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Sunesis Pharmaceuticals Reports Third Quarter 2019 Financial Results and Recent Highlights

On November 12, 2019 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the quarter ended September 30, 2019 (Press release, Sunesis, NOV 12, 2019, View Source [SID1234550972]). Loss from operations for the three and nine months ended September 30, 2019 was $6.0 million and $17.9 million. As of September 30, 2019, the Company had cash and cash equivalents, restricted cash and marketable securities of $38.3 million.

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"We continue to advance our Phase 1b/2 trial of vecabrutinib in patients with B-cell malignancies with the goal of identifying our recommended dose and studying vecabrutinib in defined patient populations in the Phase 2 portion of the study. We are currently in the 400mg cohort as the safety and pharmacokinetic data to date support continued dose escalation," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "As announced last week, we will be presenting a poster at the ASH (Free ASH Whitepaper) Annual Meeting in December that provides an update on the Phase 1b/2 trial of vecabrutinib, and we look forward to sharing the new findings. We also recently presented exciting preclinical pharmacology data for our first-in-class PDK1 inhibitor, SNS-510, at the AACR (Free AACR Whitepaper)-NCI-EORTC conference. The equity offering we completed in July strengthened our cash position and extends our runway through key milestones for the Company."

Recent Highlights

Announced Presentation at ASH (Free ASH Whitepaper) Annual Meeting. In November 2019, the Company announced that a presentation will be made at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 7-10, 2019 in Orlando, Florida. The abstract, titled "Ongoing Results of a Phase 1B/2 Dose-Escalation and Cohort-Expansion Study of the Selective, Noncovalent, Reversible Burton’s Tyrosine Kinase Inhibitor, Vecabrutinib, in B-Cell Malignancies" (Publication 3041), will be presented on Sunday, December 8, in a session titled "CLL: Therapy, excluding Transplantation: Poster II," from 6:00-8:00pm ET at the Orange County Convention Center, Hall B. The poster will be available on the Sunesis website following the presentation.

Presented Preclinical Data on SNS-510 at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). In October 2019,

Sunesis presented data profiling the oral PDK1 inhibitor SNS-510 showing potent activity in hematologic and solid tumor cancer models at the 2019 AACR (Free AACR Whitepaper)-NCI-EOTRC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, Massachusetts.

Hired Mehdi Paborji, PhD as VP Technical Operations; promoted Pietro Taverna, PhD to VP Translational Medicine & Nonclinical Development. Dr. Paborji has over 30 years of experience in the industry, including fifteen years at Bristol-Myers Squibb. More recently he served as Chief Operating Officer of Biotie Therapeutics through its sale to Acorda Therapeutics and was also the Founder and COO of Theravida. He has experience leading technical and clinical supply operations, and all aspects of manufacturing of drug substance and drug product. Dr. Paborji has a PhD. in Physical Organic and Bio-Organic Chemistry from the University of Kansas and postdoctoral training in Pharmaceutical Chemistry from the University of Kansas, the School of Pharmacy. Dr. Taverna has over 18 years of experience in the biopharmaceutical industry, exclusively in oncology pharmacology and translational medicine. He returned to Sunesis in 2017 as head of Translational Medicine after nine years at Astex (Otsuka) Pharmaceuticals leading translational medicine programs for their oncology portfolio. Prior to Astex, Dr. Taverna held senior/principal scientist positions at Sunesis and Chiron, overseeing and conducting pharmacology efforts for cancer drug candidates. He has numerous publications as well as presentations at international oncology meetings. Dr. Taverna has a Ph.D. in Pharmacological Research from M. Negri Institute for Pharmacological Research, Milano, Italy and did postdoctoral research at the Institute and at Case Western University.

Appointed Dr. Nicole Onetto to the Board of Directors. In September 2019, Sunesis appointed Dr. Nicole Onetto, M.D. to the Board of Directors, bringing to Sunesis 20 years of clinical development experience in oncology and hematology.

Completion of Public Offering. In July 2019, Sunesis completed underwritten public offerings of shares of its common stock and Series F convertible preferred stock with net proceeds of approximately $26.1 million. The offerings attracted participation from leading biotechnology investors, including existing and new investors.

Financial Highlights

Cash and cash equivalents, restricted cash, and marketable securities totaled $38.3 million as of September 30, 2019, compared to $13.7 million as of December 31, 2018. The increase of $24.6 million was primarily due to $45.1 million in net proceeds from issuance common and preferred stock, and $5.5 million in proceeds from the Silicon Valley Bank Loan Agreement, partially offset by $18.4 million in net cash used in operating activities and $7.5 million principal payment on the Bridge Bank / Solar Capital Loan Agreement and Amendments. This capital is expected to fund the Company through the identification of the Phase 2 dose and initiation of the Phase 2 portion of the ongoing trial.

Research and development expense was $3.5 million and $10.5 million for the three and nine months ended September 30, 2019, compared to $3.6 million and $11.3 million for the same periods in 2018. The decreases between the comparable three and nine month periods were primarily due to a decrease in salary and personnel expenses due to lower headcount and a decrease in clinical expense due to timing, offset by an increase in professional services related to the preparation for the Phase 2 portion of the ongoing clinical trial for vecabrutinib.

General and administrative expense was $2.5 million and $7.5 million for the three and nine months ended September 30, 2019, compared to $2.7 million and $8.9 million for the same periods in 2018. The decreases between the comparable periods were primarily due to a decrease in salary and personnel expenses due to lower headcount and stock-based compensation and a decrease in professional services expenses due to lower legal and vosaroxin patent expenses, offset by an increase in insurance premiums.

Interest expense was $0.1 million and $0.4 million for the three and nine months ended September 30, 2019, compared to $0.3 million and $0.9 million for the same periods in 2018. The decreases in interest expenses from both periods resulted from the lower interest rate paid on a lower principal amount under the SVB Loan Agreement.

Cash used in operating activities was $18.4 million for the nine months ended September 30, 2019, compared to $17.9 million for the same period in 2018. Net cash used in the nine months ended September 30, 2019 resulted primarily from the net loss of $18.0 million and changes in operating assets and liabilities of $1.8 million, offset by adjustments for non-cash items of $1.4 million. Net cash used in 2018 period resulted primarily from the net loss of $20.6 million, partially offset by adjustments for non-cash items of $2.3 million and changes in operating assets and liabilities of $0.4 million.

Sunesis reported loss from operations of $6.0 million and $17.9 million for the three and nine months ended September 30, 2019, compared to $6.3 million and $20.0 million for the same periods in 2018. Net loss was $5.9 million and $18.0 million for the three and nine months ended September 30, 2019, compared to $6.5 million and $20.6 million for the same periods in 2018.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (International) and entering passcode 4059849. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

Replimune Announces Proposed Public Offering

On November 12, 2019 Replimune Group, Inc. (Nasdaq: REPL), a biotechnology company developing oncolytic immuno-gene therapies derived from its Immulytic platform, reported a proposed public offering of up to 5,000,000 shares of its common stock (Press release, Replimune, NOV 12, 2019, View Source [SID1234550971]). All shares in the offering will be offered by Replimune . In addition, Replimune intends to grant the underwriters a 30-day option to purchase up to an additional 750,000 shares of its common stock from Replimune on the same terms and conditions.

J.P. Morgan Securities LLC, SVB Leerink LLC, and BMO Capital Markets Corp. are acting as book-running managers for the proposed offering. The offering is subject to market and other customary closing conditions, and Replimune cannot assure you as to whether or when the offering may be completed.

This proposed offering will be made only by means of a preliminary prospectus supplement and the accompanying prospectus. A copy of the preliminary prospectus supplement relating to this offering will be filed with the Securities and Exchange Commission (the "SEC") and may be obtained, when available, by visiting EDGAR on the SEC website at www.sec.gov or from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by e-mail at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by e-mail at [email protected]; or BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by e-mail at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

The shares of common stock described above are being offered by Replimune pursuant to its shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Replimune with the SEC on August 8, 2019 and declared effective by the SEC on August 15, 2019. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Omeros Corporation Reports Third Quarter 2019 Financial Results

On November 12, 2019 Omeros Corporation (Nasdaq: OMER), a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers, reported recent highlights and developments as well as financial results for the third quarter ended September 30, 2019 (Press release, Omeros, NOV 12, 2019, View Source [SID1234550970]).

Third Quarter 2019 Financial Highlights

3Q 2019 revenues were $29.9 million, another quarter of record sales of OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%. This compares to $26.8 million in 2Q 2019, an increase of $3.1 million, or 12 percent.

Net loss in 3Q 2019 was $16.5 million, or $0.33 per share. This compares to a net loss $14.5 million, or $0.29 per share, in 2Q 2019. Net loss in each period included non-cash expenses of $6.3 million, or $0.13 per share.

At September 30, 2019, Omeros had cash, cash equivalents and short-term investments available for operations of $27.3 million, a decrease of $4.5 million from June 30, 2019. Accounts receivable at September 30, 2019 were $29.9 million.

Omeros has a $50-million revolving line of credit facility with Silicon Valley Bank. The line of credit provides for borrowing availability of up to the lesser of $50 million and 85 percent of eligible accounts receivable, subject to applicable reserves. As of September 30, 2019 there were no borrowings outstanding.

Recent Business Highlights

Submitted to the U.S. Food and Drug Administration (FDA) the nonclinical sections of the Biologics License Application (BLA) for narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).

Received from the Pediatric Committee of the European Medicines Agency (EMA) a positive opinion on the pediatric investigation plan for narsoplimab in the treatment of HSCT-TMA.

Reported positive results from a Phase 1 study of the lead compound in Omeros’ OMS527 program focused on development of phosphodiesterase 7 (PDE7) inhibitors for the treatment of addiction and compulsive disorders. In the double blind, randomized Phase 1 study, the study drug, referred to as OMS182399, met the primary endpoints of safety and tolerability and showed a favorable pharmacokinetic profile supporting once-daily dosing.

Presented data on a series of discoveries showing that GPR174, a member of the family of G protein-coupled receptors (GPCRs), controls a new axis in cancer immunity. In addition to demonstrating the potential of GPR174 as a standalone anti-cancer agent, these data show that the combined inhibition of both GPR174 and the adenosine pathway synergistically enhances T-cell response. This synergistically enhanced T-cell response could significantly improve the effectiveness of checkpoint inhibitors and other anti-cancer drugs.

Scientists from Omeros along with academic collaborators from the University of Toronto were awarded the Prix Galien Canada Research Award for 2019 in recognition of their development of the drug discovery technologies underlying Omeros’ GPCR platform. The Prix Galien is the most prestigious award in the field of Canadian pharmaceutical research and innovation and recognizes the research team judged to have made the most significant contribution.

"Initiating submission of our rolling BLA for narsoplimab in stem cell transplant-associated TMA is a significant milestone on our path to becoming a multi-product commercial biopharmaceutical company and, more importantly, is a major advance in our mission to treat these patients," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "We are on track to complete submission of our BLA in the first half of 2020 and preparations for the anticipated commercial launch of narsoplimab are also progressing. We continue to grow utilization of OMIDRIA, delivering record quarterly sales in Q3 and projecting a new all-time high in the fourth quarter. The remainder of our pipeline assets are also progressing – OMS527 has successfully completed its Phase 1 trial in our addiction program, our MASP-3 inhibitor OMS906 is on track to enter the clinic in the first half of next year, and our GPR174 immuno-oncology program continues to generate exciting new in vivo data, which will be presented for the first time later this month at the AACR (Free AACR Whitepaper) conference in Boston."

Other Business Updates and Developments

Recent developments regarding OMIDRIA include the following:

The new product-specific permanent J-code for OMIDRIA became effective October 1, 2019. J-codes standardize the submission and payment of insurance claims across Medicare, Medicare Advantage, Medicaid and commercial insurance plans. The J-code has been broadly uploaded to Medicare and commercial payer systems nationwide and is expected to expand reimbursement to commercial, Medicare Advantage and Medicaid insurers that would not reimburse for OMIDRIA under the prior C-code and to enable access to the increasing number of cataract procedures performed in the physician office setting.

In October, a manuscript authored by Keith Walter, M.D. of Wake Forest University, was accepted for publication in the peer-reviewed Journal of Cataract and Refractive Surgery. Dr. Walter’s study consisted of a retrospective analysis of 504 eyes (357 patients) on whom he had performed cataract surgery using OMIDRIA plus only a topical non-steroidal anti-inflammatory drug (NSAID), assessing the incidence of CME. The control group consisted of a collection of single and meta-analytic studies published in the peer-reviewed literature in which steroids, with and without topical NSAIDs, were used in cataract surgery in the absence of OMIDRIA. Of the 504 eyes treated with OMIDRIA, only two developed postoperative CME, an incidence of 0.39 percent, which is 3- to 12-fold lower than the CME rates in the published peer-reviewed studies.

On November 1, 2019, the Centers for Medicare and Medicaid Services (CMS) issued the 2020 final rule for its outpatient prospective payment system (OPPS). CMS had described criteria that must be met in order for products to be eligible for separate payment under legislation requiring CMS to review its OPPS payments with a goal of ensuring that there are not financial incentives to use opioids for pain management instead of non-opioid alternatives. Although Omeros submitted to CMS data for OMIDRIA that meet the criteria, CMS declined in its 2020 final rule to grant separate payment for OMIDRIA beyond the expiration of its current pass through status on September 30, 2020. CMS indicated it would continue to analyze evidence and monitor utilization of OMIDRIA and Omeros intends to continue its administrative and legislative efforts to secure ongoing separate payment for OMIDRIA.

On November 4, 2019 the results of an independent investigator study of the effect of OMIDRIA use on the utilization of fentanyl, an opioid, in cataract surgery were published in the peer-reviewed journal Clinical Ophthalmology. The article, The Effect of Phenylephrine/Ketorolac Intracameral Solution 1%/0.3% on Pain and Opioid Use During Cataract Surgery, is authored by the study investigator Eric D. Donnenfeld, M.D., Clinical Professor of Ophthalmology at New York University and recent past president of the American Society of Cataract and Refractive Surgery. The prospective, controlled study showed that use of OMIDRIA in cataract surgery had a direct, clinically meaningful and statistically significant effect on reduction in fentanyl use (77% reduction, p = 0.006) while reducing visual analog scale (VAS) pain scores by approximately 50 percent (p < 0.0001).

Recent developments regarding narsoplimab, Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2) in Phase 3 clinical programs for the treatment of HSCT-TMA, Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic syndrome (aHUS), include the following:

In October, Omeros submitted to FDA the nonclinical (i.e., pharmacology, pharmacokinetics and toxicology) data, study reports, overview and summary sections of its rolling BLA for narsoplimab to treat HSCT-TMA. Once all clinical data collection, dataset compilation and data analyses are complete, the clinical sections of the BLA

will be submitted, followed by the quality (i.e., chemistry, manufacturing and controls) sections. Submission of the clinical and quality sections remains on track for scheduled completion in the first half of next year.

The Pediatric Committee of the EMA issued a positive opinion for Omeros’ pediatric investigation plan (PIP) for narsoplimab in the treatment of HSCT-TMA. Agreement with the pediatric committee on a PIP outlining a development program for the investigational product in the pediatric population is a prerequisite to EMA’s acceptance of a Marketing Authorization Application (MAA) for the product. Omeros received a deferral for completion of its pediatric plan until after EMA approval of the MAA planned for submission to EMA for narsoplimab in the treatment of HSCT-TMA. With successful completion of the PIP, narsoplimab would be eligible for up to an additional two years of marketing exclusivity.

Omeros’ Phase 3 trial evaluating narsoplimab for IgA nephropathy, referred to as ARTEMIS-IGAN, continues enrollment at an increasing number of sites in the U.S. and internationally.

A manuscript prepared by Omeros’ Academic Leadership Committee detailing the clinical data from the Phase 2 IgA nephropathy program is expected to be published in a peer-reviewed journal. In addition, a report detailing the response to narsoplimab treatment by a patient with IgA vasculitis-associated nephritis and rapidly progressive glomerulonephritis has been submitted for publication.

Updates regarding Omeros’ other development programs and platforms include the following:

IND-enabling toxicology studies have begun for OMS906, Omeros’ MASP-3 inhibitor, in advance of clinical entry slated for the first half of next year. Targeting subcutaneous dosing of twice-monthly or less frequently, this program is initially targeting paroxysmal nocturnal hemoglobinuria.

Omeros continues life-cycle management within its MASP-2 program. These efforts are directed to development of a longer-acting second-generation antibody against MASP-2 as well as an orally available small-molecule inhibitor of MASP-2, both targeted for clinical entry in 2021.

A presentation entitled "Phosphatidylserine suppresses T cells through GPR174, and co-inhibition of adenosine receptors and GPR174 synergistically enhances T cell responses" will be made at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference on Tumor Immunology and Immunotherapy to be held in Boston, November 17-20, 2019. It will include additional animal data that validate GPR174 inhibition for cancer immunotherapy. The company’s GPR174 program has also been selected for participation in the 2019 Immuno-Oncology Congress of the European Society for Medical Oncology to be held in Geneva, December 11-14, 2019.

Financial Results

3Q 2019 revenues, all related to sales of OMIDRIA, were $29.9 million, a new record high. On a sequential quarter-over-quarter basis, OMIDRIA revenues increased by $3.1 million, or 12 percent, from the $26.8 million achieved in 2Q 2019. The increase is due to a growing number of purchasing accounts as well as deeper penetration within accounts across hospitals, ASCs, Veterans Administration and other government payers.

Gross-to-net deductions in 3Q 2019 remained consistent with those in 2Q 2019 at 28 percent

3Q 2019 costs and expenses were $41.0 million compared to $36.1 million for Q2 2019. The increase reflected incremental narsoplimab manufacturing costs associated with the commencement of full-scale drug substance manufacturing in 3Q 2019 together with increased manufacturing scale-up costs in our OMS906 program in advance of planned clinical entry next year. Selling, general and administrative expenses were $16.9 million for both 2Q and 3Q 2019.

For 3Q 2019, Omeros reported a net loss of $16.5 million, or $0.33 per share, compared to a net loss of $14.5 million, or $0.29 per share, in 2Q 2019. Net loss in both 2Q 2019 and 3Q 2019 included non-cash expenses of $6.3 million ($0.13 per share).

As of September 30, 2019, Omeros had $27.3 million of cash, cash equivalents and short-term investments available for operations, a decrease of $4.5 million from June 30, 2019. Accounts receivable at September 30, 2019 were $29.9 million.

Conference Call Details

Omeros’ management will host a conference call to discuss the financial results and to provide an update on business activities. The call will be held today at 1:30 p.m. Pacific Time; 4:30 p.m. Eastern Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 9699377. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9699377.

To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select "Events" under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

Atreca Reports Third Quarter 2019 Financial Results and Recent Corporate Developments

On November 12, 2019 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported financial results for the third quarter ended September 30, 2019, and provided an overview of recent developments (Press release, Atreca, NOV 12, 2019, View Source [SID1234550969]).

"We continued to make strong progress this quarter with our Investigational New Drug (IND) application for our lead product candidate, ATRC-101 and expect to initiate a Phase 1b clinical trial in patients with solid tumors early next year," said John Orwin, Chief Executive Officer. "To highlight our progress we recently presented a poster at the annual SITC (Free SITC Whitepaper) meeting describing the discovery and preclinical evaluation of ATRC-101, underscoring both our ability to leverage the human immune response to find novel antibody-target pairs, as well as the potential of ATRC-101 to become an important treatment option for patients with a variety of solid tumor cancers."

Recent Developments and Highlights

Atreca presented a poster describing the preclinical evaluation of ATRC-101 at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019). The poster included preclinical data highlighting ATRC-101’s robust and persistent anti-tumor activity as both monotherapy and in combination with PD-1 checkpoint inhibitors.

In August 2019, Atreca appointed Lindsey Rolfe, BSc, MB ChB, MRCP, FFPM, to the company’s Board of Directors, who brings more than 20 years of drug development experience to the company.
In August 2019, the period for centralized opposition of patent rights at the European Patent Office (EPO) ended with respect to European Patent EP2702146B1, entitled "Identification of Polynucleotides Associated with a Sample", which was granted by the EPO in November 2018. This patent is part of the portfolio of patents and patent applications exclusively licensed by the Board of Trustees of the Leland Stanford Junior University to Atreca that relates to Atreca’s proprietary Immune Repertoire Capture technology.
Upcoming Milestones

Atreca anticipates completion of the IND process with the U.S. Food and Drug Administration for ATRC-101 by late 2019 and expects to initiate a Phase 1b clinical trial in patients with solid tumors in early 2020.
Third Quarter 2019 Financial Results

As of September 30, 2019, cash and cash equivalents and short-term investments totaled $201.0 million.

Research and development expenses for the three months ended September 30, 2019 were $12.8 million, including non-cash share-based compensation expense of $920,000.

General and administrative expenses for the three months ended September 30, 2019 were $4.9 million, including non-cash share-based compensation expense of $958,000.

Atreca reported a net loss of $15.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.57, for the three months ended September 30, 2019.

Cue Biopharma Reports Third Quarter 2019 Financial Results and Recent Business Highlights

On November 12, 2019 Cue Biopharma, Inc. (NASDAQ: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body, reported a business update for the third quarter 2019 (Press release, Cue Biopharma, NOV 12, 2019, View Source [SID1234550968]).

"The third quarter was marked by the dosing of the first patient in our Phase 1 clinical study of CUE-101, which represents a transformative milestone for the company as we continue to grow and develop as a clinical stage company," said Daniel Passeri, chief executive officer. "As part of this continued evolution, the promotion of Dr. Suri to President and CSO helps enhance our productivity and effectiveness by further integrating operational functions and fostering close coordination of preclinical translational studies with clinical development."

Dr. Suri stated, "We have made significant progress on several key programs in addition to CUE-101, including CUE-102, a program selected with our collaboration partner, LG Chem Life Sciences, as well as our early-stage program in auto-immune disease, through our collaboration with Merck. With our first immuno-oncology candidate now in the clinic and additional candidates in lead optimization, Cue Biopharma is well positioned for the potential of significant value inflection over the coming months."