate select external opportunities. This most recent financing has put us in a position to execute on our strategic vision of reaching over $1.5B in revenue by 2023."

Corporate Highlights:

Tegsedi (inotersen) received approval from the Brazilian health regulatory authority (ANVISA) for the treatment of stage 1 or 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR), to delay disease progression and improve quality of life. This approval will allow PTC to initiate the launch in Brazil with the only hATTR indication globally to include improvements in quality of life.
PTC acquired assets from BioElectron Technology Corporation that are focused on inflammatory and central nervous system (CNS) disorders. The lead program is pivotal trial ready for CNS disorders with substantial unmet need and significant commercial opportunity that are complementary to PTC’s existing pipeline.
Advancing CNS Gene Therapy Portfolio & Infrastructure:

PTC has entered into a strategic collaboration with Aldevron to support GMP plasmid manufacturing for the gene therapy portfolio.
As previously disclosed, PTC is on track to submit a BLA with the FDA in late 2019 followed by an MAA in Europe for the AADC deficiency gene therapy program. This will be followed by an anticipated commercial launch in 2020.
Data presented in October at the Child Neurology Society meeting demonstrated that patients receiving PTC-AADC had sustained motor, cognitive, and language milestones representing up to five years of follow up post-treatment.
The Friedreich ataxia program continues to advance with an IND submission now expected in mid-2020.
PTC has signed a long-term lease agreement securing a state-of-the-art biologics facility located in Hopewell, N.J. to support the research and operations of multiple gene therapy programs.
Updates for Small Molecule Splicing Platform:

Data from pivotal FIREFISH and SUNFISH part 1 studies were presented at the World Muscle Society Congress in October, demonstrating continued clinical benefit with risdiplam in Type 1, 2, and 3 SMA patients.
In part 1 of FIREFISH, babies with Type 1 SMA continue to achieve motor milestones including at least one patient now standing and two patients starting to walk.
Risdiplam continues to be well tolerated at all doses across studies and there have been no drug related safety findings leading to withdrawal.
Part 2 SUNFISH data is expected by the end of the year followed by part 2 FIREFISH data in early 2020.
Planned NDA filing with the FDA is on track for the second half of this year with the intention to support a broad label to treat SMA Types 1, 2, & 3 patients. Filing of the MAA in the EU is expected to occur in the first half of 2020.
Based on initial feedback from the FDA on the complexity of a clinical pathway for the small population of patients, PTC has decided to discontinue the Familial Dysautonomia oral splicing program.
PTC continues to prioritize our Huntington’s program, which is scaling up with safety and toxicology work and is expected to enter the clinic in 2020.
PTC Full Year 2019 Guidance:

PTC anticipates DMD franchise net product revenues for the full year 2019 to remain between $285 and $305 million.
PTC anticipates GAAP R&D and SG&A expense for the full year 2019 to be between $420 and $430 million.
PTC anticipates Non-GAAP R&D and SG&A expense for the full year 2019 to be between $380 and $390 million, an increase from $360 and $370 million, excluding estimated non-cash, stock-based compensation expense of approximately $40 million, an increase from $35 million. This increase in operating expense is primarily due to the acceleration of activities in our core programs, including research and gene therapy manufacturing.
Third Quarter 2019 Financial Highlights:

Total revenues were $71.4 million for the third quarter of 2019, compared to $53.6 million for the third quarter of 2018.
Translarna net product revenues were $48.3 million for the third quarter of 2019, compared to $30.4 million for the third quarter of 2018. These results reflect the expanded commercialization of Translarna.
Emflaza net product revenues were $22.9 million for the third quarter of 2019, compared to $22.6 million for the third quarter of 2018. These results reflect an increase in the utilization of Medicaid which changed our gross to net assumptions and includes the impact of transitioning to a new specialty pharmacy distributor.
GAAP R&D expenses were $63.1 million for the third quarter of 2019, compared to $54.4 million for the third quarter of 2018. The increase in R&D expenses reflects costs associated with advancing the gene therapy platform and increased investment in research programs as well as advancement of the clinical pipeline.
Non-GAAP R&D expenses were $58.1 million for the third quarter of 2019, excluding $5.0 million in non-cash, stock-based compensation expense, compared to $49.9 million for the third quarter of 2018, excluding $4.4 million in non-cash, stock-based compensation expense.
GAAP SG&A expenses were $49.3 million for the third quarter of 2019, compared to $38.4 million for the third quarter of 2018. The increase in SG&A expenses was primarily due to continued investment in support of our commercial activities.
Non-GAAP SG&A expenses were $43.8 million for the third quarter of 2019, excluding $5.5 million in non-cash, stock-based compensation expense, compared to $33.9 million for the third quarter of 2018, excluding $4.5 million in non-cash, stock-based compensation expense.
Change in the fair value of deferred and contingent consideration was $9.5 million for the third quarter of 2019. The change in fair value of deferred and contingent consideration is related to the fair valuation of potential future consideration to be paid to former equity holders of Agilis Biotherapeutics, Inc. (Agilis) in connection with PTC’s acquisition of Agilis, which closed in August 2018.
Net loss was $60.0 million for the third quarter of 2019, compared to net loss of $51.0 million for the third quarter of 2018.
Cash, cash equivalents, and marketable securities were $708.6 million at September 30, 2019, compared to $227.6 million at December 31, 2018. We completed a financing that amounted to $287.5 million in convertible bonds and $100.0 million in equity for a total consideration of $387.5 million, resulting in net offering proceeds of $376.3 million.
Shares issued and outstanding as of September 30, 2019 were 61,578,992.
Upcoming investor conferences
Credit Suisse 28th Annual Healthcare Conference, November 12th 2:25 pm MT.

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, the non-GAAP financial measures exclude non-cash, stock-based compensation expense. These non-GAAP financial measures are provided as a complement to financial measures 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 historical and projected operating performance of PTC and the company’s future outlook. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the table below.

Today’s Conference Call and Webcast Reminder:
Today’s conference call will take place at 4:30 pm ET and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 9224968. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. The accompanying slide presentation will be posted on the investor relations section of the PTC website. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks.

On October 29, 2019 Accuray Incorporated (NASDAQ: ARAY) reported its financial results for the first quarter of fiscal 2020 ended September 30, 2019 (Press release, Accuray, OCT 29, 2019, View Source [SID1234549997]).

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Recent Company Highlights

Gross orders increased 28 percent year over year to $78.5 million
11 orders received from China, including 2 orders sourced from the China joint venture
Accuray systems named in 50 out of 58 Class A licenses awarded by the China Ministry of Health
"Our first quarter performance represented a solid start to our fiscal year with double digit gross order growth," said Joshua H. Levine, president and chief executive officer. "We are also very excited about Accuray systems named in 50 out of 58 Class A licenses recently awarded by the China National Health Commission which were announced on October 9, 2019. We need to remember that the process identified by the Ministry of Health requires a tender process following the license awards for all participating end user hospitals prior to being able to take receipt of a Type A device. This tender process has been put in place to define the transactional terms and conditions related to each hospital’s equipment order and is not a competitive bidding situation that would result in changes in the specific device that the hospital has received the Type A license for. We expect that based on the timelines required for this tendering process, we would not begin to see revenue impact related to the China Type A awards until sometime in our fiscal 4th quarter, and we remain excited about the China market opportunity as a significant growth catalyst for our business."

Fiscal First Quarter Results

Gross orders totaled $78.5 million, an increase of 28 percent compared to $61.4 million for the prior year period. Backlog as of September 30, 2019 was $495.0 million, an increase of 7 percent compared to $461.9 million for the prior year period.

Total revenue was $89.6 million compared to $95.8 million for the prior year period. Product revenue totaled $37.6 million compared to $41.5 million, while service revenue totaled $52.0 million compared to $54.3 million.

Total gross profit for the fiscal 2020 first quarter was $32.9 million, or 36.8 percent of sales, comprised of product gross margin of 42.6 percent and service gross margin of 32.5 percent. This compares to total gross profit of $37.9 million, or 39.5 percent of sales, comprised of product gross margin of 40.9 percent and service gross margin of 38.5 percent for the prior fiscal year first quarter.

Operating expenses were $37.2 million, a decrease of 13 percent compared to $42.6 million in the prior fiscal year first quarter.

Net loss was $9.4 million, or $0.11 per share, compared to a net loss of $9.2 million, or $0.11 per share, for the prior fiscal year period.

Adjusted EBITDA for the first quarter of fiscal 2020 was a loss of $1.0 million, compared to $4.0 million in the prior fiscal period.

Cash, cash equivalents and short-term restricted cash were $86.7 million as of September 30, 2019 compared with $87.0 million as of June 30, 2019.

2020 Financial Guidance

The Company is reiterating its revenue and adjusted EBITDA guidance provided on August 15, 2019. Total revenue for fiscal year 2020 is expected to range between $410.0 and $420.0 million with revenue during the first half of the fiscal year expected to be approximately five to six percent below the first half of the prior fiscal year. The Company expects to generate revenue growth during the second half of fiscal year 2020 compared to the second half of the prior fiscal year. Adjusted EBITDA for fiscal year 2020 is expected to range between $19.0 to $24.0 million and include approximately $2.0 million of the Company’s share of expected loss from the joint venture operations in China.

Conference Call Information

Accuray will host a conference call beginning at 1:30 p.m. PT/4:30 p.m. ET today to discuss results for the first fiscal quarter as well as recent corporate developments. Conference call dial-in information is as follows:

U.S. callers: (855) 867-4103
International callers: (262) 912-4764
Conference ID Number (U.S. and international): 4191278
Individuals interested in listening to the live conference call via the Internet may do so by logging on to Accuray’s website, www.accuray.com. In addition, a taped replay of the conference call will be available beginning approximately two hours after the call’s conclusion and available for seven days. The replay telephone number is (855) 859-2056 (USA) or (404) 537-3406 (International), Conference ID: 4191278. An archived webcast will also be available at Accuray’s website until Accuray announces its results for the second quarter of fiscal 2020.

Use of Non-GAAP Financial Measures

Accuray has supplemented its GAAP net loss with a non-GAAP measure of adjusted earnings before interest, taxes, depreciation, amortization and stock-based compensation ("adjusted EBITDA"). Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the company and facilitates a meaningful comparison of results for current periods with previous operating results. A reconciliation of GAAP net loss (the most directly comparable GAAP measure) to non-GAAP adjusted EBITDA is provided in the schedule below.

There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the company’s consolidated financial statements prepared in accordance with GAAP.

On October 29, 2019 Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company") reported that it will release financial results for the period ended September 30, 2019 and provide a business update after market close on Tuesday, November 5, 2019 (Press release, Theravance, OCT 29, 2019, View Source [SID1234549996]).

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An accompanying conference call will be held at 5:00 pm ET on November 5, 2019. To participate in the live call by telephone, please dial (855) 296-9648 from the US, or (920) 663-6266 for international callers, using the confirmation code 6281636. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events. Please go to the website 15 minutes prior to the start of the call to register, download, and install any necessary audio software.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through December 5, 2019. An audio replay will also be available through 8:00 PM ET on November 12, 2019 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 6281636.

On October 29, 2019 Danaher Corporation (NYSE: DHR) ("Danaher") reported that its wholly owned subsidiary, DH Europe Finance II S.à r.l. ("Danaher International II"), has priced an offering of (Press release, Danaher, OCT 29, 2019, View Source [SID1234549995]):

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$700,000,000 principal amount of 2.050% senior notes due 2022 at an offering price of 99.994% of the principal amount;
$700,000,000 principal amount of 2.200% senior notes due 2024 at an offering price of 99.952% of the principal amount;
$800,000,000 principal amount of 2.600% senior notes due 2029 at an offering price of 99.903% of the principal amount;
$900,000,000 principal amount of 3.250% senior notes due 2039 at an offering price of 99.809% of the principal amount; and
$900,000,000 principal amount of 3.400% senior notes due 2049 at an offering price of 99.756% of the principal amount (collectively, the "senior notes").
Danaher estimates that the net proceeds from the sale of the senior notes in this offering will be approximately $3.97 billion, after deducting the underwriting discounts and estimated offering expenses payable by Danaher. Danaher anticipates using the net proceeds to fund a portion of the cash consideration payable for, and certain costs associated with, its acquisition of the Biopharma Business of GE Life Sciences (the "GE Biopharma Acquisition"). Pending completion of the GE Biopharma Acquisition, Danaher may invest the net proceeds of the offering in short-term bank deposits or invest them in interest-bearing, investment-grade securities. The senior notes will be fully and unconditionally guaranteed on a senior unsecured basis by Danaher. The offering is expected to close on November 7, 2019, subject to customary closing conditions.

The offering is being made pursuant to an effective shelf registration statement on file with the U.S. Securities and Exchange Commission.

The offering of senior notes may be made only by means of a prospectus and prospectus supplement. A copy of the prospectus and prospectus supplement relating to the securities can be obtained by calling BofA Securities, Inc., toll-free at 1-800-294-1322, Mizuho Securities USA LLC, toll-free at 1-866-271-7403, MUFG Securities Americas Inc., toll-free at 1-877-649-6848, U.S. Bancorp Investments, Inc., toll-free at 1-877-558-2607, or Wells Fargo Securities, LLC, toll-free at 1-800-645-3751.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, the senior notes or any other securities, nor shall there be any offer, solicitation or sale of any security mentioned in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 29, 2019 Verastem, Inc. (Nasdaq: VSTM), operating as Verastem Oncology (or "the Company"), focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported financial results for the three months ended September 30, 2019, and provided an overview of recent accomplishments and clinical development progress for duvelisib (COPIKTRA) (Press release, Verastem, OCT 29, 2019, View Source [SID1234549994]).

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"In the third quarter, we achieved $9.0 million in revenue, including $4.0 million in net product revenue from COPIKTRA, a 33% increase over the prior quarter, and we remain on track to achieve the revenue that we have guided for this year. We continue to make progress with COPIKTRA sales as the intent to prescribe and new prescriber base grows week over week due to solid progress across our commercial efforts, including physician education and contracting. We also believe in the long-term potential for our current COPIKTRA indications," said Brian Stuglik, Chief Executive Officer of Verastem Oncology. "We are deeply committed to our long-term strategy to achieve sustainable growth and progress our mission on behalf of patients. In order to achieve these ambitious goals and provide us with greater financial flexibility going forward, we are streamlining our organization and reducing operating expenses, which will result in approximately $25 million in annualized cost savings next year."

Key Third Quarter 2019 and Recent Accomplishments

Corporate and Financial

Implementing a Corporate Restructuring as Part of the Long-Term "6-2-5" Strategy – Verastem Oncology continues to deliver on its "6-2-5" strategic plan in which we aim to narrow the gap between revenue and commercial spend by year end 2019, achieve cash flow break-even for both the commercial and clinical COPIKTRA program by mid-2021, and the indications for COPIKTRA are broadened with at least one additional marketed product, along with a pipeline of assets in development by mid-2024. In order to support this strategy, the company will be reducing overall operating expenses, including the elimination of approximately 40 current positions across all functions. The workforce reduction is designed to streamline operations, speed execution, and reflect the focused, account-based approach in the field. The Company expects minimal impact on top-line revenue results with these changes. The overall reduction in operating expenses is expected to result in approximately $25 million in annualized cost savings in 2020. Verastem Oncology estimates that it will incur approximately $1.0 million in pre-tax charges for severance and other costs related to the workforce reduction, the majority of which will be incurred in 2019.
Signed Exclusive License Agreement with Sanofi for the Development and Commercialization of Duvelisib in Select Eurasian Territories – In July 2019, the Company announced its entry into an exclusive license agreement with Sanofi, under which Verastem Oncology granted exclusive rights to Sanofi to develop and commercialize products containing COPIKTRA in Russia and CIS, Turkey, the Middle East and Africa. Under the terms of the agreement, Verastem Oncology received an upfront payment of $5 million (USD) and is eligible to receive aggregate payments of up to $42 million if certain development and sales milestones are successfully achieved, plus double-digit percentage royalties based on future net sales of COPIKTRA in the licensed territories. In exchange, Sanofi received exclusive rights to develop and commercialize COPIKTRA and hold the marketing authorization and product license for COPIKTRA in the licensed territories. Additionally, Sanofi will have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities.
COPIKTRA (duvelisib)

Ongoing Commercial Rollout of COPIKTRA in the United States (U.S.) – COPIKTRA, the Company’s oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma continues to gain momentum in the U.S. generating revenues of $4.0 million during the third quarter of 2019, a 33% increase over the prior quarter. As of the end of the third quarter 2019, the number of prescribing physicians had increased by over 30%, compared to the end of the prior quarter.
Yakult Doses First Patient in Japanese Bridging Study Evaluating COPIKTRA in Relapsed or Refractory CLL/SLL – In early October, Verastem Oncology’s partner Yakult Honsha Co., Ltd. (Yakult) dosed the first patient in a Phase 1b Japanese bridging study evaluating COPIKTRA in patients with relapsed or refractory CLL/SLL following at least one prior therapy. Yakult’s multicenter, open-label Phase 1b study is expected to enroll approximately 10 patients and the primary endpoint of the study is objective response rate. Secondary endpoints of the study include overall survival, progression free survival and safety. This Phase 1b study is expected to serve as a bridging study based on the efficacy and safety observed in Verastem Oncology’s Phase 3 DUO study. The results of the Phase 1b bridging study are expected to form the basis of a regulatory submission for COPIKTRA for the treatment of relapsed or refractory CLL/SLL in Japan.
Duvelisib Receives Orphan Drug Designation from FDA for the Treatment of T-Cell Lymphoma – In early October, duvelisib (COPIKTRA) received orphan drug designation from the FDA for use in the treatment of T-Cell lymphoma. The designation was created to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases. Duvelisib is not currently approved for the treatment of T-cell lymphoma. The Company recently completed the dose optimization/dose selection phase of the PRIMO study in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and has submitted the data for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2019 Annual Meeting in December. The registration-directed portion of the PRIMO study is currently on going and is being conducted in the U.S., Europe and Japan.
Presented New Preclinical Duvelisib Data at the 5th International Conference on New Concepts in Lymphoid Malignancies– In early October, an abstract was presented at the meeting that showed superior anti-cancer activity of the dual PI3K-delta/gamma inhibitor duvelisib compared to the PI3K-delta inhibitor idelalisib in preclinical models of mantle cell lymphoma (MCL). Verastem Oncology’s goal is to expand into additional lymphoid malignancy indications and these data provide additional support for the future study of duvelisib through clinical trials in patients with MCL. Duvelisib is not approved for use in MCL.
Presented Seven COPIKTRA Abstracts at Two Prestigious Medical Meetings – Throughout September, Verastem Oncology continued to have a strong scientific presence for COPIKTRA at important medical congresses. The Company presented a total of seven COPIKTRA abstracts at two prestigious medical oncology meetings; the 18th Annual International Workshop on Chronic Lymphocytic Leukemia (iwCLL) and the Society of Hematologic Oncology 2019 Annual Meeting. Collectively, the presented abstracts highlighted a wide range of duvelisib clinical data, including data from the Phase 3 DUO study in patients with relapsed or refractory CLL/SLL, dose modification data from the Phase 3 DUO study, data from a post-hoc analysis evaluating the effect of COPIKTRA on lymphocytosis, including in patients with high-risk factors, and data from the Phase 2 DYNAMO in patients with refractory marginal zone lymphoma. These presented data continue to support the ongoing commercialization of COPIKTRA.
Third Quarter 2019 Financial Results

Total revenue for the three months ended September 30, 2019 (2019 Quarter) was $9.0 million. Net product revenue for the 2019 Quarter was $4.0 million, compared to $0.5 million for the three months ended September 30, 2018 (2018 Quarter), following the FDA’s approval of COPIKTRA on September 24, 2018. License and collaboration revenue for the 2019 Quarter was $5.0 million, compared to $15.0 million for the 2018 Quarter. The 2018 Quarter included license revenue of $15.0 million related to an upfront payment pursuant to a license and collaboration agreement executed between Verastem Oncology and CSPC Pharmaceutical Group Limited in September 2018. The 2019 Quarter includes a $5.0 million upfront payment received pursuant to a license and collaboration agreement executed between Verastem Oncology and Sanofi in July 2019.

Total operating expenses for the 2019 Quarter were $35.1 million, compared to $41.4 million for the second quarter of 2019 and compared to $37.1 million for the 2018 Quarter.

Research and development (R&D) expense for the 2019 Quarter was $12.2 million, compared to $11.6 million for the 2018 Quarter. The increase of $0.6 million, or 5.2%, was primarily related to an increase of $0.4 million in contract research organizations (CRO) costs and an increase of $0.3 million related to personnel costs, including non-cash stock-based compensation, partially offset by a decrease of $0.1 million in consulting costs. The $0.4 million increase in CRO costs is primarily related to an increase of $1.5 million for the Company’s planned DUETTO and TEMPO studies, partially offset by a decrease of $1.0 million resulting from site closures for the Phase 3 DUO and Phase 2 DYNAMO studies as patients continue to complete treatment.

Selling, general and administrative expense for the 2019 Quarter was $22.2 million, compared to $25.4 million for the 2018 Quarter. The decrease of $3.2 million, or 12.6%, was primarily due to a decrease of $2.3 million in consulting and professional fees, primarily related to the support of commercial launch preparation activities in the 2018 Quarter and a decrease of $0.9 million in personnel related costs, including non-cash stock-based compensation.

Net loss for the 2019 Quarter was $30.1 million, or $0.41 per share (basic and diluted), compared to $21.7 million, or $0.29 per share (basic and diluted), for the 2018 Quarter.

For the 2019 Quarter, non-GAAP adjusted net loss was $26.2 million, or $0.35 per share, compared to non-GAAP adjusted net loss of $19.4 million, or $0.26 per share, for the 2018 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

As of September 30, 2019, Verastem Oncology had cash, cash equivalents and short-term investments of $160.2 million.

Financial Guidance for Fiscal 2019

Verastem Oncology is reiterating its full-year 2019 guidance and expects net product revenue for COPIKTRA to be in the range of $12-14 million. This guidance is based on product revenue to date, current run rates and near-term expectations.

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Tuesday, October 29, 2019, at 4:30 PM (ET). The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 5785818.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are essentially the same disease, with the only difference being the location where the cancer primarily occurs. When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL. The symptoms of CLL/SLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL/SLL will live for years without symptoms. In 2018, there were approximately 200,000 patients in the United States affected by CLL/SLL with nearly 20,000 new diagnoses. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, representing a significant medical need. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with CLL/SLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. In 2018, this lymphoma subtype accounted for 20 to 30 percent of all NHL cases, with more than 140,000 people in the United States with FL and more than 13,000 newly diagnosed patients. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients living for many years with this form of lymphoma. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with FL.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is an aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.3,4,5 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.