GamaMabs Pharma to present new data on GM102 at two upcoming scientific conferences in November

On November 14, 2018 GamaMabs Pharma, a biotechnology company developing optimized therapeutic antibodies targeting the Anti-Müllerian Hormone Receptor II (AMHRII) for the treatment of cancer, reported its presentation of new data regarding its First-In-Class GM102 antibody at two upcoming conferences (Press release, GamaMabs Pharma, NOV 14, 2018, View Source [SID1234531457]).

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Clinical data for 20 Granulosa Cell Tumor patients treated with GM102 in the C101 clinical study, will be presented at the EORTC–NCI–AACR 2018 Symposium, Dublin (Ireland), on November 13-16, 2018. The poster describes safety and hints of activity of GM102 in this orphan disease with high unmet need and no approved therapy.

"Following the first results of the C101 study in gynecological cancers published at ASCO (Free ASCO Whitepaper) this year, we will present additional clinical data for the subset of granulosa ovarian cancer patients who do not have therapeutic alternatives at this stage in their disease," said Dr. Isabelle Tabah-Fisch, Chief Medical Officer at GamaMabs Pharma

Unveiled activation of T-cells by GM102 following macrophage activation and synergy with immune-checkpoint inhibitors targeting T-cells, will be presented at the AACR (Free AACR Whitepaper) 2018 Conference on Tumor Immunology and Immunotherapy, Miami (Florida) on November 27-30.

"We are looking forward to presenting new data on T-cell activation induced by GM102, confirming the potential of our mAb as a single agent and in combination with immune-checkpoint inhibitors," said Jean-François Prost, Chief R&D Officer at GamaMabs.

The presentation details are:

EORTC–NCI–AACR Symposium 2018
Title: ‘GM102, a first-in-class monoclonal glyco-engineered antibody (Ab) targeting Anti-Mullerian-Hormone-Receptor II (AMHRII): safety and hints of activity in Granulosa Cell Tumors (GCT)’, Leary A.
Session: Late Breaking Poster Presentation
Abstract number: 15LBA
Date and time: November 16, 2018, 10am ­– 2pm
Location: Exhibition Hall, The Convention Centre, Dublin (CCD)
AACR Conference on Tumor Immunology and Immunotherapy
Title: ‘GM102, a low fucosylated anti-Müllerian Hormone type II Receptor (AMHRII) antibody, promotes in vitro antitumoral activities of innate (macrophages) and adaptative (CD4+ and CD8+ T cells) immune cells’
Poster number: B77
Date and time: Thursday, November 29, 5pm – 7pm (EST)
Session category/title: Poster Session B
Location: Loews, Miami Beach, rooms Americana 3 and 4
GM102 is a first-in-class glyco-engineered (low-fucose) monoclonal antibody selectively targeting AMHRII-expressing tumors. AMHRII, an embryonic receptor involved in the regression of the Müllerian ducts in the male embryo, is constitutively expressed in ovarian granulosa tumors (GCT) and is re-expressed in a majority of tumor samples in a wide range of gynecological and non-gynecological tumors such as colorectal and lung cancers, hepatocarcinoma or renal cell carcinoma. GM102 is currently being studied in two clinical trials, a phase 1b in recurrent gynecological cancers and a phase 2 in advanced or metastatic colorectal cancers.

GM102 exerts its anti-tumor activity through NK cell and macrophage engagement in the tumor microenvironment, resulting in enhanced tumor phagocytosis and subsequent T cell activation.

Following presentation, the two posters will be available on the publication page of GamaMabs’ website

Athenex, Inc. Announces Third Quarter 2018 Financial Results and Provides Corporate Update

On November 14, 2018 Athenex, Inc. (NASDAQ:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported its financial results and business highlights for the three- and nine-months ended September 30, 2018 (Press release, Athenex, NOV 14, 2018, View Source;p=RssLanding&cat=news&id=2377084 [SID1234531432]).

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"We achieved continued positive momentum at Athenex in the third quarter in our strategy to build a global biopharmaceutical business and to create more effective, safer and tolerable treatments for cancer patients," stated Dr. Johnson Lau, Chief Executive Officer of Athenex. "Our Phase III Oraxol program reached an important milestone with the second positive DSMB review in September and we remain on track to complete enrollment and report data from this study in 2019. We also continue to make progress with other drug candidates in our Orascovery platform, with Oratecan and Oradoxel ready to advance to Phase II studies. The addition of the cellular immunotherapy and biologic platforms have expanded our oncology-focused product pipeline. For KX2-391, the most advanced candidate in our Src kinase program, we are working with our partner Almirall on developing a commercial plan for this product."

Third Quarter 2018 and Recent Business Highlights:

Clinical Platforms:

Announced that the Data and Safety Monitoring Board (DSMB) overseeing the Company’s ongoing randomized, controlled Phase III trial of Oraxol in metastatic breast cancer recommended unanimously that the study continue as planned. The DSMB also congratulated the Company on the rapid patient recruitment and promising results achieved.

Presented updated encouraging efficacy and safety data of Oraxol in the treatment of metastatic breast cancer patients who had failed previous chemotherapies in a pharmacokinetics (PK) and Phase II study conducted in Taiwan at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Munich, Germany.

Announced acceptance of an Investigational New Drug (IND) application for Eribulin ORA, Athenex’s oral version of Eribulin. Initiation of clinical trials is currently planned for the first half of 2019. This is the eighth US IND allowance that Athenex has obtained.

Identified suitable dosing regimens of Oratecan and Oradoxel for advancement into Phase II studies, based on recent PK data.

Announced positive results from pilot studies conducted in China by Xiangxue Life Sciences in end-stage cancer patients who were treated with T-cell receptor affinity enhancing specific T-cell therapy (TAEST), a form of cancer immunotherapy. Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences established in September 2018, owns the worldwide (excluding China) rights to research, develop and commercialize T-cell receptor-engineered T cells (TCR-T), including TAEST technology.

Announced positive data from two Phase III pivotal efficacy studies of KX2-391 in the treatment of actinic keratosis (AK).
Commercial Business

Developed detailed launch plans for Oraxol and KX2-391.

Athenex Pharmaceutical Division ("APD") currently markets a total of 25 products with 48 SKUs and is planning to launch 2 new products before year end with 4 additional new SKUs.

Athenex Pharma Solutions ("APS") currently markets 6 products in total with 16 SKUs.
Corporate and Strategic Highlights:

Promoted Mr. Randoll Sze to Chief Financial Officer.

Announced a strategic realignment of joint projects between Athenex and its collaborative partner, Hanmi Pharmaceutical.
Third Quarter 2018 Financial Results:

Revenue for the three months ended September 30, 2018 was $18.4 million, an increase of $4.4 million, or 32%, as compared to $14.0 million for the three months ended September 30, 2017. The increase was primarily attributable to an increase in licensing revenue of $5.0 million, a $1.0 million increase in sales of the Company’s 503B products, and a $0.8 million increase in medical device sales. This was offset by decreases in API sales of $1.7 million, contract manufacturing revenue of $0.2 million, grant revenue of $0.2 million, and other product sales of $0.2 million.

Cost of sales for the three months ended September 30, 2018 totaled $12.0 million, an increase of $3.9 million, or 48%, as compared to $8.1 million for the three months ended September 30, 2017. This was primarily due to the increase of $1.9 million cost of sales from the recently launched specialty products and $2.0 million cost of sales from 503B and API products. The increase in gross profit was primarily due to the licensing revenue in the current year.

Research and development expenses for the three months ended September 30, 2018 totaled $51.2 million, an increase of $39.3 million, or 329%, as compared to $11.9 million for the three months ended September 30, 2017. This was primarily due to an increase in licensing fees and clinical expenses. In particular, there was a $29.5 million non-cash license fee related to the purchase of TCR-T in connection with the establishment of Axis Therapeutics, of which $24.5 million related to the fair value of the IPR&D and $5.0 million related to the Company’s common stock issued to Xiangxue Life Sciences.

SG&A expenses for the three months ended September 30, 2018 totaled $11.5 million, an increase of $1.1 million, or 11%, as compared to $10.4 million for the three months ended September 30, 2017. This was primarily due to an increase in professional fees of $0.9 million from legal fees incurred in conjunction with the launch of 503B products and an increase in employee compensation of $0.5 million, offset by a decrease of $0.3 million in selling and marketing expenses related to the launch of specialty products.

Net loss attributable to Athenex for the third quarter ended September 30, 2018 was $46.2 million, or ($0.70) per diluted share, compared to a net loss of $23.3 million, or ($0.41) per diluted share, in the same period last year. Excluding the non-cash license fee of $24.5 million, the net loss attributable to Athenex for the third quarter ended September 30, 2018 was $21.6 million.

In July 2018, Athenex closed a privately placed debt and equity financing deal with Perceptive Advisors, LLC for gross proceeds of $100.0 million and aggregate net proceeds of $97.1 million, net of fees and offering expenses. The Company entered into a 5-year senior secured loan for $50.0 million of this financing and issued 2,679,528 shares of its common stock at a purchase price of $18.66 per share for the remaining $50.0 million.

Cash, cash equivalents and short-term investments were $141.4 million at September 30, 2018, compared to $51.0 million at December 31, 2017. Based on the current operating plan, the Company expects that its cash, cash equivalents and short-term investments as of September 30, 2018, together with cash to be generated from operating activities, will enable it to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2019.

Nine Months Ended September 30, 2018 Financial Results:

Revenue for the nine months ended September 30, 2018 was $67.8 million, an increase of $44.7 million, or 193%, as compared to $23.2 million for the nine months ended September 30, 2017. The increase was primarily attributable to $30.0 million in upfront license fees, a $13.7 million increase in specialty products sold through the Company’s Commercial Platform, a $2.0 million increase in sales of 503B products, and a $0.4 million increase in API and medical device sales.

Cost of sales for the nine months ended September 30, 2018 totaled $32.7 million, an increase of $17.6 million, or 117%, as compared to $15.1 million for the nine months ended September 30, 2017. This was primarily due to the increase of $13.2 million cost of sales from the specialty products and $4.4 million cost of sales from 503B and API products.

Research and development expenses for the nine months ended September 30, 2018 totaled $99.1 million, an increase of $43.1 million, or 77%, as compared to $55.9 million for the nine months ended September 30, 2017. This was primarily due to an increase in licensing fees and clinical expenses. In particular, there was a $29.5 million non-cash license fee related to the purchase of TCR-T in connection with the establishment of Axis Therapeutics, of which $24.5 million related to the fair value of the IPR&D and $5.0 million related to the Company’s common stock issued to Xiangxue Life Sciences.

SG&A expenses for the nine months ended September 30, 2018 totaled $37.4 million, an increase of $3.6 million, or 11%, as compared to $33.8 million for the nine months ended September 30, 2017. This was primarily due to an increase in costs related to operating as a public company.

Net loss attributable to Athenex for the nine months ended September 30, 2018 was $90.3 million, or ($1.42) per diluted share, compared to a net loss of $102.9 million, or ($2.18) per diluted share, for the nine months ended September 30, 2017. Excluding the non-cash license fee of $24.5 million, the net loss attributable to Athenex for the nine months ended September 30, 2018 was $65.8 million.

Outlook and Upcoming Milestones:

Due to the timing of a collaborative payment from a partner, the Company currently expects its full year 2018 revenue to be in the lower end of the guidance range of $100 million to $125 million, inclusive of licensing-fee revenue. The operational business is on track and the Company expects to receive the collaborative payment in the first half of 2019.

Clinical Platforms:

12 month follow-up data from KX2-391 Phase III studies for the treatment of AK are expected in the second quarter of 2019.
Oraxol Phase III clinical trial in metastatic breast cancer is expected to complete target enrollment by the end of 2018, with top line data expected in mid-2019.
Oratecan and Oradoxel Phase II studies are expected to initiate in the first half of 2019.
Expect to file INDs for TCR-T candidates and Pegtomarginase by mid-2019.
Corporate Updates:

The Company will be hosting a Research and Development Day for the investment community on December 17, 2018 to provide an update on its major clinical programs.
The exterior of the Dunkirk facility is expected to be completed by the first half of 2019. The facility is expected to be completed by the end of 2019 and operational in mid-2020.
Construction of the Chongqing API plant is expected to be completed by the end of 2018, with completion of the facility expected by mid-2019.
Construction of the Chongqing dosage plant is expected to break ground in the first half of 2019.
Conference Call and Webcast Information:

The Company will host a conference call and live audio webcast today, Wednesday, November 14, 2018 at 8:00 a.m. Eastern Time to discuss the financial results and provide a business update.

To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13683946.

To join the webcast, click on View Source

A replay of the call will be accessible two hours after its completion through November 21 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 13683946. The live conference call and replay can also be accessed via audio webcast on the Investor Relations section of the Company’s website, located at www.athenex.com.

CLEVELAND BIOLABS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS AND DEVELOPMENT PROGRESS

On November 14, 2018 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the third quarter ended September 30, 2018 (Press release, Cleveland BioLabs, NOV 14, 2018, View Source [SID1234531430]).

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Cleveland BioLabs reported a net loss of $(1.1) million, excluding minority interests, for the third quarter of 2018, or $(0.10) per share, compared to a net loss, excluding minority interests, of $(1.26) million, or $(0.11) per share, for the same period in 2017. The decrease in net loss was primarily due to a decrease in the non-cash adjustment to our warrant liabilities, reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization with the U.S. Food and Drug Administration ("FDA") for entolimod as a medical radiation countermeasure partially offset by an increase in General and Administrative costs related to the corporate formation of Genome Protection, Inc. (GPI), our joint venture with Everon Biosciences, Inc. focused on developing anti-aging medications.

As of September 30, 2018, the Company had $5.3 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The development, pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority."

Further Financial Results

Revenue for the third quarter of 2018 decreased to $0.28 million compared to $0.3 million for the third quarter of 2017. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure and decreased revenue from our service contract with Incuron.

Research and development costs for the third quarter of 2018 decreased to $0.8 million compared to $0.9 million for the third quarter of 2017. The reduction in research and development costs is due to a $0.2 million reduction in spending for biodefense applications of entolimod and a $0.1 million reduction in spending on Panacela’s product candidates partially offset by a $0.2 million increase in expenses related to the oncology applications of the entolimod family of compounds.

General and administrative costs for the third quarter of 2018 increased to $0.7 million compared to $0.6 million for the third quarter of 2017. This increase was primarily attributable to one-time legal costs associated with the corporate formation of GPI and Norma Investments Limited’s investment in GPI, and expense related to a one-time settlement for the previously completed research contracts with the Russian Ministry of Trade.

CStone Pharma Files for Hong Kong IPO to Support its Oncology Portfolio

Suzhou’s CStone Pharma has filed for a Hong Kong IPO. Founded in 2015, CStone has quickly built a portfolio of 14 oncology candidates. The company says its three core products are IO drugs — PD-1, PD-L1 and CTLA-4 antibodies — which will be paired with other of its assets to offer combination therapies. As part of its development, CStone has in-licensed molecularly targeted compounds from Agios (a $424 million deal) and Blueprint (a $386 million, three-drug agreement), which CStone will develop in greater China.

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Prometic Reports Third Quarter 2018 Financial Results and Highlights

On November 14, 2018 Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic or the Corporation) reported today its unaudited financial results for the third quarter ended September 30, 2018 (Press release, ProMetic Life Sciences, NOV 14, 2018, View Source [SID1234531350]).

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"Several initiatives that we have been pursuing during the past quarter should bear fruit in the coming weeks and months," said Pierre Laurin, Prometic’s President and Chief Executive Officer. "We have implemented cost-control measures to reduce our cash use while at the same time have made significant progress to advance our two lead drug candidates, Ryplazim (plasminogen) and PBI-4050. As previously stated, our current business plan calls for a significant reduction in R&D expenditures of up to $30 million in 2019 as compared to this year’s budget. Our primary objective remains to close the gap between the fundamental enterprise value we have built and our current market valuation by strengthening our financial position through the closing of commercial partnerships and equity-related initiatives."

Commenting on the third quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer, said, "We are ahead of target with the financial guidance provided during the AGM in May 2018 and our last few conference calls. We have effectively implemented cost control measures as evidenced by the trending quarterly decrease in R&D, Administration and Sales & Marketing expenses as well as decreases in net loss and cash flows used in operating activities. Cash used in operations year-to-date was $57 M compared to $95 M for the same period in 2017".

Small Molecule Therapeutics Highlights

PBI-4050 – Received a Rare Pediatric Disease designation from the US Food and Drug Administration for the treatment of Alström syndrome
PBI-4050 – Published a paper further elucidating the mechanism of action of its lead drug candidate, PBI-4050, on liver fibrosis in the Journal of Pharmacology and Experimental Therapeutics. The paper entitled "PBI-4050 reduces stellate cell activation and liver fibrosis through modulation of intracellular ATP levels and LKB1-AMPK-mTOR pathway" details the antifibrotic signaling pathway modulated by PBI-4050.
PBI-4050 – Hosted a Key Opinion Leader meeting in New York on PBI-4050 as a novel treatment for Alström syndrome and non-alcoholic steatohepatitis (NASH).
Plasma-Derived Therapeutics Highlights

RyplazimTM (Plasminogen) – Completed a Type C meeting in which the FDA agreed with the Company’s proposed action plan for the implementation of additional analytical assays and in-process controls related to the RyplazimTM (plasminogen) manufacturing process. As a result of the feedback received during the Type C meeting, Prometic is finalizing the process performance qualification (PPQ) protocols in anticipation of commencing the manufacturing of additional RyplazimTM (plasminogen) conformance lots.

Subsequent Events to Third Quarter 2018

Closed a deal with Structured Alpha LP (SALP), an affiliate of Thomvest Asset Management Inc., to extend the maturity dates of the USD $80 million (CAD $100 million) line of credit and the Original Issue Discount Notes to September 2024.
2018 Third Quarter Financial Results

Revenues
Total revenues for the third quarter ended September 30, 2018 were $12.3 million and $36.8 million for the nine months ended September 30, 2018. Revenues from the sale of goods, representing most of the 2018 revenues to date, were $35.3 million during the first nine months ended September 30, 2018 compared to $11 million during the corresponding 2017 period. The $24.3 million increase for 2018 is mainly due to $19.7 million in sales of normal source plasma which occurred in the second and third quarters of 2018 following a change in the production forecast due to the delay of the BLA approval for RyplazimTM (plasminogen). The remainder of the increase of $4.6 million for the nine month period is due to an increase in third party sales in the bioseparation segment. 2018 bioseparation sales are expected to exceed $21 million, which would represent a 30% increase compared to 2017 bioseparation revenues. A comparable level of revenue growth for 2019 is anticipated and is mainly due to the expansion of manufacturing activities by existing clients who utilize Prometic’s products in their production processes, the adoption of products by new clients, the introduction of new products and the continuing expansion of the market for bioseparation products.

Cost of sales and other production expenses
Cost of sales and other production expenses were $9.2 million for the third quarter ended September 30, 2018 compared to $3.8 million for the corresponding period in 2017, representing an increase of $5.5 million. Cost of sales and other production expenses were $30.4 million during the nine months ended September 30, 2018 compared to $7.7 million for the corresponding period in 2017, representing an increase of $22.7 million. The increase was due primarily to the cost of the plasma inventory sold.

Research and Development (R&D)
Total R&D expenses were $24.1 million for the third quarter ended September 30, 2018 compared to $23.3 million for the third quarter ended September 30, 2017. Total R&D expenses were $70.5 million for the nine months ended September 30, 2018 compared to $72.2 million for the corresponding period in 2017, representing a decrease of $1.7 million. The completion of the pivotal phase 3 clinical programs for IVIG and for Ryplazim (plasminogen) and termination of non core preclinical and clinical programs will translate into a significant R&D cost reduction in 2019 compared to 2018.

Administration, Sales & Marketing
Administration, selling and marketing expenses were $6.2 million for the third quarter ended September 30, 2018 compared to $7.7 million for the third quarter ended September 30, 2017. The $1.4 million decrease was due to a reduction in consulting fees and employee compensation expenses. Administration, selling and marketing expenses declined slightly at $20.9 million during the nine months ended September 30, 2018 compared to $22.7 million for the corresponding period in 2017.

Finance Costs
Finance costs were $5.9 million for the third quarter ended September 30, 2018 compared to $2.1 million during the corresponding period of 2017, representing an increase of $3.8 million. Finance costs were $15.5 million for the nine months ended September 30, 2018 compared to $5.3 million during the corresponding period of 2017, representing an increase of $10.2 million. This increase reflects higher debt levels during the nine months ended September 30, 2018 compared to the same period of 2017.

Net Loss
Prometic incurred a net loss of $28.9 million for the third quarter ended September 30, 2018 compared to a net loss of $17.8 million for the third quarter ended September 30, 2017. Prometic incurred a net loss of $96.6 million for the nine months ended September 30, 2018 compared to a net loss of $78.4 million for the corresponding period of 2017. The main reason for the increase in the net loss is that the results for the quarter and the nine months ending September 30, 2017 included $19.7 million in milestone and licensing revenues related to the licensing agreement signed with Jiangsu Renshou Pharmaceutical Co, Ltd.

With the delay of the anticipated launch of its most advanced product, RyplazimTM (plasminogen), the Corporation had to finance its R&D activities via various sources. To date, the Corporation has financed its activities through the sale of products in the bioseparations segment, collaboration arrangements and licensing arrangements, the issuance of debt and equity, operational restructuring as well as investment tax credits. Prometic is currently actively involved in negotiating both equity and equity-linked financing initiatives and continues to be in dialogue with potential licensing partners. Although the Corporation believes that it will be able to obtain the necessary funding as in the past, there can be no assurance of the success of these plans.

Conference Call Information

Prometic will host a conference call at 11:00 am (ET) on Thursday November 15, 2018. The telephone numbers to access the conference call are (647) 427-7450 and 1-888-231-8191 (toll-free). A replay of the call will be available as of Thursday November 15, 2018 at 2:00 pm. The numbers to access the replay are 1-416-849-0833 and 1-855-859-2056 (passcode: 1190238). A live audio webcast of the conference call, with slides, will be available through the following: View Source

Additional Information in Respect to the Third Quarter Ended September 30, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended September 30, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.