Mannkind has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Mannkind, 2017, NOV 7, 2017, View Source [SID1234521818]).

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On November 7, 2017 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the third quarter 2017 (Press release, Cambrex, NOV 7, 2017, View Source [SID1234521628]).

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Highlights

Net Revenue increased 13% to $112.6 million compared to $99.4 million in the same quarter last year. Excluding the impact of foreign exchange, net revenue increased 12%.
GAAP Diluted EPS from continuing operations increased 24% to $0.52 from $0.42 in the same quarter last year. Adjusted Diluted EPS increased 20% to $0.55 compared to $0.46 in the same quarter last year.
EBITDA increased 29% to $33.3 million compared to the same quarter last year (see table at the end of this press release).
Net cash was $118.4 million at the end of the quarter, an increase of $24.2 million during the quarter.
The Company continued to execute on its strategic growth plan, investing in new manufacturing capacity and analytical laboratory space at its facilities in Charles City, High Point, Karlskoga, and Milan.
The Company continues to expect full year 2017 Net Revenue, excluding the impact of foreign currency, to increase between 7% and 11% compared to 2016, Adjusted EBITDA to be between $171 and $177 million, an 11% to 15% increase compared to 2016 and Adjusted income from continuing operations to be between $3.00 – $3.12 per share.
The Company now expects 2017 free cash flow to be between $60 and $70 million, an increase of $5 million from the mid-point and capital expenditures to be between $65 and $70 million, a reduction of $5 million from the mid-point (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).
"We are pleased with our financial performance in the third quarter, and when combined with an expected strong fourth quarter, we are positioned to finish 2017 within our financial expectations. Continued strong performance at our manufacturing facilities resulted in higher profit margins in the quarter and year-to-date," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"We recently completed the installation of new, large scale manufacturing capacity at our Karlskoga and Charles City facilities. Construction of the new High Potency facility at our Charles City plant has begun, and the recently announced investment in R&D and manufacturing capabilities to support the development of generic APIs at our Milan facility should be completed by the end of this year. In addition, we are adding pilot plant capacity and new analytical laboratories at our High Point location. These investments will enable Cambrex to increase its capabilities and ensure our facilities continue to address favorable industry trends and the evolving demands of our customers."

Basis of Reporting

The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Third Quarter 2017 Operating Results – Continuing Operations

Net revenue was $112.6 million, an increase of $13.2 million, or 13%, compared to the third quarter of 2016. Excluding a 1% favorable impact of foreign exchange compared to the third quarter of 2016, net revenue increased 12%. The increase primarily reflects higher volumes partially offset by lower pricing. The increase in volumes was driven primarily by growth in all product categories, as well as the addition of Cambrex High Point.

Gross margin increased to 42% from 38% compared to the same quarter last year. The increase was primarily driven by high capacity utilization, manufacturing efficiency improvements and favorable product mix, partially offset by lower pricing.

Selling, general and administrative expenses were $17.6 million, compared to $15.0 million in the same quarter last year. The increase was mainly due to the addition of Cambrex High Point, higher personnel related expenses, and higher expenses related to the evaluation of acquisition opportunities.

Research and development expenses were $4.2 million, compared to $3.2 million in the same quarter last year. The increase was mainly driven by costs to develop new generic drug products.

Operating profit increased to $25.1 million from $19.5 million in the same quarter last year. The increase was primarily the result of higher gross profits in 2017 partially offset by higher operating expenses as described above. Adjusted EBITDA was $33.3 million compared to $25.9 million in the same quarter last year (see table at the end of this press release).

Income tax expense was $7.5 million resulting in an effective tax rate of 30% compared to $5.4 million and an effective tax rate of 28% in the same quarter last year. Excluding the favorable impact of immediately recognizing certain effects of share-based compensation as required by a recently adopted accounting standard, the effective tax rate in the current period would have been 33%.

Income from continuing operations was $17.3 million or $0.52 per share compared to $13.7 million or $0.42 per share in the same quarter last year. Adjusted income from continuing operations was $18.5 million or $0.55 per share, compared to $15.1 million or $0.46 per share in the same quarter last year (see table at the end of this press release).

Capital expenditures and depreciation were $14.9 million and $7.7 million, respectively, compared to $11.7 million and $6.2 million, respectively, in the same quarter last year.

Net cash was $118.4 million at the end of the third quarter, an increase of $24.2 million during the quarter.

Financial Expectations – Continuing Operations

The following table shows the Company’s current expectations for its full year 2017 financial performance versus its previous expectations:

Current Expectations Previous Expectations
Net revenue increase 7% – 11% 7% – 11%
Adjusted EBITDA $171 – $177 million $171 – $177 million
Adjusted income from continuing operations per share $3.00 – $3.12 $3.00 – $3.12
Free cash flow $60 – $70 million $55 – $65 million
Capital expenditures $65 – $70 million $70 – $75 million
Depreciation and amortization $32 – $34 million $32 – $34 million
Adjusted effective tax rate 31% – 33% 31% – 33%

Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities and outcomes of tax disputes. Net revenue expectations exclude the impact of foreign exchange. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2017 will be computed on a basis consistent with the reconciliation of the third quarter 2017 financial results in the tables at the end of this press release. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes certain effects of share-based payments that were possibly deferred under the previous guidance. The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax codes within the countries in which the Company operates and the effects of certain share-based payments.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s Form 10-Q for third quarter 2017 is filed with the SEC.Conference Call and Webcast

A conference call to discuss the Company’s third quarter 2017 results will begin at 8:30 a.m. Eastern Time on November 7, 2017 and can be accessed by calling 1-866-548-4713 for domestic and +1-323-794-2093 for international. Please use the passcode 1511082 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through November 14, 2017 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 1511082 to access the replay.

On November 7, 2017 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported details on its three poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting taking place November 8 to 12, 2017 at the Gaylord National Hotel & Convention Center in National Harbor, Maryland (Press release, Genocea Biosciences, NOV 7, 2017, View Source [SID1234521649]). The posters, all of which will be presented on Saturday, November 11, highlight the power of Genocea’s proprietary antigen identification system ATLAS to identify and profile CD4+ and CD8+ T cell responses to neoantigens and tumor-associated antigens (TAAs) for potential use in cancer vaccines and as non-invasive biomarkers.

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"These data demonstrate the versatility of ATLAS and support our use of the technology in the development of next-generation neoantigen cancer vaccines," said Jessica Baker Flechtner, Ph.D., chief scientific officer at Genocea. "With our first personalized vaccine candidate expected to enter the clinic in 2018, we are excited that ATLAS continues to demonstrate superiority to in silico methods of neoantigen identification and believe that our ability to identify true neoantigens will be key to developing more effective immunotherapies. We are also eager to further explore, through partnerships, the potential of ATLAS in the identification of novel tumor-associated antigens for biomarkers and common antigen cancer vaccines."

Poster #430: "Neoantigen identification using ATLAS across multiple tumor types highlights limitations of prediction algorithms," will be presented during the session on Personalized Vaccines and Technologies/Personalized Medicine. Highlights include:

ATLAS identified true neoantigens of CD8+ and CD4+ T cells, independent of patient HLA type, across a broad cohort of patients with different tumor types, including those with high or low mutational burden
Cancer types studied include renal cell carcinoma, and prostate, colorectal, pancreatic, and non-small cell lung cancers
Only 4% of ATLAS-identified neoantigens were predicted by NetMHCpan (a widely used in silico tool for neoantigen prediction)
88% of neoantigens that were predicted by NetMHCpan and confirmed by ATLAS were inhibitory and thus questionable for inclusion in cancer vaccines
The identification of activating and inhibitory neoantigens for CD8+ and CD4+ T cells should better enable neoantigen vaccines to stimulate a protective immune response
Poster #8: "T cell response profiling in colorectal carcinoma patients reveals an enrichment in responses to specific tumor-associated antigens," will be presented during the session on Biomarkers and Immune Monitoring. Highlights include:

Tumor stage at time of diagnosis is considered to be the most important predictor of survival in colorectal cancer (CRC) patients; tumor-associated antigen (TAA)-specific responses in peripheral blood can be detected using ATLAS
ATLAS identified T cell responses to a subset of TAAs in individuals with pre-malignant adenomatous polyps that were similar to those in CRC patients and distinguishable from healthy individuals
Three TAAs that were most frequently identified in this cohort of patients were not aligned with those previously investigated as therapeutic vaccines
Data support investigation of this new set of TAAs as antigens for a novel vaccine to complement personalized cancer vaccine approaches
Data also support potential development of a non-invasive blood-based assay for early detection and diagnosis of CRC
Poster #28 entitled "Profiling of T cell responses to tumor-associated antigens in lung cancer patients treated with checkpoint inhibitors," will be presented during the session on Biomarkers and Immune Monitoring. Highlights include:

ATLAS identified both stimulatory and inhibitory CD8+ and CD4+ T cell responses to TAAs in lung cancer patients treated with checkpoint inhibitors
ATLAS confirmed two TAAs that elicited more frequent responses than NY-ESO-1, MUC1, and MAGEA3, three TAAs that have been studied previously in clinical trials as vaccine antigens for lung cancer patients
Data support investigation of these TAAs as antigens to include in a common-antigen immunotherapy for lung cancer
T cell response profiles associating with effective treatment with checkpoint blockade are under investigation

On November 7, 2017 CytomX Therapeutics, Inc. (NASDAQ: CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported third quarter 2017 financial results (Press release, CytomX Therapeutics, NOV 7, 2017, View Source;p=RssLanding&cat=news&id=2315188 [SID1234521674]).

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As of September 30, 2017, CytomX had cash, cash equivalents and short-term investments of $331.3 million. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations into 2020.

"We have continued to enjoy a highly productive year with excellent progress in advancing our deep pipeline of potentially transformative Probody therapeutics and the addition of another major partner in Amgen," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "I am delighted with the team’s strong execution across all areas of the organization, and we continue to be well positioned for initial data read outs in 2018 from our lead, wholly owned programs, CX-072 and CX-2009. We also expect that Probody therapeutics targeting CTLA-4, PD-1, and CD71 will enter the clinic next year, demonstrating the considerable momentum behind our pipeline."

Q3’17 BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

Patient enrollment continued in the monotherapy dose escalation arm (Part A1) of the study evaluating CX-072 in patients with advanced unresectable solid tumors or lymphomas. Enrollment is expected to be complete by year-end.
Patient enrollment has now been initiated in all other dose escalation arms of the study:
Monotherapy expansion in patients with PD-L1-positive tumors at multiple dose levels (Part A2);
Concomitant schedule for CX-072 plus ipilimumab in patients with advanced unresectable solid tumors or lymphomas (Part B1);
Phased schedule for CX-072 plus ipilimumab in patients with advanced unresectable solid tumors or lymphomas (Part B2); and
Combination of CX-072 plus vemurafinib in patients with V600E BRAF-positive melanoma (Part C)
During the first half of 2018, an expansion cohort of the study at the recommended Phase 2 dose is expected to begin enrolling patients to evaluate CX-072 as monotherapy in a tumor type with known sensitivity to PD-L1 and/or PD-1 inhibitors (Part D).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a first-in-class Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancers, but has been considered undruggable given that it is also expressed in normal tissue.
Patient enrollment continues in the PROCLAIM-CX-2009 study, a Phase 1/2 clinical trial evaluating CX-2009 as monotherapy in a subset of CD166-positive cancers.
The study was initiated at a dose of 0.25 mg/kg, has advanced through several patient cohorts and is currently enrolling at a dose of 2 mg/kg.
Expansion cohorts at the recommended Phase 2 dose in one or more CD166 positive tumor types are expected to initiate in 2018.
CX-2029 (CD71 Probody Drug Conjugate) Preclinical Program

CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC, through Investigational New Drug (IND) application-enabling studies and expects to file an IND application in the first half of 2018.
A $15 million milestone payment ($14 million net of associated license fees) was received from AbbVie in conjunction with meeting certain criteria allowing the initiation of GLP toxicology studies by CytomX.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program

CytomX is advancing CX-188, a PD-1-directed Probody therapeutic, through IND application-enabling studies and expects to file an IND application in the second half of 2018.
Amgen Partnership

During the quarter, Amgen and CytomX entered into a strategic collaboration in immuno-oncology in the field of Probody T-cell engaging bispecific antibodies including the co-development of a CytomX Probody T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types.
Under the terms of the agreement, Amgen and CytomX will co-develop a Probody T-cell engaging bispecific against EGFR-CD3 with CytomX leading early development. Amgen will lead later development and commercialization with global late-stage development costs shared between the two companies.
Amgen made an upfront payment of $40 million and purchased $20 million of CytomX common stock.
CytomX is eligible to receive up to $455 million in development, regulatory and commercial milestones for the EGFR program.
Amgen will lead global commercial activities with CytomX able to opt into a profit share in the U.S. and receive tiered, double-digit royalties on net product sales outside of the U.S.
Amgen also received exclusive worldwide rights to develop and commercialize up to three undisclosed targets. Should Amgen ultimately pursue all of these targets, CytomX will be eligible to receive up to $950 million in additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products.
CytomX also received the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific program; Amgen is eligible to receive milestones and royalty payments on any resulting products from this CytomX program.
Bristol-Myers Squibb (BMS) Partnership

BMS continues to advance its CTLA-4-directed Probody therapeutic, which is expected to enter the clinic in early 2018.
In addition, CytomX and Bristol-Myers Squibb are evaluating a Probody version of Bristol-Myers Squibb’s CTLA-4 nonfucosylated (CLTA-4-NF) version of ipilimumab as part of the current collaboration.
Third Quarter Financial Results
Cash, cash equivalents and investments totaled $331.3 million as of September 30, 2017, compared to $181.9 million as of December 31, 2016. The increase reflects a $200 million upfront payment received from BMS in connection with the expansion of the existing collaboration.

Revenue was $24.1 million for the three months ended September 30, 2017, compared to $3.5 million for the three months ended September 30, 2016. The increase was primarily attributable to the recognition of $14.0 million, net of the associated license fees, from the milestone payment received from AbbVie as a result of the Company achieving certain milestones required to be met to begin GLP toxicology studies under the CD71 Agreement and an increase of $6.3 million related to the recognition of the an upfront payment received from BMS in connection with the expansion of our collaboration pursuant to an amendment of our Collaboration and License Agreement entered into in March 2017.

Research and development expenses were $28.9 million for the three months ended September 30, 2017, compared to $13.3 million for the corresponding period in 2016. The increase was primarily attributable to $10.7 million of in-process research and development expense recognized and a $1.2 million sublicense fee payable to UCSB as a result of the Amgen agreement, an increase of $1.7 million in pharmacology studies and clinical trial expenses resulting from the advancement of CX-072, CX- 2009 and CX-2029 in 2017, an increase of $0.9 million in allocations resulting from increases in facilities-related expenses, an increase of $0.4 million in consulting and contracted services and an increase of $0.4 million in personnel-related expense resulting from an increase in headcount.

General and administrative expenses were $6.2 million for the three months ended September 30, 2017, compared to $5 million for the corresponding period in 2016. The increase was primarily attributable to an increase of $0.3 million in personnel-related expenses due to an increase in headcount, an increase of $0.3 million in legal expenses and an increase of $0.4 million in consulting and public relations expenses.

On November 7, 2017 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported two data presentations which were held on Fexapotide Triflutate studies at the Annual Meeting of the American Urological Association, New York Section in Havana, November 6 (Press release, Nymox, NOV 7, 2017, View Source;fvtc=4&fvtv=6907 [SID1234521687]). The abstract from the presentation is available at [email protected].

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The Podium presentation was given by Dr. Ivan Grunberger MD FACS, Professor of Clinical Urology, Weill Cornell Medical College and Chief of Urology, NYP Brooklyn Methodist Hospital. The paper was entitled "Prospective Randomized Double Blind Phase 3 Long-Term Results of U.S. Studies of Fexapotide Triflutate For BPH." Co-authors of the Podium presentation were Ronald Tutrone MD FACS of Baltimore MD, Mitchell Efros MD FACS of Garden City NY, Mohammed Bidair MD of San Diego CA, James Bailen MD FACS of Louisville KY, Franklin Gaylis MD FACS of San Diego CA, Barton Wachs MD of Long Beach CA, Richard Levin MD FACS of Baltimore MD, Susan Kalota MD of Tucson AZ, Sheldon Freedman MD FACS of Las Vegas NV, Barry Shepard MD FACS of Garden City NY, Jed Kaminetsky MD FACS of New York NY, Steven Gange MD FACS of Salt Lake City UT and Dr. Grunberger of Brooklyn NY.

Dr. Grunberger said, "Our presentation of the long-term data was very well received by the participants at the NY Section AUA meeting today. I received a lot of positive feedback following the presentation, and a great deal of interest in the use of Fexapotide Triflutate for patients with BPH once available."

The symposium "Fexapotide Triflutate: First in Class Injectable for BPH" was chaired by Dr. Tutrone. The other panel members at the Symposium were Dr. Jeffrey Snyder MD FACS of Denver CO, Dr. Kenneth Goldberg MD FACS of Carrollton TX, and Dr. Grunberger of Brooklyn NY.

Dr. Tutrone said, "I see Fexapotide Triflutate as a first line therapy for men suffering from BPH. It is a quick, painless and safe in-office procedure that takes minutes to do, and does not require a catheter. Its long term efficacy is better than oral medications, and there are no sexual side effects."

At the Symposium detailed clinical data on the Phase 3 clinical trials that have been completed for Fexapotide and that have shown excellent safety and efficacy for the treatment of BPH was presented. The main presentation was followed by a panel discussion and by an interactive question and answer session with the specialist doctors in attendance.

Dr. Snyder said, "I am most encouraged by the clinical trial data presented at the NY Section of the AUA meeting in Havana, Cuba today. This compound is a novel and effective approach to caring for men with symptoms of an enlarged prostate. It is my opinion that the drug will enhance the therapeutic armamentarium of urologists worldwide and maintain our expertise in the treatment of prostate disease. "

Fexapotide has been filed for approval in Europe and the filing was accepted for review in September 2017‎. Nymox’s lead drug Fexapotide has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. The same clinical program has also shown in a long-term blinded placebo crossover group study an 82-95% reduction in the number of these patients who required surgery after they received crossover Fexapotide in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001).