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Constellation Pharmaceuticals Announces Second-Quarter and Six-Month 2019 Financial Results

On August 7, 2019 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported its second-quarter and six-month 2019 financial results (Press release, Constellation Pharmaceuticals, AUG 7, 2019, View Source [SID1234538296]).

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"2019 is a year of data for Constellation," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "We made multiple important data presentations in the second quarter that help to advance our vision of becoming a late-stage oncology development company, with an exciting pipeline of development and discovery programs.

"We look forward to providing further data updates in the second half of 2019 across our pipeline," Mr. Raythatha continued. "We remain deeply committed to delivering important new medicines to cancer patients around the world in order to reduce their suffering and improve their lives."

Program Updates

CPI-0610

Data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) from the MANIFEST study suggest that CPI-0610 may have disease-modifying effects.

In addition to improvements in spleen volume and constitutional symptoms, the interim data suggest improvements in anemia, transfusion dependence, and bone marrow fibrosis.

Our vision for CPI-0610 is to create a differentiated treatment for MF in ruxolitinib-resistant patients and to transform standard of care as a first-line therapy. We have begun planning for pivotal trials.
EZH2 Franchise

Enrollment for the ProSTAR clinical trial for CPI-1205 continues on track.

We are enrolling patients in three cohorts:
— CPI-1205 + abiraterone in second-line mCRPC;
— CPI-1205 + enzalutamide in second-line mCRPC, randomized against enzalutamide alone; and
— CPI-1205 + enzalutamide in heavily pre-treated patients who have progressed after treatment with each of enzalutamide, abiraterone, and chemotherapy.

We plan to provide an update for ProSTAR in the fourth quarter and additional data in early 2020.

The IND for CPI-0209, our second-generation and potentially best-in-class EZH2 inhibitor, was filed and cleared by the FDA.

CPI-0209 could address additional patient populations beyond those targeted by first-generation EZH2 inhibitors.
Milestones

The Company anticipates achieving the following milestones during the second half of 2019:

CPI-0610 MANIFEST Study

Update spleen volume, symptom, and anemia data from about 40 ruxolitinib-resistant patients and bone-marrow-fibrosis changes from a subset of patients.

Update status of conversion from transfusion dependence to transfusion independence from about 16 ruxolitinib-resistant patients.

Disclose spleen volume and symptom data for 10-15 JAK-inhibitor-naïve (first-line) patients.
EZH2 Franchise

Dose the first patients in a Phase 1 clinical trial of CPI-0209.

Provide an update from the ProSTAR clinical trial of CPI-1205 across various patient contexts.
Second Quarter 2019 Financial Results

Cash, cash equivalents, and marketable securities as of June 30, 2019, were $98.1 million, a decline of 14.4% compared to December 31, 2018, primarily due to operating expenses.

Research and development (R&D) expenses increased 67.3% year over year to $16.0 million in the second quarter of 2019 mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 96.5% year over year to $4.9 million in the second quarter of 2019, primarily due to building out the organization of the company.

The net loss increased 73.9% year over year to $20.8 million for the second quarter of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 92.0% to $0.80 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
First Half 2019 Financial Results

Research and development (R&D) expenses increased 63.0% year over year to $31.6 million in the first half of 2019, mainly due to increased clinical trial expenses.

General and administrative (G&A) expenses grew 94.5% year over year to $9.3 million in the first half of 2019, primarily due to building out the organization of the company.

The net loss increased 67.2% year over year to $40.2 million for the first half of 2019, mainly due to increased R&D and G&A expenses. The net loss per share attributable to common shareholders decreased 92.9% to $1.56 per share due to an increase in shares outstanding as a result of the initial public offering in 2018 and conversion of preferred stock to common stock.
Financial Guidance

Constellation expects that cash, cash equivalents, and marketable securities as of June 30, 2019, will enable the Company to fund planned operating expenses and capital expenditure requirements until late third-quarter 2020.

Radius Health Announces Second Quarter 2019 Operating Results

On August 7, 2019 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the second quarter ended June 30, 2019 and provided a business update (Press release, Radius, AUG 7, 2019, View Source [SID1234538295]).

"I am delighted to see continued market share growth of TYMLOS, which puts us on track to attain our goal of anabolic leadership of new patient starts in the second half of 2019," said Jesper Hoeiland, President and Chief Executive Officer of Radius. "Initiation of the Company’s Phase 3 abaloparatide-patch study has been a major milestone toward our mission of addressing the needs of osteoporosis patients."

TYMLOS (abaloparatide) injection

Second quarter 2019 U.S. net sales of TYMLOS were $41.0 million, an 81% increase from the second quarter of 2018. The anabolic market grew 4% in the first half of 2019 as compared to the first half of 2018.

In the second quarter of 2019, TYMLOS continued to increase its market share and captured, on average, 35% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) and 46% of new anabolic patient starts (NBRx).

During the second half of 2019, Radius expects TYMLOS to become the NBRx anabolic market leader by reaching over 50% of new patient starts. If achieved, the Company further expects this performance would translate to total TRx market leadership for TYMLOS during 2020.

Financial Guidance

Radius tightens its full-year 2019 financial guidance for TYMLOS U.S. net sales to $165 to $170 million and increases guidance for its year-end cash, cash equivalents and investments balance to over $120 million.

Pipeline Highlights

Abaloparatide-Patch

In July 2019, Radius obtained preliminary results from the abaloparatide-transdermal patch (abaloparatide-patch) patient assessment study which evaluated self-administration of abaloparatide-patch over 29 days in 22 postmenopausal women with low bone density. The patients were observed at a study site on the first, 15th and 29th day of the study. Top-line study results showed that patients were able to follow the instructions for use (IFU) and applied the patches with a 99.7% success rate. The data also measured patient acceptability and indicated changes in patient PINP (procollagen type I propeptide) levels. The mean subject acceptability score on a 5-point scale was ≥ 4.5 at each site visit. An exploratory assessment of PINP levels, a biomarker that indicates bone formation, compared the PINP results at one month in this study with the one-month results in the Phase 3 ACTIVE study of TYMLOS (abaloparatide injection). The PINP levels and baseline increase at one month in this study were consistent with those values seen with abaloparatide injection at one month in the ACTIVE trial. At baseline, the median PINP level was 50.5 ng/ml, increasing to a median value of 100.1 ng/ml at day 29. The median PINP values observed with abaloparatide injection in the ACTIVE study were 50.6 ng/ml at baseline and 100.5 ng/ml at one month.

On August 5, 2019, the first patient was randomized in the Phase 3 wearABLe clinical trial studying the safety and efficacy of abaloparatide-patch in the treatment of postmenopausal patients with osteoporosis at high risk for fracture.

Prior to initiating the study, the Company achieved a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the acceptability of the overall protocol design. An SPA agreement provides a concurrence with the FDA that the study can be considered adequate and well-controlled in support of a marketing application.

The wearABLe Phase 3 study is a pivotal, randomized, open label, active-controlled, bone mineral density ("BMD") non-inferiority bridging study that will evaluate the efficacy and safety of abaloparatide-patch versus TYMLOS (abaloparatide injection) in approximately 470 patients with postmenopausal osteoporosis at high risk of fracture. The primary endpoint of the study is the percentage of change in lumbar spine BMD at 12 months. Non-inferiority of abaloparatide-patch to abaloparatide injection will be concluded if the lower bound of the 2-sided 95% confidence interval for the estimated treatment difference (abaloparatide-patch minus abaloparatide injection) in the percentage change from baseline in lumbar spine BMD at 12 months is above -2.0%. A non-inferiority margin of 2% preserves ~77% of the historical effect of TYMLOS based on the data from the Phase 3 ACTIVE Study which showed placebo-adjusted increase in lumbar spine BMD of 9.1% (95% CI: 8.6%, 9.6%) at 12 months.

The wearABLe Phase 3 study is currently open for enrollment at multiple clinical sites. Radius plans to complete patient recruitment in this study by the end of 2019.

Anticipated Milestones in 2019

Elacestrant

Advance recruitment in Phase 3 EMERALD monotherapy study

Global co-development/co-commercialization partnership for elacestrant

Initiate a combination trial for elacestrant in conjunction with a partner

TYMLOS/Financial

Grow full-year TYMLOS U.S. net sales to between $165M to $170M

Deliver greater than $120M cash, cash equivalents and investments balance at year-end

Expected Radius Presentations at Upcoming Conferences in Q2 2019

On September 5, 2019, the Company will host one-on-one meetings at the Citi’s 14th Annual Biotech Conference in Boston, MA.

On September 11, 2019, the Company will present and host one-on-one meetings at the Morgan Stanley 17th Annual Global Healthcare Conference in New York City, NY.

Second Quarter 2019 Financial Results

Three Months Ended June 30, 2019

For the three months ended June 30, 2019, Radius reported a net loss of $35.5 million, or $0.77 per share, compared to a net loss of $68.9 million, or $1.52 per share, for the three months ended June 30, 2018.

For the three months ended June 30, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $25.4 million, or $0.55 per share, compared to non-GAAP adjusted net loss of $44.6 million, or $0.98 per share, for the three months ended June 30, 2018.

For the three months ended June 30, 2019, TYMLOS net product revenues were $41.0 million compared to approximately $22.6 million for the three months ended June 30, 2018.

For the three months ended June 30, 2019, research and development expense was $27.2 million compared to $26.3 million for the three months ended June 30, 2018, an increase of $0.9 million, or 3%. This increase was primarily driven by a $5.0 million increase in abaloparatide-patch project costs, and a $0.5 million increase in abaloparatide-SC project costs. These increases were partially offset by a $0.7 million decrease in project costs for elacestrant, a $0.3 million decrease in professional costs, and a $3.6 million decrease in compensation expenses.

For the three months ended June 30, 2019, selling, general and administrative expense was $40.1 million compared to $48.6 million for the three months ended June 30, 2018, a decrease of $8.5 million, or 17%. This decrease was primarily the result of a $6.2 million decrease in compensation related expenses attributed to a decrease in headcount from 338 selling, general, and administrative employees as of June 30, 2018 to 289 selling, general, and administrative employees as of June 30, 2019, a $1.2 million decrease in professional costs, a $0.3 million decrease in travel and expense related costs, and a $0.8 million decrease in occupancy, depreciation, and other operating costs.

Six Months Ended June 30, 2019

For the six months ended June 30, 2019, Radius reported a net loss of $78.2 million, or $1.70 per share, compared to a net loss of $130.4 million, or $2.89 per share, for the six months ended June 30, 2018.

For the six months ended June 30, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $57.2 million, or $1.25 per share, compared to non-GAAP adjusted net loss of $94.7 million, or $2.10 per share, for the six months ended June 30, 2018.

For the six months ended June 30, 2019, TYMLOS net product revenues were $70.9 million compared to approximately $37.2 million for the six months ended June 30, 2018.

For the six months ended June 30, 2019, research and development expense was $50.4 million compared to $49.2 million for the six months ended June 30, 2018, an increase of $1.3 million, or 3%. This increase was primarily driven by a $6.8 million increase in abaloparatide-patch project costs, a $2.4 million increase in project costs for elacestrant, and a $0.9 million increase in abaloparatide-SC project costs. These increases were partially offset by a $1.2 million decrease in RAD140 project costs, a $0.5 million decrease in occupancy and depreciation costs, a $0.4 million decrease in other operating and support costs, and a $6.7 million decrease in compensation expenses.

For the six months ended June 30, 2019, selling, general and administrative expense was $81.3 million compared to $96.6 million for the six months ended June 30, 2018, a decrease of $15.3 million, or 16%. This decrease was primarily the result of a $10.8 million decrease in compensation related expenses attributed to a decrease in headcount from 338 selling, general, and administrative employees as of June 30, 2018 to 289 selling, general, and administrative employees as of June 30, 2019, a $2.8 million decrease in travel and expense related costs, a $1.0 decrease in professional fees, and a $1.0 million decrease in other operating costs. These decreases were partially offset by a $0.3 million increase in occupancy and depreciation expenses.

As of June 30, 2019, Radius had $189.0 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of June 30, 2019, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.

Immunomedics Reports Second Quarter 2019 Results and Provides Corporate Update

On August 7, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported financial results for the second quarter of 2019 (Press release, Immunomedics, AUG 7, 2019, View Source [SID1234538294]). Please refer to the Company’s Quarterly Report on Form 10-Q for more details on the Company’s financial results.

"We continued to execute well against our key strategic priorities for sacituzumab govitecan this quarter. In particular, we are very pleased to have reached target enrollment in the ASCENT study in less than twenty months. We believe this rapid pace is testament to the unmet need in late-stage metastatic triple-negative breast cancer (mTNBC) and the confidence of our investigators in the safety and efficacy of our ADC to provide a meaningful clinical benefit to patients," commented Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics.

Based on current projections, the Company anticipates reporting top-line data from ASCENT in mid-2020. "We are grateful to the patients, their families and caregivers who have participated in our studies. We look forward to the data readout as we continue to work on delivering this important, potential new treatment paradigm to mTNBC patients," added Dr. Aghazadeh.

"The Company’s preparation of the Biologics License Application (BLA) for sacituzumab govitecan in mTNBC is progressing according to plan," said Scott Canute, Executive Director of Immunomedics. "Our goal is to have a high-quality resubmission and a successful reinspection. To that end, we have made steady progress in both areas and we remain confident that we will meet our guided resubmission timeline of early fourth quarter 2019."

Building on the ASCENT momentum and leveraging the existing relationships with breast cancer specialists, the Company has launched the registrational Phase 3 TROPICS-02 in hormonal receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (mBC).

"Given our experience treating patients with sacituzumab govitecan in ASCENT, we are excited to be a participant in the TROPICS-02 study," stated Principal Investigator Hope S. Rugo, M.D., FACP, Professor of Medicine; and Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA. "We are very encouraged about sacituzumab govitecan’s efficacy and look forward to utilizing the ADC for patients with mTNBC. Additional effective treatment options for those with both mTNBC and HR+ disease are critical for our patients."

The randomized global TROPICS-02 study has dosed the first patients with HR+/HER2– mBC who have failed at least two prior chemotherapy regimens for metastatic disease. With progression-free survival (PFS) and overall response rate (ORR) serving as co-primary endpoints, the study allows for an analysis of ORR on a pre-specified number of patients as a basis of a potential accelerated approval submission.

"Targeting HR+/HER2– mBC, which accounts for 70% of all breast cancers, signifies our intention to establish sacituzumab govitecan as a foundational therapy for mBC," continued Dr. Aghazadeh. "To further unlock the full potential of sacituzumab govitecan, we have initiated, for the first time, a Trop-2-enriched study in various difficult-to-treat cancers, beginning with non-small cell lung cancer (NSCLC). Finally, the combination study with sacituzumab govitecan and rucaparib in second-line mTNBC and other cancers, in collaboration with Clovis, is now open for patient enrollment."

Recent Company Highlights

The Phase 3 confirmatory ASCENT study (NCT02574455) has reached its target enrollment for mTNBC patients previously treated with at least two systemic chemotherapy regimens. Top-line data is expected to be available in mid-2020 based on projected event trajectory and timelines associated with central review, database lock and analysis.

The global randomized, open-label, Phase 3 registrational TROPICS-02 study (NCT03901339) has dosed the first patients with HR+/HER2– mBC. This study includes an ORR analysis on a pre-specified number of patients for a potential accelerated approval submission. Enrollment of 400 patients is expected to take approximately eighteen months to complete.

The Company launched TROPICS-03 (NCT03964727), an open-label, Trop-2-enriched multi-cohort Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in patients with metastatic solid tumors, including NSCLC, small cell lung cancer, head and neck cancer, and endometrial cancer. Dosing of the first NSCLC patient is expected in the third quarter of 2019.

The open-label Phase 1b/2 SEASTAR study (NCT03992131) of sacituzumab govitecan in combination with Clovis’ PARP inhibitor, rucaparib, in mTNBC, mUC, and platinum resistant ovarian cancer is recruiting patients with at least one prior line of standard therapy for advanced disease.

Initiated by Dr. Aditya Bardia, Massachusetts General Hospital is sponsoring a Phase 1b/2 study (NCT04039230) evaluating sacituzumab govitecan in combination with Pfizer’s PARP inhibitor, talazoparib, in patients with mTNBC previously treated with no more than one prior therapeutic regimens for metastatic disease.
Second Quarter and Six Months 2019 Financial Results
The Company had no revenues for the quarter and six months ended June 30, 2019, due primarily to the discontinued sale of LeukoScan in February 2018 in order for the Company to focus on its ADC business. Revenues in the comparable quarter and six months ended June 30, 2018 were $0.4 million and $0.9 million, respectively.

Total costs and expenses were $67.2 million for the quarter and $146.8 million for the six months ended June 30, 2019, compared to $52.8 million for the comparable quarter and $90.9 million for the six months ended June 30, 2018. The increases were due primarily to increased expenses in research and development and sales and marketing, partially offset by decreases in general and administrative expenses. The increases in research and development costs were mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for metastatic TNBC in the United States and expanded clinical development of sacituzumab govitecan into other indications.

The Company had no non-cash warrant-related income or expense for the quarter and six months ended June 30, 2019, compared to non-cash warrant-related expenses of $58.9 million for the comparable quarter and $49.0 million for the six months ended June 30, 2018, due to the net appreciation in the fair value of then outstanding warrants. There were no warrants outstanding as of June 30, 2019.

Interest expense was $10.6 million for the quarter and $20.6 million for the six months ended June 30, 2019, compared to $9.4 million for the comparable quarter and $20.3 million for the six months ended June 30, 2018. The increases were due primarily to the net appreciation in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.

Net loss attributable to stockholders was $76.0 million, or $0.40 per share, for the quarter ended June 30, 2019, compared to $117.0 million, or $0.68 per share, for the comparable quarter ended June 30, 2018. Net loss attributable to stockholders was $163.3 million, or $0.85 per share, for the six months ended June 30, 2019, compared to $152.6 million, or $0.91 per share, for the six months ended June 30, 2018.

As of June 30, 2019, the Company had $432.7 million in cash, cash equivalents, and marketable securities, including the $65 million upfront payment received from the licensing agreement with Everest Medicines for sacituzumab govitecan for Greater China. The Company believes this amount is adequate to support its clinical development plan for sacituzumab govitecan, further build its clinical and manufacturing infrastructure and fund its operations through 2020.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss second quarter 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 2069775. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

Celldex Provides Corporate Update and Reports Second Quarter 2019 Results

On August 7, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2019 (Press release, Celldex Therapeutics, AUG 7, 2019, View Source [SID1234538293]). The Company will host a conference call at 4:30 p.m. ET today to provide an update on its pipeline and upcoming milestones for the remainder of 2019.

"Celldex made considerable progress in the first half of the year across multiple programs," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We presented exciting data from our CDX-3379 program in head and neck squamous cell carcinoma at ASCO (Free ASCO Whitepaper), where we observed intriguing clinical activity across a number of patients with similar gene mutation patterns. As a result, we have expanded the study to allow for a deeper evaluation of these biomarkers for patient selection. This could be important for the field as patients with refractory head and neck cancer face extremely limited treatment options and a particularly poor prognosis.

We also reported data from multiple programs at AACR (Free AACR Whitepaper), including from our ongoing dose escalation study of CDX-1140. We recently successfully completed the monotherapy dosing cohorts and are advancing nicely through the combination cohorts with our dendritic cell growth factor, CDX-301. We are currently finalizing plans to initiate a combination cohort with a checkpoint inhibitor and look forward to presenting data from the ongoing program this fall.

Finally, we made an important addition to the Celldex leadership team. In June, we announced that Dr. Diane Young has joined Celldex as Senior Vice President, Chief Medical Officer. Dr. Young brings a deep background in successful drug development to Celldex that will strengthen our clinical development efforts and support the continued progress of our product pipeline," concluded Marucci.

Recent Pipeline Highlights:

· CDX-1140—a potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

Enrollment is complete in the monotherapy arm and progressing on track in the CDX-301 combination arm of the Phase 1 dose-escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. Celldex plans to present data from the ongoing study at a medical meeting this fall.
— Eight monotherapy dosing cohorts ranging from 0.01 to 3.0 mg/kg have been completed and the dose limiting toxicity (DLT) window successfully cleared.
— Three combination cohorts in solid tumors (0.09, 0.18 and 0.36 mg/kg) with CDX-301 have been completed and the DLT window successfully cleared. Patients enrolled in the fourth cohort at 0.72 mg/kg have been dosed and are currently completing the DLT observation period. Assuming successful clearance, the 1.5 mg/kg combination cohort with CDX-301 should open shortly.
— Additional patient enrollment (backfill) has been initiated to characterize the effects of CDX-1140 in the tumor microenvironment and expansion cohorts are being actively planned. Future combination opportunities include PD-1 or PD-L1 inhibitors, chemotherapy, radiation therapy and Celldex’s potent CD27 agonist monoclonal antibody varlilumab.
Interim data from the study were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in April and support that CDX-1140 is a potent activator of CD40 and can be safely administered at doses that Celldex believes will support good tissue and tumor penetration.
· CDX-3379—a differentiated human monoclonal antibody designed to block the activity of ErbB3 (HER3). ErbB3 is expressed in many cancers, including head and neck squamous cell cancer (HNSCC) and is believed to be an important receptor regulating cancer cell growth and survival as well as resistance to targeted therapies.

Enrollment continues in the Phase 2 study of CDX-3379 in advanced HNSCC in combination with Erbitux in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy.
— Interim data from the study (n=15) were presented at the 2019 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June that suggested notable clinical activity in this refractory patient population and a promising biomarker strategy.
— Emerging data from the Phase 2 study and earlier studies of CDX-3379 suggest that antitumor activity may be associated with somatic mutations in the FAT1 and NOTCH1, NOTCH2 or NOTCH3 (NOTCH1-3) genes—genes associated with tumor suppression.
— In the exploratory analyses presented at ASCO (Free ASCO Whitepaper), seven patients were identified as having FAT1 mutated tumors and four of these patients demonstrated clinical response (3 confirmed).
– All four clinical responses occurred in patients with the primary tumor site of oral cavity.
– Three of the four clinical responses occurred in patients with NOTCH1-3 mutations.
– Also, of note, all patients (n=7 of 18) who experienced clinical benefit (objective response or stable disease greater than or equal to 12 weeks) had FAT1 and/or NOTCH1-3 mutations.
— Inactivating mutations in the FAT1 and NOTCH genes occur in sizeable subsets of HPV negative HNSCC tumors, having been identified in 32% (FAT1) and 26% (NOTCH) of these tumors, respectively.
— Based on these biomarker observations and the clinical activity observed in the ongoing Phase 2 study, the study has been expanded (n= ~45 patients, including at least 15 patients with FAT1 mutations) to allow for an evaluation of the utility of biomarkers for patient selection. Enrollment is ongoing.
· CDX-0159—a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), mast cell degranulation plays a central role in the onset and progression of the disease.

Celldex plans to submit an Investigation New Drug (IND) Application and initiate a Phase 1a study of CDX-0159 by year-end 2019. The study is designed to evaluate the safety profile, pharmacokinetics and pharmacodynamics of single ascending doses of CDX-0159 in healthy subjects. Following completion of this study, the Company plans to further study CDX-0159 in CIU, a mast cell-related disease. CIU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over years or even decades. The prevalence of CIU is estimated to be 0.5% to 1% of the total population or up to 3.2 million cases in the United States. About 50% of patients with CIU achieve symptomatic control with antihistamines or leukotriene receptor antagonists. Omalizumab, an IgE inhibitor, provides relief for roughly half of the remaining antihistamine/leukotriene refractory patients. Consequently, there is a need for more effective later line therapies.
· Celldex continues to advance a robust preclinical portfolio with data from multiple programs presented at AACR (Free AACR Whitepaper).

Data from the Company’s CDX-527 bispecific candidate and its TAM program were presented in April 2019 at the AACR (Free AACR Whitepaper) Annual meeting. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. TAM receptors (Tyro3, Axl, MerTK) are receptor tyrosine kinases (RTKs) expressed in innate immune cells. These receptors have been gaining importance in the immunotherapy field due to their role as checkpoint molecules on macrophages, dendritic cells and other immune cells, where they can negatively regulate anti-tumor immunity.
Recent Business Highlights:

· Diane C. Young, M.D. joined Celldex as Senior Vice President, Chief Medical Officer in July 2019. Over the span of a 30 year career in biopharmaceuticals, Dr. Young, a medical oncologist, has led clinical and cross-functional research and development teams responsible for the global development of numerous novel therapies from Phase 1 through successful product registrations. Dr. Young received her M.D. from Harvard Medical School and is board certified in Internal Medicine and Medical Oncology.

· Celldex continues to preserve our financial resources and direct them towards reaching meaningful development milestones across our pipeline. In June, the Company decided to consolidate its Massachusetts lab and manufacturing facilities. The lease for the Needham, MA facility will not be renewed and most functions and employees will be integrated into the Company’s Fall River, MA facility. The Company estimates that this consolidation along with a reduction in square footage at our Hampton, NJ facility earlier this year will decrease our facility footprint by over 35% and will save the Company over $3.5 million annually, starting in the second half of 2020.

Second Quarter 2019 Financial Highlights and 2019 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2019 were $81.3 million compared to $85.1 million as of March 31, 2019. The decrease was primarily driven by second quarter cash used in operating activities of $11.0 million, partially offset by $7.2 million in net proceeds from sales of common stock under the Cantor agreement. At June 30, 2019, Celldex had 14.8 million shares outstanding.

Revenues: Total revenue was $0.7 million in the second quarter of 2019 and $2.1 million for the six months ended June 30, 2019, compared to $2.8 million and $6.8 million for the comparable periods in 2018. The decrease in revenue was primarily due to lower revenue from the collaboration agreement with Bristol-Myers Squibb Company and the contract manufacturing and research and development agreements with the International AIDS Vaccine Initiative and Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $10.1 million in the second quarter of 2019 and $21.2 million for the six months ended June 30, 2019, compared to $21.4 million and $43.3 million for the comparable periods in 2018. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.

G&A Expenses: General and administrative (G&A) expenses were $3.9 million in the second quarter of 2019 and $8.8 million for the six months ended June 30, 2019, compared to $5.6 million and $11.2 million for the comparable periods in 2018. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs and lower lease restructuring expense.

Changes in Fair Value Remeasurement of Contingent Consideration: The Company recorded a $1.0 million gain on fair value remeasurement of contingent consideration during the second quarter of 2019 and a $0.5 million loss on fair value remeasurement of contingent consideration during the six months ended June 30, 2019, primarily due to changes in discount rates and the passage of time.

Net Loss: Net loss was $11.8 million, or ($0.84) per share, for the second quarter of 2019, and $29.0 million, or ($2.21) per share, for the six months ended June 30, 2019, compared to a net loss of $16.4 million, or ($1.67) per share, for the second quarter of 2018 and $134.5 million, or ($14.01) per share, for the six months ended June 30, 2018.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2019, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Webcast and Conference Call
Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2019 objectives. The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 9256839.

A replay of the call will be available approximately two hours after the live call concludes through August 14, 2019. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 9256839. The webcast will also be archived on the Company’s website.

Erbitux is a registered trademark of Eli Lilly & Co.

MannKind Corporation Reports 2019 Second Quarter Financial Results and Recent Business Highlights

On August 7, 2019 MannKind Corporation (NASDAQ:MNKD) reported financial results for the quarter and six months ended June 30, 2019 (Press release, Mannkind, AUG 7, 2019, View Source [SID1234538292]).

"We continue to execute our commercial strategy for Afrezza, which resulted in product growth of 62% versus the second quarter of 2018," said Michael Castagna, Chief Executive Officer of MannKind Corporation. "Our partner in Brazil, Biomm, received marketing approval for Afrezza and expects to launch in the second half of this year. Meanwhile, our partnership with United Therapeutics continues to gain strength as we celebrated the completed construction of a new high-potency manufacturing suite in our Danbury facility in July."

Second Quarter 2019 Results
Total revenues were $15.0 million for the second quarter of 2019, reflecting Afrezza net revenue of $6.1 million and collaboration and services revenue of $8.9 million. Afrezza net revenue increased 62% compared to $3.8 million in the second quarter of 2018, primarily driven by higher product demand, a more favorable mix of Afrezza cartridges and price. Collaboration and services revenue increased $8.9 million compared to the second quarter of 2018, reflecting the licensing and research agreements signed with United Therapeutics in September 2018.

Afrezza gross profit was $1.7 million for the second quarter of 2019, an increase of $3.1 million, or 230%, compared to a gross loss of $1.3 million for the same period in 2018, primarily due to an increase of $2.3 million in net revenue, a $0.4 million decrease in realized currency loss associated with a foreign exchange contract and a $0.2 million decrease in inventory write-offs, partially offset by increased costs due to higher sales.

Research and development (R&D) expenses for the second quarter of 2019 were $1.6 million compared to $3.0 million for the second quarter of 2018. This 45% decrease was primarily attributable to a $0.5 million decrease in clinical trial spending and a $0.5 million decrease in personnel costs.

Selling, general and administrative (SG&A) expenses for the second quarter of 2019 were $16.6 million compared to $21.7 million for the second quarter of 2018. This decrease of $5.1 million, or 24%, was primarily attributable to a $2.3 million decrease in personnel related costs, a $1.3 million decrease in professional fees and a $1.0 million decrease in marketing spending.

Interest expense on notes (facility financing obligation and senior convertible notes) for the second quarter of 2019 was $0.6 million compared to $1.7 million for the second quarter of 2018. This $1.1 million decrease was primarily due to a reduction in debt principal balances.

The net loss for the second quarter of 2019 was $12.4 million, or $0.07 per share compared to a $22.7 million net loss in the second quarter of 2018 or $0.16 per share. The decrease was primarily the result of total revenues increasing from higher Afrezza commercial demand and from our licensing and research agreements with United Therapeutics.

Six Months Ended June 30, 2019
Total revenues were $32.5 million for the six months ended June 30, 2019, reflecting Afrezza net revenue of $11.1 million and collaboration and services revenue of $21.3 million. Afrezza net revenue increased 56% compared to $7.2 million for the six months ended June 30, 2018, primarily due to higher product demand, a more favorable mix of Afrezza cartridges and price. Collaboration and services revenue increased $21.2 million compared to the six months ended June 30, 2018, reflecting the licensing and research agreements signed with United Therapeutics in September 2018.

Afrezza gross profit was $2.8 million for the six months ended June 30, 2019, an increase of $4.7 million or 243% compared to a gross loss of $1.9 million in the same period in 2018, primarily due to an increase of $4.0 million in net revenue, a $0.8 million decrease in inventory write-offs, partially offset by increased costs due to higher sales.

R&D expenses for the six months ended June 30, 2019 were $3.3 million compared to $5.6 million for the six months ended June 30, 2018. This 41% decrease was primarily attributable to a $1.0 million decrease in personnel related costs and a $0.7 million decrease in clinical trial spending.

SG&A expenses for the six months ended June 30, 2019 and June 30, 2018 were both $42.3 million. The first half of 2019 included a $9.3 million expenditure for a television campaign for Afrezza offset by a $4.5 million decrease in personnel related costs, a $2.0 million decrease in professional fees, a $1.6 million decrease in marketing spending and a $0.4 million decrease in sponsorship expense.

Interest expense on notes (facility financing obligation and senior convertible notes) for the six months ended June 30, 2019 was $1.2 million compared to $3.5 million for the six months ended June 30, 2018. This $2.3 million decrease was primarily due to a reduction in debt principal balances.

The net loss for the six months ended June 30, 2019 was $27.3 million, or $0.15 per share compared to a $53.1 million net loss for the six months ended June 30, 2018 or $0.41 per share. The lower net loss was mainly attributable to a $25.1 million increase in total revenues.

Cash and Cash Equivalents
Cash, cash equivalents, restricted cash, and short-term investments at June 30, 2019 was $38.2 million compared to $71.7 million at December 31, 2018. The decrease was primarily due to net cash used in operating activities of $31.5 million for the six months ended June 30, 2019, including the receipt of a $12.5 million milestone payment from United Therapeutics, and a principal payment to Deerfield of $2.5 million.

Business Update
On August 6, 2019, MannKind Corporation and MannKind LLC entered into a Credit and Security Agreement with Apollo Investment Corporation, as lender, and MidCap Financial Trust, as lender and agent, which provides a secured term loan facility in an aggregate principal amount of up to $75.0 million and which matures on August 1, 2024 (the "MidCap Credit Facility"). MannKind borrowed the first advance of $40.0 million on August 6, 2019. In connection with the MidCap Credit Facility, MannKind also entered into privately negotiated exchange agreements with each of its existing creditors in order to pay off (in the case of Deerfield as a secured creditor) and restructure (in the case of Bruce & Co. and The Mann Group as unsecured creditors) MannKind’s existing debt obligations. When combined with a July 2019 exchange agreement with Deerfield, these exchanges reduced the principal amount of existing debt by $28.4 million and extended the maturity until November 2024 for $75.1 million (out of $80.3 million) of the remaining debt.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. To participate in the live call by telephone, please dial (866) 548-4713 or (323) 794-2093 and use the participant passcode: 8241782. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 8241782#. A replay will also be available on MannKind’s website for 14 days.