Harpoon Therapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Update

On August 5, 2019 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the second quarter and six months ended June 30, 2019 and provided a corporate update (Press release, Harpoon Therapeutics, AUG 5, 2019, View Source [SID1234538132]).

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"I am pleased with the exciting progress Harpoon has made so far in 2019 with two T cell engagers, HPN424 and HPN536, in the clinic as planned," said Gerald McMahon, Ph.D., President and Chief Executive Officer of Harpoon Therapeutics. "The dose escalation portion of the clinical trial for our lead product candidate, HPN424, continues to advance and we expect to present an interim dataset during the first half of 2020 at an appropriate medical meeting. Our confidence in our TriTAC platform continues to solidify as we learn more about its capabilities and promise."

"Consistent with the TriTAC mechanism of action, we observed T cell activation and cytokine induction with HPN424 treatment, which prompted us to explore the use of dexamethasone as a premedication to limit potential adverse events," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon Therapeutics. "We have found that the addition of weekly dexamethasone premedication, tapered over several weeks, has successfully limited adverse events. When patients completed the scheduled taper, they continued to receive weekly HPN424, without dexamethasone, with no complications observed thus far. This strategy has allowed us to proceed with dose escalations of HPN424 and further advance this promising potential therapy."

Second Quarter 2019 Business Highlights and Other Recent Developments

HPN424, Harpoon’s lead product candidate in development as a potential treatment for prostate cancer, continues to enroll patients in a Phase 1 clinical trial. The treatment regimen has been modified to include premedication with dexamethasone, tapered over several weeks. Several patients have completed the scheduled taper, and have successfully continued treatment with HPN424 in the absence of dexamethasone. Enrollment is ongoing, with patients now being treated in the seventh dose-escalation cohort. Pharmacokinetics observed to date continue to support once-weekly dosing of HPN424. Harpoon plans to present interim results at a medical meeting in the first half of 2020.

In April, Harpoon advanced its second TriTAC, HPN536, a mesothelin-targeting T cell engager, into the clinic and dosed the first patient in a Phase 1/2a clinical trial for ovarian and other mesothelin-expressing solid tumors. Patient enrollment continues as planned and two dosing cohorts have been completed. The study consists of two phases, an initial dose escalation phase of approximately 20 ovarian cancer patients, followed by an expansion phase of up to three additional parallel cohorts of 20 patients each with ovarian, pancreatic and mesothelioma cancer. The study is collecting data to evaluate the safety, tolerability, pharmacokinetics and activity of HPN536. For additional information about the trial, please visit clinicaltrials.gov using the identifier NCT03872206.

Anticipated Milestones

HPN424 – present interim Phase 1 data in the first half of 2020 at a medical conference and initiate expansion cohort in 2020

HPN536 – present proof of concept data in 2020

HPN217 – submit IND by the end of 2019 and initiate Phase 1 trial in the first quarter of 2020

HPN328 – initiate Phase 1 trial in 2020

Second Quarter Financial Results

Harpoon Therapeutics ended the second quarter of 2019 with $133.9 million in cash, cash equivalents, and marketable securities compared to $89.5 million as of December 31, 2018. The increase was due to approximately $71 million in net proceeds from Harpoon’s initial public offering, completed in February 2019, partially offset by cash used in operations.

Net loss for the second quarter ended June 30, 2019 was $11.8 million compared to $6.0 million for the second quarter ended June 30, 2018. The net loss for the six months ended June 30, 2019 was $25.4 million compared to $10.9 million in the first six months of the prior year.

Revenue for the second quarter of 2019 was $1.1 million compared to $1.1 million for the second quarter of 2018. For the six months ended June 30, 2019, revenue was $2.1 million compared to $2.6 million for the six months ended June 30, 2018. For the six months ended June 30, 2019, the decrease was due to an upfront payment of $0.5 million recognized in the first quarter of 2018 related to our license agreement with Werewolf Therapeutics, Inc. During both the three and six month periods, revenue primarily consisted of the amortized portion of the deferred $17.0 million upfront payment received in October 2017 under the collaboration agreement with AbbVie.

Research and development (R&D) expense for the second quarter of 2019 was $10.0 million compared to $6.2 million for the second quarter of 2018. For the six months ended June 30, 2019, R&D expense was $19.4 million, compared to $11.7 million for the six months ended June 30, 2018. The increase for both periods primarily arose from clinical development expenses and an increase in personnel-related expenses, which included conducting preclinical studies, the continuation of the clinical trials for HPN424 and HPN536, and manufacturing activities for four TriTAC product candidates in various stages of development.

General and administrative (G&A) expense for the second quarter of 2019 was $3.7 million compared to $1.0 million for the second quarter of 2018. G&A expense for the six months ended June 30, 2019 was $9.6 million compared to $1.9 million for the six months ended June 30, 2018. The increase for both periods was due to an increase in consulting and accounting services primarily related to the 2018 audit, legal fees, headcount, and other professional services to support our ongoing operations as a public company.

China Biologic Reports Financial Results for the Second Quarter of 2019

On August 5, 2019 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its unaudited financial results for the second quarter of 2019 (Press release, China Biologic Products, AUG 5, 2019, View Source [SID1234538148]).

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Second Quarter 2019 Financial Highlights

Total sales in the second quarter of 2019 increased by 20.4% in RMB terms and 12.7% in USD terms to $135.7 million from $120.4 million in the same quarter of 2018.
Gross profit increased by 9.9% to $90.9 million from $82.7 million in the same quarter of 2018. Gross margin decreased to 67.0% from 68.7% in the same quarter of 2018.
Income from operations increased by 34.3% to $48.2 million from $35.9 million in the same quarter of 2018. Operating margin increased to 35.5% from 29.8% in the same quarter of 2018.
Non-GAAP adjusted income from operations increased by 23.1% in RMB terms and 15.2% in USD terms to $56.7 million from $49.2 million in the same quarter of 2018.
Net income attributable to the Company increased by 55.2% in RMB terms and 45.5% in USD terms, to $41.6 million from $28.6 million in the same quarter of 2018. Fully diluted earnings per share increased to $1.06 compared to $0.83 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company increased by 29.1% in RMB terms and 21.1% in USD terms to $48.7 million from $40.2 million in the same quarter of 2018. Non-GAAP adjusted earnings per share increased to $1.24 from $1.17 in the same quarter of 2018.
"China Biologic continued to deliver solid financial results in the second quarter, driven primarily by higher-than-usual sales volumes of albumin and a high growth in sales volume for certain hyper-immunoglobulin products. However, IVIG sales remained sluggish, and the growth of albumin sales slowed down. While we closely monitor the impact of changes in the policy and market environment, we maintain our outlook for the year," said Joseph Chow, Chairman and CEO of China Biologic.

"As expected, the growth in albumin sales that we had experienced in the first quarter decelerated during the second quarter, reflecting the alleviation of the albumin supply shortage situation in the market due to relaxation of import constraints imposed in the earlier months of 2019. We expect growth in albumin sales to slow down further during the second half of the year, as a result of our relatively fixed level of annual production of albumin and the large volume of albumin which was oversold in the first half of the year. Sales of IVIG products during the second quarter still lagged behind our expectations, reflecting the continued negative impact of the policy controls on higher-unit-cost prescription drugs. Looking ahead, our polypeptide products may be included in China’s national and regional key drug lists for monitoring and prescription control, which we expect would significantly impact its sales. In addition, due to the increase of our account receivable turnover days relative to peer companies in the last two quarters, we have decided to begin a comprehensive review of our existing credit sale policies regarding pricing and credit terms, and to increase collection efforts to ensure our credit exposure is within the limits of our risk tolerance level. These measures could potentially impact our sales in the near term."

"In June, we obtained approval from the China National Medical Products Administration to begin human clinical trials on a Human von Willebrand Factor (VWF) product, which is intended to be used for the treatment of bleeding episodes including surgical bleeding in patients with von Willebrand disease. We expect that it will take approximately three years to complete the clinical trials. In late July, we received the operating permit for our new Wenchang plasma collection station in Hainan Province and immediately commenced commercial operations. We are also pleased to announce that in early August we completed the acquisition of the remaining 20% interest in TianXinFu and made it an indirect wholly-owned subsidiary of the Company, which will allow us to fully capture the growth potential of this leading player in the regenerative medical bio-material industry, better realize the synergies between TianXinFu’s business and China Biologic’s high-end coagulation factor business, and receive the full benefits and earnings accretion from existing and future TianXinFu products."

"Moving forward, with a stable and experienced team in place, we will continue our efforts to execute our sales and marketing strategies, including expanding our sales coverage and enhancing promotion of IVIG and high-end coagulation factor products to improve their prescription volumes in hospitals."

Appointment of Joseph Chow as CEO

The Company reported that its board of directors (the "Board") has appointed Mr. Joseph Chow as the CEO of the Company, effective August 5, 2019.

Mr. Chow is an experienced executive and has held managerial positions in various public and private companies. Mr. Chow has been a member of our Board since November 2014, our Chairman since February 2019 and our acting CEO since May 2019. After the departure of our former CEO in May 2019, the Board formed a search committee to seek a new CEO for the Company. After several months’ search and evaluation of both internal and external candidates, the search committee recommended Mr. Chow to the Board and the Board approved his appointment. The Board believes that, with his deep understanding of the Company and extensive experience in corporate finance and management, Mr. Chow is well qualified for the position and will lead the Company towards long-term sustainable growth.

Mr. Chow will continue to serve as a director and the Chairman of the Company. In order to fully devote to the affairs of the Company, Mr. Chow has resigned from all positions he previously held at Centurium Capital and no longer holds any interest in Centurium Capital or funds managed by it.

Mr. Chow stated, "I am thankful for the confidence and trust the Board has placed in me as the Company’s new CEO. I am looking forward to working with the management, employees and partners to redevelop the future roadmap for our business that charts its course and ensures long-term improved and sustainable growth."

Share Repurchase Program

In May 2019, the Board authorized a share repurchase program under which China Biologic may repurchase up to US$150 million worth of shares over a 12-month period. As of June 30, 2019, the Company had repurchased 121,852 shares at a total of $11.0 million under this program.

Second Quarter 2019 Financial Performance

Total sales in the second quarter of 2019 increased by 20.4% in RMB terms, or 12.7% in USD terms, to $135.7 million from $120.4 million in the same quarter of 2018.

Total sales for biopharmaceutical products (including plasma products and placenta polypeptide products) increased by 21.6% in RMB terms, or 14.0% in USD terms, to $122.3 million from $107.3 million in the same quarter of 2018, as a result of increased sales of human albumin products, certain hyper-immune products and coagulation factor products, which was partly offset by decreased sales of placenta polypeptide products. For plasma products, total sales in the second quarter of 2019 increased by 31.2% in RMB terms, or 22.8% in USD terms, to $111.0 million from $90.3 million in the same quarter of 2018.

Total sales for biomaterial products in the second quarter of 2019 increased by 9.9% in RMB terms, or 3.1% in USD terms, to $13.4 million from $13.0 million in the same quarter of 2018, as a result of higher sales concentration of higher-unit-price artificial dura mater products.

During the second quarter of 2019, human albumin and IVIG products remained the Company’s two largest sales contributors. Revenue from human albumin increased by 36.9% in RMB terms, or 28.3% in USD terms, from $38.1 million in the second quarter of 2018 to $48.9 million in the second quarter of 2019. Revenue from IVIG products increased by 4.0% in RMB terms, or decreased by 2.5% in USD terms, from $28.1 million in the second quarter of 2018 to $27.4 million in the second quarter of 2019. As a percentage of total sales, sales from human albumin and IVIG products were 36.0% and 20.2%, respectively, in the second quarter of 2019.

Sales volume of human albumin products increased by 38.2% for the second quarter of 2019, primarily due to increased sales volumes in the distributor and pharmacy channels, supplemented by increased direct sales to hospitals and inoculation centers. The sales volume of IVIG products increased by 5.3% for the second quarter of 2019 as a result of increased sales through the direct sales channel.

The average prices for human albumin and IVIG products decreased by 0.9% and 1.2%, respectively, in RMB terms in the second quarter of 2019 compared to the same quarter of 2018 because of higher sales volume in the distributor channel and lower prices to certain distributors reflecting intensified market competition for major plasma products. In USD terms, the average price for human albumin and IVIG products decreased by 7.2% and 7.5%, respectively, in the second quarter of 2019 compared to the same quarter of 2018.

Revenue from other immunoglobulin products increased by 31.9% in RMB terms, or 23.5% in USD terms in the second quarter of 2019 compared to the same quarter of 2018, reaching 14.0% of total sales as compared to 12.8% of total sales in the same quarter of 2018. The revenue increase was mainly attributable to increased sales volume of human rabies immunoglobulin and human tetanus immunoglobulin products.

Revenue from other plasma products, including human coagulation factor VIII, human prothrombin complex concentrate, and human fibrinogen products, increased by 92.7% in RMB terms, or 80.5% in USD terms, in the second quarter of 2019 compared to the same quarter of 2018, representing 11.5% of total sales in the second quarter of 2019. The growth mainly came from increased sales through the distributor channel.

Revenue from placenta polypeptide products decreased by 29.0% in RMB terms, or 33.5% in USD terms for the second quarter of 2019 as compared to the same quarter of 2018, accounting for 8.3% of total sales compared to 14.1% of total sales in the second quarter of 2018, mainly in line with a decrease in sales volume as a result of the inclusion of placenta polypeptide products in regional adjuvant drug lists, which put a downward pressure on their prescription volume.

Cost of sales increased by 19.1% to $44.8 million in the second quarter of 2019 from $37.6 million in the same quarter of 2018. As a percentage of total sales, cost of sales increased to 33.0% from 31.2% in the same quarter of 2018, mainly due to decreased sales prices for most of the Company’s plasma products and increased plasma collection costs.

Gross profit increased by 9.9% to $90.9 million in the second quarter of 2019 from $82.7 million in the same quarter of 2018. Gross margin was 67.0% and 68.7% in the second quarter of 2019 and 2018, respectively.

Total operating expenses in the second quarter of 2019 decreased by $4.2 million, or 9.0%, to $42.7 million from $46.9 million in the same quarter of 2018. This decrease mainly consisted of a decrease of $5.9 million in general and administrative expenses, partially offset by an increase of $1.2 million in selling expenses and $0.5 million in research and development expenses. As a percentage of total sales, total operating expenses decreased to 31.5% in the second quarter of 2019 from 39.0% in the same quarter of 2018.

Selling expenses in the second quarter of 2019 increased by $1.2 million, or 4.9%, to $25.6 million from $24.4 million for the second quarter of 2018. The increase is primarily due to increased selling expenses for plasma products and biomaterial products, which is partly offset by a decrease in marketing and promotion expenses related to placenta polypeptide products. As a percentage of total sales, selling expenses decreased to 18.9% for the second quarter of 2019 from 20.3% in the same quarter of 2018.

General and administrative expenses in the second quarter of 2019 decreased by $5.9 million, or 28.6%, to $14.7 million from $20.6 million in the same quarter of 2018. As a percentage of total sales, general and administrative expenses decreased to 10.8% for the second quarter of 2019 from 17.1% for the same quarter of 2018. The decrease in general and administrative expenses was mainly because of a decrease in share-based compensation expenses and a reversal of allowance for doubtful accounts receivable.

Research and development expenses in the second quarter of 2019 increased by $0.5 million, or 26.3%, to $2.4 million from $1.9 million in the same quarter of 2018. As a percentage of total sales, research and development expenses increased to 1.8% from 1.6% in the same quarter of 2018.

Income from operations in the second quarter of 2019 increased by 43.4% in RMB terms, or 34.3% in USD terms, to $48.2 million from $35.9 million in the same quarter of 2018. Operating margin increased to 35.5% in the second quarter of 2019 from 29.8% in the second quarter of 2018.

Income tax expense in the second quarter of 2019 increased by 22.4%, to $8.2 million from $6.7 million in the same period of 2018. The effective income tax rate was 14.4% and 16.5% for the second quarter of 2019 and 2018, respectively.

Net income attributable to the Company increased by 55.2% in RMB terms, or 45.5% in USD terms, to $41.6 million in the second quarter of 2019 from $28.6 million in the same period of 2018. Net margin increased to 30.7% in the second quarter of 2019 from 23.8% in the same period of 2018. Diluted net earnings per share increased to $1.06 in the second quarter of 2019 compared to $0.83 in the same period of 2018.

Non-GAAP adjusted income from operations increased by 23.1% in RMB terms, or 15.2% in USD terms, to $56.7 million in the second quarter of 2019 from $49.2 million in the same period of 2018.

Non-GAAP adjusted net income attributable to the Company increased by 29.1% in RMB terms and 21.1% in USD terms, to $48.7 million in the second quarter of 2019 from $40.2 million in the same period of 2018. Non-GAAP net margin increased to 35.9% in the second quarter of 2019 from 33.4% in the same period of 2018. Non-GAAP adjusted net income per diluted share increased to $1.24 in the second quarter of 2019 from $1.17 in the same period of 2018.

Non-GAAP adjusted income from operations for the second quarter of 2019 excludes $6.5 million in non-cash employee share-based compensation expenses, and $2.0 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the second quarter of 2019 exclude $5.6 million in non-cash employee share-based compensation expenses, and $1.4 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

First Half 2019 Financial Performance

Total sales in the first half of 2019 increased by 21.3% in RMB terms, or 14.0% in USD terms, to $265.5 million from $232.8 million in the same period of 2018.

Total sales for biopharmaceutical products increased by 21.9% in RMB terms, or 14.5% in USD terms, to $238.7 million from $208.4 million in the same period of 2018, as a result of increases in the sales of human albumin products, immunoglobulin products and coagulation factor products, which was partly offset by decreases in the sales of placenta polypeptide products. For plasma products, total sales in the first half of 2019 increased by 33.4% in RMB terms, or 25.4% in USD terms, to $219.8 million from $175.3 million in the same period of 2018. As a percentage of total sales, sales from human albumin and IVIG products accounted for 39.8% and 21.3%, respectively, in the first half of 2019.

Total sales for biomaterial products in the first half of 2019 increased by 16.4% in RMB terms, or 9.4% in USD terms, to $26.7 million from $24.4 million in the same period of 2018, as a result of higher sales concentration in higher-unit-price artificial dura mater products.

Cost of sales increased by 24.8% to $89.0 million in the first half of 2019 from $71.3 million in the same period of 2018. As a percentage of total sales, cost of sales increased to 33.5% from 30.6% in the same period of 2018, mainly because of decreased sales prices for most of the Company’s plasma products, and increased plasma collection costs.

Gross profit increased by 9.3% to $176.5 million in the first half of 2019 from $161.5 million in the same period of 2018. Gross margin was 66.5% and 69.4% in the first half of 2019 and 2018, respectively.

Total operating expenses in the first half of 2019 decreased by $2.3 million, or 2.7%, to $84.4 million from $86.7 million in the same period of 2018. This decrease mainly consisted of a decrease of $2.7 million in general and administrative expenses and $0.6 million in selling expense, partially offset by an increase of $1.1 million in research and development expenses. As a percentage of total sales, total operating expenses decreased to 31.8% in the first half of 2019 from 37.2% in the same period of 2018.

Income from operations in the first half of 2019 increased by 30.9% in RMB terms, or 23.1% in USD terms, to $92.1 million from $74.8 million in the same period of 2018. Operating margin increased to 34.7% in the first half of 2019 from 32.1% in the first half of 2018.

Income tax expense in the first half of 2019 increased by $2.6 million, or 19.3%, to $16.1 million from $13.5 million in the same period of 2018. The effective income tax rate was 14.7% and 15.9% for the first half of 2019 and 2018, respectively.

Net income attributable to the Company increased by 40.2% in RMB terms, or 31.7% in USD terms, to $79.3 million in the first half of 2019 from $60.2 million in the same period of 2018. Net margin increased to 29.9% in the first half of 2019 from 25.9% in the same period of 2018. Diluted net earnings per share increased to $2.01 in the first half of 2019 compared to $1.75 in the same period of 2018.

Non-GAAP adjusted income from operations increased by 16.7% in RMB terms and 9.7% in USD terms to $108.9 million in the first half of 2019 from $99.3 million in the same period of 2018.

Non-GAAP adjusted net income attributable to the Company increased by 21.6% in RMB terms, and 14.3% in USD terms, to $93.2 million in the first half of 2019 from $81.6 million in the same period of 2018. Non-GAAP net margin remained comparatively stable at 35.1% in the first half of 2019 compared with 35.0% in the same period of 2018. Non-GAAP adjusted net income per diluted share was $2.36 and $2.37, respectively, in the first half of 2019 and 2018.

Non-GAAP adjusted income from operations for the first half of 2019 excludes $12.8 million in non-cash employee share-based compensation expenses, and $4.1 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the first half of 2019 exclude $11.1 million in non-cash employee share-based compensation expenses, and $2.8 million in amortization of intangible assets and land use rights related to the acquisition of TianXinFu.

As of June 30, 2019, the Company had $202.5 million in cash on hand and demand deposits, $523.9 million in time deposits, and $191.1 million in short term investments.

Net cash provided by operating activities for the first half of 2019 was $94.2 million as compared to $45.5 million for the same period of 2018. The $48.7 million increase in net cash provided by operating activities was a combined result of the increase in net income and a slowdown of increase in accounts receivable and inventories compared to the first half of 2018.

Accounts receivable increased by $15.2 million during the first half of 2019 as compared to $30.3 million during the same period of 2018. The accounts receivable turnover days for plasma products increased to 102 days during the first half of 2019 from 88 days during the same period of 2018, reflecting longer credit terms to hospitals as a result of the nationwide implementation of healthcare reform measures and intensified competition in the distributor channel.

Inventories increased by $4.3 million in the first half of 2019, which was milder than the increase of $21.4 million in the same period of 2018. This reflected a lower level of albumin inventory attributable to higher-than-expected albumin sales, which was partially offset by higher IVIG inventory due to sluggish IVIG sales.

Net cash used in investing activities for the first half of 2019 was $117.5 million as compared to $168.9 million for the same period of 2018. During the first half of 2019, the Company paid $15.1 million for the acquisition of property, plant and equipment, intangible assets and land use rights, and the Company also purchased time deposits and short-term investments in the amount of $1,265.0 million. This was partly offset by $1,162.7 million from the maturity of time deposits and short term investments. Net cash used in investing activities in the first half of 2018 mainly consisted of $529.6 million payment for purchase of time deposits and short term investments, and $19.1 million for the acquisition of property, plant and equipment, intangible assets, and land use rights, which was partly offset by $97.7 million cash received upon acquisition of TianXinFu and the maturity of $282.1 million time deposits and short term investments.

Net cash used in financing activities for the first half of 2019 was $114.9 million as compared to net cash provided by financing activities of $0.8 million for the same period of 2018. In the first half of 2019, $110.0 million was remitted to an investment bank by the Company to execute the previously approved share repurchase program on behalf of the Company. During this period, 1,196,228 shares were repurchased at a total amount of $111.0 million. Net cash provided by financing activities in the first half of 2018 represented proceeds of $0.8 million from stock options exercised.

Financial Outlook

The Company reiterates its forecast for the full year 2019. The company expects both non-GAAP adjusted income from operations and non-GAAP adjusted net income to increase by 4% to 6% in RMB terms over full year 2018 financial results.

This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.59 = $1.00 based on weighted average quarterly exchange rates in 2018 in translating 2018 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2019 could be affected by the foreign currency translation impact.

This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2019. This forecast reflects the Company’s current and preliminary views, which are subject to change.

Conference Call

The Company will host a conference call at 7:30 am Eastern Time on Tuesday, August 6, 2019, which is 7:30 pm Beijing Time on August 6, 2019, to discuss its second quarter 2019 results and answer questions from investors. Listeners may access the call by dialing:

US:

1 888 346 8982

International:

1 412 902 4272

Hong Kong:

800 905 945

China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through August 13, 2019. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10133955

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source

SELLAS Announces Completion of Enrollment in Randomized Phase 2 VADIS Trial of Nelipepimut-S (NPS) in Women with Ductal Carcinoma In Situ (DCIS) of the Breast

On August 5, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported completion of enrollment in a Phase 2 randomized investigator-sponsored trial (IST) of nelipepimut-S (NPS) in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) in women with ductal carcinoma in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive, express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or post-menopausal (Press release, Sellas Life Sciences, AUG 5, 2019, View Source [SID1234538133]).

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"We are pleased to announce completion of enrollment in the Phase 2 VADIS trial, an important milestone for our NPS clinical program. The premise of the VADIS study is quite innovative, as it will provide valuable data and give us the opportunity to gauge in a controlled, randomized setting whether NPS can effectively induce an antitumor immune response in DCIS patients. We believe NPS could serve as an earlier stage treatment for women with breast cancer and hope to gain through this study further insights on the immunobiological mechanism underlying the clinical activity of NPS. The VADIS results could inform us as to potential synergies between NPS and standard therapies in women with DCIS. We are excited to move NPS another step closer to our goal of improving the therapeutic options for breast cancer patients by potentially serving as an early stage treatment for patients with DCIS. We look forward to seeing the initial data by the end of 2019," said Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS.

"We are delighted to have completed enrollment in the VADIS study, which will test for an array of sophisticated histologic, immunodynamic and molecular markers of immune responses following treatment with NPS, including induction of HER2-specific cytotoxic T lymphocyte (CTL) and epitope spreading, the latter being the herald of clinical efficacy for a successful peptide vaccine," said Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale Distinguished Chair in Surgical Oncology, Director of Research, Breast Surgical Oncology Brigham and Women’s Hospital, Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer Center, and the Principal Investigator of the Phase 2 VADIS trial. "VADIS is poised to inform us on the design of future treatment strategies for DCIS, which remains an unmet medical need, including combinations of NPS with standard therapies in a broad population," concluded Dr. Mittendorf.

About the Phase 2 VADIS Trial

This Phase 2 randomized trial is sponsored and operationalized by the National Cancer Institute (NCI) to study NPS’ potential clinical effects in earlier-stage disease. Patients are randomized to receive, prior to surgery, either GM-CSF followed by NPS two weeks later or GM-CSF alone. The primary endpoint of the trial is the difference in the frequency of newly induced NPS-cytotoxic T lymphocytes (CTL; CD8+ T-cell) in peripheral blood between the two arms of the study, using a dextramer assay. Secondary endpoints to be compared between the two arms include the nature and incidence of adverse events and in vivo immune response to NPS, in addition to other select histologic and molecular biomarkers. Initial data from this trial are expected by the end of 2019.

About DCIS

DCIS is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct and have not spread outside the duct to other tissues in the breast. DCIS is the most common type of breast neoplasm with malignant potential. In some cases, DCIS may become invasive cancer and spread to other tissues and, currently, it is not possible to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. Tamoxifen is given in cases with hormone receptor positivity only. No targeted or immune therapies have shown any definitive clinical activity in DCIS to date. The current standard treatment aims at forestalling the progression of DCIS to invasive cancer. In approximately 15-25% of cases progression does occur. DCIS is diagnosed in more than 60,000 women each year in the United States, comprising 1 in 5 newly diagnosed cases of breast cancer.

Mirati Therapeutics Reports Second Quarter 2019 Financial Results

On August 5, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported financial results for the second quarter ended June 30, 2019 (Press release, Mirati, AUG 5, 2019, View Source [SID1234538149]).

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Second Quarter Highlights:

Initiated the Phase 3 randomized clinical trial, evaluating the combination of sitravatinib and nivolumab versus single-agent docetaxel, in second line patients with advanced non-squamous non-small cell lung cancer (NSCLC), following treatment with a first line, platinum-based regimen and a checkpoint inhibitor.
Completed a successful public offering of common stock in June that provided net cash proceeds of $219.9 million.
Appointed Dr. Julie Cherrington, Ph.D. to Mirati’s Board of Directors.
"The first half of 2019 continued to bring significant advancements across our pipeline. We strengthened our financial position following our successful public offering in June and are well positioned to expand clinical development of MRTX849 as both a single agent and in combination with other therapies. Additionally, the appointment of Dr. Julie Cherrington to our Board brings significant research and development expertise that will strengthen our programs," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "We expect that the second half of 2019 will be an exciting time for Mirati as we expect to advance MRTX849 into the single-agent expansion cohorts and into combination studies. In addition, we continue to expand the development efforts of sitravatinib in multiple indications and through our collaboration with BeiGene."

Financial Results for the Second Quarter 2019

Cash, cash equivalents, and short-term investments were $485.5 million at June 30, 2019, compared to $222.8 million at December 31, 2018. In January 2019, we completed a public offering of common stock that provided net cash proceeds of $107.9 million. In June 2019, we completed a public offering of common stock that provided net cash proceeds of $219.9 million.

License and collaboration revenues relate to the Collaboration and License Agreement between the Company and BeiGene, Ltd. ("BeiGene"), dated January 7, 2018. License and collaboration revenues for the three and six months ended June 30, 2019 were $0.6 million and $1.8 million, respectively, compared to none and $9.5 million for the three and six months ended June 30, 2018, respectively. The 2019 revenues relate to revenues earned in connection with a manufacturing supply services agreement with BeiGene and the 2018 revenues relate to the license the Company granted to BeiGene under the Collaboration and License Agreement.

Research and development expenses for the second quarter of 2019 were $38.3 million, compared to $23.8 million for the same period in 2018. Research and development expenses for the six months ended June 30, 2019 were $72.6 million, compared to $43.5 million for the same period in 2018. The increase in research and development expenses is due to an increase in expense associated with sitravatinib and MRTX849, as well as an increase in salaries and related expense, including an increase in share-based compensation expense. The increase in sitravatinib expense is due to increased costs to support the expansion of existing and new clinical trials, and the increase in MRTX849 expense relates to the Phase 1 clinical trial, which was initiated in the first quarter of 2019. The Company recognized research and development-related share-based compensation expense of $6.6 million during the second quarter of 2019, compared to $1.8 million for the same period in 2018, and $11.8 million during the six months ended June 30, 2019, compared to $3.3 million for the same period in 2018.

General and administrative expenses for the second quarter of 2019 were $9.9 million, compared to $4.8 million for the same period in 2018. General and administrative expenses for the six months ended June 30, 2019 were $19.7 million, compared to $10.0 million for the same period in 2018. The increase is primarily due to an increase in share-based compensation expense due to an increase in the fair value of stock options granted during the three and six months ended June 30, 2019 compared to the same periods in 2018. The Company recognized general and administrative-related share-based compensation expense of $6.0 million during the second of 2019, compared to $2.1 million for the same period in 2018, and $12.0 million during the six months ended June 30, 2019, compared to $4.3 million for the same period in 2018.

Net loss for the second quarter of 2019 was $45.7 million, or $1.26 per share basic and diluted, compared to net loss of $27.9 million, or $0.94 per share basic and diluted for the same period in 2018. Net loss for the six months ended June 30, 2019 was $86.6 million, or $2.43 per share basic and diluted, compared to net loss of $42.6 million, or $1.45 per share basic and diluted for the same period in 2018.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

Sitravatinib is also being evaluated as a single-agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma.

About MRTX849

MRTX849 is an investigational, orally-available small molecule that is designed to potently and selectively inhibit a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of non-small cell lung cancer adenocarcinoma patients, 4% of colorectal cancer patients, and subsets of other types of cancer. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MRTX849 is being evaluated in a Phase 1/2 trial treating patients with molecularly-identified, KRAS G12C-positive advanced solid tumors.

Syndax to Participate in the BTIG Biotechnology Conference

On August 5, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will participate in a panel discussion on targeted oncology therapies at the BTIG Biotechnology Conference on Monday, August 12, 2019 at 4:00 p.m. ET at the St. Regis New York (Press release, Syndax, AUG 5, 2019, View Source [SID1234538134]).

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

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