On August 8, 2016 Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, including high value and difficult to manufacture proteins, reported financial results for the second quarter ended June 30, 2016 and provided a business update (Press release, Pfenex, AUG 8, 2016, View Source [SID:1234514353]).

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Pfenex disclosed today in a separate press release that the company will be regaining the full rights to PF582, a biosimilar candidate to Lucentis (ranibizumab), based on our collaboration partner’s strategic review of the current therapeutic focus of its biosimilar pipeline. In addition, today Pfenex disclosed the Phase 1/2 PF582 data in the separate press release.

Pfenex also announced today the positive interim data from our anthrax vaccine Phase 1a study, which may be referred to in the separate press release issued today.

"We believe that PF582 has significant value as highlighted by the Phase 1/2 data we released this morning. As the program transitions back to Pfenex, we will be moving ahead with strategic options for PF582. Our diverse pipeline continues to advance as demonstrated by the positive anthrax vaccine update today. Additionally, the announcement of the Jazz collaboration on July 28th underscores the value of the Pfenex Expression Technology platform and our development capability," stated Bertrand C. Liang, chief executive officer of Pfenex. "As part of the Jazz collaboration, we have the opportunity to efficiently develop a portfolio of hematology programs. Given this productive collaboration and our recent pipeline review, we have decided to advance the assets that are part of the Jazz collaboration ahead of the PF530 biosimilar Betaseron opportunity and reduce the expenses associated with PF530. The PF530 program is at an important inflection point, having accessed an abbreviated biosimilar development path in the United States, consisting of a pivotal PK/PD study in healthy subjects and an immunogenicity study in multiple sclerosis patients. However, by focusing on pipeline programs that balance value creation with development costs, we will continue to improve our capital efficiency. Potential strategic opportunities for the PF530 program will be explored, given the successful advancement of PF530 and the positive regulatory feedback. This re-alignment underscores our disciplined approach to capital allocation. Over the remainder of 2016, we are looking forward to key data readouts and study initiations which we believe will further highlight our differentiated business strategy and capabilities."

Business Review and Update

Pfenex initiated the Phase 1 trial for its recombinant anthrax vaccine in 2015 and today reported positive interim data from the study in a separate press release. In August 2015, Pfenex announced signing a five year, cost plus fixed fee contract valued at up to $143.5 million with the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), for the advanced development of our mutant recombinant protective antigen anthrax vaccine, which offers the potential for a dramatic improvement in the rapid production of large amounts of high value stable recombinant anthrax vaccine for the U.S. Government.

Pfenex has regained full rights to PF582 and announced in a separate release today the results of the phase 1/2 trial. Pfenex enrolled a total of 25 VEGF-inhibitor naïve patients with neovascular age-related macular degeneration (AMD) in the PF582 Phase 1/2 trial (13 received PF582, including 1 sentinel patient who received open label PF582, 12 received Lucentis). All patients received 3 monthly intravitreal injections. The primary endpoint of the study was safety and tolerability of PF582 compared to that of Lucentis in patients with neovascular AMD. With respect to safety, there were no meaningful differences in intra-ocular pressure between PF582 and Lucentis at any of the timepoints. Additionally, there were no imbalances in local or systemic adverse events. The immunogenicity results showed comparable anti-drug antibody findings between PF582 and Lucentis throughout the 3 month study period. The efficacy and pharmacodynamic results indicated that there were no meaningful differences in best corrected visual acuity and the decreases in central retinal thickness between PF582 and Lucentis at any of the timepoints were also similar.

The Pfenex collaboration with Jazz Pharmaceuticals on multiple early stage hematology product candidates also includes an option for Jazz Pharmaceuticals to negotiate a license for a recombinant pegaspargase product candidate with Pfenex. Pfenex received upfront and option payments totaling $15 million and may be eligible to receive additional payments of up to $166 million based on the achievement of certain development-, regulatory-, and sales-related milestones, including up to $41 million for certain non-sales-related milestones. Pfenex may also be eligible to receive tiered royalties on worldwide sales of any products resulting from the collaboration. Both parties will be contributing to development efforts.

We anticipate initiating the PF708 clinical program by year end to satisfy the regulatory filing requirements. PF708 is our peptide product candidate that we are developing as a therapeutic equivalent to Forteo (teriparatide) through the 505(b)(2) regulatory development pathway. The PF708 clinical program is expected to include an immunogenicity/pharmacokinetic study in subjects with osteoporosis.

Process development for PF529, our biosimilar candidate to Neulasta (pegfilgrastim), is ongoing and we anticipate receiving regulatory feedback by the end of 2016.

Given the Jazz collaboration and our recent pipeline review, Pfenex has decided to advance the hematology assets that are part of the Jazz collaboration ahead of the PF530 biosimilar Betaseron opportunity. The expenses associated with PF530 will be reduced as part of the portfolio re-alignment. Pfenex completed a Phase 1 trial of PF530, a biosimilar candidate to Betaseron, in 2015 which enrolled 12 healthy subjects. Based on the analysis of the trial PK and PD parameters, no meaningful differences between PF530 compared to the reference compound were observed. Potential strategic opportunities for the PF530 program will be explored, given the successful advancement of PF530 and the positive regulatory feedback.

Financial Highlights for the Second Quarter

Total Revenue increased by $0.8 million, or 37%, to $3.1 million in the three month period ended June 30, 2016 compared to $2.3 million in same period in 2015. The increase in revenue was due to the stage of development of our anthrax vaccine product candidates under our government contracts, offset by a decrease in product sales. Given the nature of the novel vaccine development process, revenue will fluctuate depending on stage of development.

Cost of revenue of $1.4 million increased by approximately $0.5 million in the three month period ended June 30, 2016 compared to $0.9 million in the same period in 2015. The increase in cost of revenue was due primarily to an increase in costs for our anthrax vaccine product candidates under our government contracts. The increase was offset by a decrease in product sales, which is impacted by our customers’ product development and clinical progression. Given the nature of the novel vaccine development process, these costs will fluctuate depending on stage of development.

Research and development expenses increased by approximately $4.0 million to $7.6 million in the three month period ended June 30, 2016 compared to $3.6 million in same period in 2015. The increase in research and development expense was due to the increase in development activity of our product candidates PF708 and PF530 and the hiring of additional personnel dedicated to our research and development efforts. We expect research and development expenses to increase for the foreseeable future as we advance our lead candidates and pipeline product candidates.

Selling, general and administrative expenses increased by $0.6 million, or 17%, to $4.3 million in the three month period ended June 30, 2016 compared to $3.7 million in the same period in 2015. The increase in selling, general and administrative expenses during the periods presented were primarily due to an increase in headcount, as well as increases in salaries and other personnel costs. We expect general and administrative costs to continue to increase for activities associated with operating as a publicly-traded company.

Cash and cash equivalents as of June 30, 2016 was $89.6 million.

On August 8, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported its financial results for the second quarter ended June 30, 2016 and recent company developments (Press release, TG Therapeutics, AUG 8, 2016, View Source [SID:1234514354]).

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Michael S. Weiss, the Company’s Executive Chairman and Interim Chief Executive Officer, stated, "The second quarter was a busy time for the Company, with data presented at both the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) meetings on the safety and activity of TGR-1202 alone and in combination with TG-1101, which we believe continues to show that TGR-1202 is a differentiated PI3K delta inhibitor. With the recent high profile setbacks encountered for both idelalisib and duvelisib, more than ever there is a need for a PI3K delta inhibitor with a favorable therapeutic index. Outside of mantle cell lymphoma, BTK inhibitors have shown limited activity in lymphoma, making a safe and effective PI3K delta inhibitor critically important. We are committed to bringing TGR-1202 forward in CLL and across aggressive and indolent lymphomas. Accordingly, we remain highly focused on executing our ongoing Phase 3 clinical programs in CLL, our registration directed UNITY-DLBCL study, and commencing additional registration programs in iNHL in the future." Mr. Weiss continued, "During the second quarter we were also very excited to commence our first study of TG-1101 in patients with multiple sclerosis, which we intend to utilize to inform our plans for a registration study in multiple sclerosis, which we hope to commence in the first half of 2017."

Recent Developments and Highlights

Presented long-term follow-up data of TGR-1202 both alone and in combination with TG-1101 in an integrated analysis at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress demonstrating a differentiated safety profile and high response rates in CLL and NHL

Presented clinical data from the study of TGR-1202 in combination with ibrutinib in patients with advanced CLL and Mantle Cell Lymphoma at the EHA (Free EHA Whitepaper) Annual Congress demonstrating the safety and efficacy of this all oral combination

Entered into a global collaboration to develop and commercialize novel BET inhibitors for the treatment of hematological malignancies

Enrolled the first patient in the registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101 and TGR-1202 as a combination compared to TGR-1202 monotherapy in patients with advanced relapsed/refractory DLBCL

Commenced the Company’s first clinical trial evaluating TG-1101 in patients with relapsing remitting multiple sclerosis
Key Remaining 2016 Milestones

Aggressively enroll into our Phase 3 and registration directed trials, including the GENUINE Phase 3, the UNITY-CLL Phase 3, and the UNITY-DLBCL Phase 2b
Continue enrollment into the Phase 2 clinical trial in Multiple Sclerosis
Present clinical data from a variety of Phase 1 and 2 clinical trials at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in December 2016, held in San Diego, CA
Financial Results for the Second Quarter 2016

At June 30, 2016 the Company had cash, cash equivalents, investment securities, and interest receivable of $75.8 million, which we believe will be sufficient to fund our operations into the second quarter of 2018.

Our net loss for the second quarter ended June 30, 2016, excluding non-cash items, was approximately $14.3 million, which included approximately $3.4 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation for potential commercialization. The GAAP net loss for the second quarter ended June 30, 2016, inclusive of non-cash items, was $15.9 million, or $0.33 per basic and diluted share, compared to a net loss of $17.1 million, or $0.38 per basic and diluted share during the comparable quarter in 2015. The decrease in net loss during the second quarter ended June 30, 2016 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2015, partially offset by an increase in clinical trial expenses (other research and development expenses) related to ongoing and planned future Phase 3 registration programs.

Our net loss for the six months ended June 30, 2016, excluding non-cash items, was approximately $26.4 million, which included approximately $7.7 million of manufacturing and CMC expenses for Phase 3 clinical trials and in preparation for commercialization. The GAAP net loss for the six months ended June 30, 2016, inclusive of non-cash items, was $29.7 million, or $0.61 per diluted share, compared to a consolidated net loss of $31.7 million, or $0.73 per basic and diluted share during the comparable period in 2015. The decrease in net loss of $1.9 million during the six months ended June 30, 2016 was the result of a decrease in non-cash compensation expense related to equity incentive grants over the comparable period in 2015, partially offset by an increase in clinical trial expenses (other research and development expenses) related to ongoing and planned future Phase 3 registration programs.

On August 8, 2016 ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company developing orally-administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, reported financial results for the second quarter ended June 30, 2016 and provided an update on the Company’s clinical development activities (Press release, ChemoCentryx, AUG 8, 2016, View Source [SID:1234514396]).

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"The positive results from the CLASSIC trial with CCX168 mark the successful culmination of our AAV Phase II program and we now look forward to initiating Phase III development of CCX168 in AAV," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "We also anticipate reporting initial results from our ongoing trial of CCX872 in patients with pancreatic cancer during the second half of this year. We are very pleased to have achieved such important clinical, regulatory and business development goals thus far in 2016 and with them, the added validation of our approach to treating autoimmune diseases, inflammatory disorders and cancer. We look forward to building on that momentum as we enter the second half of the year."

Pipeline Developments Across Key Therapeutic Areas

Orphan and Rare Diseases: CCX168 is an orally-administered complement inhibitor targeting the C5a receptor (C5aR), and is being developed for several rare disease indications, including ANCA-associated vasculitis (AAV) and atypical hemolytic uremic syndrome (aHUS). CCX168 acts by blocking the destructive action of neutrophils that are activated as a consequence of the complement protein known as C5a binding to C5aR on neutrophils during autoimmune inflammatory events including the destruction of blood vessels in AAV.

Reported positive top-line results from the Phase II CLASSIC trial with CCX168 in patients with AAV. The goal of the CCX168 development program in AAV is to reduce or eliminate the use of chronic high dose glucocorticosteroids (steroids) in the current standard of care (SOC) treatment. To inform potential regulatory queries and eventual labeling requirements for CCX168 in AAV, the Phase II CLASSIC study was designed largely to assess the safety profile of CCX168 when added to the current SOC. The CLASSIC safety trial met its objectives as follows:
The addition of CCX168 to current SOC therapy did not add safety concerns beyond those seen with SOC alone. The incidence of serious adverse events (SAEs) was similar across treatment groups in the study and consistent with effects related to background therapy.
While the CLASSIC safety study was not designed or powered for inferential statistical analyses on efficacy, the Birmingham Vasculitis Activity Score (BVAS) response endpoint was numerically superior in patients who received CCX168, and rapid BVAS remission (BVAS = 0 at week 4) was also seen in patients receiving the clinically relevant 30 mg dose of CCX168 + SOC (5 of 15 patients) vs. SOC alone (2 of 13 patients) and SOC + 10 mg CCX168 (1 of 12 patients).
Announced exclusive regional license agreement with Vifor Pharma to commercialize CCX168 in Europe and certain other markets. The agreement included $85 million upfront payment to ChemoCentryx, comprising $60 million in cash in addition to $25 million equity investment from Vifor Pharma. ChemoCentryx retains all ongoing and future development of CCX168, other than country-specific development in the licensed territories, as well as commercialization rights to CCX168 in the United States and other countries not licensed to Vifor Pharma.
Granted PRIority MEdicines (PRIME) designation by the European Medicines Agency (EMA) for CCX168 for the treatment of AAV. PRIME provides enhanced scientific guidance and supports accelerated review of investigational therapies that show the potential to benefit patients with unmet medical needs based on clinical data.
Awarded a U.S. Food and Drug Administration (FDA) Orphan Products Development one-year grant of $500,000 to assist in the clinical development of CCX168 for treatment of AAV.
Presented positive results from the Phase II CLEAR trial at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress. The CLEAR trial met its primary endpoint based on the BVAS response at week 12 in patients receiving CCX168, compared to those patients receiving the high dose steroid-containing SOC. Specifically, all treatment groups receiving CCX168 demonstrated a numerically superior, statistically significant (P=0.002) non-inferior clinical efficacy outcome when compared to SOC.
Presented preclinical data at the ERA-EDTA Congress which used CRISPR-Cas9 technology to create novel murine models of complement over activation and C5a generation, as found in aHUS and C3 glomerulopathy (C3G), and found evidence of impaired renal function in these mice.
Immuno-Oncology: CCX872 is a potent and selective inhibitor of the chemokine receptor known as CCR2, and is the Company’s most advanced drug candidate that is designed to block the infiltration of immune suppressor cells in the tumor microenvironment. CCX872 is being evaluated in patients with non-resectable pancreatic cancer in an ongoing, multi-center clinical trial. The primary outcome measurement of the study is progression-free survival (PFS) after at least 24 weeks of treatment. Overall response rate after 12 weeks of treatment will also be evaluated. ChemoCentryx is conducting earlier stage research with various chemokine receptor inhibitors, such as CCX9588, an inhibitor of the chemokine receptor known as CCR1, in combination with checkpoint inhibitors. The Company’s immuno-oncology efforts further include research to identify potential drug candidates targeting additional receptors that are believed to play an important role in the tumor microenvironment.

Advanced Phase Ib pancreatic cancer trial of CCR2 inhibitor CCX872 in combination with FOLFIRINOX; and
Identified preclinical candidates that target CXCR2 and CXCR7, two receptors that are believed to play an important role in the tumor microenvironment.
Other Inflammatory and Autoimmune Diseases: Research suggests that a type of T cells known as Th-17 cells, which produce the pro-inflammatory cytokine IL-17, are involved in the origin and development of many autoimmune diseases, including psoriasis. It is thought that therapeutic solutions to Th-17 driven autoimmune diseases could include inhibiting CCR6 inhibitor, and ChemoCentryx has produced several unique CCR6 inhibitor candidates and demonstrated that Th-17 cells are regulated by CCR6.

Presented preclinical data demonstrating that novel CCR6 inhibitors developed by ChemoCentryx have efficacy in models of psoriasis and achieved equivalent results when compared to an antibody to the IL-17 receptor. These novel CCR6 inhibitors reduced skin inflammation in models of psoriasis, and reduced the number of IL-17-secreting T cells in psoriatic skin. These results were presented at the 2016 Society for Investigational Dermatology Annual Meeting.
Anticipated Milestones

Orphan and Rare Diseases:

Evaluate formal feedback from End of Phase II and scientific advice meetings with U.S. and EU regulatory agencies and formalize the CCX168 AAV Phase III development plan in the second half of 2016;
Initiate Phase III development program with CCX168 for the treatment of AAV by the end of 2016; and
Report early results from the Phase II pilot study of CCX168 in aHUS patients who are on dialysis in late 2016.
Immuno-Oncology:

Report overall response rate and initial PFS data from pancreatic cancer trial of CCX872 in combination with FOLFIRINOX in the third and fourth quarter 2016, respectively.
Chronic Kidney Disease:

Review End of Phase II meeting plans and a potential Phase III clinical development program for CCX140 in diabetic nephropathy in the context of a partnership.
Second Quarter 2016 Financial Results and Outlook

Cash, cash equivalents and investments totaled $139.9 million at June 30, 2016, and include the $85.0 million upfront payment received in connection with the partnership with Vifor Pharma announced during the second quarter.

Revenue was $2.8 million for the three months ended June 30, 2016 compared to zero in the same period in 2015. The increase in revenue from 2015 to 2016 was due to: (i) amortization of the upfront payment from Vifor Pharma and (ii) grant revenue from the FDA to support the clinical development of CCX168 for the treatment of patients with AAV.

Research and development expenses were $9.1 million for the three months ended June 30, 2016 compared to $8.6 million reported for the same period in 2015. The increase in research and development expenses from 2015 to 2016 was primarily attributable to higher expenses associated with CCX872, our second generation CCR2 inhibitor, following the completion of enrollment of our clinical trial in patients with advanced pancreatic cancer. This increase was partially offset by lower expenses associated with CCX168, our C5aR inhibitor, due to the completion of the CLEAR Phase II clinical trial in Europe for the treatment of AAV and the completion of the treatment period in the CLASSIC Phase II clinical trial for the same in North America in 2016.

General and administrative expenses were $3.9 million for the three months ended June 30, 2016 compared to $3.6 million for the comparable period in 2015. The increase from 2015 to 2016 was primarily due to higher intellectual property related expenses and travel and professional fees associated with our business development efforts.

Net loss was $10.0 million for the second quarter ended June 30, 2016 compared to $12.1 million in the same period in 2015.

Total shares outstanding at June 30, 2016 were approximately 47.8 million shares.

About ANCA-Associated Vasculitis and Other Rare Renal Diseases

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, or AAV, is a type of rare autoimmune inflammation caused by auto-antibodies. AAV encompasses granulomatosis with polyangiitis (GPA, formerly known as Wegener’s granulomatosis), microscopic polyangiitis (MPA), eosinophilic polyangiitis (formerly Churg-Strauss syndrome) and renal limited vasculitis.

AAV represents a severe and often fatal autoimmune disease that is characterized by inflammation that can destroy different organ systems. AAV is the lead indication in the Company’s orphan and rare disease program which has the objective of eliminating chronic high dose steroids, which are associated with significant safety issues including death, from the standard of care (SOC) regimen in AAV and replace steroids with CCX168.

AAV affects approximately 40,000 people in the U.S. (with approximately 4,000 new cases each year) and greater than 75,000 people in Europe (with at least 7,500 new cases each year), and is currently treated with courses of immuno-suppressants (cyclophosphamide or rituximab) combined with high dose steroid administration. Following initial treatment, up to 30 percent of patients relapse within six to 18 months, and approximately half of all patients will relapse within three to five years.

Current SOC for AAV is associated with significant safety issues. First year mortality is approximately 11 to 18 percent. The single major cause of premature mortality is not disease-related adverse events, but rather infection that is thought largely to be a consequence of steroid administration. Indeed, the multiple adverse effects of courses of steroid treatment (both initial courses and those that are repeated as a consequence of relapse) are major causes of both short-term and long-term disease and death. Such therapy related adverse events contribute significantly to patient care costs, as well as to the diminution of quality of life for patients.

By damaging the body’s small blood vessels, AAV affects many organ systems, mostly the kidneys, eyes, lungs, sinuses and nerves. This damage is caused by the destructive activity of inflammatory leukocytes in the body, with neutrophils considered to be the terminal effector cell. In AAV, neutrophils are attracted to sites of vascular destruction as well as activated at those sites by the activity of the complement system product known as C5a and its receptor, C5aR, which is the target of CCX168. By blocking the C5aR, CCX168 is thought to reduce vasculitis by reducing neutrophil activation, accumulation, and adhesion, as well as vascular permeability.

Atypical hemolytic uremic syndrome, or aHUS, an ultra-rare, life threatening disease that causes chronic blood vessel damage, thrombosis or clotting within blood vessels, hemolysis or red blood cell rupture, and sudden, progressive organ failure, such as kidney failure. The disease is caused by genetic defects in factors that control the activation of the complement system. Current treatment options are still quite limited and prognosis and quality of life are extremely poor.

About Pancreatic Cancer

It is estimated that over 337,000 cases of pancreatic cancer are diagnosed worldwide every year, accounting for 2.4 percent of all cancers. The incidence of pancreatic cancer in the U.S. is about 45,000, with prevalence being only negligibly higher owing to the poor survival rates on current therapy. Current standards of care include surgical resection and chemotherapeutic regimens such as gemcitabine and FOLFIRINOX. These regimens are limited by marked toxicities. Almost 67 percent of cases are diagnosed in people aged 65 and over. In the U.S., pancreatic cancer is the fourth most common cause of deaths due to cancer. Pancreatic cancer has a low survival rate regardless of stage of disease, with 93 percent of patients dying from their disease within five years.

On August 8, 2016 MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) reported financial results for the second quarter and the six months ended June 30, 2016 (Press release, Mannkind, AUG 8, 2016, View Source [SID:1234514495]).

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For the second quarter ended June 30, 2016, total operating expenses were $19.1 million as compared to $24.1 million for the same quarter in 2015. Research and development expenses were $4.3 million for the second quarter of 2016, a decrease of 44% compared to the second quarter of 2015, primarily due to a reduction in force in 2015 following the completion of Afrezza registration trials. Selling, general and administrative costs were $11.1 million for the second quarter of 2016, an increase of 5% compared to general and administrative costs for the second quarter of 2015, mainly due to sales and marketing expenses.

Manufacturing of commercial product resumed in the second quarter of 2016, in preparation for the relaunch of Afrezza in the third quarter of 2016, resulting in the recognition of product manufacturing costs of $3.7 million for the three months ended June 30, 2016. With limited production and underutilization of the manufacturing facility in the same period of 2015, product manufacturing costs were $5.7 million for the second quarter of 2015 due to under absorbed labor and overhead.

For the first six months ended 2016, total operating expenses were $39.1 million, a decrease of 15% as compared to $45.8 million for the same period in 2015. Research and development expenses were $9.4 million for the six months ended June 30, 2016, a decline of 45% compared to the same period in 2015, primarily due to the reduction in force in 2015 and the transition from development to commercial activities. Selling, general and administrative expenses for the six months ended June 30, 2016 were $18.5 million, a decrease of 13% compared to the same period in 2015, primarily due to the reduction in force, reduced professional fees related to strategic planning activities and lower non-cash stock compensation expense in 2015, offset by increased sales and marketing expense in 2016. Product manufacturing costs were $11.2 million for the six months ended June 30, 2016, an increase of 47% compared to the same period in 2015, as manufacturing of commercial product resumed in preparation for the relaunch of Afrezza in the third quarter of 2016.

For the three months ended June 30, 2016, the Company earned $0.3 million under the Sanofi License Agreement, which is required to be applied as a prepayment against the balance owed under the Sanofi Loan Facility. As of June 30, 2016, the total amount owed to Sanofi is $70.3 million, which includes accrued interest of $4.3 million.

Included in net loss for the three and six months ended June 30, 2016 is the non-cash effect of a $5.3 million fair value adjustment of the warrant liability related to the registered direct public offering completed in May 2016.

The net loss for the second quarter of 2016 was $30.0 million, or $0.07 per share, based on 455.3 million weighted average shares outstanding, compared with to the net loss of $28.9 million, or $0.07 per share, based on 401.0 million weighted average shares outstanding for the second quarter of 2015. The number of common shares outstanding at June 30, 2016 was 477.7 million.
Cash and cash equivalents at June 30, 2016 were $63.7 million, compared to $27.7 million at March 31, 2016. In May 2016, the Company received net proceeds of $47.4 million upon completion of a registered direct public offering, $9.2 million from Sanofi for the sale of insulin inventory in connection with a contractual obligation upon termination of the Sanofi License Agreement, and $0.7 million from Connecticut as a Research & Development tax credit. Currently, $30.1 million remains available for borrowing under the amended loan arrangement with The Mann Group along with $50.0 million available under the ATM facility.

On August 5, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported that it has completed the settlement of its recommended public offer to the shareholders of Meda Aktiebolag (publ.) to tender all their shares in Meda to Mylan (the "Offer") (Press release, Mylan, AUG 5, 2016, View Source [SID:1234514657]). As previously announced, the Offer was accepted by shareholders holding approximately 94% of the total number of outstanding shares and votes in Meda, as of July 29, 2016. Upon the completion and settlement of the Offer, Mylan acquired each of these shares in accordance with the terms of the Offer. The Offer was initially announced on Feb. 10, 2016 and it was declared unconditional on Aug. 2, 2016. The acceptance period expired on July 29, 2016 and will not be extended.

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Mylan Chairman Robert Coury commented, "We are very pleased to have received the overwhelming shareholder support required to complete our acquisition of Meda. Mylan continues to differentiate itself among the world’s pharmaceutical companies in terms of our unique profile and growth trajectory. The addition of Meda will only further add to our existing leadership position within our space and continue to create significant value for our shareholders and other stakeholders. On behalf of Mylan’s entire board of directors, we welcome our new Mylan shareholders and look forward to them sharing in the anticipated future success of our combined company."

Mylan CEO Heather Bresch continued, "The addition of Meda builds on everything we have put in place around the world, creating even greater scale, breadth and diversity across products, geographies and sales channels. As a result, our R&D and manufacturing platform is unmatched, and we now have a more powerful global commercial infrastructure across developed and emerging markets and branded, generic and over-the-counter products. This transaction also is extremely compelling financially, providing significant accretion to Mylan’s adjusted earnings per share, the opportunity for substantial synergies and further acceleration of our growth. Importantly, I would like to welcome Meda’s talented and dedicated workforce to the Mylan family, and I look forward to their contributions as we strive to deliver better health for a better world."

Mylan President Rajiv Malik added, "With the addition of Meda, Mylan now has six $1 billion therapeutic franchises, and through our enhanced scale and expanded commercial capabilities, we see significant opportunities to further distinguish Mylan among our customers and patients. Allergy/respiratory, pain/CNS and dermatology – recently bolstered by our acquisition of the Renaissance topicals business – represent just a few of the exciting areas where we expect to create additional value from our combined portfolio, pipeline and capabilities. Meda also opens up a number of new opportunities for us, such as significantly expanding our over-the-counter presence into a $1 billion business. Additionally, Meda accelerates our expansion in attractive emerging markets, such as China, Southeast Asia, Russia and the Middle East, and provides us opportunities to maximize our efficient, high quality operating platform and broad product portfolio. I too would like to extend a warm welcome to the Meda team and am excited to begin integrating our businesses and bringing together the best from both of our organizations."

Meda is now a controlled subsidiary of Mylan. Mylan intends to initiate compulsory acquisition proceedings for the remaining shares in Meda in accordance with the Swedish Companies Act (Sw. aktiebolagslagen (2005:551)) and has acted to have the Meda shares delisted from Nasdaq Stockholm.

Mylan discloses the information provided herein pursuant to Nasdaq Stockholm’s Takeover Rules (the "Takeover Rules"). The information was submitted for publication on Aug. 5, 2016, 15:00 CET.