On April 29, 2021 Shanghai Junshi Biosciences Co., Ltd. ("Junshi Biosciences", HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), reported that a late-breaking abstract detailing clinical data of anti-PD-1 antibody, toripalimab, in first-line treatment for recurrent or metastatic nasopharyngeal carcinoma will be featured at ASCO (Free ASCO Whitepaper) 2021 in the plenary session on Sunday, June 6, 2021 (Press release, Coherus Biosciences, APR 29, 2021, View Source [SID1234578802]). The abstract has also been selected for ASCO (Free ASCO Whitepaper)’s official press program.

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Details regarding the plenary session and abstract publication are as follows:

Title: JUPITER-02: Randomized, double-blind, phase 3 study of toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC)

Abstract #: LBA2

Presentation: Plenary Session, June 6, 2021, 1:00 p.m. – 4:00 p.m. Eastern Daylight Time

Publication: June 3, 2021, 5:00 p.m. Eastern Daylight Time
"We are excited that results of JUPITER-02, a Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, have been selected for presentation during ASCO (Free ASCO Whitepaper)’s plenary session, which traditionally features high-impact studies," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Treatment of nasopharyngeal carcinoma, a specific type of head-and-neck cancer, is challenging, as the diagnosis usually occurs when the cancer is in an advanced stage and treatment options are limited."

In addition to the JUPITER-02 late-breaking abstract, ASCO (Free ASCO Whitepaper) accepted for publication or presentation more than two dozen additional abstracts, primarily investigator-sponsored studies, that evaluate the utility of toripalimab in a variety of cancer types including lung cancer, melanoma, urothelial carcinoma, gastroesophageal cancer, and hepatobiliary malignancies.

About Toripalimab

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). On December 17, 2018, Toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

On April 29, 2021 City of Hope, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, reported that now recruiting patients for a Phase 2 clinical trial to investigate whether pills containing white button mushroom extract could regulate the immune system, affecting prostate-specific antigen (PSA) levels to either remain stable or decline (Press release, City of Hope, APR 29, 2021, View Source [SID1234578838]). Heightened levels of PSA in men may indicate the existence of prostate tumors.

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Shiuan Chen, Ph.D., the Lester M. and Irene C. Finkelstein Chair in Biology, has been investigating the potential beneficial effects of white button mushroom (Agaricus bisporus) at City of Hope for about 20 years. His translational preclinical and clinical research has found that this "bioactive food" available in most supermarkets might prevent or slow the spread of prostate and breast cancers. The common fungus appears to block the activity of dihydrotestosterone (DHT), a strong form of the male hormone.

"White button mushroom — like green tea, turmeric, soybean, rosemary and tomato — has been considered a ‘superfood’ with positive effects on human health," said Chen, co-investigator of the clinical trial. "What we’re trying to do is scientifically prove whether the hype is true. If white button mushroom can slow the progression of prostate cancer, we want to know what the active agent is and what biological mechanisms are at work."

City of Hope in Duarte, California, is leading the multisite Phase 2 clinical trial, which will also recruit patients at City of Hope community locations (South Pasadena, West Covina, Rancho Cucamonga) and at John Wayne Cancer Institute in Santa Monica. This National Cancer Institute-funded study will seek to recruit 132 male participants who have recurrent prostate cancer following local therapy or who are undergoing active surveillance and have not yet received any therapy.

"This trial may reveal a possible alternative to or may obviate or delay the need for local or salvage treatments for prostate cancer. These standard-of-care therapies may cause significant short-term and long-term side effects such as incontinence and erectile dysfunction, or weight gain, hot flashes and osteoporosis," said Clayton Lau, M.D., the Pauline & Martin Collins Family Chair in Urology and director of City of Hope’s Prostate Cancer Program. Lau is principal investigator of the trial.

Results from the Phase 1 white button mushroom trial indicated that white button mushroom extract is safe and potentially effective against prostate cancer. About 36% of study participants had some decline in PSA levels after three months of white button mushroom tablet intake, and no dose-limiting toxicities were observed. There were no negative side effects. Androgen deprivation therapy, on the other hand, is an approved therapy with side effects including fatigue, weight gain, muscle weakness, hot flashes, loss of libido, increased risk of diabetes and cardiovascular problems — all these side effects, yet androgen deprivation therapy is not curative.

White button mushroom consumption seemed to stimulate the immune system into action and limited the growth of prostate cancer cells. Upon further research in the laboratory, City of Hope scientists found that white button mushrooms contain chemicals that can block the activity of the androgen receptor in animal models, indicating this common fungus could reduce PSA levels. This research was recently published in The Journal of Nutritional Biochemistry.

The objective of the Phase 2 trial is to assess if recurrent prostate cancer patients experience any PSA reduction at three months. The experimental groups will consume 14 grams of the mushroom-powder tablet per day — roughly 2/3 of a container of white button mushrooms purchased from the supermarket. Tablets will be prepared from freeze-dried powder of white button mushrooms. Those in the control group (observation only) will be able to receive the mushroom tablet after three months.

In addition, for 12 months, the scientists will assess the relative change in PSA levels in men under active surveillance who have not received any localized prostate cancer treatment. Furthermore, scientists will look at biopsy material to identify what molecular changes are linked to intake of white button mushrooms.

On April 29, 2021 Scandion Oncology reported that Annual Report 2020 has now been published and is available on the company’s website (www.scandiononcology.com ) (Press release, Scandion Oncology, APR 29, 2021, View Source;scandion-oncology-is-setting-the-pace-for-the-future,c3336417 [SID1234578868]).

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Bo Rode Hansen, President & CEO, Scandion Oncology A/S comments:

"In 2020, we met major catalysts with initiation of clinical trials, securing financing, preparing for list change to Nasdaq and internationalization. We saw the first signs of activity with SCO-101 and FOLFIRI in patients. This enabled the company to secure a strong financial position and start building the organization for the future.

In 2021, we are expecting the first conclusive data to read out from our CORIST study in Q2. We will use the results from the CORIST study together with a new international positioning analysis of the broader commercial platform potential for Scandion Oncology to focus our clinical strategies going ahead.

We will continue to focus on value for patients and shareholders on our journey towards building the Cancer Drug Resistance Company."

On April 29, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, May 6, 2021 to report its first quarter 2021 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, APR 29, 2021, View Source [SID1234578743]).

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To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 5770919. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On April 29, 2021 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter ended March 31, 2021 (Press release, Emergent BioSolutions, APR 29, 2021, View Source [SID1234578760]).

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FINANCIAL HIGHLIGHTS (1) (in millions)

Q1 2021
Q1 2020
% Change
Total revenues
$343.0
$192.5
78%
Net income (loss)
$69.7
($12.5)
*
Net income (loss) per diluted share
$1.28
($0.24)
*
Adjusted net income (2)
$83.6
$0.3
*
Adjusted net income (2) per diluted share
$1.53
$0.01
*
Adjusted EBITDA (2)
$123.5
$15.3
*
* % change is greater than 100%
2021 FINANCIAL PERFORMANCE (1)
(I) Quarter Ended March 31, 2021 (Q1)
Revenues
(in millions)
Q1 2021
Q1 2020
% Change
Product sales, net (5):
• NARCAN Nasal Spray
$74.2
$72.2
3%
• Anthrax vaccines
$55.0
$51.9
6%
• Other
$8.7
$24.1
(64)%
Total product sales, net
$137.9
$148.2
(7)%
Contract development and manufacturing (CDMO) services
$183.8
$21.7
*
Contracts and grants
$21.3
$22.6
(6)%
Total revenues
$343.0
$192.5
78%
(5) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.
* % change is greater than 100%

Product Sales, net

For Q1 2021, revenues from NARCAN Nasal Spray and Anthrax vaccines were consistent as compared to Q1 2020.
For Q1 2021, revenues from other product sales decreased $15.4 million as compared to Q1 2020. The decrease is primarily due to lower sales of BAT[Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)], due to timing of deliveries to the U.S. government (USG) and the Strategic National Stockpile, and lower sales of the Company’s travel health vaccines, largely Vivotif (Typhoid Vaccine Live Oral Ty21a), due to the currently low level of global travel.

Contract Development and Manufacturing (CDMO) Services

For Q1 2021, revenue from contract development and manufacturing services was $183.8 million, an increase of
$162.1 million, as compared to Q1 2020. The increase is largely due to the public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) to support the USG’s efforts to address the COVID-19 pandemic and CDMO services in support of commercial innovators.

Contracts and Grants

For Q1 2021, revenues from contracts and grants were consistent as compared to Q1 2020.
Operating Expenses
(in millions)
Q1 2021
Q1 2020
% Change
Cost of product sales and CDMO services
$99.3
$76.9
29%
Research and development
$52.5
$42.7
23%
Selling, general and administrative
$80.9
$69.7
16%
Amortization of intangible assets
$14.9
$14.8
1%
Cost of Product Sales and CDMO Services
For Q1 2021, cost of product sales and contract development and manufacturing services increased $22.4 million as compared to Q1 2020. The increase is primarily due to a higher volume of CDMO services, largely the Company’s arrangements to address the COVID-19 pandemic, partially offset by a decline in costs associated with product sales due to the lower total product sales, net.

Research and Development

For Q1 2021, research and development expenses increased $9.8 million as compared to Q1 2020. The increase is primarily due to higher costs associated with the development of the COVID-HIG therapeutic product candidate, offset by a decline in costs associated with the development of the AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) product candidate as this program is nearing completion. Net of contracts and grants revenue, which consists primarily of reimbursements against development investments, research and development expenses were $31.2 million for Q1 2021.

Selling, General and Administrative

For Q1 2021, selling, general and administrative expenses increased $11.2 million as compared to Q1 2020. The increase is primarily due to higher staffing and professional service costs to support the Company’s growth.
Additional Financial Information

Gross Margin (2)
(in millions)
Q1 2021
Q1 2020
% Change
Gross margin
$222.4
$93.0
139%
Gross margin % (gross margin divided by adjusted revenues (2))
69%
55%
14%
Adjusted gross margin
$223.5
$93.6
139%
Adjusted gross margin % (adjusted gross margin divided by adjusted revenues (2))
69%
55%
14%
CDMO Metrics
CDMO Backlog Rollforward
(in millions)
Beginning backlog (12/31/2020)
$1,340.0
Revenue recognized during Q1 2021
($183.8)
New business (net new contracted value included in backlog)
$186.6
Ending backlog (3/31/2021)
$1,342.8

(in millions)
March 31, 2021
December 31, 2020
% Change
CDMO services backlog (3)
$1,342.8
$1,340.0
—%
CDMO services opportunity funnel (4)
$807.1
$689.0
17%
Capital Expenditures
(in millions)
Q1 2021
Q1 2020
% Change
Gross capital expenditures
$56.1
$24.2
132%
– Capital expenditures reimbursed
($7.2)
$—
—%
Net capital expenditures
$48.9
$24.2
102%
Gross capital expenditures as a % of total revenues
16%
13%
3%

2021 FINANCIAL FORECAST

For full year 2021, the Company’s revised and previous forecast of the following financial metrics is as follows:
(in millions)
Revised 2021 Forecast
Previous 2021 Forecast
Total revenues
$1,700 – $1,900
$1,950 – $2,050
• NARCAN nasal spray
$305 – $325
$305 – $325
• Anthrax vaccines
$280 – $310
$280 – $310
• ACAM2000
$185 – $205
$185 – $205
• CDMO services
$765 – $875
$925 – $965
Adjusted EBITDA (2)
$620 – $720
$750 – $810
Adjusted net income (2)
$395 – $470
$475 – $525
Gross margin (2)
63% – 65%
65%
The Company’s revised financial forecast for 2021 includes the following additional considerations:

Revised considerations

CDMO services revenues have been reduced primarily due to the hold of certain COVID-19 vaccine bulk drug substance lots and commitment not to initiate new manufacturing at Bayview pending further review by the U.S. Food and Drug Administration (FDA). Even assuming FDA concurrence to re-initiate new manufacturing and/or release of lots, the Company expects a delay in the timing of expected revenue.

Total revenues, specifically other product sales, are expected to be impacted due to the Company’s assumption that a new raxibacumab contract will be awarded later than previously planned.
Unchanged considerations

Anthrax vaccines revenues are expected to continue to primarily reflect procurement of AV7909 under the terms of the Company’s existing contract with BARDA at a more normalized annual level.

ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) vaccine deliveries are expected to continue under the terms of the Company’s existing contract with the U.S. Department of Health and Human Services (HHS) at unit volume levels consistent with 2020 deliveries.

Narcan (naloxone HCl) Nasal Spray revenues assume the naloxone market remains competitive, that at least one new entrant will enter the market by year end, and that no generic entrant will enter the market prior to the anticipated appellate decision related to the pending patent litigation, which is expected in the second half of 2021.
Pipeline progress is expected across the vaccines, therapeutics, and devices portfolios, anticipating at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing.
Capital expenditures, net of reimbursement, are expected to be in a range of 8% to 9% of total revenues, reflecting ongoing investments in capacity and capability expansions in support of the Company’s CDMO services business and product portfolio.

Q2 2021 REVENUE FORECAST

For Q2 2021, the Company expects total revenues of $370 million to $430 million.

FOOTNOTES

(1) All financial information incorporated within this release is unaudited
(2) See "Reconciliation of Net Income to Adjusted Net Income," "Reconciliation of Net Income to Adjusted EBITDA," "Reconciliation of Gross Margin and Adjusted Gross Margin" and "Reconciliation of Net Research and Development Expenses" for a definition of terms and the reconciliation tables.
(3) CDMO backlog is defined as estimated remaining contract value as of the indicated period pursuant to signed contracts, the majority of which is expected to be recognized over the next 24 months.
(4) CDMO opportunity funnel is defined as proposal values from new work with new customers, new work with existing customers and extensions/expansions of existing contracts with existing customers, that if converted to new business the majority of which is expected to be realized over the next 24 months. This excludes any value associated with an extension of the commercial supply agreements (CSA) with Johnson & Johnson and AstraZeneca.
(5) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.

CONFERENCE CALL, PRESENTATION SUPPLEMENT, AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, April 29, 2021, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the following:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 9153099
Live Webcast Information:
Visit View Source for the webcast.
A replay of the call can be accessed from the Emergent website.