On December 10, 2018 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported that it has appointed Philippe P. Calais, Pharm.D., Ph.D. as its interim Chief Executive Officer, effective December 7, 2018 (Press release, CohBar, DEC 10, 2018, View Source [SID1234532004]). Dr. Calais will continue to serve on the company’s Board of Directors, which he joined in June 2018. CohBar is currently engaged in search activities for a successor CEO, for which Dr. Calais is considered a leading candidate, as well as for an additional independent director to join CohBar’s Board.

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"We are very pleased that Philippe has agreed to contribute his extensive biopharmaceutical leadership experience to our management team at this important time for CohBar," said Albion J. Fitzgerald, Chairman of the Board of Directors. "We anticipate the coming year will be instrumental to the ongoing development of our lead clinical candidate, CB4211, for the treatment of NASH and obesity, as well as to the advancement of our preclinical pipeline of mitochondria based therapeutics targeting other large-population diseases with underlying metabolic dysfunction. We believe Philippe’s broad range of management experience and extensive therapeutic expertise, spanning all aspects of drug development, financing, partnering and commercialization, make him particularly well-suited to lead the company."

"On behalf of the Board, I would like to thank Simon Allen for his contributions and leadership during CohBar’s evolution to a clinical stage NASDAQ listed biotechnology company, and for his support through this transition," Mr. Fitzgerald concluded.

"I joined CohBar’s Board earlier this year with a firm belief in the potential of the company’s discoveries and intellectual property to be developed as mitochondria based therapeutics to improve clinical outcomes for large and growing patient populations suffering from age-related diseases," commented Dr. Calais. "My tenure as a director has strengthened my belief in the CohBar team’s ability to translate these discoveries into a new class of therapeutics for the potential benefit of patients and shareholders alike. I look forward to working with the management team to efficiently advance the company’s clinical and preclinical pipeline, while continuing to explore strategic partnership and funding opportunities."

Dr. Calais brings to the CohBar team more than 30 years of large and small-cap biopharmaceutical experience in product development and commercialization, partnerships, collaborations and financings. He most recently served as Chief Executive Officer of Isarna Therapeutics B.V., a developer of oligonucleotide therapeutics, where he led the company through a successful Phase 1 study of ISTH0036 in advanced glaucoma, and was responsible for a number of strategic licensing, partnering and asset sale transactions during his tenure. Prior to Isarna, Dr. Calais led several clinical stage biopharmaceutical companies in Canada and in Europe, and headed Univalor LTD, a large technology transfer organization focused on commercializing innovations from the University of Montreal. Earlier in his career, he had multiple roles of increasing responsibility over a ten year period at F. Hoffmann-La Roche, ultimately becoming Global Head of its Anti-Infectives, Dermatology and Anti-Fungals Business Unit, with direct responsibility over strategy, marketing, and licensing transactions. Dr. Calais received his bachelor’s degree in pharmacy and his doctor of pharmacy from the Université François-Rabelais in Tours, France.

Details for Conference Call

Date: December 11, 2018
Time: 5:00 p.m. Eastern Time

Dial-in U.S. and Canada: (800) 239-9838
Dial-in International: (323) 794-2551
Conference ID Number: 1003502
We kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on December 11, 2018, through 11:59 p.m. Eastern Time on January 1, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 1003502. The audio replay will also be available at www.cohbar.com from December 11, 2018, through January 1, 2019.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.

On December 10, 2018 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the second quarter of fiscal year (FY) 2019 ended October 31, 2018, and provided an update on its contract manufacturing operations, and other corporate highlights (Press release, Avid Bioservices, DEC 10, 2018, View Source [SID1234538987]).

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Highlights Since July 31, 2018

"During the second quarter we have made very significant progress in both the commercial arena and in our operations as we continue to execute to plan. Re-launching the company as a dedicated biologics contract development and manufacturing organization is a challenging endeavor and I am exceptionally pleased with our progress," said Roger Lias, Ph.D., Avid’s president and chief executive officer.

"On the commercial front we continue to see strong demand and we are making substantial progress in advancing both new and existing projects and improving our profitability. We are engaged in negotiations on new programs that will contribute revenue both during the current fiscal year and through fiscal year 2020 and, perhaps more importantly, many of our current customer programs expanded during the quarter. In addition to securing nearer-term business, our recently installed and highly experienced business development team is advancing longer lead time discussions with established biopharmaceutical clients for future commercial opportunities.

"To support the on-boarding of new projects and to deliver robust, compliant and cost-effective processes to our expanding and diversifying customer base, we continue to strengthen our process development function via the expansion and enhancement of our laboratories and the addition of state-of-the-art equipment. Process development services will become an increasingly important contributor to revenue and will build a strong pipeline of future manufacturing opportunities.

"It’s pleasing to be able to report revenue of over $10 million and a backlog of $36 million during a quarter in which revenue generating potential was limited by planned sequential maintenance shutdowns of both of Avid’s cGMP manufacturing facilities. These shutdowns, during which we undertook important maintenance activities and upgraded systems represent the most comprehensive overhaul program in the company’s history and were crucial to maintaining compliance; serving our current clients and winning new business, as well as minimizing operational and regulatory risk.

"Collectively our significant operational and commercial progress, along with diligent management of our financial resources position Avid Bioservices well for transition to cash generation and positive EBITDA."

Recent Developments

Signed project expansion orders with current clients representing future revenue in the amount of $6.3 million during the second quarter.

Increased marketing and media activities during the quarter to enhance industry visibility. Received double the number of Requests for Proposal in Q2 2019 as compared to Q1 2019 and increased the number of proposals issued by 100% during the same period.

Sold remaining legacy R&D asset, r84, to Oncologie, Inc., for $1.0 million upfront. r84 is a pre-clinical novel therapeutic antibody asset targeting VEG-F that has demonstrated anti-tumor activity in animal models. Under the terms of the purchase and assignment agreement, Avid is eligible to receive up to an additional $21.0 million in development, regulatory and commercialization milestones, as well as low to mid-single digit royalties on net sales upon commercialization of products utilizing r84.

Continued progress with ongoing expansion and optimization of our process development capabilities and laboratory space, including:

Expanding the total available process development laboratory space to more than 6,000 square feet;

Upgrading the infrastructure and equipment within the existing process development laboratories;

Implementing new state-of-the-art technologies and equipment designed to facilitate efficient, high-throughput development of upstream and downstream manufacturing processes.

Successfully executed the most comprehensive sequential maintenance overhaul in the company’s history, to best serve our existing customers and entice new business.
Financial Highlights and Guidance

The company is reaffirming revenue guidance for the full FY 2019 of $51 million – $55 million.

The revenue backlog as of October 31, 2018 was $36 million, the majority of which we expect to recognize in FY 2019.

Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services was $10.2 million for the second quarter of FY 2019 compared to $12.8 million for the second quarter of FY 2018. The decline in the second quarter of FY 2019 was primarily due to decreased demand from our two lead customers as previously disclosed. In addition, our revenues were impacted by the scheduled facility maintenance and upgrade shutdown.

Gross margin for the second quarter was a positive 3%, a significant improvement compared to a gross margin of negative 27% during the prior year period. The increase in gross margin for the quarter was primarily attributed to our product mix resulting in improved overhead efficiencies.

Selling, general and administrative expenses for the second quarter of FY 2019 were $2.8 million, compared to $3.6 million for the second quarter of FY 2018. The decrease in the second quarter of FY 2019 was primarily due to reductions in facility costs and legal, accounting and other professional fees.

For the second quarter of FY 2019, the company recorded consolidated net loss attributable to common stockholders of $2.9 million, or $0.05 per share, compared to a consolidated net loss attributable to common stockholders of $14.1 million, or $0.31 per share, for the second quarter of FY 2018.

Avid reported $32.7 million in cash and cash equivalents as of October 31, 2018, compared to $42.3 million on April 30, 2018.
More detailed financial information and analysis may be found in Avid’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Conference Call

Avid will host a conference call and webcast this afternoon, December 10, 2018, at 4:30 PM EST (1:30 PM PST).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

On December 10, 2018 Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, and LG Chem Life Sciences, the life sciences division of the South Korean LG Group, reported a multi-target collaboration and development agreement (Press release, Avacta, DEC 10, 2018, View Source [SID1234531989]). The agreement provides LG Chem with the exclusive rights to develop and commercialize, on a worldwide basis, multiple Affimer therapeutics intended for treatment of patients in the fields of inflammatory disorders, and oncology. Under the terms of the agreement, Avacta will generate and carry out the discovery, optimization and protein engineering of Affimer drug candidates against a set of undisclosed targets. LG Chem and Avacta will collaborate to progress these candidates through to drug candidate selection and LG Chem will be responsible for preclinical and clinical development and world-wide marketing of any resulting products.

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Additionally, the agreement provides that Avacta and LG Chem will collaborate jointly in the development of two different Affimer PK/ADME modifiers – Affimers that can be fused to other therapeutic proteins to modify certain properties of those biological drug moieties such as serum half-life and tissue localization. Both parties will have the right to develop PK/ADME modified products, and by exercise of an option, to take exclusive responsibility for the development, manufacture and commercialization of those products.

This multi-target therapeutics development agreement provides upfront and near-term milestone payments, plus longer-term clinical development milestones. Avacta will also receive royalties on any future product sales and LG Chem will cover Avacta’s costs of research and development associated with the collaboration. Avacta may receive additional option fees and milestone payments should LG Chem elect to exercise their options for additional targets.

The Affimer technology is Avacta’s proprietary alternative to antibodies with wide applications in the life sciences for drug development, diagnostics and research tools. Avacta’s in-house therapeutic pipeline is focused on immuno-oncology and it expects to advance its lead programme, a PD-L1/LAG3 bispecific, into the clinic in 2020 whilst building out its pipeline of innovative Affimer drug candidates.

Alastair Smith, Chief Executive of Avacta Group, commented:
"I am delighted to be entering into this therapeutic development partnership with LG Chem which is a strong validation of the potential of the Affimer platform.

"This alliance is an exciting opportunity, not only to work with a partner who has first class biologics manufacturing and clinical development capabilities, but who also has a pioneering vision to develop innovative therapies.

"This landmark agreement with LG Chem reflects the substantial progress that we have made in developing the Affimer technology as a therapeutic platform and I look forward to updating the market on future progress and other partnerships."

Dr. Jeewoong Son, President of LG Chem Life Sciences, commented:
"We are very pleased to announce this collaboration with Avacta Group. Utilizing Avacta’s Affimer technology – a novel non-antibody protein format overcoming limitations of classical antibody-based therapy – and LG Chem’s biologics capability in development and manufacturing, it will take us to the next level of treatment paradigm and to open up a new horizon in biologics therapeutic strategies. I believe, this innovative collaboration will deliver value to patients and will transform patients’ lives"

On December 10, 2018 Biogen Inc. (Nasdaq:BIIB) reported it will report fourth quarter and year-end 2018 financial results Tuesday, January 29, 2019, before the financial markets open (Press release, Biogen, DEC 10, 2018, View Source [SID1234532005]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website

On December 10, 2018 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application, indicating that Sermonix may proceed directly to a Phase 2 clinical study in the personalized medicine arena involving its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, DEC 10, 2018, View Source [SID1234532259]).

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The open-label, randomized, multi-center study is expected to begin enrollment in early 2019 and will evaluate the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation.

"We are delighted the IND application was favorably reviewed by the FDA and brings us ever closer to delivering a novel endocrine treatment option for these women in great need," said Sermonix Chairman Dr. Anthony Wild. "This marks an important milestone in Sermonix’s effort to develop lasofoxifene as a precision medicine for women with advanced breast cancer."

A large amount of clinical data from earlier non-oncology development, along with new, compelling preclinical data have enabled Sermonix to commence directly into the Phase 2 study. The study will include postmenopausal women with ESR1 mutations, identified using a liquid biopsy clinical trial assay, who have progressed after aromatase inhibitor and CDK 4/6 inhibitor therapy. ESR1 mutations occur in up to 40 percent of women with metastatic breast cancer and may confer a worse prognosis and poor response to currently available endocrine treatments1.

"As ESR1 mutations are highly prevalent in ER+ metastatic breast cancer, we look forward to demonstrating lasofoxifene’s potential promise in this area of significant unmet medical need," said Dr. David Portman, Sermonix founder and chief executive officer. "Acceptance of the IND application allows us to maintain momentum in the important effort to bring lasofoxifene to patients who desperately need more options for this incurable disease, so we are thrilled to receive this news from the FDA."

1 Chandarlapaty S et al, JAMA oncology 2016 Oct 1;2(10):1310-1315)

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide.

Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.