On August 7, 2019 Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, reported that the company is scheduled to present at the 2019 Wedbush PacGrow Healthcare Conference on Wednesday, August 14th, at 9:45 a.m. ET (Press release, Arvinas, AUG 7, 2019, View Source [SID1234538308]).

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A live audio webcast of the presentation will be available at www.arvinas.com under the Events & Presentations page. A replay of the webcast will be archived on the Arvinas website for 30 days following the presentation.

On August 7, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported financial and operating results for the second quarter ended June 30, 2019 (Press release, Affimed, AUG 7, 2019, View Source [SID1234538324]).

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"After reaching agreement with the U.S. Food and Drug Administration on the study protocol design, we are now in the process of preparing to initiate the AFM13 registration-directed Phase 2 study," said Dr. Adi Hoess, Affimed’s CEO. "The recent positive final and interim results from two clinical studies of AFM13 add to the growing body of evidence supporting AFM13’s activity in CD30-positive lymphoma patients, and give us increased confidence in the potential of AFM13 to demonstrate clinical benefit in CD30-positive peripheral T cell lymphoma. To execute the Phase 2 study and to further advance our internal and partnered CD16A-targeting innate cell engager pipeline, we have significantly strengthened our organization through the addition of multiple key hires in the U.S. and Germany of individuals who have substantial drug development experience."

Corporate Updates

Affimed strengthened its drug development team with the addition of experienced personnel in several key areas, including Regulatory Affairs, Clinical Development and Operations, Drug Safety, Chemistry, Manufacturing and Control (CMC), Drug Safety & Pharmacovigilance, Biostatistics and Commercial Strategy. The new hires previously held positions at Novartis, Pfizer Inc., Abbott, Eli Lilly and Company and other large pharmaceutical or biotechnology companies.
In April, Affimed received a payment from Genentech triggered by the achievement of a preclinical milestone under its research collaboration to develop and commercialize novel natural killer (NK) cell engager-based immunotherapeutics based on Affimed’s ROCK platform to treat multiple cancers.
Affimed was added to the Russell 2000, Russell 3000, and Russell Microcap Indexes, effective after the U.S. markets closed on Friday, June 28, 2019 as part of Russell’s annual index rebalance process. Russell U.S. Indexes are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for active investment strategies.
In June 2019, Affimed’s subsidiary AbCheck entered into a five-year licensing agreement with Icosagen granting AbCheck access to Icosagen’s QMCF protein production technology. Under the terms of the agreement, AbCheck acquires the rights to utilize Icosagen’s QMCF technology platform for its commercial activities in antibody discovery.
Pipeline Updates

CD16A innate cell engager programs

AFM13 (CD30/CD16A)

Affimed reached agreement with the U.S. Food and Drug Administration regarding the design of its planned Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T cell lymphoma (PTCL). The results, if positive, could form the basis for a Biologics License Application (BLA) submission and support an accelerated approval given the unmet medical need for safe and effective new treatments in this hard-to-treat patient population. The study will also enroll a cohort of patients with transformed mycosis fungoides, an aggressive subtype of cutaneous T cell lymphoma. Study start-up activities are under way, with study commencement anticipated in the second half of 2019.
Updated data from an investigator-sponsored translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University was presented at the International Conference on Malignant Lymphomas (ICML) in Lugano in June 2019. The data confirmed single-agent activity of AFM13 in CD30-positive lymphoma patients, with an objective response rate (ORR) of 50% (5 out of 10 patients). Tumor biopsies showed increased infiltration of NK cells in responders compared to non-responders, and evidence of NK cell-mediated killing.
Affimed reported the final results from the Phase 1b dose escalation study of AFM13 plus pembrolizumab that showed encouraging efficacy in the intent-to-treat (ITT) patient population (n=30) with an ORR of 83%, including complete responses (CR) in 40% and partial responses (PR) in 43% of patients with hard-to-treat Hodgkin lymphoma. At the highest treated dose (n=24), patients showed an ORR of 88% (CR of 46% and PR of 42%) as determined by independent assessment. Overall, the combination of AFM13 and pembrolizumab showed a favorable safety profile in patients, including some patients who did not respond to first-line chemotherapy and a subgroup of patients who were primary refractory to brentuximab vedotin. Importantly, a deepening of responses was reported over time in multiple patients. In addition, patients previously transplant-ineligible transitioned to transplant after achieving an objective response with the combination of AFM13 and pembrolizumab, thus increasing the chance for a cure. These positive results, taken together with data demonstrating single-agent activity of AFM13 in CD30-positive T cell lymphoma patients, form the basis for Affimed to initiate a registration-directed study of AFM13 as monotherapy in patients with PTCL.
The combination of AFM13 with allogeneic NK cells represents a novel approach in order to further improve response rates and durability of responses in patients with relapsed/refractory CD30-positive lymphoma. In a preclinical collaboration with the University of Texas MD Anderson Cancer Center (MDACC), AFM13 has been shown to bind to CD16A with much higher affinity than other CD16A binding moieties such as monoclonal antibodies, thus enabling the formation of a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells. This stable complex showed strong efficacy in in vitro and in vivo experiments, forming the basis for an investigator-sponsored Phase 1 study by MDACC. In the study, MDACC intends to administer this stable complex in different doses (numbers of pre-loaded NK cells) into patients with relapsed/refractory CD30-positive malignancies.
AFM24 (EGFR/CD16A)

AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager from Affimed’s ROCK platform. It is designed to target EGFR-expressing solid tumors by a new mechanism of action that activates innate immunity. This is a differentiated approach from cetuximab and other EGFR targeting approaches that inhibit tumor growth by EGFR-mediated signal transduction. Affimed presented data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 Annual Meeting that demonstrated AFM24’s ability to bridge NK cells and macrophages to EGFR expressing tumor cell lines and induce lysis through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to AFM24’s different mode of action these effects were independent of RAS mutational status. Importantly, AFM24 enhanced tumor infiltration of NK cells and elicited dose-dependent anti-tumor efficacy in in vivo tumor models. AFM24 showed reduced inhibition of EGFR phosphorylation relative to the monoclonal antibody cetuximab. Treatment of cynomolgus monkeys with AFM24 resulted in a favorable safety profile, even when treated at high dose levels, demonstrating AFM24’s potential to have significantly lower toxicities in humans compared to standard of care. Affimed currently anticipates submitting the investigational new drug (IND) application for AFM24 around the end of the third quarter 2019.
Technology Updates

Data describing Affimed’s ROCK antibody platform was published in the mAbs journal, titled, "Redirected optimized cell killing (ROCK): A highly versatile multispecific fit-for-purpose antibody platform for engaging innate immunity." The paper discusses aspects of the modular platform, including the advantages of innate immune cell engagement over monoclonal antibodies and other engager concepts. The article also describes the potential of the ROCK platform to engineer a fit-for-purpose innate immune cell engager format that can be equipped with unique CD16A domains, modules that influence pharmacokinetic properties and molecular architectures that influence the activation of immune effectors, as well as tumor targeting. The article is available at: View Source
Financial Highlights

(Figures for the second quarter and six months ended June 30, 2019 and 2018 are unaudited.)

Cash, cash equivalents and current financial assets totaled €87.7 million as of June 30, 2019, compared to €108.8 million as of December 31, 2018. Based on its current operating and budget assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets as of June 30, 2019 will enable the Company to fund its planned clinical development and early development activities into 2021.

Net cash used in operating activities was €18.9 million for the six months ended June 30, 2019, compared to net cash used in operating activities of €15.2 million for the six months ended June 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.

Total revenue was €4.0 million for the three months ended June 30, 2019 compared to €0.2 million for the three months ended June 30, 2018. The increase in revenue is attributable to the recognition of €3.7 million as revenue from the Genentech collaboration in the second quarter of 2019.

Research and development (R&D) expenses for the second quarter of 2019 were €11.5 million, including accrued termination costs of €1.4 million associated with the wind-down activities for the two Phase 1 studies of AFM11. R&D expenses for the second quarter of 2018 were €7.1 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, startup activities for the AFM13 registration study in PTCL, early stage development and discovery activities, and the termination costs for the two AFM11 clinical studies.

General and administrative (G&A) expenses for the second quarter of 2019 were nearly unchanged at €2.3 million compared to €2.2 million for the second quarter of 2018.

Net loss was €10.3 million, or €0.17 per common share, for the second quarter of 2019, compared to a net loss of €8.0 million, or €0.13 per common share, for the second quarter of 2018.

Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast today, Wednesday, August 7, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (917) 720-0178 for U.S. callers, or +44 (0) 203 0095710 for international callers, and reference conference ID 9396039 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.

On August 7, 2019 PDL BioPharma, Inc. ("PDL" or "the Company") (Nasdaq: PDLI) reported financial results for the three and six months ended June 30, 2019 (Press release, PDL BioPharma, AUG 7, 2019, View Source [SID1234538342]):

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Second Quarter and Recent Financial Highlights

Generally Accepted Accounting Principles ("GAAP") net loss attributable to PDL’s shareholders of $4.4 million or $0.04 per share.
Non-GAAP net income attributable to PDL’s shareholders of $12.7 million. A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 at the end of this news release.
Cash and cash equivalents of $284.9 million as of June 30, 2019.
Invested $60.0 million in Evofem Biosciences, Inc. ("Evofem") in the second quarter of 2019.
Investment in Evofem resulted in an unrealized gain of $45.5 million due to the significant increase in Evofem’s stock price at the end of the second quarter of 2019.
Repurchased 8.0 million shares of common stock in the open market during the second quarter of 2019 for $26.0 million. The $100 million share repurchase program was completed in July 2019.
"Our investment in Evofem reflects our strategic shift with a focus on applying our capital and expertise to support the successful development and commercialization of innovative therapeutics by our partner companies," said Dominique Monnet, president and CEO of PDL. "We are transitioning away from our legacy portfolio of passive investments to build a focused portfolio of actively managed companies with exciting revenue growth potential.

"Indeed, a highlight of the second quarter is the completion of our $60 million equity investment in Evofem Biosciences," he added. "We are committed to working with Evofem’s experienced and inspired management team to support the successful launch of its flagship product, Amphora, with the ultimate goal of building the company into a leader in women’s health. This investment is a strong fit with our mission of creating value for shareholders and patients alike by enabling partner companies to maximize the potential of their novel therapeutics that address underserved needs. We expect to have an active role in managing this investment, as I have been appointed to the Evofem board of directors and PDL also has a board observer.

"We see significant revenue potential with Evofem’s investigational non-hormonal, on-demand contraceptive, Amphora, which addresses a considerable market opportunity," Monnet continued. "Evofem is preparing for a U.S. commercial launch in 2020, subject to FDA product approval, and has a well-defined commercial strategy designed to maximize product adoption and a strong balance sheet to support precommercial activities.

"The disappointing non-cash writedown of the fair market value of the AcelRx royalty asset underlines the importance of shifting our business model from passive investments to actively managed assets. We are pleased with the continued performance of our operating companies, Noden and LENSAR, which are both on target with the execution of their 2019 plans. We continue to receive significant royalties from the Assertio royalty asset and have ample cash on hand to execute on our business strategy. We expect cash flow generated by our current business will be in excess of our operational needs, thereby providing additional cash to invest in our future. We continue to review numerous opportunities and consider a broad range of potential transactions to build our portfolio," concluded Monnet.

Revenue Highlights

Total revenues for the second quarter of 2019 of negative $22.5 million included:
Product revenue of $17.8 million, which consisted of $7.4 million of product revenue from the LENSAR Laser System and $10.4 million from the sales of the Company’s branded prescription medicine products Tekturna and Tekturna HCT in the U.S. and Rasilez and Rasilez HCT in the rest of the world, as well as revenue generated from the sale of an authorized generic form of Tekturna in the U.S. (collectively, "the Noden Products").
Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of negative $40.4 million, primarily related to the non-cash AcelRx royalty asset fair value decrease of $60.0 million in the second quarter of 2019.
Following is a brief discussion by business segment:

Medical Devices

The Medical Devices segment consists of revenue derived from the LENSAR Laser System sales made by the Company’s subsidiary, LENSAR, Inc. ("LENSAR") and associated costs of operating the business. LENSAR is a medical device company focused on the next generation femtosecond cataract laser technology for refractive cataract surgery.

Product revenue from the LENSAR Laser System was $7.4 million, a 26% increase from the second quarter of 2018, and a 10% increase from the first quarter of 2019. Revenue generated outside the U.S. accounted for the majority of the increases. LENSAR procedure volume for the three months ended June 30, 2019 increased by 28% from the prior-year period and 7% from the first quarter of 2019.

Pharmaceutical

The Company’s Pharmaceutical segment consists of revenue derived from the Noden Products and associated costs of operating the business.

Product revenue from the Noden Products for the three months ended June 30, 2019 was $10.4 million, compared with $25.9 million in the prior-year period. Sales in the three months ended June 30, 2019 were comprised of $2.7 million in the U.S. and $7.7 million in the rest of the world, compared with $10.4 million and $15.5 million, respectively, in the prior-year period.

The decline in U.S. revenue in the three months ended June 30, 2019 is primarily due to the previously disclosed initial inventory stocking of the authorized generic launched late in the first quarter of 2019, which limited shipments of the authorized generic in the second quarter of 2019.
Sales of branded Tekturna in the U.S. declined due to both the Company’s launch of an authorized generic and the launch of a third-party generic form of aliskiren late in the first quarter of 2019.
Branded Tekturna and the authorized generic of Tekturna maintained a 74% U.S. market share at the end of the second quarter of 2019.
Sales of Rasilez and Rasilez HCT in the rest of the world declined primarily due to the initial inventory stocking in Japan in the second quarter of 2018 and to lower sales volume of Rasilez in other territories.
Income Generating Assets

The Company’s Income Generating Assets segment consists of revenue derived from (i) royalty rights – at fair value, (ii) notes and other long-term receivables, (iii) equity investments and (iv) royalties from issued patents in the U.S. and elsewhere covering the humanization of antibodies ("Queen et al. patents") and associated costs to manage these assets.

PDL recognized negative $40.4 million in revenue from royalty rights – change in fair value, compared with $12.8 million in the prior-year period.

The decrease is primarily related to a non-cash adjustment to the AcelRx royalty asset fair value of $60.0 million.
Due to the slower than expected adoption of Zalviso (sufentanil sublingual tablet system) since it was launched in Europe by Grünenthal relative to the Company’s estimates and the increased variance noted between the Company’s forecast model and actual results in the three months ended June 30, 2019, the Company utilized a third-party expert in the second quarter of 2019 to reassess the market and expectations of the product.
Key findings from the third-party study included: the post-surgical PCA (Patient-Controlled Analgesia) market was smaller than previously forecasted; the price of the product was higher relative to alternative therapies; the product was not being used as a replacement for systemic opioids; and, the design of the delivery device, which is pre-filled for up to three days of treatment, restricted its use for shorter recovery time procedures. The reduction in forecasted sales had a direct impact on both the sales-based royalties and the sales-based milestones expected to be received through 2033.
This decline was partially offset by higher royalty rights – change in fair value from the Assertio royalty asset.
PDL received $20.1 million in net cash royalties from all of its royalty rights in the three months ended June 30, 2019 compared with $19.4 million in the three months ended June 30, 2018.
Total revenues for the first half of 2019 were $16.4 million, compared with $85.1 million for the first half of 2018.
Following is a brief discussion by business segment:

Medical Devices

Product revenue from the LENSAR Laser System for the six months ended June 30, 2019 increased by $3.3 million, or 30%, to $14.1 million from $10.9 million for the six months ended June 30, 2018. Revenue generated outside of the U.S. was responsible for the majority of the increase. LENSAR procedure volume for the six months ended June 30, 2019 increased by 31% from the prior-year period.

Pharmaceutical

Product revenue from the Noden Products for the six months ended June 30, 2019 was $30.4 million, a $13.8 million decrease from $44.2 million for the prior-year period. Sales in the six months ended June 30, 2019 were comprised of $14.9 million in the U.S. and $15.5 million in the rest of the world, compared with $20.9 million and $23.3 million, respectively, in the prior-year period.

The decrease in sales of the Noden Products in the U.S. is due primarily to the launch and related initial inventory stocking of an authorized generic form of Tekturna in the U.S. and the launch of a third-party generic form of aliskiren late in the first quarter of 2019.
The decline in sales in the rest of the world is due to initial inventory stocking in Japan in the second quarter of 2018 and lower sales volume of Rasilez in other territories, in part reflecting additional measures to maximize the product profitability.
Income Generating Assets

Revenue from royalty rights – change in fair value was negative $28.1 million for the first half of 2019, compared with $23.9 million in the prior-year period.

The decrease is primarily related to a non-cash adjustment to the AcelRx royalty asset fair value of $60.0 million.
PDL received $32.7 million in net cash royalties from its royalty rights in the first half of 2019.
Royalties from PDL’s licensees to the Queen et al. patents were less than $0.1 million for the first half of 2019, compared with $4.0 million for the prior-year period, reflecting the runout of the royalties on the sales of Tysabri.

Interest revenue decreased by $1.5 million from the prior-year period due to modifications to the Company’s agreement with CareView Communications which suspended interest payments for the first half of 2019.

Operating Expense Highlights

Operating expenses for the three months ended June 30, 2019 were $27.4 million, a $144.3 million decrease from $171.7 million for the three months ended June 30, 2018. The decrease was primarily a result of:
the $152.3 million impairment of the Noden Products intangible assets in the second quarter of 2018 due to the increased probability of a third-party generic version of aliskiren being launched in the U.S.,
a $4.8 million decline in amortization expense for the Noden intangible assets as a result of the 2018 impairment recorded for these intangible assets,
a $4.0 million, or 28%, decline in general and administrative expenses primarily due to lower professional fees,
a $3.3 million, or 62% decline in sales and marketing expenses, reflecting the cost savings from the change in the Company’s marketing strategy for the Noden Products, and
a $2.2 million decrease in cost of product revenue.
The decrease was partially offset by:
the $22.1 million reduction to the contingent liability in the second quarter of 2018 for future Noden products milestone payments that were less likely to be made with the increased probability of a third-party generic version of aliskiren being launched in the U.S., and
increased research and development expenses of $0.2 million associated with product development in our Medical Devices segment.
Operating expenses for the six months ended June 30, 2019 were $55.8 million, a $150.1 million decrease from $205.9 million for the prior-year period. The decrease was primarily a result of:
the net impact of the above-described impairment of the Noden Products intangible assets in the second quarter of 2018 and related reductions to the Noden Products contingent liability and amortization expense associated with those intangible assets, which, in aggregate, accounted for $139.1 million of the decrease,
a $5.2 million, or 20%, decline in general and administrative expenses primarily due to lower professional fees, and
a $6.1 million, or 56%, decline in sales and marketing expenses, reflecting the cost savings from the change in the Company’s marketing strategy for the Noden Products.
The decrease was partially offset by:
increased research and development expenses of $0.3 million associated with product development in our Medical Devices segment.
Stock Repurchase Programs

In November 2018, PDL began repurchasing shares of its common stock pursuant to the $100.0 million share repurchase program authorized by the Company’s board of directors in September 2018. During the second quarter of 2019, the Company repurchased 8.0 million shares for an aggregate purchase price of $26.0 million.
Subsequent to the close of the second quarter of 2019, the Company repurchased 1.3 million shares of its common stock for a total of $4.1 million. These repurchases concluded this share repurchase program. Under this program, the Company repurchased a total of 31.0 million shares for $100.0 million, at an average cost of $3.22 per share.
Since initiating its first stock repurchase program in March 2017, the Company has repurchased a total of 53.1 million shares for $155.0 million, at an average cost of $2.92 per share.
As of July 30, 2019, the Company had approximately 114.2 million shares of common stock outstanding.
Other Financial Highlights

PDL had cash and cash equivalents of $284.9 million as of June 30, 2019, compared with cash and cash equivalents of $394.6 million as of December 31, 2018.
The $109.7 million reduction in cash and cash equivalents during the first six months of 2019 was primarily the result of common stock repurchases of $71.3 million and the Company’s investment in Evofem of $60.0 million, partially offset by the proceeds from royalty rights.
In August 2019, PDL received a royalty payment from Bausch Health in the amount of $11.3 million for royalties earned on sales of Glumetza for the month of June. This royalty payment will be recognized in the third quarter of 2019.
Conference Call and Webcast Details

PDL will hold a conference call to discuss financial resultsand provide a business update at 4:30 p.m. Eastern time today. Slides to accompany the conference call will be available in the Investor Relations section of www.pdl.com.

To access the live conference call via phone, please dial 844-535-4071 from the U.S. and Canada or 706-679-2458 internationally. The conference ID is 9787426. A telephone replay will be available beginning approximately one hour after the call through one week following the call and can be accessed by dialing 855-859-2056 from the U.S. and Canada or 404-537-3406 internationally. The replay passcode is 9787426.

To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of www.pdl.com and select "Events & Presentations."

On August 7, 2019 Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, reported that it has signed a definitive agreement to be acquired by an affiliate of the Permira funds in a transaction valued at approximately $2.4 billion, including Cambrex’s net debt (Press release, Cambrex, AUG 7, 2019, View Source [SID1234538416]). Under the terms of the merger agreement, Cambrex shareholders will receive $60.00 in cash for each share of Cambrex common stock, which represents a 47.1% premium to the August 7 closing stock price and a 37.3% premium to the 60-day volume weighted average closing price leading up to this announcement.

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Cambrex has grown to become the premier contract development and manufacturing organization in the small molecule space over the last several years. The recent acquisitions of Halo Pharma in 2018 and Avista Pharma Solutions in 2019 added drug product manufacturing and a full range of early stage and analytical testing services to the company’s leading position in drug substance manufacturing, allowing Cambrex to broaden customer relationships over the full product lifecycle, from pre-clinical through commercial.

"We are excited to announce this transaction with Permira, a global private equity firm that has made significant investments in the pharma services space. This agreement is a strong endorsement of our strategy and represents significant value for our shareholders," commented Steve Klosk, President and CEO of Cambrex. "Cambrex will continue to invest aggressively in our commitment to our global customer base, where we are constantly looking at ways to provide the broadest possible range of world class services."

"We are very excited to back Cambrex in its next phase of growth," said Henry Minello, Principal in the Global Healthcare Group of Permira. "Over many years, Cambrex has built a leading position with best-in-class capabilities and facilities, backed by an excellent reputation for quality and technical expertise. We look forward to partnering with Cambrex’s talented management and employees to support the growth of its integrated services offering."

Completion of the transaction is subject to customary closing conditions, including receipt of approval by Cambrex’s shareholders and customary regulatory approvals. Closing is expected to occur during the fourth quarter of 2019.

The transaction will be financed through a combination of debt and equity financing.

Under the terms of the agreement, Cambrex may actively solicit acquisition proposals from third parties during a 45-day "go-shop" period starting from the date of the agreement (which period may be extended under certain circumstances for an additional 15 days), and subject to customary requirements included in the agreement, enter into or recommend a transaction with a person or group that makes a superior proposal. There can be no assurance that this process will result in a superior proposal. Cambrex does not intend to disclose developments during this process unless and until the Board makes a decision with respect to any superior proposal it may receive.

Morgan Stanley & Co. LLC is acting as exclusive financial advisor and Kirkland & Ellis, LLP is serving as legal advisor to Cambrex. RBC Capital Markets is acting as exclusive financial advisor and provided committed debt financing to the Permira funds and Skadden, Arps, Slate, Meagher & Flom, LLP is serving as legal advisor to the Permira funds.

On August 7, 2019 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, reported financial results for the quarter ended June 30, 2019, and provided an update on recent clinical developments (Press release, Scynexis, AUG 7, 2019, View Source [SID1234538449]).

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"We are pleased with the rapid enrollment observed in our Phase 3 VANISH program for vulvovaginal candidiasis (VVC), which underscores the significant unmet need in this patient population," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. "We look forward to sharing top-line data from the U.S. study in the first quarter of 2020, and from the global study in the second quarter of 2020. We are making great progress toward our goal of a planned New Drug Application (NDA) submission for VVC in the second half of 2020."

Dr. Taglietti continued, "We are committed to maximizing the full value of ibrexafungerp in multiple settings. As we approach important milestones for our VVC registration program, we are also excited by the promising data supporting the potential role of oral ibrexafungerp as a treatment for a broad range of life-threatening, hospital-based, fungal infections, including Candida auris and other multidrug-resistant pathogens for which few existing treatment options are available."

Ibrexafungerp (formerly SCY-078), the first representative of a novel family of antifungal compounds referred to as triterpenoids, is being developed for oral and intravenous (IV) administration and is in clinical development for the treatment of both serious outpatient fungal infections, including VVC, and hospital-based life-threatening fungal infections, including invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. If approved, ibrexafungerp could potentially address significant unmet medical needs as the only oral non-azole antifungal therapy.

Ibrexafungerp Update

Significant progress made in Phase 3 VANISH program evaluating the safety and efficacy of oral ibrexafungerp (300mg BID for one day) versus placebo for the treatment of VVC
The VANISH Phase 3 program is comprised of two Phase 3, randomized, double-blind, placebo-controlled, multicenter studies:
The VANISH 303 study is being conducted in U.S. centers and is expected to enroll approximately 350 patients; enrollment in the study is exceeding expectations and SCYNEXIS anticipates top-line data in the first quarter of 2020. More information about this study can be found at: View Source
The global VANISH 306 study is being conducted in U.S. and European centers and is expected to enroll approximately 350 patients; enrollment is progressing as planned, and the Company anticipates top-line data in the second quarter of 2020. More information about this study can be found at: View Source
All NDA preparatory activities remain on track to support a planned NDA submission in the second half of 2020.
Phase 3 CANDLE study evaluating the safety and efficacy of oral ibrexafungerp versus placebo for the prevention of recurrent VVC is on track to start enrollment this quarter following the Special Protocol Assessment (SPA) agreement received from the U.S. Food and Drug Administration (FDA) in July 2019
The Company recently announced an agreement with the FDA under a SPA, on the design, trial population, endpoints and statistical analysis of the CANDLE study, a pivotal Phase 3 clinical trial of oral ibrexafungerp for the prevention of recurrent VVC. This SPA provides agreement with the FDA that the Phase 3 protocol design adequately addresses efficacy objectives that, if met, would form the primary basis of a regulatory submission for approval of oral ibrexafungerp for the prevention of recurrent VVC, an indication with no FDA-approved therapies.
The CANDLE study is a global Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of oral ibrexafungerp (300mg BID for one day, given once per month for a total of six treatment days) compared to placebo in female patients with recurrent VVC (defined as three or more episodes of VVC in the past 12 months, including the episode at screening). The study is being conducted at approximately 50 sites and is expected to enroll approximately 320 patients. Enrollment is expected to commence this quarter with an expected supplemental NDA submission in 2021.
More information about the CANDLE study can be found at: View Source
An open-label sub-study within CANDLE will evaluate the efficacy of oral ibrexafungerp in fluconazole-failure VVC patients
All patients in the CANDLE study will initially receive three doses of oral fluconazole to treat their acute episode of VVC present at screening before progressing to the prevention phase of the study.
Patients who fail to sufficiently respond to fluconazole treatment for their acute episode will be included in the sub-study, in which they will be offered one day of oral ibrexafungerp treatment (300mg BID) for their unresolved acute episode.
More information about the sub-study within the CANDLE study can be found at: View Source
Continued advancement of oral ibrexafungerp for hospital-based invasive fungal infections with two Phase 3 studies (FURI in refractory infections and CARES in Candida auris infections) and one Phase 2 study in invasive aspergillosis (SCYNERGIA)
Enrollment is ongoing in the Company’s refractory invasive fungal infection (rIFI) program, which comprises two open-label Phase 3 studies (FURI and CARES) designed to support a potential future NDA submission through the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). Positive clinical findings from these studies have so far reinforced the potential role of oral ibrexafungerp as a novel therapy to combat severe and difficult-to-treat fungal infections, including multidrug-resistant Candida auris. More information about these studies can be found at:
View Source
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Enrollment continues in the Phase 2 SCYNERGIA study, a randomized, double-blind clinical trial assessing the safety and efficacy of oral ibrexafungerp in combination with voriconazole, compared to voriconazole alone. More information about this study can be found at: View Source
Data presented at the American Society for Microbiology (ASM) Microbe 2019 Meeting demonstrates broad potential utility of ibrexafungerp for the treatment and prevention of multiple severe fungal infections
A total of nine presentations revealed data further demonstrating the potential of ibrexafungerp as a treatment for invasive fungal infections (visit scynexis.com/science to view the presentations). The data presented highlighted the potent activity of ibrexafungerp against difficult-to-treat and/or multidrug-resistant pathogens, including Candida auris, Candida glabrata, and Pneumocystis pneumonia. The activity of ibrexafungerp was tested against many Candida strains resistant to echinocandins, the current standard of care for these infections, and potent activity of ibrexafungerp was observed.
In vivo chronic toxicology studies further support the safety profile of ibrexafungerp, allowing for patients suffering from invasive fungal infections to use oral ibrexafungerp for an extended period of time and enabling its potential development as a prophylactic agent and as a treatment for chronic fungal infections.
Corporate Highlight

Management Team strengthened with appointment of Dr. Nkechi Azie as Vice President of Clinical Development.
SCYNEXIS announced the appointment of Nkechi Azie, MD, MBA, FIDSA, as Vice President of Clinical Development. Dr. Azie will lead clinical development activities and strengthen medical affairs efforts in anticipation of ibrexafungerp’s potential approval and commercial launch. She joins SCYNEXIS with over 25 years of experience in drug development and medical affairs, having worked in therapeutic areas including infectious disease, women’s health and immunology.
Second Quarter 2019 Financial Results

Cash, cash equivalents and short-term investments totaled $35.2 million as of June 30, 2019, with net working capital of $28.9 million. Based upon its existing operating plan, SCYNEXIS believes its existing cash, cash equivalents, short-term investments, and the sale of a portion of its New Jersey net operating losses (NOLs), will be sufficient to fund operations beyond the planned NDA submission for acute VVC in the second half of 2020.

Research and development expenses increased to $8.5 million for the quarter ended June 30, 2019, compared to $5.6 million in the second quarter of 2018. The increase of $2.9 million, or 51%, was primarily driven by an increase of $3.2 million in clinical development costs, an increase of $0.4 million in chemistry, manufacturing, and controls (CMC) costs, a net increase in other research and development costs of $0.6 million, offset in part by a decrease of $1.3 million in preclinical development expense.

Selling, general and administrative expenses in the second quarter of 2019 increased to $2.8 million, compared with $2.1 million in the second quarter of 2018. The increase of $0.7 million, or 31%, was primarily driven by a $0.4 million increase in business development costs.

Total other income increased to $2.8 million in the second quarter of 2019, compared to a $3.1 million loss in the second quarter of 2018. The increase in other income is attributable to the non-cash gains recognized during the second quarter of 2019 of $2.0 million and $1.3 million associated with the fair value adjustments for warrant liabilities and derivative liability, respectively.

Net loss for the second quarter of 2019 was $8.4 million, or $0.16 per share. This compares with a net loss for the second quarter of 2018 of $10.8 million, or $0.23 per share.

About Ibrexafungerp
Ibrexafungerp [pronounced eye-BREX-ah-FUN-jerp] is an investigational antifungal agent and the first representative of a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids. This agent combines the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. Ibrexafungerp is currently in development for the treatment of fungal infections caused primarily by Candida (including C. auris) and Aspergillus species. It has demonstrated broad spectrum antifungal activity, in vitro and in vivo, against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. The FDA has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations for the formulations of ibrexafungerp for the indications of invasive candidiasis (IC) (including candidemia), invasive aspergillosis (IA) and VVC (including prevention of recurrent VVC), and has granted Orphan Drug Designation for the IC and IA indications. Ibrexafungerp is formerly known as SCY-078.