On August 6, 2020 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported second quarter 2020 financial results and business updates (Press release, Monopar Therapeutics, AUG 6, 2020, View Source [SID1234563042]).

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Second Quarter and Recent Highlights

Collaboration with NorthStar Medical Radioisotopes to Develop Potential Therapeutic for Severe COVID-19 and Other Respiratory Diseases

Monopar and NorthStar entered into a 50/50 collaboration to develop potential Radio-Immuno-Therapeutics (RITs) to treat severe COVID-19.

Monopar will provide its pre-IND stage humanized uPAR targeted monoclonal antibody, known as MNPR-101, and NorthStar will supply a cytotoxic radioisotope. The aim is to create a highly selective agent that has the potential to kill aberrantly activated cytokine-producing immune cells thought to be largely responsible for the severe lung injury that contributes to poor outcomes and death in patients with severe COVID-19.

Provisional patent has been filed that covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radio-immuno-therapeutics (uPRITs) for the treatment of severe COVID-19 and other respiratory diseases.
Validive Phase 2b/3 Clinical Trial and Camsirubicin Phase 2 Clinical Trial Continue on Schedule

Monopar’s two clinical-stage programs both continue to be on schedule for first patient dosing in the second half of 2020.
Second Quarter Summary Financial Results

Results for the Quarter Ended June 30, 2020 Compared to the Quarter Ended June 30, 2019

Cash and cash equivalents as of June 30, 2020 were $12.5 million. Net loss for the three months ended June 30, 2020 was $1.4 million or $0.14 per share compared to net loss of $0.9 million or $0.10 per share for the three months ended June 30, 2019.

Research and Development (R&D) Expenses

R&D expenses for the three months ended June 30, 2020 were $0.8 million, compared to $0.3 million, for the three months ended June 30, 2019. This represents an increase of $0.5 million primarily attributed to increases in camsirubicin and Validive clinical trial planning and materials manufacturing costs and increases in personnel expenses for three new R&D employees and higher salary and stock-based (non-cash) compensation for 2020.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended June 30, 2020 were $0.6 million, compared to $0.6 million, for the three months ended June 30, 2019.

On August 6, 2020 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended June 30, 2020 (Press release, PRA Health Sciences, AUG 6, 2020, View Source [SID1234563041]).

"Considering the very difficult circumstances, I was delighted with our second quarter financial results. We reported revenue and earnings that were better than the revised guidance we provided in May and had record levels of gross and net new business awards. Our second quarter results were obviously impacted by the pandemic, but our team did an excellent job delivering to our revised forecast," said Colin Shannon, PRA’s President and Chief Executive Officer. "For the remainder of 2020, we will continue to manage our business in a fiscally responsible manner and continue to look for ways to provide innovative solutions to our customers. I would like to thank all of our employees for their hard work during this challenging period."

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Net new business for our Clinical Research segment for the three months ended June 30, 2020 excluding reimbursement revenue was $701.6 million, representing a net book-to-bill ratio of 1.35 for the period. Net new business for our Clinical Research segment for the three months ended June 30, 2020 including reimbursement revenue was $1,083.3 million, representing a net book-to-bill of 1.62 for the period. Consistent with the first quarter, we did not experience any material COVID-19 related cancellations during the second quarter. Net new business, excluding reimbursement revenue, contributed to an ending backlog at June 30, 2020 of $4.9 billion.

For the three months ended June 30, 2020, revenue was $729.9 million, which represents a decrease of 4.4%, or $33.4 million, compared to the three months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, revenue decreased $28.8 million, a decrease of 3.8% compared to the second quarter of 2019. By segment, the Clinical Research segment generated revenues of $667.3 million, while the Data Solutions segment generated revenues of $62.6 million. The decrease in revenue for the quarter was attributable to the impact the COVID-19 pandemic had on our business and the global economy. We saw a decrease in billable hours and volume-related clinical activities, primarily driven by a lack of access to investigator sites and an inability to screen and enroll patients due to stay at home orders and travel restrictions.
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Direct costs, exclusive of depreciation and amortization, were $395.3 million during the three months ended June 30, 2020 compared to $386.2 million for the three months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, direct costs increased $16.8 million compared to the second quarter of 2019. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 54.2% of revenue during the second quarter of 2020 compared to 50.6% of revenue during the second quarter of 2019.

Selling, general and administrative expenses were $110.0 million during the three months ended June 30, 2020 compared to $98.8 million for the three months ended June 30, 2019. Selling, general and administrative costs were 15.1% of revenue during the second quarter of 2020 compared to 12.9% of revenue during the second quarter of 2019.

GAAP net income was $13.9 million for the three months ended June 30, 2020, or $0.22 per share on a diluted basis, compared to GAAP net income of $41.1 million for the three months ended June 30, 2019, or $0.62 per share on a diluted basis.

EBITDA was $65.4 million for the three months ended June 30, 2020, representing a decrease of 38.9% compared to the three months ended June 30, 2019. Adjusted EBITDA was $95.1 million for the three months ended June 30, 2020, representing a decrease of 26.5% compared to the three months ended June 30, 2019.

Adjusted net income was $55.2 million for the three months ended June 30, 2020, representing a decrease of 32.4% compared to the three months ended June 30, 2019. Adjusted net income per diluted share was $0.86 for the three months ended June 30, 2020, representing a decrease of 29.5% compared to the three months ended June 30, 2019.
First Half 2020 Financial Highlights

For the six months ended June 30, 2020, revenue was $1,513.6 million, which represents an increase of 1.9%, or $28.3 million, compared to the six months ended June 30, 2019 at actual foreign exchange rates. On a constant currency basis, revenue increased $38.2 million, representing an increase of 2.6% compared to the six months ended June 30, 2019. For the six months ended June 30, 2020, our revenue growth was impacted by the COVID-19 pandemic. We saw an increase in billable hours during January and February, however, from mid-March through the end of June billable hours were impacted by limited accessibility to investigator sites and an inability to screen and enroll patients due to stay at home orders and travel restrictions.

Reported GAAP income from operations was $106.8 million, reported GAAP net income was $54.5 million and reported GAAP net income per diluted share was $0.85 for the six months ended June 30, 2020.

Adjusted Net Income was $122.6 million for the six months ended June 30, 2020, a decrease of 21.0% compared to the same period in 2019. Adjusted Net Income per diluted share was $1.90 for the six months ended June 30, 2020, down 18.1% compared to the same period in 2019.
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Full Year 2020 and Q3 2020 Guidance

The full extent of the COVID-19 pandemic and its impact on the Company’s 2020 operations remains uncertain. Specifically, the duration of the pandemic, the geographic location of specific outbreaks, and the length and scope of travel restrictions and business closures imposed by the governments of impacted countries could impact our financial results in the second half of 2020. These uncertainties could impact the assumptions used in the Company’s 2020 guidance if they result in business interruptions, such as the closure of our Phase I clinics, a slowdown in recruitment activities, or limited access to sites worldwide. However, the Company has used its best efforts to estimate the impact of COVID-19 on its business and the resulting impact on financial performance for the remainder of the year.

For full year 2020, the Company expects to achieve total revenues between $3.07 billion and $3.13 billion, GAAP net income per diluted share between $2.40 and $2.60 and adjusted net income per diluted share between $4.35 and $4.55, with an expected effective income tax rate of 23%.

For Q3 2020, the Company expects to achieve total revenues between $754 million and $784 million, GAAP net income per diluted share between $0.58 and $0.68 and adjusted net income per diluted share between $1.09 and $1.19, with an expected effective income tax rate of 23%.

Our actual effective tax rate may differ from our estimate due to, among other things, changes in the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies.

Our Full Year and Q3 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of June 30, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our full year and Q3 2020 guidance to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on August 7, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 7368954. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 7368954.

Additional Information

A financial supplement with second quarter 2020 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q2 2020 Earnings Presentation."

On August 6, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2020 (Press release, Coherus Biosciences, AUG 6, 2020, View Source [SID1234563040]).

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Second Quarter 2020 and Recent Corporate Highlights

Net product revenue for the second quarter of 2020 was $135.7 million, and net income was $59.0 million, or $0.70 per share on a diluted basis.

Non-GAAP income during the second quarter of 2020 was $68.3 million, or $0.81 per share on a diluted basis.

Cash flow from operating activities was $60.2 million for the second quarter of 2020.

The Healthcare Distribution Alliance recognized Coherus’ successful launch of UDENYCA (pegfilgrastim-cbqv) by awarding the 2019 Diana Award in the category for Best New Product Introductions in the Biotechnology Pharmaceutical Product sector.

The Company appointed veteran healthcare leader, Kimberly Tzoumakas, J.D. to its Board of Directors.
Second Quarter 2020 Financial Results

Net product revenue for the second quarter of 2020 was $135.7 million. Net product revenue included a favorable revision of the Company’s prior period payer rebate estimate of $13.3 million recorded in the second quarter of 2020. Cost of goods sold for the second quarter of 2020 was $10.1 million, resulting in a gross profit margin of 93%.

Research and development (R&D) expense for the second quarter of 2020 was $26.2 million, as compared to $18.9 million for the same period in 2019. R&D expense for the six months ended June 30, 2020 was $59.3 million, as compared to $37.7 million for the same period in 2019. The increase in R&D expense in both periods was primarily due to preparations for the biologics license application (BLA) filing of CHS-1420, Coherus’ biosimilar to Humira (adalimumab), and to the manufacturing scale-up to initiate planned clinical trials in 2021 for CHS-2020, Coherus’ biosimilar to Eylea (aflibercept).

Selling, general and administrative (SG&A) expense for the second quarter of 2020 was $34.1 million, as compared to $36.5 million for the same period in 2019. SG&A expense for the six months ended June 30, 2020 was $69.4 million, as compared to $69.1 million for the same period in 2019.

Cash, cash equivalents and investments in marketable securities for the second quarter increased to $456.5 million as of June 30, 2020, as compared to $193.3 million as of March 31, 2020 and $177.7 million as of December 31, 2019. The increase in the second quarter of 2020 is primarily due to generating $60.2 million in net cash from operating activities and receiving $222.8 million in net proceeds from issuing convertible debt notes due 2026 in April 2020, which was offset by purchasing $18.2 million in capped call options related to the convertible notes.

Net income for the second quarter of 2020 was a $59.0 million, or $0.70 per share on a diluted basis, compared to $23.6 million, or $0.32 per share on a diluted basis for the same period in 2019.

Non-GAAP net income for the second quarter of 2020 was $68.3 million, or $0.81 per share on a diluted basis, compared to non-GAAP income of $31.5 million, or $0.43 per share on a diluted basis for the same period in 2019. See "Non-GAAP Financial Measures" below for a discussion on how the Company calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measure.

Guidance for the Remainder of 2020

Coherus will continue to lay the foundation for long-term growth across its three therapeutic areas:

Oncology

Deliver continued market success with UDENYCA (pegfilgrastim-cbqv) against all Neulasta dosage forms, while maintaining average selling price ("ASP") discipline, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments.

Advance the Company’s biosimilar candidate to Avastin (bevacizumab) in-licensed from Innovent toward an expected 351(k) BLA submission with the U.S. FDA in 2021, depending on the outcome and the timing of required interactions with the FDA in completing a three-way pharmacokinetic ("PK") study, as well as completing additional analytical similarity exercises.
Ophthalmology

Facilitate Bioeq’s resubmission of a 351(k) BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in the second half of 2020.

Advance the Company’s internally developed CHS-2020 biosimilar candidate to Eylea (aflibercept) to an expected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.
Immunology

Complete certain manufacturing, regulatory and development activities for the Company’s internally developed Humira (adalimumab) biosimilar, CHS-1420, and file the 351(k) BLA in the fourth quarter of 2020. The Company expects this timing will enable a projected market entry in the United States on or after July 1, 2023, if approved.
Financial Guidance

R&D and SG&A expenses combined together are expected to range between $285 million and $310 million for the full fiscal year 2020, excluding upfront or milestone payments from any potential new collaborations, consistent with prior quarter guidance.
Conference Call Information

When: Thursday, August 6, 2020 starting at 4:30 p.m. ET

Webcast: at View Source

The conference call will be broadcast live in listen-only mode on the Company’s investor relations website at View Source If you would like to ask a question, the dial in number for the conference call is 844-452-6826 (Toll-Free U.S. and Canada) or 765-507-2587 (International).

Conference ID: 4956327

Please dial-in 15 minutes early to ensure a timely connection to the call.

Second quarter 2020 financial results are posted on the Coherus website at View Source The webcast will be archived on the Coherus website.

On August 6, 2020 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported financial results for the second quarter of 2020 (Press release, Dynavax Technologies, AUG 6, 2020, View Source [SID1234563039]).

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"Vaccines play a crucial role in protecting people, particularly those at high risk, from infectious diseases," commented Ryan Spencer, Chief Executive Officer of Dynavax. "The current global pandemic highlights the need for continued development of new and improved vaccines. Our first product, HEPLISAV-B, provides adults protection from hepatitis B, a highly infectious deadly virus which, thankfully, can be prevented with effective vaccination. With a demonstrated profile that provides adults higher levels of protection from hepatitis B in one month, compared to other hepatitis B vaccines that require six months, we believe that HEPLISAV-B has the potential to become the standard of care for adult hepatitis B vaccination in the U.S."

Mr. Spencer added, "As expected from the pandemic driven disruption to non-COVID medical care, the adult hepatitis B vaccine market experienced a significant decline early in the second quarter. Despite the short-term impact, we continue to be optimistic about HEPLISAV-B’s long-term value, particularly with the global focus on vaccination efforts as a result of the pandemic. Additionally, we see tremendous opportunity for CpG 1018, our advanced vaccine adjuvant. We have entered into numerous collaborations to develop adjuvanted vaccines across multiple indications, including COVID-19, pertussis, and universal flu. Adjuvanted coronavirus vaccines may play a critical role in providing protection to older adults and people with other chronic conditions, who are at greater risk for COVID-19 and have historically been less responsive to vaccinations."

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

Net product revenue for second quarter 2020 of $2.4 million declined from $8.3 million for the second quarter of 2019, due to the COVID-19 pandemic. Overall adult hepatitis B vaccine utilization declined significantly beginning in late March, reached a low in the middle of the second quarter, and improved in the later part of the quarter.
Interim data were reported from the ongoing study of HEPLISAV-B in patients on hemodialysis showing HEPLISAV-B was well tolerated with a seroprotection rate of 86.4% in 44 patients.
CpG 1018 proprietary toll-like receptor 9 (TLR9) agonist adjuvant
·Announced collaborations with Sinovac Biotech, Valneva SE, Medicago, Medigen Vaccine Biologics and Mount Sinai to further advance CpG 1018 in adjuvanted vaccines. A summary of CpG 1018 collaborations is provided below:

Indication Collaborator Status
COVID-19 Clover Biopharmaceuticals Phase 1
Medicago Phase 1
Medigen Vaccine Biologics Preclinical
Sinovac Biotech Preclinical
Valneva SE Preclinical
Pertussis Serum Institute of India Preclinical
Universal Influenza Mount Sinai Preclinical

Additional Corporate Updates

Completed an $80.5 million public offering of common stock
Appointed Ms. Julie Eastland and Mr. Brent MacGregor to Board of Directors
Entered into a purchase agreement with TriSalus Lifesciences for SD-101 and related assets for $9 million in cash payments, up to an additional $250 million in development and commercial milestone payments and low double-digit royalties on potential future sales
2020 Milestones

Final immunogenicity data from the ongoing study of HEPLISAV-B in patients on hemodialysis anticipated in the fourth quarter with publication planned in the first quarter of 2021.
Completion of safety follow-up for HEPLISAV-B post-marketing studies in the fourth quarter.
Completion of Phase 1-enabling animal studies and toxicology for an improved pertussis vaccine with CpG 1018 is planned for the fourth quarter.
Preliminary safety and immunogenicity results from Phase 1 COVID-19 studies with Clover Biopharmaceuticals and Medicago expected by September and October, respectively.
Financial Results

Product Revenue, Net. Product revenue, net decreased to $2.4 million in the second quarter of 2020 compared to $8.3 million in the same period in 2019, due to lower sales volume caused by the COVID-19 global pandemic. For much of the second quarter, medical centers and physician practices restricted activities at their facilities. This led to a significant decline in adult hepatitis B vaccine utilization, which fell as much as approximately 70% in April. For HEPLISAV-B, product sales to distributors were lower than end user demand as distributors elected to reduce inventory levels during the quarter. With states beginning to reopen, medical centers have gradually expanded their services under strict social distancing rules. Adult hepatitis B vaccine utilization began to increase in mid-June, reached approximately 60% of pre-COVID levels in July and is expected to continue growing as the U.S. returns to more normal conditions.

Cost of Sales – Product. Cost of sales – product for the second quarter 2020 decreased to $1.0 million, compared to $2.1 million for the second quarter of 2019, primarily due to lower sales volume and lower overhead following the May 2019 restructuring, partially offset by higher unit costs as we produce and then sell inventory that reflects the full cost of manufacturing.

Research and Development Expenses. Research and development (R&D) expenses for the second quarter of 2020 decreased to $5.9 million, compared to $16.2 million for the second quarter of 2019 as personnel costs, facilities overhead cost allocations and non-cash stock-based compensation decreased due to lower R&D headcount because of our restructuring in May 2019 and outside services costs decreased with the winding down of our immuno-oncology programs.

SG&A Expenses. Selling, general and administrative (SG&A) expenses for the second quarter of 2020 were $19.0 million, compared to $17.9 million for the second quarter of 2019 as compensation and related personnel costs decreased due to lower headcount and business travel decreased due to COVID-19 travel restrictions, offset by increased administrative expense, expenses related to the post-marketing studies and facility costs due to higher overhead allocation to SG&A.

Loss from Operations and Net Loss. Loss from operations for the second quarter of 2020 decreased to $23.3 million from $39.0 million in the second quarter of 2019. Net loss for the second quarter of 2020 was $51.6 million, or $0.53 per basic and diluted share, compared to a net loss of $42.7 million, or $0.66 per basic and diluted share, for the second quarter of 2019. The net loss in the quarter ended June 30, 2020 includes expense of $25.7 million due to an increase in the estimated fair value of outstanding warrants.

Cash Position. Cash, cash equivalents and marketable securities totaled $200.7 million at June 30, 2020.

Conference Call and Webcast Information
Dynavax will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at www.dynavax.com. Alternatively, participants may dial 800-939-4079 or 212-231-2911 and refer to conference ID 21967375. A replay of the webcast will be available for 30 days following the live event.

Please see Important Safety Information below.

For more information about HEPLISAV-B, visit View Source

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Indication and Use
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

About CpG 1018
CpG 1018 is the adjuvant used in HEPLISAV-B, an adult hepatitis B vaccine approved by the U.S. Food and Drug Administration (FDA). Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B. In pre-clinical and clinical studies, results demonstrated that the addition of CpG 1018 increases antibody concentrations, stimulates helper (CD4+) and cytotoxic (CD8+) T cell populations and generates robust T and B cell memory responses. Additionally, CpG 1018 strongly favors development of the Th1 subset of helper T cells, the type of helper T cell that is essential for protection from infections with viruses and intracellular bacteria. CpG 1018 targets a single, well defined receptor (TLR9) expressed on only a few key cell types and the mechanisms of action as an adjuvant are quite well understood. CpG 1018 provides a well- developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of a COVID-19 vaccine. Upon completion of on-going scale up activities, the existing equipment capacity for CpG 1018 will be 600 million to 1.2 billion adjuvant doses annually, depending on final dose selected.

On August 6, 2020 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2020 (Press release, Celldex Therapeutics, AUG 6, 2020, View Source [SID1234563038]). The Company will host a conference call at 4:30 p.m. ET today to provide an update on its pipeline and upcoming milestones.

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"In the second quarter of 2020, we presented data from our KIT inhibitor, CDX-0159, in a late breaking session at the EAACI Annual Congress that suggested significant potential to dramatically impact mast cell driven disorders," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "These data provided important proof of concept for the CDX-0159 program and helped support a $150 million public offering driven by high quality health care investors to fully fund the Company’s planned operations through 2023. We are on track to initiate two studies in chronic urticaria later this year and are vetting additional mast cell driven indications to support expanded development in 2021."

"We continue to focus our resources on the programs we believe hold the most promise for patients and shareholders and have prioritized the development of CDX-0159, CDX-1140, and the first candidate from our bi-specific program, CDX-527. We are discontinuing development of CDX-3379, which is in an exploratory study with cetuximab to assess the utility of biomarkers in head and neck cancer. The side effect profile of the combination remains challenging even with prophylactic treatment and, when considered with the emerging clinical activity, we believe our resources are best utilized to expand the development of CDX-0159 and our other pipeline programs. To this end, we intend to start the two planned studies of CDX-0159 this fall and to initiate a combination cohort of CDX-1140 with chemotherapy in treatment naïve metastatic pancreatic cancer and a Phase 1 study of CDX-527 in refractory, advanced cancers later this year. These programs will support data read outs later this year and in 2021," concluded Marucci.

Recent Pipeline Highlights

CDX-0159—a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells.

Results from the Phase 1a dose escalation study of CDX-0159 were featured in a late breaking presentation in June at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2020. CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, indicative of systemic mast cell ablation. Tryptase suppression below the level of detection was observed after a single 1.0 mg/kg dose and was maintained for more than 2 months at single doses of both 3.0 and 9.0 mg/kg of CDX-0159.

— As indicated in the EAACI presentation, a subset of subjects from the 3mg/kg and 9 mg/kg cohorts agreed to continued follow up for tryptase suppression. This follow up and analysis was completed in July and tryptase levels remained below the level of detection for over 3 months (14 weeks) in 50% of subjects in the 3 mg/kg cohort and over 4 months (18 weeks) in all subjects in the 9 mg/kg cohort.
Celldex plans to initiate Phase 1b studies of CDX-0159 in chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), both mast cell driven diseases, this fall. Celldex is exploring cold-induced and symptomatic dermographism (scratch-induced) urticarias. Celldex is also exploring additional mast cell driven diseases for potential future development, including mast cell activation syndromes, asthma, allergic conditions and mast cell driven gastrointestinal disorders.

Data from the Phase 1b studies in CIndU and CSU are anticipated in the first quarter and second half of 2021, respectively.
CDX-1140—a potent CD40 human agonist antibody developed by Celldex that the Company believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile.

In the Phase 1 dose-escalation study of CDX-1140 in patients with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas, both the monotherapy and combination with CDX-301 dose escalation portions of the trial are complete with an identified maximum tolerated dose (MTD) and recommended Phase 2 dose of CDX-1140 at 1.5 mg/kg—one of the highest systemic dose levels in the CD40 agonist class. Expansion cohorts are actively recruiting including:

— CDX-1140 with KEYTRUDA (pembrolizumab) in patients who have progressed on checkpoint therapy; and,
— CDX-1140 with CDX-301 in patients with head and neck squamous cell carcinoma (HNSCC); and,
— A combination of CDX-1140 with standard of care chemotherapy in first line metastatic pancreatic cancer is expected to initiate later this year.

A data update from the ongoing Phase 1 study is planned for presentation in the fall of 2020.
CDX-527—the first candidate developed by Celldex from its bispecific platform which utilizes the Company’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.

Celldex anticipates initiating a Phase 1 dose-escalation study in up to ~90 patients with advanced or metastatic solid tumors that have progressed during or after standard of care therapy later this year to be followed by tumor-specific expansion cohorts. The study is designed to determine the MTD during a dose-escalation phase and to recommend a dose level for further study in the subsequent expansion phase. The expansion is designed to further evaluate the tolerability, biologic and anti-tumor effects of selected dose level(s) of CDX-527 in specific tumor types.

Initial data from the Phase 1 study are anticipated in the first half of 2021.
Recent Business Highlights

On June 18, 2020, Celldex announced the closing of an underwritten public offering raising total gross proceeds of approximately $150.0 million.
Second Quarter 2020 Financial Highlights and 2020 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2020 were $206.9 million compared to $53.7 million as of March 31, 2020. The increase was primarily driven by net proceeds of $141.4 million from our June 2020 underwritten public offering and net proceeds of $23.7 million from sales of common stock under our Controlled Equity OfferingSM agreement with Cantor completed in the second quarter prior to the offering in June. These increases were offset by second quarter cash used in operating activities of $11.2 million.

Revenues: Total revenue was $0.2 million in the second quarter of 2020 and $3.0 million for the six months ended June 30, 2020, compared to $0.7 million and $2.1 million for the comparable periods in 2019. The increase in revenue for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 was primarily due to the $1.8 million milestone payment from Rockefeller University related to our manufacturing and development services agreement, partially offset by a decrease in services performed under our manufacturing and research and development agreement with Duke University.

R&D Expenses: Research and development (R&D) expenses were $9.7 million in the second quarter of 2020 and $21.4 million for the six months ended June 30, 2020, compared to $10.1 million and $21.2 million for the comparable periods in 2019. The increase in R&D expense for the six months ended June 30, 2020 compared to the six months ended June 30, 2019 was primarily due to an increase in clinical trial and contract manufacturing expenses, partially offset by lower stock-based compensation expense.

G&A Expenses: General and administrative (G&A) expenses were $3.5 million in the second quarter of 2020 and $7.2 million for the six months ended June 30, 2020, compared to $3.9 million and $8.8 million for the comparable periods in 2019. The decrease in G&A expenses was primarily due to lower stock-based compensation expense.

Changes in Fair Value Remeasurement of Contingent Consideration: The gain on fair value remeasurement of contingent consideration was $5.1 million during the second quarter of 2020 and $4.9 million during the six months ended June 30, 2020, primarily due to updated assumptions for CDX-3379 related milestones due to the discontinuation of the CDX-3379 program and the passage of time.

Intangible Asset Impairment: The Company recorded a non-cash impairment charge of $3.5 million during the second quarter of 2020 due to the discontinuation of the CDX-3379 program.

Net Loss: Net loss was $11.0 million, or ($0.50) per share, for the second quarter of 2020, and $23.7 million, or ($1.20) per share, for the six months ended June 30, 2020, compared to a net loss of $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.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2020 are sufficient to meet estimated working capital requirements and fund planned operations through 2023.

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 2020 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 (800) 446-2782 (within the United States) or (847) 413-3235 (outside the United States). The passcode is 49870841.

A replay of the call will be archived on the Company’s website.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.