On March 12, 2020 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported findings from a sub-analysis of data from its PROCEED registry comparing overall survival (OS) in African American (AA) and Caucasian (CAU) men with metastatic castrate-resistant prostate cancer (mCRPC) who were treated with PROVENGE (sipuleucel-T) in a real-world treatment setting (Press release, Dendreon, MAR 12, 2020, View Source [SID1234555513]).

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When comparing PSA-matched AA men to CAU men with a baseline PSA less than or equal to the median (29.48 ng/mL), AA men in the PROCEED registry demonstrated a median OS of over 4.5 years (54.3 months) versus over 2.7 years (33.4 months) for CAU men – an improvement of 20.9 months and a 48% relative risk reduction in death.1,2

"Racial differences in the effectiveness of treatments in mCRPC are well documented," said Oliver Sartor, M.D., co-lead author of the publication, associate dean for oncology at Tulane University School of Medicine and medical director of the Tulane Cancer Center. "The high percentage of AA men enrolled in PROCEED compared to other trials provided a unique opportunity to evaluate the effectiveness of immunotherapy in extending survival in this patient population."

The PROCEED registry enrolled nearly 2,000 patients with mCRPC who received PROVENGE between 2011 and 2014 in everyday treatment settings, and followed them for three years. Approximately 12% of patients enrolled in PROCEED were AA. This analysis compared OS in a subset of AA patients (n=107) and CAU patients (n=222) matched by baseline PSA.3

"Black men tend to present with aggressive prostate cancer and have twice the mortality rate as compared to white men," said Andrew J. Armstrong, M.D., co-lead author of the publication, professor of medicine at Duke University School of Medicine and member of the Duke Cancer Institute. "However, in the context of immunotherapy for men with mCRPC, we observe that black men have significantly improved overall survival as compared to similar white men. While we do not yet understand the reasons for this improved survival by self-identified race, these data provide evidence to support the early use of sipuleucel-T immunotherapy regardless of race in order to improve long-term survival."

PROCEED evaluated the real-world use of PROVENGE in men with asymptomatic or minimally symptomatic mCRPC. These data were published online in Prostate Cancer and Prostatic Diseases (PCAN), a peer-reviewed Nature Research journal. The publication in PCAN is the first time these sub-group data have been published in a peer-reviewed journal.

"These findings add to the growing body of published clinical evidence that PROVENGE extends life in men with mCRPC and underscore its added effectiveness in African American men," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "No other prostate cancer treatment has shown this level of added benefit in African American men with mCRPC, so these findings are exciting."

About the PROCEED Registry

PROCEED (NCT01306890) was a multicenter, open-label, observational registry conducted at urology and medical oncology clinics in private practice and academic sites. PROCEED enrolled 1,976 patients with mCRPC, of whom 1,902 received PROVENGE between 2011 and 2014 in everyday treatment settings. Of these, approximately 12% were African American. In the entire PROCEED population, patients were followed for a median of 46.6 months. Their median age was 72 years and their median baseline PSA was 15.0 ng/mL. The sub-analysis published in PCAN compared OS in a subset of African American patients (n=219) and Caucasian patients (n=438) matched by baseline PSA.

About Prostate Cancer in African American Men

Prostate cancer is the most frequently occurring non-cutaneous cancer among men in the United States and is second only to lung cancer among the leading causes of cancer-related deaths. In 2020, an estimated 191,930 new cases of prostate cancer will be diagnosed in the United States and 33,330 men will die from the disease.4

African American men have the highest prostate cancer incidence rate of any racial or ethnic group in the world.5 In the United States, the risk of prostate cancer is 74% higher in black men than non-Hispanic white men.6 The incidence of prostate cancer is about 60% higher in blacks than in whites for reasons that remain unclear.4 Prostate cancer death rates in blacks are more than double those of every other racial and ethnic group in the United States.4

About PROVENGE (sipuleucel-T)

PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

On March 12, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the pricing of an underwritten public offering of 8,333,334 ordinary shares at a price to the public of $9.00 per share (Press release, Compugen, MAR 12, 2020, View Source [SID1234555454]). The gross proceeds to Compugen from the offering are expected to be approximately $75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Compugen. In addition, Compugen has granted the underwriters a 30-day option to purchase up to an additional 1,250,000 ordinary shares, at the public offering price less underwriting discounts and commissions. The offering is expected to close on or about March 16, 2020, subject to customary closing conditions.

SVB Leerink and Stifel are acting as joint bookrunning managers for the offering. SunTrust Robinson Humphrey is acting as lead manager for the offering and Oppenheimer & Co. is acting as co-manager for the offering.

The securities described above are being offered by Compugen pursuant to a shelf registration statement on Form F-3, including a base prospectus, that was previously filed by Compugen with the Securities and Exchange Commission (the "SEC") and that was declared effective on August 12, 2019. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at +1(800) 808-7525, ext. 6218, or by email at [email protected], or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at +1(415) 364-2720 or by email at [email protected].

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

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On March 12, 2020 Champions Oncology, Inc. (Nasdaq: CSBR), engaged in an end-to-end range of research and development technology solutions and services to improve the development and use of oncology drugs, reported its financial results for the third fiscal quarter ended January 31, 2020 (Press release, Champions Oncology, MAR 12, 2020, View Source [SID1234555483]).

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Third Quarter Highlights:

Record quarterly revenue of $9.0 million, an increase of 40% year-over-year

Reported income of $881,000 excluding stock-based compensation and depreciation

Achieved record quarterly bookings

Ronnie Morris, CEO of Champions, commented, "Our third quarter revenue results were record breaking, exceeding $9 million for the first time. We continued to see bookings strength, aided by an increase in end point analysis testing in our studies. The pipeline of opportunities in GCLP flow cytometry services continued to expand and we are confident GCLP flow will contribute to future revenue growth."

David Miller, CFO of Champions added, "As anticipated, we started the second half of the year with very strong results with near record income on both a GAAP and Non-GAAP basis and we anticipate remaining profitable for the remainder of the year."

Third Fiscal Quarter Financial Results

For the third quarter of fiscal 2020, revenue increased 40.6% to $9.0 million compared to $6.4 million for the third quarter of fiscal 2019. The increase in revenue is due to increased sales, both in number and size of studies. Additionally, customers are seeking more complex study designs and end point analysis testing, leading to larger contracts, contributing to the revenue growth. Total costs and operating expenses for the third quarter of fiscal 2020 were $8.6 million compared to $6.8 million for the third quarter of fiscal 2019, an increase of $1.8 million or 26.5%.

Exhibit 99.1

For the third quarter of fiscal 2020, Champions reported income from operations of $433,000, including $229,000 in stock-based compensation and $219,000 in depreciation expenses, an increase of $803,000 compared to the loss from operations of $370,000, inclusive of $335,000 in stock-based compensation and $164,000 in depreciation expenses, in the third quarter of fiscal 2019. Excluding stock-based compensation and depreciation expenses, Champions reported non-GAAP income from operations of $881,000 for the third quarter of fiscal 2020 compared to non-GAAP income from operations of $129,000 in the third quarter of fiscal 2019, an increase of $752,000.

Cost of oncology solutions was $4.3 million for the three-months ended January 31, 2020, an increase of $900,000, or 26.5% compared to $3.4 million for the three-months ended January 31, 2019. For the three- months ended January 31, 2020, gross margin was 52.0% compared to 46.7% for the three-months ended January 31, 2019. Gross margin varies based on timing differences between expense and revenue recognition. The increase in cost of oncology services for the three-month period was mainly due to an increase in compensation and lab supply expenses. The overall expense increase is generally in line with the expected contribution based on the growth in revenue and study volume.

Research and development expense was $1.4 million and $1.3 million for the three-months ended January 31, 2020 and January 31, 2019, respectively. We continued to invest in research and development to offer new PDx models, ex-vivo assays and to expand our endpoint analysis testing. Sales and marketing expense for the three-months ended January 31, 2020 was $1.3 million, an increase of $428,000, or 48.7%, compared to $879,000 for the three-months ended January 31, 2019. The increase was primarily due to compensation expense driven by the continued expansion of the sales force and commissions earned. General and administrative expense was $1.6 million for the three-months ended January 31, 2020 compared to $1.2 million for the three-months ended January 31, 2019, an increase of $400,000 or 33.3%. The increase was mainly due to an increase in compensation expense and a non-recurring bad debt write-off.

Net cash used in operating activities was $41,000. The quarter’s use of cash from operations was primarily due to ordinary course of business timing differences in working capital items for the third quarter of 2020, including an increase in accounts receivable, of $759,000 and a decrease in accounts payable of $893,000.

The Company ended the quarter with $3.3 million of cash. Additionally, subsequent to the quarter end, approximately 700,000 warrants were cash exercised, adding an additional $4 million to the balance sheet. The Company has no debt.

Year-to-Date Financial Results

For the first nine months of fiscal 2020, revenue increased 20.8% to $23.4 million, as compared to $19.3 million for the first nine months of fiscal 2019. For the first nine months of fiscal 2020, total operating expenses increased 22.7% to $23.3 million, as compared to $19.0 million for the first nine months of fiscal 2019. The increase in revenue is due to increased sales, both in number and size of studies, and expanding our customer base.

For the first nine months of fiscal 2020, Champions reported income from operations of $109,000, which includes $437,000 in stock-based compensation and $579,000 in depreciation expenses, a decrease of $277,000 or 71.8%, compared to income from operations of $386,000, inclusive of $498,000 in stock-based compensation and $433,000 depreciation expenses, for the first nine months of fiscal 2019. Excluding stock-based compensation and depreciation, Champions reported non-GAAP operating income of $1.1

Exhibit 99.1

million for the first nine months of fiscal 2020 compared to income of $1.3 million for the same period last year.

Cost of oncology solutions was $12.0 million for the first nine months of fiscal 2020 compared to $10.0 million for the first nine months of fiscal 2019 an increase of $2.0 million or 20.0%. Gross margin was 48.8% for the first nine months of fiscal 2020, consistent with 48.5% for the first nine months of fiscal 2019. The increase in cost of oncology services for the nine-month period was mainly due to an increase in compensation and supply expenses.

Research and development expense was $4.0 million for the first nine months of fiscal 2020 an increase of $485,000, or 13.7% compared to $3.6 million for the first nine months of fiscal 2019. The increase is due to increased compensation and lab supply expenses related to new model development and product expansion. Sales and marketing expense for the first nine months of fiscal 2020 was $3.2 million, an increase of $1.0 million, or 47.6% compared to $2.1 million for the first nine months of fiscal 2019. The increase is the result of the continued expansion of the sales force. General and administrative expense was $4.1 million for the first nine months of fiscal 2020, an increase of $807,000 or 24.4% compared to $3.3 million for the first nine months of fiscal 2019. The increase for the nine-month period was mainly due to an increase in compensation, professional fees, and depreciation expenses offset by a reduction in recruiting costs.

Net cash provided by operations was $360,000 for the first nine months of fiscal 2020 compared to net
cash provided by operations of $1.6 million in 2019, a decrease of $1.3 million or 81.3%. The decrease in net cash provided by operations is primarily due to a decrease in working capital items for the third quarter of 2020 including an increase in accounts receivable and a decrease in accounts payable.

Conference Call Information:

The Company will host a conference call today at 4:30 p.m. EST (1:30 p.m. PST) to discuss its third quarter financial results. To participate in the call, please call 877-407-8035 (domestic) or 201-689-8035 (international) ten minutes ahead of the call and give the verbal reference "Champions Oncology."

On March 12, 2020 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, provided an update on recent company developments and reported fourth quarter and full-year financial results for the period ended December 31, 2019 (Press release, SpringWorks Therapeutics, MAR 12, 2020, View Source [SID1234555498]).

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"2019 was a very successful year for SpringWorks. We initiated three clinical trials, including two potentially registrational trials in rare oncology indications, formed MapKure with BeiGene to advance a next-generation B-RAF inhibitor, and signed our first collaboration with GlaxoSmithKline to evaluate nirogacestat in combination with BCMA-directed therapies in patients with relapsed and refractory multiple myeloma," said Saqib Islam, Chief Executive Officer of SpringWorks. "Our strong execution in 2019 positions us to deliver on our planned strategy in 2020 and beyond. We are pursuing a broad effort with industry-leading BCMA developers to advance potentially best-in-class multiple myeloma combination therapies using nirogacestat, are focused on continuing to enroll our ongoing clinical trials and further expanding our portfolio through additional in-licenses and collaborations."

Recent Business Highlights

Initiated a Phase 1 clinical trial of BGB-3245, a selective next-generation B-RAF inhibitor, in adult patients with biomarker-defined advanced or refractory solid

tumors. BGB-3245 is being advanced by MapKure LLC, a clinical-stage company that is jointly owned by SpringWorks and BeiGene, Ltd.

 Entered into a clinical collaboration agreement with Allogene Therapeutics to evaluate nirogacestat in combination with ALLO-715, an investigational anti-B-cell maturation antigen (BCMA) allogeneic CAR T cell therapy, in patients with relapsed or refractory multiple myeloma.

 Presented data at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting showing activity of nirogacestat alone and in combination with GlaxoSmithKline’s investigational BCMA antibody-drug conjugate (ADC), belantamab mafodotin, in preclinical models of human multiple myeloma.

Dosed the first patients in the Phase 2b ReNeu clinical trial evaluating mirdametinib in children and adults with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

Fourth Quarter and Full Year 2019 Financial Results

 Research and Development (R&D) Expenses: R&D expenses were

$12.2 million and $42.5 million for the fourth quarter and year-to-date periods, respectively, compared to $3.7 million and $9.9 million for the comparable periods of 2018, respectively. The increases in R&D expenses in 2019 were primarily attributable to increased clinical study and drug supply costs related to the ongoing Phase 3 DeFi and Phase 2b ReNeu trials, as well as growth in employee costs, including non-cash share-based compensation associated with increases in the number of R&D personnel.

 General and Administrative (G&A) Expenses: G&A expenses were $5.2 million and $16.7 million for the fourth quarter and year-to-date periods, respectively, compared to $2.7 million and $8.6 million for the comparable periods of 2018, respectively. The increases in G&A expenses in 2019 were primarily attributable to growth in employee costs, including non-cash share-based compensation associated with increases in the number of G&A personnel, and increases in consulting and professional services related to the expansion of our business activities.

 Net Loss Attributable to Common Stockholders: SpringWorks reported net losses of $16.2 million, or $0.39 loss per share, and $50.6 million, or $3.81 loss per share, for the fourth quarter and year-to-date periods ended December 31, 2019, respectively. This compares to net losses of $6.2 million, or $10.82 loss per unit, and $17.8 million, or $52.24 loss per unit, for the comparable periods of 2018, respectively.

Cash Position: Cash and cash equivalents were $327.7 million as of December 31, 2019.

On March 12, 2020 China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its financial results for the fourth quarter and fiscal year of 2019 (Press release, China Biologic Products, MAR 12, 2020, View Source [SID1234555515]).

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Fourth Quarter 2019 Financial Highlights

Total sales in the fourth quarter of 2019 decreased by 9.6% in RMB terms and 11.1% in USD terms to $102.2 million from $114.9 million in the same quarter of 2018.
Gross profit decreased by 17.2% to $64.0 million from $77.3 million in the same quarter of 2018. Gross margin decreased to 62.6% from 67.3% in the same quarter of 2018.
Income from operations decreased by 56.2% to $18.6 million from $42.5 million in the same quarter of 2018. Operating margin decreased to 18.2% from 37.0% in the same quarter of 2018.
Non-GAAP adjusted income from operations decreased by 28.9% in RMB terms and 30.2% in USD terms to $27.8 million from $39.8 million in the same quarter of 2018.
Net income attributable to the Company decreased by 64.1% to $12.5 million from $34.8 million in the same quarter of 2018. Diluted earnings per share decreased to $0.32 compared to $0.87 in the same quarter of 2018.
Non-GAAP adjusted net income attributable to the Company decreased by 31.2% in RMB terms and 32.6% in USD terms to $20.7 million from $30.7 million in the same quarter of 2018. Non-GAAP adjusted earnings per diluted share decreased to $0.53 from $0.76 in the same quarter of 2018.
Fiscal Year 2019 Financial Highlights

Total sales in 2019 increased by 12.3% in RMB terms and 7.9% in USD terms to $503.7 million from $466.9 million in 2018.
Gross profit increased by 2.8% to $329.1 million from $320.1 million in 2018. Gross margin decreased to 65.3% from 68.6% in 2018.
Income from operations increased by 11.9% to $163.6 million from $146.2 million in 2018. Operating margin increased to 32.5% from 31.3% in 2018.
Non-GAAP adjusted income from operations increased by 16.6% in RMB terms and 11.6% in USD terms to $198.3 million from $177.7 million in 2018.
Net income attributable to the Company increased by 8.4% to $138.8 million from $128.1 million in 2018. Diluted earnings per share remained stable at $3.53 in 2019 as compared to 2018.
Non-GAAP adjusted net income attributable to the Company increased by 20.5% in RMB terms and 15.4% in USD terms to $168.4 million from $145.9 million in 2018. Non-GAAP adjusted earnings per diluted share increased to $4.28 from $4.02 in 2018.
NOTE: Detailed financial statements and information are available through this link: View Source

"We are pleased to report that China Biologic surpassed our upwardly revised guidance for the full year 2019. As anticipated, however, we saw a year-over-year decline in the fourth quarter after exceptionally strong results for the first nine months of the year," said Joseph Chow, Chairman and CEO of China Biologic. "During the fourth quarter we continued our various initiatives to transform our business, including improving our earnings quality, distribution network, and credit policy management. We saw encouraging progress in several areas including distribution channel consolidation, plasma collection expansion and improving accounts receivable turnover. In 2020, we expect to face challenges including increasingly strict industry regulations, intensified market competition and disruptions to our operations as a result of the coronavirus outbreak. Despite these challenges, we are confident our newly-reorganized management team will successfully implement our strategies as we pursue our mission of raising standards in China’s plasma industry and improving lives through the application of groundbreaking medical science."

Financial Outlook

The COVID-19 outbreak has impacted various aspects of CBPO’s operations, including plasma collection, production of certain products, and sales and marketing activities. The Company is actively evaluating the overall impact on CBPO’s business, and has decided to postpone the release of financial guidance for the full year 2020. The Company will provide financial guidance to the market when it has better visibility.

Conference Call

The Company will host a conference call at 7:30 a.m. Eastern Time on Friday, March 13, 2020, which is 7:30 p.m. Beijing Time on March 13, 2020, to discuss its fourth quarter and fiscal year 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

Mainland China:

400 120 1203

A telephone replay will be available one hour after the conclusion of the conference all through March 20, 2020. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10139946

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