On October 30, 2019 Cotinga Pharmaceuticals Inc. (TSX Venture: COT; OTCQB: COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported its financial and operating results today for the three months ended July 31, 2019 (Press release, Cotinga, OCT 30, 2019, View Source [SID1234550034]). Recent highlights are outlined below. The Company also announces the reinstatement of Victor Hugo, of Marrelli Services Inc, as CFO, effective October 10, 2019; and the resignation of John Yoo, MD, from the Board of Directors, effective September 24, 2019. Dr. Yoo will remain as an advisor to the Company.

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Advanced the clinical development of COTI-2:

• Cotinga announced the initiation of dosing patients in the first three cohorts in the combination therapy trial at MD Anderson Cancer Center evaluating COTI-2 and cisplatin in a wide spectrum of cancers.

• The Company announced early interim data from cohorts 1 and 2, reporting signs of clinical activity in both cohorts determined by disease stabilization or regression. Additionally, the Company announced the closings of a two-tranche debenture in May and June, 2019, bringing $300,000 CDN into the company to fund the clinical trial and general operations. Upcoming Milestones COTI-2:

• Continue the dose escalation Phase 1b/2a combination therapy trial evaluating the effect of COTI2 plus cisplatin in patients with solid tumors;

• Contingent on the raising of necessary funds, initiate the TNBC trial with COTI-2 plus eribulin. Corporate:

• Strengthen the balance sheet;

• Opportunistically pursue regional or co-development partnerships for COTI-2, pipeline programs and other technologies.

Financial Results

The Company’s operational activities during the quarter were primarily focused on advancing the Phase 1b/2a clinical trial of COTI-2.

For the three-months ended July 31, 2019, the Company incurred a net loss of $0.527 million, or $0.02 per share, compared to a net loss of $0.982 million, or $0.04 per share, for the three-months ended July 31, 2018. The decrease in net loss during the three-month period is primarily due to decreases in Research and Development (R&D) expense and General and Administrative (G&A) expense. Press Release Page | 2

There was no revenue for the three months ended July 31, 2019 or in the comparative periods in the prior year.

R&D expense in the three-month period ended July 31, 2019 decreased by $0.218 million over the same period in the prior year. The decrease in R&D expense in the three-month period is primarily due to a decrease in clinical trial expenses and synthesis and miscellaneous R&D expenses.

S&M expense in the three-month period ended July 31, 2019 decreased by $0.028 million over the same period in the year prior. The decrease in S&M expense in the three-month period is primarily due to less travelling and conferences and in 2019, and professional fees on marketing.

G&A expense in the three-month period ended July 31, 2019 decreased by $0.158 million over the same period in the year prior. The decrease in G&A expense in the three-month period is primarily due to primarily due to lower professional fees and share-based compensation.

Detailed operating and financial results can be found in the Company’s Unaudited Condensed Interim Financial Statements and Management Discussion and Analysis for the three months ended July 31, 2019, which can be found on SEDAR at www.sedar.com or on the Company’s website at www.cotingapharma.com.

On October 30, 2019 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2019 (Press release, Cerus, OCT 30, 2019, View Source [SID1234550032]).

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Recent developments and highlights include:

FDA issued its final guidance document on strategies to mitigate the risk of bacterial contamination in transfused platelet components
Total third quarter revenue of $22.8 million
Quarterly product revenue of $18.0 million, a 17% increase compared to the prior year quarter
Government contract revenue of $4.8 million
Worldwide demand for INTERCEPT continued to increase; calculated number of treatable platelet doses increased nearly 20% worldwide compared to the prior year quarter
2019 product revenue guidance reaffirmed at $72 million to $75 million, up 18-23% over 2018, driven by strong global demand for INTERCEPT platelets
Over 20 posters and abstracts presented at the 2019 AABB Conference, highlighting the clinical and operational benefits of INTERCEPT
"The recent finalization of the FDA guidance document is great for patients, transfusion medicine and Cerus," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "INTERCEPT is uniquely positioned to provide a solution for blood centers to comply with the final guidance that confers optimal operational simplicity, clinical efficacy, and economic value to blood centers and hospitals. In this regard, the American Red Cross and many other large U.S. blood centers have stated that pathogen reduction is their preferred solution to safeguarding the platelet supply."

"We have built a strong foundation of awareness for INTERCEPT as evidenced by another quarter of strong commercial execution with the calculated number of treatable platelet doses in the U.S. up nearly 70% compared to the prior year. With this solid base of existing blood center customers scaling their production of INTERCEPT platelets, we are ramping our efforts to support U.S. blood centers and hospitals to be compliant with the FDA’s final guidance document by the end of Q1 2021," continued Greenman.

Revenue

Product revenue during the third quarter of 2019 was $18.0 million, compared to $15.4 million during the same period in 2018. Revenue growth in the quarter benefited from continued demand for INTERCEPT platelet kits in the U.S. and the timing of large plasma kit orders in EMEA, which were partially offset by the conversion to our double dose platelet kits in France and a 4% negative impact of foreign currency exchange rates. Year-to-date product revenue totaled $53.7 million, an increase of 21% compared to the same period in 2018.

Government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $4.8 million during the third quarter of 2019, compared to $3.9 million during the same period in 2018, as a result of increasing INTERCEPT red blood cell clinical and development activities. Year-to-date government contract revenue totaled $13.6 million compared to $11.4 million in the first nine months of 2018. The total potential value of the current BARDA agreement is $201 million with $39 million recognized as revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the third quarter of 2019 were 58%, compared to 47% for the third quarter of 2018. The increase in gross margin was tied to economies of scale realized for our cost of goods sold, favorable platelet product mix, namely the French conversion to double dose platelet kits and additional manufacturing efficiencies. Gross margins during the first nine months of 2019 were 55% compared to 48% reported in the same period the year prior.

Operating Expenses

Total operating expenses for the third quarter of 2019 were $32.2 million compared to $24.8 million for the same period the prior year. Year-to-date, operating expenses totaled $93.0 million compared to $72.2 million for the first three quarters of 2018.

Selling, general, and administrative (SG&A) expenses for the third quarter of 2019 totaled $16.1 million, compared to $14.0 million for the third quarter of 2018. The year-over-year increase in SG&A expenses was tied to increased non-cash stock compensation, higher investments in our supply chain capabilities and focused investments on preparatory activities for our anticipated cryoprecipitate launch. Year-to-date SG&A expenses totaled $49.0 million compared to $42.0 million for the first nine months of 2018.

Research and development (R&D) expenses for the third quarter of 2019 were $16.1 million, compared to $10.8 million for the third quarter of 2018. The increase in year-over-year R&D expenses was largely due to product enhancements and initiatives for expanded label claims, development activities to support our anticipated cryoprecipitate PMA supplement, as well as additional activities tied to the development of our INTERCEPT red blood cell system. Year-to-date R&D expenses totaled $43.9 million compared to $30.1 million for the first nine months of 2018.

Net Loss

Net loss for the third quarter of 2019 was $18.0 million, or $0.13 per diluted share, compared to a net loss of $14.2 million, or $0.11 per diluted share, for the third quarter of 2018. Year-to-date net loss was $54.3 million or $0.39 per diluted share compared to $41.4 million, or $0.32 per diluted share in the first nine months of 2018.

Cash, Cash Equivalents and Investments

At September 30, 2019, the Company had cash, cash equivalents and short-term investments of $85.1 million, compared to $117.6 million at December 31, 2018.

At September 30, 2019, the Company had approximately $39.4 million in outstanding term loan debt and $5.0 million of borrowings under its revolving loan credit agreement, compared to $29.9 million in outstanding term loan debt at December 31, 2018.

2019 Product Revenue Guidance

The Company reaffirms its 2019 product revenue guidance to the range of $72 million to $75 million. The guidance range represents 18% to 23% growth compared to 2018 reported product revenue and is based on the strong global demand for INTERCEPT platelet kits.

QUARTERLY CONFERENCE CALL AND WEBCAST

The Company will host a conference call and webcast at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 2392137. The replay will be available approximately three hours after the call through November 13, 2019.

On October 30, 2019 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, reported Jarrod Longcor, chief business officer of Cellectar, presented a poster highlighting preclinical data with CLR 180099 at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, being held from October 26– 30, 2019 in Boston, MA (Press release, Cellectar Biosciences, OCT 30, 2019, View Source [SID1234550031]). CLR 180099 is a Phospholipid Drug ConjugateTM (PDC) composed of a uniquely designed phospholipid ether conjugated to a flavagline (FLV) analogue payload.

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The poster, entitled: "CLR 180099, a lipid raft targeted phospholipid-drug conjugate, shows potent improved safety and efficacy against colorectal tumors," highlighted data demonstrating a greater reduction in tumor volume and improved survival with CLR 180099 than docetaxel in a colorectal cancer model. Additionally, as compared to the FLV payload alone, the PDC demonstrated improved tolerability with greater than a 20 fold increase in the maximum tolerated dose. CLR 180099 was also shown to have potent nanomolar activity in other select solid tumorsincluding breast cancer and lung cancer models.

"This new investigational program shows compelling efficacy and safety in these preclinical studies further demonstrating the versatility and potential of PDCs as a new therapeutic class of drugs for cancer," said Jarrod Longcor, chief business officer of Cellectar. "The ability to specifically deliver a variety of oncologic payloads to a broad range of tumor cells emphasizes the PDC technology’s unique and targeted treatment approach. These results further demonstrate this and represent another important advancement in the development and validation of our PDC platform."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized phospholipid ether-drug conjugates (PDCs) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

On October 30, 2019 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will take part in a fireside chat at the Wolfe Research Healthcare Conference on Wednesday, November 6, 2019, in New York (Press release, Bristol-Myers Squibb, OCT 30, 2019, View Source [SID1234550030]). Giovanni Caforio, M.D., chairman and chief executive officer will answer questions at 3:10 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

On October 30, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that its third quarter 2019 operational progress and financial results will be released before the market opens on Thursday, November 7, 2019 (Press release, Atara Biotherapeutics, OCT 30, 2019, View Source [SID1234550029]). Following the release, the Company will host a live conference call and webcast at 8:00 a.m. EST.

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Analysts and investors can participate in the conference call by dialing (888) 540-6216 for domestic callers and (734) 385-2715 for international callers, using the conference ID 6069034. A live audio webcast can be accessed by visiting the Investor Events and Presentations section of atarabio.com. An archived replay will be available on the Company’s website for approximately 14 days following the live webcast.