MyBiotics Signs Second Option to License Agreement with Ferring Holding for Microbiome-Based Therapies

On March 5, 2018 MyBiotics Pharma Ltd., a microbiome therapeutics company, reported that it has entered into a second option agreement with Ferring Holding Ltd. for the validation of MyBiotics’ microbiome-based therapeutics in the field of women’s health (Press release, MyBiotics, MAR 5, 2018, View Source [SID1234577656]). This agreement follows the first agreement between the two parties signed in June 2017, for the validation of MyBiotics’ technology in the treatment of a non-disclosed gastroenterology condition.

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MyBiotics has developed breakthrough and robust production and fermentation techniques for growing a highly stable and diverse bacterial community that can be delivered to the gut efficiently and can reliably restore microbiome equilibrium. The technology is highly potent and suitable for patients with medical indications related to the microbiome or for those who use antibiotics. Preclinical tests have shown that MyBiotics’ products deliver enhanced durability in various gastrointestinal and manufacturing conditions, enable targeted release in different gastrointestinal locations and exhibit robust colonization in the gut, with a stable bacterial population observed for 14 days following treatment.

"Within a few months we have entered into two collaborations with Ferring Holding, which is a true vote of confidence in the potential of our therapeutic approach", stated David Daboush, CEO of MyBiotics Pharma. "Our technology enables us to generate concentrated and effective bacterial raw material that can be introduced into the gastrointestinal tract and restore ecological equilibrium to the gut microbiota. Combining our innovative technology with the extensive drug development and marketing expertise of the Ferring Group has the potential to lead to novel treatments in the fields of gastroenterology and women’s health, offering patients long term relief without significant risks."

"This agreement is further evidence of Ferring’s commitment to seek out novel treatments for important medical conditions. Ferring is very active in the areas of gastroenterology and women’s health, and this partnership with MyBiotics is another indication of our commitment to discover and develop innovative microbiome-based treatments," said Dov Kanner, Director of Ferring Holding. "It is clear by now that the microbiome is of profound importance to a wide variety of pathologies, ranging from digestive disorders through obesity, immune disorders, women’s health and more. Microbiome-based therapies are gaining increasing interest for a variety of microbiome-related indications, and we believe that MyBiotics’ technology will enable the development of such therapies, potentially offering treatment to millions of people around the globe."

Currently available probiotic drugs and dietary supplements have limited clinical impact due to the low survival rates of the delivered bacteria in the gastrointestinal tract. This significantly reduces the ability of probiotic bacteria to impact the microbial diversity of the gut, thus failing to create a healthier community of bacteria.

ArQule Reports Fourth Quarter and Full Year 2017 Financial Results

On March 5, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, will present at the 30th Annual Roth Conference on March 12th, 2018, at 5:00 p.m. PT at the Ritz-Carlton in Dana Point, California (Press release, ArQule, MAR 5, 2018, View Source [SID1234524382]).

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You can access the live webcast of the presentation via the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

Vericel Reports Fourth Quarter and Year End 2017 Financial Results and Provides Full Year 2018 Financial Guidance

On March 5, 2018 Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the fourth quarter and year ended December 31, 2017 and full year 2018 financial guidance (Press release, Vericel, MAR 5, 2018, View Source [SID1234524400]).

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Fourth Quarter 2017 Financial Highlights

Total net revenues increased 41% to $23.4 million compared to $16.5 million in the fourth quarter of 2016; excluding license revenue, net revenue increased 34% to $22.2 million;

Gross margins of 64% compared to gross margins of 54% in the fourth quarter of 2016;

Operating income of $1.2 million, compared to operating loss of $5.9 million in the fourth quarter of 2016;

Net income of $0.3 million, or $0.01 per share, compared to net loss of $6.2 million, or $0.34 per share, in the fourth quarter of 2016; and

•As of December 31, 2017, the company had $26.9 million in cash compared to $23.0 million in cash at December 31, 2016.
Full Year 2017 Financial Highlights

•Total net revenue increased 18% to $63.9 million compared to $54.4 million in 2016; excluding license revenue, net revenue increased 15% to $62.8 million;

•Gross margins of 53% compared to gross margins of 48% in 2016;

•Operating loss of $15.0 million, compared to operating loss of $19.2 million in 2016; and

•Net loss of $17.3 million, or $0.52 per share, compared to net loss of $19.6 million, or $1.18 per share, in 2016.

Recent Business Highlights
During and since the fourth quarter of 2017, the company:

•Achieved record fourth quarter revenues and the third straight quarter of 30% or greater revenue growth versus the same quarter of the prior year;

•Trained approximately 600 surgeons on the MACI (autologous cultured chondrocytes on porcine collage membrane) surgical procedure to date;

Increased MACI biopsies 48% in the fourth quarter of 2017 compared to the same period in 2016, the second consecutive quarter with over 40% growth versus the same quarter of the prior year;

Expanded the MACI sales force from 28 to 40 sales territories;

Achieved significant growth in burn centers utilizing Epicel (cultured epidermal autografts), with 40 burn centers utilizing Epicel in 2017 compared to 20 centers in 2014 when the business was acquired;

•Launched the MACI "It’s Your Move" campaign with world champion swimmer, five-time Olympian, best-selling author and recent MACI patient Dara Torres to empower patients with knee pain to seek treatment;

•Entered into an expanded $25 million debt facility providing approximately $8 million of incremental capital; and

•Initiated collaboration with Innovative Cellular Therapeutics (ICT), receiving $5.1 million for the purchase of warrants and an upfront license fee.
"We had record fourth quarter revenues and achieved both positive operating income and net income for the quarter, an important milestone for the company," said Nick Colangelo, president and CEO of Vericel. "Our record fourth quarter revenues represent the third straight quarter of 30% or higher revenue growth compared to the same quarter of the prior year, and this strong growth and margin expansion were driven by both the accelerating uptake of MACI as well as substantial growth for Epicel in the quarter."
Fourth Quarter 2017 Results
Total net revenues for the quarter ended December 31, 2017 were $23.4 million, which included $16.1 million of MACI net revenue and $6.1 million of Epicel net revenue, compared to $12.8 million of Carticel (autologous cultured chondrocytes) net revenue and $3.8 million of Epicel net revenue, respectively, in the fourth quarter of 2016. Total net revenues for the quarter ended December 31, 2017 also included $1.2 million in license revenue related to the company’s collaboration agreement with ICT. Total net revenues increased 41% compared to the fourth quarter of 2016, with MACI revenue increasing 26% and Epicel revenue increasing 62%, respectively, compared to the same period in 2016. Excluding license revenue, net revenues increased 34% compared to the fourth quarter of 2016.
Gross profit for the quarter ended December 31, 2017 was $15.0 million, or 64% of net revenues, compared to $8.9 million, or 54% of net revenues, for the fourth quarter of 2016.
Total operating expenses for the quarter ended December 31, 2017 were $13.8 million compared to $14.8 million for the same period in 2016. Operating expenses for the quarter

December 31, 2016 included $2.6 million from the write-off of commercial use rights related to Carticel. Given the approval of MACI in December 2016 and the replacement of Carticel with MACI, it was determined that the Carticel-related intangible asset was fully impaired as of December 31, 2016. Excluding the impairment, the increase in fourth quarter operating expenses is primarily due to an increase in the MACI sales force during 2017 as well as case management services to support MACI.
Income from operations for the quarter ended December 31, 2017 was $1.2 million, compared to a loss of $5.9 million for the fourth quarter of 2016. Material non-cash items impacting the operating income for the quarter included $0.7 million of stock-based compensation expense and $0.4 million in depreciation expense.
Other expense for the quarter ended December 31, 2017 was $0.9 million compared to $0.3 million for the same period in 2016. The change in other expense for the quarter is primarily due to the loss on extinguishment of debt associated with the expanded long-term debt facility which closed in December 2017.
Vericel’s net income for the quarter ended December 31, 2017 was $0.3 million, or $0.01 per share, compared to a net loss of $6.2 million, or $0.34 per share, for the same period in 2016.
Full Year 2017 Results
Total net revenues for the year ended December 31, 2017 were $63.9 million, including $43.9 million of Carticel and MACI net revenues, $18.9 million of Epicel net revenue and $1.2 million in license revenue. Total net revenues for the year ended December 31, 2017 increased 18% over 2016.
Gross profit for the year ended December 31, 2017 was $33.6 million, or 53% of net revenues, compared to $26.1 million, or 48% of net revenues, for the year ended December 31, 2016.
Total operating expenses for the year ended December 31, 2017 were $48.6 million compared to $45.3 million in 2016. Operating expenses for the year ended December 31, 2016 included $2.6 million from the write-off of commercial use rights related to Carticel. The increase in operating expenses during 2017 is primarily due to an increase in the MACI sales force, expenses for marketing initiatives related to the launch of MACI, and an increase in case management services to support MACI.
Loss from operations for the year ended December 31, 2017 was $15.0 million, compared to a loss of $19.2 million in 2016. Material non-cash items impacting the operating loss for the year included $2.7 million of stock-based compensation expense and $1.6 million in depreciation expense.
Other expense for the year ended December 31, 2017 was $2.3 million compared to $0.3 million in 2016. The change in other expense is primarily due to the loss on extinguishment of debt associated with the expanded long-term debt facility which closed in December 2017 and the interest expense related to the outstanding revolver and credit term loans.

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Vericel’s net loss for the year ended December 31, 2017 was $17.3 million, or $0.52 per share, compared to a net loss of $19.6 million, or $1.18 per share, in 2016.
As of December 31, 2017, the company had $26.9 million in cash compared to $23.0 million in cash at December 31, 2016.
Full Year 2018 Financial Guidance
The company expects total net product revenues for the full year 2018, excluding additional license revenue, to be in the range of $73 million to $78 million compared to total net product revenue, excluding license revenue, of $62.8 million in 2017. The company also expects the seasonality of MACI and Epicel revenues for 2018 to be in line with prior years, wherein total product quarterly revenues were, on average, 21%, 25%, 21%, and 33% in the first through the fourth quarters.
"We successfully executed the launch of MACI and expanded Epicel utilization in 2017," added Mr. Colangelo. "These successes, combined with a strong balance sheet and an expanded sales force in 2018, have positioned the company for continued strong revenue growth in the years ahead."
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern time in the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s fourth-quarter 2017 earnings call. If calling from outside the U.S., please use the international phone number (253) 237-1173.
If you are unable to participate in the live call, the webcast will be available at View Source until March 5, 2019. A replay of the call will also be available until 11:30am (EST) on March 10, 2018 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 4899311.

Calithera Biosciences to Report Fourth Quarter 2017 Financial Results on Thursday, March 8, 2018

On March 2, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that the Company’s fourth quarter 2017 financial results will be released on Thursday, March 8, 2018 (Press release, Calithera Biosciences, MAR 2, 2018, View Source [SID1234535245]). Company management will host a conference call on Thursday, March 8, 2018 at 1:30 p.m. Pacific Time/ 4:30 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 3398144. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 day

Molecular Templates Closes $10 Million Debt Facility with Perceptive Advisors

On March 2, 2018 Molecular Templates, Inc., (Nasdaq:MTEM) a clinical stage biopharmaceutical company focused on the discovery and development of Engineered Toxin Bodies (ETBs), a new class of targeted biologic therapies that possess unique mechanisms of action in oncology, reported the closing of a $10 million debt facility with Perceptive Advisors (Press release, Molecular Templates, MAR 2, 2018, View Source [SID1234524341]). The proceeds from the debt facility will be used to repay an existing debt facility with Silicon Valley Bank and to support the Company’s build out of its manufacturing facility.

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"Molecular Templates’ ETB platform is enabling development of new and differentiated products for the treatment of cancer. Perceptive is delighted to provide debt financing to support the build out of Molecular Template’s manufacturing facility and the advancement of the Company’s pipeline of ETB product candidates," said Sam Chawla of Perceptive Advisors.

"We appreciate the support from Perceptive. This financing provides Molecular Templates with capital to support the build out of our GMP manufacturing facility in Austin, Texas. Having our own GMP facility should shorten the time from lead development to IND and allow us to better support our own pipeline as well as existing and prospective partnerships," said Eric Poma Ph.D., Chief Executive and Chief Scientific Officer of Molecular Templates. "We are highly focused on advancing our pipeline, with updated clinical results for MT-3724 expected in 1H18 and new IND filings for other pipeline programs expected by year-end."