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GeneCentric Therapeutics Announces New US Patent Granted for Molecular Characterization of Non-Squamous Non-Small Cell Lung Cancer

On March 9, 2021 GeneCentric Therapeutics, a company making precision medicine more precise, reported the granting of Patent No. 10,934,595 by the United States Patent and Trademark Office (USPTO), protecting another one of its novel RNA-based lung cancer gene signatures (Press release, GeneCentric Therapeutics, MAR 9, 2021, View Source [SID1234576311]). This new patent provides further demonstration of the novel RNA-based technology achievements of the GeneCentric team and its growing pipeline of predictive response signatures developed using its Tumor and Immune Micro-Environment (T(I)ME) Explorer platform.

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The patent covers the use of reduced RNA gene sets to characterize tumors from patients diagnosed with non-squamous non-small cell lung cancer (NSCLC), which are foundational to the development of the company’s predictive response signatures and diagnostics for this important patient population. The use of RNA-based gene signatures allows for a deeper understanding of the T(I)ME than DNA mutations alone, often allowing for the identification of a broader patient population that may benefit from targeted therapy compared to use of traditional DNA mutation analysis.

"Those of us who study the genomics of lung cancer have known for more than a decade that there is a rich and reproducible story to be told though gene expression assays," said Neil Hayes, MD, GeneCentric co-founder, and Scientific Director, University of Tennessee West Institute for Cancer Research. "The signatures inherent to clinically relevant subgroups are opaque to the microscope but revealed through the genome. We are thrilled to open the door to applications applicable to prognosis and response for traditional cytotoxic chemotherapy, targeted therapies, and emerging immune-oncologic approaches."

GeneCentric continues to make significant progress with its growing pipeline of RNA-based predictive response signatures and molecular diagnostics, with the lung cancer program as its cornerstone. Further updates will be provided as the company presents additional data validating its novel RNA-based signatures and diagnostic tests across multiple tumor types at upcoming scientific meetings and in peer-reviewed publications.

"This is an important time for GeneCentric as we clinically validate and prepare to launch this diagnostic test," said Dr. Mike Milburn, President, and CEO of GeneCentric Therapeutics. "The granting of this latest lung cancer patent by the USPTO demonstrates the utility and uniqueness of our growing pipeline of RNA-based diagnostics,"

Five Prime Cancels Fourth Quarter and Full-Year 2020 Financial Results Conference Call

On March 9, 2021 Five Prime Therapeutics, Inc. (NASDAQ: FPRX) reported that it has canceled its fourth quarter and full year 2020 earnings conference call, which was previously scheduled for Wednesday, March 10, 2021 at 1:30 p.m. PT / 4:30 p.m. ET (Press release, Five Prime Therapeutics, MAR 9, 2021, View Source [SID1234576310]).

The cancellation is the result of the company’s announcement on March 4, 2021 that it has entered into an agreement under which Amgen Inc. will acquire Five Prime Therapeutics. Five Prime will issue its fourth quarter and full-year 2020 financial results in its Form 10-K that it will file with the Securities and Exchange Commission.

Evelo Biosciences Announces Fourth Quarter and Full Year 2020 Financial Results and Business Highlights

On March 9, 2021 Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, reported financial results and business highlights for the fourth quarter and full year 2020 (Press release, Evelo Biosciences, MAR 9, 2021, View Source [SID1234576309]).

"Building on a series of positive clinical data announcements and strong progress in 2020, we are pleased to begin 2021 by announcing a further positive clinical data readout with EDP1815. We have now shown positive clinical data with EDP1815 in five separate cohorts across psoriasis, atopic dermatitis, and a human experimental model of inflammation. EDP1815’s observed profile of broad inflammation resolving effects and tolerability is highly differentiated and supports the potential of EDP1815 as a foundational treatment for all stages of inflammatory disease," said Simba Gill, Ph.D., Chief Executive Officer of Evelo. "The new EDP1815 data we are reporting today is from a healthy volunteer experimental model of inflammation. This study showed that an increase in the concentration of drug in a capsule resulted in enhanced effect for the same overall dose. We are also pleased with the accelerated recruitment of the Phase 2b trial of EDP1815 in psoriasis, and we will now report top-line data for the full cohort of patients in the third quarter of this year."

Dr. Gill continued, "The results we have observed with EDP1815 provide evidence for the entire SINTAX platform and support the potential of our investigational medicines to control systemic inflammation and immunity. EDP1815 and dermatological diseases are only the beginning. In February, we initiated the first clinical trial of our next anti-inflammatory candidate, EDP1867. We are progressing our two extracellular vesicle candidates, EDP2939 for inflammatory diseases and EDP1908 for oncology. In addition, we have strengthened our balance sheet with $88 million in net proceeds from recent sales of our common stock and have expanded our team with the appointments of Jonathan Zung, Ph.D., as Chief Development Officer, and John Hohneker, M.D., to our Board of Directors. We now have the resources and team in place to advance our broad portfolio to later-stage development."

Fourth Quarter/Full Year 2020 Highlights and Recent Progress

EDP1815 in Human Experimental Model of Inflammation

Evelo reported positive data from a healthy volunteer experimental model of inflammation with EDP1815.
○ A total of 32 healthy volunteers were dosed daily for 28 days with either of two concentrations of EDP1815, or placebo.

○ The study was designed to investigate the relative effectiveness of two different concentrations of EDP1815 in capsules.

○ The increased concentration of drug results from improvements made in the commercial-scale manufacturing process (referred to as A2). This is the same active drug at four times the concentration compared to a prior manufacturing process (referred to as A’).

○ Healthy volunteers were immunized with the same antigen used in preclinical inflammation experiments. After 28 days of daily oral treatment with EDP1815 or placebo, subjects were given a skin challenge with the antigen which causes measurable skin inflammation a day later. 12 subjects were given A’ EDP1815. Another 12 subjects were given the higher concentration A2. The 8 subjects who received a placebo were divided between the two treatment groups.

○ As shown in the figure below, the higher concentration A2, given in fewer capsules, resulted in numerically superior reductions across the full range of skin evaluation scores compared to A’ and to placebo. A2 and A’ were given at the same total daily dose of drug.

○ These results are consistent with preclinical data showing that increased drug concentration resulted in increased effects.

○ This is a key advancement in Evelo’s understanding of how to get even more benefit from SINTAX medicine candidates.

A figure accompanying this announcement is available at: View Source

Based on these data, Evelo is expanding its ongoing Phase 1b clinical trial to include additional cohorts evaluating the higher concentration A2 in both tablet and capsule formulations. Results from the Phase 1b trial and ongoing Phase 2b trial together will position the Company to go forward into Phase 3 trials with an optimized dose and formulation of EDP1815 which may further improve on the positive results already seen.
EDP1815 in Psoriasis

Evelo has completed enrollment in its ongoing Phase 2b dose-ranging trial using A’ EDP1815. Given accelerated recruitment, the Company now plans to report top-line data for all patients in the study in the third quarter of this year in place of an interim data readout on the first 113 patients.
EDP1815 in Atopic Dermatitis

In December and January, Evelo announced positive clinical data from a cohort of patients with mild and moderate atopic dermatitis in its Phase 1b clinical trial.
In addition to being well tolerated with no treatment-related adverse events of moderate or severe intensity and no serious adverse events, the data showed consistent improvements in percentage change from baseline compared to placebo for Eczema Area and Severity Index (EASI), Investigator’s Global Assessment and Body Surface Area (IGA*BSA) and SCORing Atopic Dermatitis (SCORAD). Treatment with EDP1815 also resulted in clinically meaningful improvement in the patient-reported outcomes of Dermatology Life Quality Index (DLQI) and Patient-Oriented Eczema Measure (POEM).
EDP1867 in Atopic Dermatitis

In February, Evelo initiated a Phase 1b trial of EDP1867 in healthy volunteers and patients with moderate atopic dermatitis.
EDP1908 in Oncology

In November, Evelo presented preclinical data for EDP1908 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting. The data showed that orally administered EDP1908, an extracellular vesicle, resulted in superior tumor growth control versus either the parental microbial strain or anti-PD-1 therapy, with an observed dose-dependent reduction of tumor growth. The observed effects were comparable to those reported in the literature for intratumorally administered immune stimulators. Evelo subsequently announced the decision to prioritize EDP1908 as its lead clinical candidate in oncology.
Business Highlights

In December 2020, Evelo announced the appointment of Jonathan Zung, Ph.D., as Chief Development Officer and a member of the Evelo Executive Team. Dr. Zung brings more than 25 years of global pharmaceutical development and commercialization experience to Evelo.
In February 2021, Evelo closed an underwritten public offering of shares of its common stock at a public offering price of $15.00 per share, and a private placement of shares of its common stock at an offering price of $15.00 per share, resulting in gross proceeds of approximately $85.1 million, before underwriting discounts and commissions.
In February 2021, Evelo announced the appointment of John A. Hohneker, M.D., to its Board of Directors.
Upcoming Key Milestones

EDP1815 – Psoriasis; all data anticipated to be reported in 3Q 2021

Data from Phase 1b cohorts with A2 tablets and A2 capsules
Full data from Phase 2b dose-ranging trial
EDP1815 – Atopic Dermatitis

Subject to regulatory approval, initiation of Phase 2 trial in 3Q 2021
EDP1815 – COVID-19

Data from Phase 2 trial with Rutgers University in 2Q 2021
Interim safety and futility analysis from Phase 2/3 TACTIC-E trial in 2Q 2021
EDP1867 – Atopic Dermatitis

Interim data from Phase 1b trial expected in 4Q 2021
EDP2939 – Inflammation

Initiation of clinical development in 2022
EDP1908 – Oncology

Initiation of clinical development in 2022
Fourth Quarter and Full Year 2020 Financial Results

Cash Position: As of December 31, 2020, cash and cash equivalents were $68.9 million, as compared to cash and cash equivalents of $77.8 million as of December 31, 2019. This decrease was primarily due to cash used in operating activities, partially offset by $48.4 million in net proceeds from the Company’s June 2020 follow-on offering of common stock and draw down of an additional $10 million under its existing debt facility in July 2020. During the first quarter of 2021, the Company raised net proceeds of $82.2 million from the issuance of common stock exclusive of certain other fees payable by the Company.
Research and Development Expenses: R&D expenses were $22.1 million for the three months ended December 31, 2020 and $69.6 million for the full year ended December 31, 2020, compared to $16.4 million for the three months ended December 31, 2019, and $63.1 million for the full year ended December 31, 2019. The increase of $6.5 million year over year was primarily due to increased costs related to Evelo’s inflammation clinical development programs, clinical development and technical operations headcount growth and platform investment, partially offset by lower oncology spend.
General and Administrative Expenses: G&A expenses were $6.1 million for the three months ended December 31, 2020 and $22.3 million for the full year ended December 31, 2020, compared to $6.3 million for the three months ended December 31, 2019 and $23.2 million for the full year ended December 31, 2019. The decrease of $1.0 million year over year was primarily due to lower cost associated with legal, consulting and other professional fees, partially offset by higher IT and other office expense costs.
Net Loss: Net loss was $29.1 million for the three months ended December 31, 2020 and $93.7 million for the full year ended December 31, 2020, or $(0.62) and $(2.37) per basic and diluted share, respectively, as compared to a net loss of $22.6 million for the three months ended December 31, 2019 and $85.5 million for the full year ended December 31, 2019, or $(0.70) and $(2.67) per basic and diluted share, respectively.
Conference Call

Evelo will host a conference call and webcast at 8:30 a.m. ET today to review fourth quarter and full year 2020 highlights. To access the call, please dial (866) 795-3242 (domestic) or (409) 937-8909 (international) and refer to conference ID 3094547. A live webcast of the event will also be available under "News and Events" in the Investors section of Evelo’s website at View Source The archived webcast will be available on Evelo’s website approximately two hours after the completion of the event and will be available for 30 days following the call.

Curis to Release Fourth Quarter 2020 Financial Results and Hold Conference Call on March 16, 2021

On March 9, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the Company will release its fourth quarter 2020 financial results on Tuesday, March 16, 2021, after the close of US markets (Press release, Curis, MAR 9, 2021, View Source [SID1234576308]). Management will host a conference call on the same day at 4:30 pm ET.

To access the live conference call, please dial (888) 346-6389 from the United States or (412) 317-5252 from other locations, shortly before 4:30 pm ET. The conference call can also be accessed on the Curis website at www.curis.com in the ‘Investors’ section. A replay of the financial results conference call will be available on the Curis website shortly after completion of the call.

CUMBERLAND PHARMACEUTICALS
REPORTS 9% REVENUE GROWTH IN 2020

On March 9, 2021 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care, gastroenterology and rheumatology, reported fourth quarter and full year 2020 financial results (Press release, Cumberland Pharmaceuticals, MAR 9, 2021, View Source [SID1234576307]). Net Revenues for the fourth quarter were $10.3 million, up 10% over the prior year period. For the full year 2020, Net Revenues totaled $37.4 million, a 9% increase over 2019. The company also recorded an additional $3.2 million in revenue during the year associated with divested product rights for two brands it is no longer distributing.

As of December 31, 2020, the total assets of the Company were $96.5 million, including $24.8 million in cash and investments. Total Liabilities were $49.6 million, and Total Shareholder’s Equity was $47 million. Cumberland also had approximately $44 million in tax net operating loss carryforwards, resulting from the prior exercise of stock options.

2020 Highlights:

Implemented national launch of a Next Generation Caldolor product featuring a ready-to-use formulation in a pre-mixed bag
Commenced several national initiatives during 2020 to help hospitals access Cumberland’s acute care brands during the COVID-19 pandemic
Announced a series of publications featuring important new data associated with the Company’s Caldolor (ibuprofen) Injection, for the treatment of pain and fever and Vibativ (telavancin) Injection, for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections
Introduced an FDA-approved RediTrex line of injectable methotrexate products, featuring an innovative delivery system for patients with arthritis
"We are grateful that Cumberland was able to successfully manage through the pandemic during 2020, in spite of the significant market headwinds and other challenges we encountered," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Our facilities remained open, our operations continued, and our organization remained intact." He continued, "I would like to acknowledge and thank my colleagues for their continued dedication during such trying times for many. Together, we remain focused on our mission of advancing patient care through the delivery of high-quality medicines."

Caldolor

Early in 2020, Cumberland implemented a national launch of its Next Generation Caldolor product featuring a ready-to-use formulation, offering time and cost savings associated with its administration. Caldolor is a non-steroidal anti-inflammatory drug (NSAID) and may be used as the sole method of treatment for mild-moderate pain or as part of a multimodal treatment for severe pain. Cumberland’s new formulation of Caldolor comes in a pre-mixed bag that is ready for use. It is the first FDA-approved pre-mixed bag of ibuprofen.

Caldolor was also the subject of several clinical studies published during the year. These studies demonstrated that patients given Caldolor experienced less postoperative pain and had decreased opioid use. Due to these studies, Caldolor was recommended for consideration in Enhanced Recovery After Surgery protocols for the management of postoperative pain – including that of traumatic origin.

Vibativ

Cumberland launched several national initiatives during 2020 to help hospitals access the Company’s acute care brands during the healthcare emergency. Cumberland’s Vibativ product was used to help COVID-19 patients who developed secondary-bacterial infections in their lungs. Vibativ is a potent antibiotic, FDA approved to treat hospital and ventilator acquired pneumonia that can result from a variety of infectious agents. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

Additionally, there were a series of clinical study manuscripts published during the year regarding Vibativ. One study suggested that Vibativ is a promising and viable option for patients with bacteremia or endocarditis, including those with MRSA or another S. aureus pathogen. Two other studies confirmed the continued in vitro potency of Vibativ and detailed the positive outcomes that resulted.

RediTrex

The Company implemented a soft launch of its newly FDA-approved RediTrex product line during the fourth quarter. Cumberland is now preparing for a full national launch during the second half of 2021, once product supplies are assured and market conditions return to normal. The Company believes that RediTrex will be a valuable addition to the portfolio and help further diversify and grow its business.

RediTrex is approved for patients with severe, active rheumatoid arthritis and polyarticular juvenile idiopathic arthritis who have difficulty tolerating or responding to orally delivered methotrexate. It is also approved for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Omeclamox-Pak

Cumberland closely monitored its supply chain during the 2020 pandemic. This included monitoring the facilities that supply the raw materials along with those that manufacture the Company’s products. Overall, the chain remained intact with batches of finished goods shipped to the warehouses that supply the country’s hospital and retail pharmacies. However, there was one exception, as the facility packaging Omeclamox-Pak encountered financial difficulties due to the pandemic and suspended operations. Subsequently, Cumberland learned that this facility is reorganizing, and the Company awaits the resumption of its operations.

Ifetroban Phase II Clinical Programs

Cumberland’s development pipeline includes a series of product candidates in Phase II development. Enrollment in the Company’s studies significantly slowed during the pandemic, due to trial suspensions and the decrease in eligible patient admissions to medical centers across the country. While enrollment of new patients was limited most of the year, the Company ensured that patients already entered into a trial continued to receive their study drug. Cumberland looks forward to an improvement in study enrollment as the pandemic subsides and centers begin to reopen.

The Company has Phase II clinical programs underway evaluating its ifetroban product candidates in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis, and Aspirin-Exacerbated Respiratory Disease.

FINANCIAL RESULTS:

Net Revenue: For the three months ended December 31, 2020, net revenues were $10.3 million, up 10% from $9.3 million for the prior year period. The company also recorded an additional $900,000 in revenue during the fourth quarter associated with divested product rights.

Net revenue by product for the three months ended December 31, 2020, included $5.2 million for Kristalose, $2.3 million for Vibativ, $1.7 million for Caldolor, and $0.9 million for the Company’s newest brand, RediTrex.

For the year ended December 31, 2020, net revenues were $37.4 million, an 8.9% increase compared to $34.4 million for the year ended December 31, 2019. Additionally, the company recorded a total of $3.2 million in revenue during 2020 associated with divested product rights.

Net revenue by product for the year ended December 31, 2020, included $15.6 million for Kristalose, $10.9 million for Vibativ, $5.3 million for Caldolor, $1.9 million for Acetadote (including the brand and Company’s Authorized Generic), $1.1 million for Vaprisol, $0.9 million for RediTrex, and $0.3 million for Omeclamox- Pak.

Operating Expenses: Total operating expenses for the three months ended December 31, 2020 were $12.0 million, down from $12.7 million for the prior year period. Total operating expenses for the year ended December 31, 2020 were $43.8 million, similar to $43.7 million for 2019.

Adjusted Earnings: Adjusted Earnings for the three months ended December 31, 2020 were $0.2 million, or $0.01 per share, compared to a loss of $(1.9) million, or $(0.12) per share for the prior year period. Adjusted Earnings for the full year ended December 31, 2020 were a loss of $(0.1) million, or $(0.01) per share, a significant turnaround over the loss of $(3.4) million, or $(0.22) per share in 2019.

This performance measure represents net income attributable to common shareholders with adjustments for the impact of income taxes, depreciation, amortization, share based compensation expenses and expenses that are non-core to the operating performance of the period. The definition and the reconciliation of Adjusted Earnings are provided in this release.

Cash Flow: Cash flow from operations for the year ended December 31, 2020 was $5.4 million, compared to $3.1 million for the prior year.

Balance Sheet: At December 31, 2020, Cumberland had $24.8 million in cash and cash equivalents. Total assets at December 31, 2020 were $96.5 million. Total Liabilities were $49.6 million, including $15.0 million outstanding on the Company’s revolving line of credit and $8.2 million related to contingent liabilities related to the Vibativ acquisition, resulting in Total Shareholder’s Equity of $47 million.

Conference Call and Webcast

A conference call and live Internet webcast will be held on Tuesday, March 9, 2021 at 4:30 p.m. Eastern Time to discuss the Company’s fourth quarter and annual 2020 financial results. To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 7005878. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source