On May 8, 2020 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company, reported that Oncogenuity, Inc. ("Oncogenuity"), a new Fortress partner company, has entered into an exclusive worldwide licensing agreement with Columbia University to develop novel oligonucleotides for the treatment of genetically driven cancers (Press release, Fortress Biotech, MAY 8, 2020, View Source [SID1234557345]). The proprietary platform produces oligomers, now known as "ONCOlogues," that are capable of binding gene sequences 1,000 times more effectively than complementary native DNA. The technology comes from the labs of Gary Schwartz, M.D., Division Chief, Hematology/Oncology, and Jeffrey Rothman, M.D., Ph.D., Assistant Professor of Medicine.

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ONCOlogues are sensitive to a single base pair mismatch, resistant to degradation and use a proprietary delivery sequence to enter cells. ONCOlogues’ selectivity enables Oncogenuity to target genetically driven cancers caused by mutations without impacting wild-type ("WT") DNA sequences, potentially limiting off-target toxicity. In addition, this allows ONCOlogues to target mutations that have historically been considered "un-druggable."

Oncogenuity has established proof-of-concept in a pre-clinical setting for various cancer types. The company’s most advanced program is targeting the KRAS mutation G12D, which was previously considered un-druggable and plays a significant role in various cancer types with substantial unmet need, including pancreatic and colorectal. Given the platform’s ability to target any mutation, Oncogenuity will continue to evaluate other mutations simultaneously. The company anticipates additional data publications in the coming 12 months.

Additionally, Oncogenuity is exploring the platform’s potential to treat coronaviruses. Coronaviruses have single-stranded RNA genomes, making them strong targets for ONCOlogues. The company is studying replacement sequences, which could help combat COVID-19 and provide proof-of-concept as a treatment for coronaviruses. These ongoing experiments would validate ONCOlogues as a possible treatment for COVID-19, as well as potentially expedite the discovery of treatments for future coronavirus outbreaks.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "We are excited to work with the excellent scientists and physicians at Columbia University again. Our last joint effort with Columbia University led to the formation of our partner company, Caelum Biosciences, Inc. ("Caelum"). Since formation, Caelum has raised approximately $60 million in development funding from a number of sources, with additional amounts available upon the satisfaction of certain milestones and will be initiating two registration clinical trials in the next several weeks. Building upon our success with Caelum, we are grateful to Columbia University for entrusting us to develop this highly innovative technology using oligonucleotides to target genetically driven cancers and coronaviruses. Using a targeted genetic approach to treat cancer has become essential to limiting toxicity and treating patients effectively. This technology has the potential to target mutations that have previously been considered un-druggable. Oncogenuity will aggressively pursue the development of ONCOlogues to ultimately provide patients with new, safe and effective treatment options."

Scientific Co-Founder Jeffrey Rothman, M.D., Ph.D., said, "Through rigorous statistical, mechanical and molecular modeling, combined with gene sequence data, we are able to create sequence-specific, targeted therapeutics against oncogenes, which are the cause of and specific to tumor cells. Until now, achieving this goal had been considered nearly impossible. However, with these novel design features, we now have the ability to target cancer while potentially avoiding side effects, which are the main cause of dose-limitation, by design. There is much potential because we are able to target multiple genes and therefore, multiple cancers. Moreover, due to their single-strand format, application toward viral targets such as in COVID are even more facile given their easier accessibility. We are excited and determined to pursue this endeavor with Fortress Biotech and very much welcome their continued support."

On May 8, 2020 Amyris, Inc. (Nasdaq: AMRS), a leading synthetic biotechnology company in Clean Health and Beauty markets through its consumer brands and a top supplier of sustainable and natural ingredients, reported financial results for its first quarter ended March 31, 2020 (Press release, Amyris Biotechnologies, MAY 8, 2020, View Source [SID1234557432]).

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Keeping our people, partners and communities safe and healthy while benefiting from strong product demand has been our number one priority during these unprecedented times with COVID-19.

Management Comments
"COVID-19 has dominated all of our lives with a significant impact both from a health and economic perspective. Keeping our people, our partners and our communities safe and healthy while delivering on very strong product demand from consumers has been our number one priority. This meant that we had to adjust our ways of working across our supply chain, innovation center and offices. Our people have been amazing, and we have continued to deliver on our commitments to our customers," said John Melo, President and Chief Executive Officer. "We play a critical role in helping those who have been impacted by the pandemic. This includes rapidly launching a new hand sanitizer of which we have donated over 20,000 units to frontline healthcare workers. Also, we supply key ingredients for household cleaning and personal care products and are exploring how our science can be further utilized to fight the virus."

Continued Melo, "We are pleased with our first quarter results for what is typically our lowest sales quarter of the year due to seasonality. We have seen limited impact to our business performance from COVID-19. During the month of April we delivered our best single month of consumer product sales. We are experiencing significant demand for our ingredients into cleaning products and personal care products. We are encouraged by the growth in our top and bottom-line performance and see continued opportunity with our strong portfolio of branded consumer products and functional ingredients. Our focus on higher margin product sales and reducing unit costs by adapting our supply chain are delivering strong results. At our current performance we expect to achieve positive operating cash performance by the fourth quarter of this year. We remain committed to our current guidance and will update our view on the year as we get more visibility."

Q1 Financial Highlights

Performance was in line with expectations with Sales Revenue of $29 million up 103% versus the prior year quarter with strong growth seen in Consumer & Ingredients product sales
Gross Margin as a percentage of sales improved to 63% which compares to -33% in Q1 2019 and 56% for the full year 2019. Year-over-year margin growth delivered a $23 million improvement and was driven by improved sales mix from higher consumer brand sales and lower unit cost
Adjusted EBITDA of -$27 million improved $19 million versus the same quarter last year driven by the aforementioned margin improvements
GAAP Net Income of -$87 million was down $23 million. EBITDA improvements of $19 million were offset by non-cash debt related adjustments of $37 million.
Adjusted Net Income of -$44 million improved $15 million versus prior year.
Diluted EPS improved $0.26 or 32% to -$0.56
Adjusted Diluted EPS improved $0.47 or 63% to -$0.28 per share
Debt principal was reduced by $88 million or 30% during the quarter from $297 million to $209 million
Strategic Priorities
At the start of 2020 we set out four strategic priorities to focus our execution on accelerated growth and a clear path to profitability and sustained cash generation:

High growth consumer brands: build on our Clean Beauty market leadership and double sales year over year. Extend offering of clean and safe ingredients and products
Scientific and commercial collaboration: Execute on R&D collaboration programs to scale 3-4 new molecules yearly. Establish market leadership in sustainable Health and Wellness markets
Supply chain optimization: Deliver lower unit costs targeting gross margins >60 of sales. Drive agile and robust supply network to support sales growth
Improved balance sheet, earnings and cash flow: Reduced balance sheet leverage. Be fully funded to deliver growth. Deliver on path to sustained cash generation from operational performance
During the first quarter we made strong progress on each of our strategic priorities:

Consumer brands sales more than doubled; mostly driven by Biossance, our Clean Beauty brand
Launched a new Pipette branded hand sanitizer product responding to COVID-19 needs. We donated first production batches to front-line healthcare workers
Collaboration revenue grew by more than 150%
Gross Margin grew to 63%
Expanded supply and fulfillment network to respond to continued consumer brand growth
Reduced and simplified debt. Delivered much improved earnings both in absolute terms and per diluted share
Q1 2020 Results
Variance $ and Variance % in the following tables and comments may not foot due to rounding

Sales Revenue improved by 103% due to a 92% improvement in Consumer & Ingredients and 158% growth in Collaboration & Grants
Gross Margin as a percentage of sales improved to 63%, and delivered a $23 million improvement driven by a combination of higher margins from consumer brand sales and lower unit costs in ingredients
GAAP Net Income of -$87 million was down $23 million impacted by non-cash adjustments and fair value assessments in debt instruments of $37 million. Adjusted Net Income of -$44 million improved $15 million versus prior year driven by operational improvements from sales mix and lower unit costs
Operating expenses of $44 million were up 5% due to investments in marketing and sales, partly offset by lower R&D expense
Adjusted EBITDA of -$27 million improved $19 million versus the same quarter last year primarily driven by margin improvements
Adjusted Diluted EPS improved $0.47 or 63% to -$0.28 per share
Q1 2020 Category Sales Revenue
Variance $ and Variance % in the following tables and comments may not foot due to rounding

Note: Consumer & Ingredients sales is the total of Renewable Products and Licenses and Royalties

Consumer & Ingredients (C&I) sales grew 92% year over year (price +3%, volume/mix +89%) with growth seen in both direct-to-consumer branded products (+233%) and business-to-business ingredients (+50%). Excluding a $4 million one-off value share C&I sales were up 56%
Collaboration & Grants were up 158% year over year due to higher revenue from several strategic partnership programs
Full Year 2020 Outlook
Our current Sales Revenue guidance is maintained albeit that COVID-19 presents uncertainties to which we do not have full visibility.

Full year Sales Revenue is expected to grow approximately 44% versus 2019 GAAP sales of $153 million. 2020 recurring sales are expected to grow approximately 80% versus 2019 recurring sales of $104 million.

Gross Margin is expected to operate at greater than 60% of sales due to improved sales mix and lower unit costs. Based on sales revenue guidance, Adjusted EBITDA is expected to turn positive during Q4 of this year.

FINANCIAL RESULTS AND NON-GAAP INFORMATION

To supplement our financial results and guidance presented on a GAAP basis, we use non-GAAP measures that we believe are helpful in understanding our results. These non-GAAP measures are among the factors management uses in planning and forecasting future periods. These non-GAAP financial measures also facilitate management’s internal comparisons to Amyris’s historical performance as well as comparisons to the operating results of other companies. Management believes these non-GAAP financial measures are useful to investors because they allow for greater transparency into the indicators used by management to understand, manage, and evaluate our business and make operating decisions. Our non-GAAP financial measures include the following:

Non-GAAP net income (loss) is calculated as GAAP net income/loss excluding stock-based compensation expense, gains or losses from change in fair value of debt, gains and losses from changes in the fair value of derivatives, losses on debt extinguishment, and losses allocated to participating securities.

Adjusted diluted EPS is calculated by dividing Non-GAAP net income (loss) by the weighted average shares, basic and diluted outstanding for the period.

Non-GAAP Gross Margin (Gross Margin) is calculated as GAAP revenues divided by GAAP cost of products sold excluding excess capacity, depreciation and amortization and other costs/provisions.

EBITDA is calculated as GAAP net loss less losses allocated to participating securities, interest, tax provision, depreciation and amortization.

Adjusted EBITDA is calculated as EBITDA less stock-based compensation expense, gains or losses from change in fair value of debt, gains and losses from changes in the fair value of derivatives, losses on debt extinguishment and other expense, net.

Non-GAAP financial information is not prepared under a comprehensive set of accounting rules, and therefore, should only be read in conjunction with financial information reported under U.S. GAAP in order to understand Amyris’s operating performance. A reconciliation of the non-GAAP financial measures presented in this release to the most directly comparable GAAP financial measure, is provided in the tables attached to this press release.

Conference Call
Amyris will host its first quarter 2020 conference call today May 8, 2020 at 9:00 am ET (6:00 am PT) to discuss its financial results. Those who wish to listen to the conference call should dial into (888) 390-3967 (U.S. and International) and ask to be joined to the Amyris, Inc. call. A live webcast of the call will be available online on the Amyris website. To listen via live webcast, please visit: View Source

If you are unable to listen to the live call, the webcast will be archived on the Company’s website. A replay of the webcast will be available on the Investor Relations section of the company’s website approximately two hours after the conclusion of the call. Additional information on Amyris’ first quarter 2020 results can also be found on the Company’s website.

On May 8, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, reported the grant of a new patent (number 6691054) entitled "Combined Preparations for the Treatment of Cancer" by the Japanese Patent Office (Press release, Immutep, MAY 8, 2020, View Source [SID1234557346]).

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This Japanese patent follows the grant of the corresponding European and Australian patents (announced 23 May 2019 and 21 June 2019, respectively) and protects Immutep’s intellectual property relating to combined therapeutic preparations comprising its lead active immunotherapy candidate eftilagimod alpha ("efti" or "IMP321") and a chemotherapy agent. The chemotherapy agent is oxaliplatin, carboplatin, or topotecan.

The new patent highlights the broad potential of efti as an immunostimulant and provides patent protection in Japan for a range of novel and highly relevant chemo-immunotherapies featuring efti that may be pursued in the future.

The patent expiry date is 19 December 2034.

On May 8, 2020 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that President Rajiv Malik and Chief Financial Officer Ken Parks will present at the BofA Securities Virtual Health Care Conference 2020 on Thursday, May 14, 2020 at 3:40 p.m. ET (Press release, Mylan, MAY 8, 2020, View Source [SID1234557433]).

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Interested parties can access a live webcast of the presentation via the investor relations section of Mylan’s website at investor.mylan.com. An archived version also will be available following the live presentation and can be accessed at the same location for a limited time.

On May 8, 2020 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the first quarter ended March 31, 2020 (Press release, Synlogic, MAY 8, 2020, View Source [SID1234557347]).

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"In the first quarter, we continued to advance our programs and enhance our Synthetic Biotic platform capabilities in synthetic biology, manufacturing and development. While the coronavirus pandemic necessitated we update a number of our development plans, I am very grateful to our dedicated employees who have enabled us to continue to execute on our strategy under challenging circumstances," said Aoife Brennan, M.B., Ch.B., Synlogic’s president and chief executive officer. "We look forward to showcasing our deep platform capabilities and expanding program portfolio at our upcoming virtual R&D event on May 27th, which will include more details on one of our newest and rapidly advancing programs in enteric hyperoxaluria."

2020 Priorities

Pipeline

Initiation of a Phase 2 clinical trial to evaluate a solid formulation of SYNB1618 in patients with phenylketonuria (PKU). SYNB1618 is an orally administered Synthetic Biotic medicine that is being developed as a treatment for PKU.
Synlogic intends to continue to work with sites to complete preparatory work, however as a result of the coronavirus pandemic it does not expect to be able to enroll subjects into its Phase 2 clinical trial of SYNB1618 until it is safe for patients to enter clinical trial sites.
The Phase 2 trial is designed to evaluate safety and tolerability of a solid formulation of SYNB1618 as well as its potential to lower blood phenylalanine levels in PKU patients. In addition, the study is expected to provide valuable information to validate predictive pharmacodynamic and preclinical modeling.
Evaluation of data from the monotherapy arm of the Phase 1 clinical study of SYNB1891 in patients with advanced solid tumors or lymphoma. SYNB1891 is an intra-tumorally administered Synthetic Biotic medicine engineered to produce cyclic di-AMP, an agonist of the STING pathway, that is designed to serve as a dual innate activator of the immune system as a potential treatment for solid tumors or lymphoma. SYNB1891 is being evaluated as a monotherapy in an ongoing Phase 1 open-label, multicenter, dose escalation clinical trial (NCT04167137) in patients with advanced solid tumors or lymphoma.
While this clinical trial and most clinical sites have remained open and enrolled patients have continued on study, Synlogic expects slower enrollment of new patients as a result of the coronavirus pandemic, which has the potential to impact the availability of data in 2020.
Continued development of patient and commercialization-appropriate drug presentations of SYNB1618.
Synlogic has developed and manufactured a solid formulation of its Synthetic Biotic SYNB1618 that it plans to use in future clinical trials and continues to evaluate and develop different drug presentations (e.g. capsule, pressed pill, sachet) for eventual commercialization.
Advancement of new Synthetic Biotic programs in metabolic diseases with high unmet medical need.
Synlogic is conducting preclinical studies of Synthetic Biotic medicines to treat enteric hyperoxaluria, an acquired metabolic disorder in which patients develop recurrent kidney stones due to elevated urinary oxalate levels and are at an increased risk of kidney failure. Synlogic expects to move a clinical candidate in its enteric hyperoxaluria program, into IND-enabling studies in 2020.
In addition, Synlogic is also developing Synthetic Biotic medicines for the treatment of other metabolic diseases, including maple syrup urine disease (MSUD), a rare inherited metabolic disease caused by defective enzymes that metabolize branched chain amino acids (BCAAs) which are components of protein.
Publication and presentation of data demonstrating the breadth and potential of its Synthetic Biotic platform.
On March 8th, Nature Communications published a Perspective authored by Synlogic scientists entitled, "Developing a new class of engineered live bacterial therapeutics to treat human diseases." The paper, which highlights the considerations for the design and development of engineered live bacteria, including Synthetic Biotic medicines, is available on the Synlogic website on the Presentations and Publications page of the Investors and Media section.
On May 27th, 2020 Synlogic will host its first virtual R&D event
The webcast event will highlight the Company’s progress in developing its platform capabilities and pipeline of rare metabolic disease programs for internal prosecution and programs in immunomodulation for potential partnering. Dr. David Goldfarb, Professor of Medicine and Physiology at NYU School of Medicine, Clinical Chief of the Nephrology Division at NYU Langone Health, and Chief of the Nephrology Section and Director of the Hemodialysis Unit at the New York VA Medical Center in Manhattan will also present an overview of enteric hyperoxaluria. A link to the live webcast will be available on Synlogic’s website on the News & Events page of the Investors and Media section.
First Quarter 2020 Financial Results
As of March 31, 2020, Synlogic had cash, cash equivalents, and short-term investments of $114.2 million.

For the three months ended March 31, 2020, Synlogic reported a consolidated net loss of $15.8 million, or $0.46 per share, compared to a net loss of $12.9 million, or $0.51 per share, for the corresponding period in 2019.

Research and development expenses were $12.7 million for the three months ended March 31, 2020 compared to $10.4 million for the corresponding period in 2019. The increase in expenses was primarily due to use of synthetic biology services provided under Synlogic’s collaboration with Ginkgo and increased clinical activities associated with the SYNB1618 bridging study and the SYNB1891 Phase 1 clinical trial.

General and administrative expenses for the three months ended March 31, 2020 were $3.8 million compared to $3.7 million for the corresponding period in 2019.

Revenue was $0.1 million for the three months ended March 31, 2020 compared to $0.3 million for the three months ended March 31, 2019. Revenue is associated with services performed under the Synlogic’s collaboration with AbbVie to develop a Synthetic Biotic medicine for the treatment of IBD.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast today at 8:00 a.m. ET today, Friday, May 8, 2020. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 6869043. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.