On November 8, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported its financial and operational results for the third quarter ended September 30, 2018 (Press release, Sierra Oncology, NOV 8, 2018, View Source [SID1234531378]).

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"During the third quarter, we fundamentally transformed Sierra with the addition of momelotinib to our portfolio, a differentiated, demonstrably active and well-tolerated Phase 3 drug candidate for the treatment of myelofibrosis. We are currently preparing for discussions with regulators to determine the registration path for momelotinib and anticipate reporting next steps in the first half of 2019. Our anticipated registration strategy envisions a single Phase 3 trial in second line myelofibrosis patients, a population for which no approved therapies currently exist, to recapitulate the meaningful clinical benefits observed in the two previously completed SIMPLIFY Phase 3 trials, with a particular emphasis on reinforcing momelotinib’s differentiated anemia benefits," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We also continue to advance our DNA Damage Response (DDR) drug candidates, SRA737 and SRA141. During the quarter, we made substantial progress enrolling genetically-selected patients into the indication specific cohorts of our two SRA737 trials, with a focus on recruiting patients with High Grade Serous Ovarian Cancer (HGSOC). We plan to report preliminary efficacy results from these trials in the first half of 2019. We also prepared for the initiation of a trial of SRA737 in combination with a PARP inhibitor in prostate cancer and for our first clinical trial with SRA141 for the treatment of colorectal cancer. We are currently evaluating the optimal timing of these trials within the context of our recently expanded portfolio."

Highlights for the Third Quarter of 2018:

Acquired momelotinib, a potent, selective and orally-bioavailable JAK1, JAK2 and ACVR1 inhibitor with a differentiated therapeutic profile in myelofibrosis.
Continued to enroll patients in the monotherapy trial for SRA737, our potent, highly selective, orally bioavailable small molecule inhibitor of Chk1. The trial is enrolling patients across five indications with a primary focus on HGSOC. Preliminary data from this trial are anticipated to be reported in the first half of 2019.
Continued to enroll patients in the combination trial of SRA737 potentiated by low dose gemcitabine, which is enrolling patients across four indications, including into a prioritized cohort of patients with HGSOC. Preliminary data from this trial are anticipated to be reported in the first half of 2019.
Prepared for the planned initiation of a Phase 1b/2 trial of SRA737 with the PARP inhibitor niraparib, which will evaluate this combination in subjects with metastatic castration-resistant prostate cancer (mCRPC).
Successfully completed the Investigational New Drug Application (IND) filing process with the U.S. Food and Drug Administration (FDA) for SRA141, our potent, highly selective, orally bioavailable small molecule inhibitor of Cdc7. The company plans to conduct a Phase 1/2 trial of the drug candidate in patients with colorectal cancer.
Third Quarter 2018 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $12.9 million for the three months ended September 30, 2018, compared to $7.4 million for the three months ended September 30, 2017. The increase was primarily due to a $3.0 million upfront fee paid to Gilead for the acquisition of our lead product candidate, momelotinib, an increase of $2.0 million in clinical trial costs and a $0.7 million increase in personnel-related and overhead costs, partially offset by a decrease of $0.2 million in research and preclinical costs related to SRA737 and SRA141. Research and development expenses included non-cash stock-based compensation of $1.2 million and $1.0 million for the three months ended September 30, 2018 and 2017, respectively.

Research and development expenses were $30.0 million for the nine months ended September 30, 2018, compared to $22.6 million for the nine months ended September 30, 2017. The increase was primarily due to a $3.0 million upfront fee paid to Gilead for the acquisition of our lead product candidate momelotinib, an increase of $5.4 million in clinical trial costs and a $1.4 million increase in personnel-related costs, partially offset by decreases of $1.5 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.9 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $3.3 million and $3.0 million for the nine months ended September 30, 2018 and 2017, respectively.

General and administrative expenses were $3.1 million for the three months ended September 30, 2018, compared to $2.8 million for the three months ended September 30, 2017. This increase was primarily due to increases in personnel-related costs, professional fees and allocated overhead. General and administrative expenses included non-cash stock-based compensation of $0.7 million and $0.5 million for the three months ended September 30, 2018 and 2017, respectively.

General and administrative expenses were $10.7 million for the nine months ended September 30, 2018, compared to $9.2 million for the nine months ended September 30, 2017. This increase was primarily due to a $1.3 million increase in personnel-related costs, professional fees and allocated overhead and a $0.2 million increase in business development costs. General and administrative expenses included non-cash stock-based compensation of $1.8 million and $1.5 million for the nine months ended September 30, 2018 and 2017, respectively.

For the three months ended September 30, 2018, Sierra incurred a net loss of $15.6 million compared to a net loss of $10.0 million for the three months ended September 30, 2017. For the nine months ended September 30, 2018, Sierra incurred a net loss of $39.1 million compared to a net loss of $31.4 million for the nine months ended September 30, 2017.

Cash and cash equivalents totaled $116.1 million as of September 30, 2018, compared to $100.3 million as of December 31, 2017. At September 30, 2018, there were 74,364,165 shares of common stock issued and outstanding, with another 10,793,266 issuable upon exercise of stock options and warrants, and a term loan of $4.9 million.

Equity Inducement Plan
On November 5, 2018, the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 30,000 shares of its common stock to two new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity award to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

The options have an exercise price of $1.73 per share, which is equal to the closing price of Sierra’s common stock on the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant

On November 8, 2018 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported financial results for the third quarter ended September 30, 2018 and provided a summary of recent events (Press release, Regulus, NOV 8, 2018, View Source [SID1234531200]).

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Third Quarter 2018 Corporate Highlights and Recent Updates

Amended and restructured its Collaboration and License Agreement with Sanofi: In November, Regulus and Sanofi agreed to restructure their Collaboration and License Agreement and immediately transfer development responsibilities of RG-012 for the treatment of Alport syndrome to Sanofi. Sanofi will assume all future costs and development activities associated with the advancement of RG-012, currently in Phase 2 for the treatment of Alport syndrome. Under the terms of the Amendment, Regulus is eligible to receive approximately $7 million in upfront and material transfer payments. Regulus is also eligible to receive up to $40 million in development milestone payments, including a $10 million payment for an interim enrollment milestone. In addition, Sanofi will reimburse Regulus for certain out-of-pocket expenses associated with transition activities and assume Regulus’ upstream license royalty obligations.

Initiated new chronic mouse toxicity study for RGLS4326; data anticipated in Q1 2019: In September 2018, and in consultation with the FDA, the Company initiated a new 27-week chronic mouse toxicity study for RGLS4326 for the treatment of autosomal dominant polycystic kidney disease (ADPKD), incorporating several changes believed to address the unexpected findings in the earlier terminated chronic mouse toxicity study. This study is ongoing, and data are anticipated in Q1 2019. The Company anticipates the advancement of the RGLS4326 clinical program upon successful resolution of the unexpected findings.

Completed reverse stock split and regained compliance with NASDAQ listing requirements: In a special meeting of stockholders, held September 28, 2018, stockholders voted to approve a proposal authorizing the Board of Directors of the Company to amend the Company’s certificate of incorporation to affect a reverse stock split of Regulus’ outstanding common shares. Following the special meeting of stockholders, the Board of Directors approved a 1-for-12 reverse stock split. The Company’s shares began trading on a split-adjusted basis on October 4, 2018. On October 18, 2018, The Nasdaq Stock Market notified Regulus that it had regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market.

"The recently announced Sanofi restructuring represents a significant achievement for Regulus, bringing non-dilutive capital and eliminating future spend for this partnered program. Importantly, we are eligible to receive approximately $17 million in upfront and milestone payments anticipated over the next twelve months," said Jay Hagan, President and Chief Executive Officer of Regulus. "In July, we established several near-term key objectives, including reducing our cash burn, restructuring the Sanofi collaboration, advancing our prioritized pipeline, including ADPKD, and positioning other programs for business development opportunities. Regulus has made significant progress towards completing all of these objectives, and we look forward to the continued advancement of our ADPKD and HBV programs."

Program Updates

Presented preclinical data supporting RGLS4326 as a novel therapeutic for the treatment of ADPKD at the American Society of Nephrology’s Kidney Week 2018: In October 2018, Regulus presented three posters during the American Society of Nephrology’s Kidney Week describing the discovery and preclinical evaluation of RGLS4326, a novel single-stranded, chemically-modified oligonucleotide designed to preferentially target the kidney and inhibit miR-17 functions to treat ADPKD. In preclinical studies, RGLS4326 inhibited miR-17 activity and reduced cyst formation and proliferation of primary cyst cultures derived from human donors with ADPKD. The data presented also demonstrated that RGLS4326 has favorable pharmacokinetic and pharmacodynamic profiles in normal and polycystic kidney disease (PKD) mouse models, where preferential distribution to kidney and localization to collecting duct cysts were evident. Furthermore, data demonstrated that RGLS4326 directly modulates expression of genes implicated in ADPKD pathogenesis including Pkd1 and Pkd2, and conferred efficacy in multiple PKD mouse models following subcutaneous administration.

Advancement of Hepatitis B virus (HBV) Programs: The Company has identified multiple human microRNA targets that serve as host factors for the virus. Compounds directed at modulating these targets are under active in vitro and in vivo preclinical investigation. The Company believes that targeting a host factor in the liver represents a unique mechanism of action for treatment of the virus compared to other programs in development and holds the potential for achieving a functional cure. The Company currently expects to file an IND for the HBV program in the second half of 2019, with the potential of achieving human proof-of-concept in a Phase 1 study.

Additional Program Updates: In September 2018, the Company announced progress of its glioblastoma multiforme (GBM) and non-alcoholic steatohepatitis (NASH) preclinical programs. The Company’s GBM program, targeting microRNA-10b, demonstrated statistically significant improvements in survival as both a monotherapy as well as in combination with temozolomide (TMZ) in an orthotopic GBM animal model. The Company’s lead NASH candidate demonstrated improvement in key endpoints, including NAFLD Activity Score (NAS), liver transaminases, hyperglycemia, and disease-related gene expression. In the diet-induced NASH mouse model (Amylin model) after 2-4 weekly doses, early onset of improvement across multiple disease parameters including liver triglycerides and blood levels of transaminases was observed. The Company plans to seek partners to further advance these programs’ development.

Third Quarter 2018 Financial Results

Cash Position: As of September 30, 2018, Regulus had $20.5 million in cash, cash equivalents and short-term investments. Under the terms of the Sanofi Amendment, Regulus is eligible to receive approximately $7 million in upfront and material transfer payments. Including these additional proceeds, the Company expects its cash runway to extend through Q2 2019.

Research and Development (R&D) Expenses: R&D expenses were $6.9 million and $28.7 million for the three and nine months ended September 30, 2018, respectively, compared to $12.7 million and $42.7 million for the same periods in 2017. The decreases were primarily attributable to the pausing of the RG-012 and RGLS4326 programs early in the third quarter of 2018, the discontinuation of the RG-101 and RGLS5040 programs in 2017 and reductions in personnel-related expenses primarily attributable to our corporate restructurings.

General and Administrative (G&A) Expenses: G&A expenses were $3.0 million and $10.1 million for the three and nine months ended September 30, 2018, respectively, compared to $2.7 million and $13.8 million for the same periods in 2017. The increase for the three months ended September 30, 2018 as compared to the three months ended September 30, 2017 was driven by non-recurring severance charges recorded in the third quarter of 2018 in connection with our July 2018 corporate restructuring. The decrease for the nine months ended September 30, 2018 as compared to the nine months ended September 30, 2017 was driven by non-recurring severance charges and non-recurring, non-cash stock-based compensation charges recorded in connection with our May 2017 corporate restructuring.

Revenue: Revenue was less than $0.1 million for each of the three and nine months ended September 30, 2018 and 2017.

Net Loss: Net loss was $10.3 million, or $1.18 per share (basic and diluted), and $40.1 million, or $4.62 per share (basic and diluted), for the three and nine months ended September 30, 2018, respectively, compared to $15.8 million, or $2.11 per share (basic and diluted), and $57.5 million, or $10.52 per share (basic and diluted), for the same periods in 2017. Historical and current period net loss per share values have been retroactively adjusted to reflect our October 2018 reverse stock split.

Upcoming Events

On November 14, 2018, Regulus will present survival data on its lead anti-miR candidate targeting microRNA-10b for glioblastoma multiforme at the Society for Neuro-Oncology Meeting in New Orleans, Louisiana.

On November 14, 2018, Regulus will present a corporate overview at the Stifel 2018 Healthcare Conference in New York.

On November 8, 2018 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its first quarter ended September 30, 2018 (Press release, MEI Pharma, NOV 8, 2018, View Source [SID1234531199]).

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"Fiscal 2019 is off to a strong start both financially and strategically, with more than $90 million in cash and investments on our balance sheet at the start of the quarter, $10 million additional cash due under the recently executed Japan licensing agreement with Kyowa Hakko Kirin, a new clinical collaboration with BeiGene, and progress in preparations to start the ME-401 Phase 2 study around year-end," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "With the planned start of the ME-401 Phase 2 study, we will have two ongoing clinical trials with the potential to support FDA marketing approval."

Dr. Gold continued: "We are also excited by our continued progress in the other programs across our pipeline, including interim data from the Phase 2 study of pracinostat in MDS, the evaluation of our CDK9 inhibitor, voruciclib, in B-cell malignancies and data from the investigator-initiated study of ME-344 in breast cancer."

Recent Program Highlights and Upcoming Milestones

Upcoming Milestones

MEI will present data from three clinical stage drug development programs at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 1-4, 2018 in San Diego:
Updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma (FL) and other indolent B-cell malignancies.
Data from an interim analysis of pracinostat in an ongoing Phase 2 study evaluating patients with high/very high-risk myelodysplastic syndrome (MDS).
Results from a preclinical study demonstrating that voruciclib and venetoclax synergistically induce apoptosis in acute myeloid leukemia (AML) cells in vitro.
MEI plans to initiate the Phase 2 study to support accelerated approval of ME-401 in relapsed or refractory FL around year-end of calendar 2018.
MEI expects to report updates regarding the ongoing voruciclib Phase 1 study at medical meetings in 2019.
MEI expects to report additional data from the investigator-sponsored Phase 1 study evaluating ME-344 at medical meetings in 2019.
Clinical Development Highlights

In October 2018, MEI announced a clinical collaboration to evaluate the safety and efficacy of MEI’s ME-401, an investigational phosphatidylinositol 3-kinase (PI3K) delta inhibitor, in combination with BeiGene’s zanubrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with B-cell malignancies.
In July 2018, the Company discussed with FDA a ME-401 monotherapy accelerated approval strategy in patients with relapsed or refractory FL. Informed by the discussions with the FDA, the Company is advancing ME-401 into a Phase 2, single-agent study for the treatment of adults with relapsed or refractory FL. The Phase 2 study is intended to support accelerated approval and is planned to begin around the end of 2018. Accelerated approval of ME-401 will be subject to FDA review of the improvement provided by ME-401 over other therapies available at the time of the regulatory action.
Corporate Highlights

In November 2018, MEI announced the execution of a license development and commercialization agreement granting Kyowa Hakko Kirin exclusive rights to develop and commercialize ME-401 in Japan. Under the terms of the agreement, MEI will receive a $10.0 million upfront payment and is eligible to receive up to $87.5M in additional development and commercialization milestones, and royalties on sales.
In July 2018, the Company announced that David M. Urso, J.D., senior vice president of corporate development and general counsel, was promoted to chief operating officer. Mr. Urso is also continuing as the Company’s general counsel and head of corporate development.
Financial Highlights

As of September 30, 2018, MEI had $90.8 million in cash, cash equivalents and short-term investments, with no outstanding debt. Additionally, a $10 million upfront payment is due under the Japan license agreement executed with Kyowa Hakko Kirin.
Research and development expenses were $6.1 million for the quarter ended September 30, 2018, compared to $6.1 million for the same period in 2017. Research and development expenses reflect increased costs for the development of ME-401, offset by a reduction in expenses related to voruciclib, as the prior year amounts included acquisition costs for voruciclib.
General and administrative expenses were $3.4 million for the quarter ended September 30, 2018, compared to $2.5 million for the same period in 2017. The increase primarily relates to professional services expenses, share-based compensation, and general corporate expenses.
The Company recognized revenues of $0.5 million for the quarter ended September 30, 2018, compared to $0.3 million for the same period in 2017. The increase is related to higher levels of research and development activities performed pursuant to the Helsinn license agreement.
Net loss for the quarter ended September 30, 2018, was $14.5 million, or $0.21 per share compared $8.8 million, or $0.24 per share for the same period in 2017. The Company had 71,115,444 shares of common stock outstanding as of September 30, 2018, compared with 36,950,177 shares as of September 30, 2017.
The adjusted net loss, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure) for the quarter ended September 30, 2018, was $9.6 million, or $0.14 per share.
Cash expenditures for operating activities were $12.8 million for the quarter ended September 30, 2018, compared to $6.6 million for 2017. The increase in cash used for the three months ended September 30, 2018 primarily relates to changes in working capital associated with our clinical development programs, including start-up costs related to the ME-401 Phase 2 accelerated approval study.

On November 8, 2018 AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, reported financial results for the third quarter ended September 30, 2018 (Press release, AmpliPhi Biosciences, NOV 8, 2018, View Source [SID1234531191]). AmpliPhi Biosciences will not be conducting a conference call in conjunction with this financial release.

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"We made significant progress in the third quarter of 2018. We announced an updated set of positive outcomes from our ongoing expanded access program for seriously ill patients, who suffer from resistant bacterial infections. Additionally, we received agreement from the FDA to proceed to randomized clinical trials for our lead product candidates, AB-SA01 and AB-PA01," said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. "AmpliPhi now intends to initiate one of the FDA agreed clinical trials for AB-SA01 in 2019, the bacteremia trial, and also to seek non-dilutive financing for our AB-PA01 program."

Recent Business Highlights

Announced in September 2018 that 84% of patients achieved treatment success at the end of therapy for the company’s expanded access program. Twenty-one patients at 7 hospitals, with serious or life-threatening infections not responding to antibiotics, were treated with AB-SA01 or AB-PA01. Over 1,000 doses of AmpliPhi’s bacteriophage product candidates have now been administered as part of the program since mid-2017. Treatment was generally well tolerated, with no treatment-related serious adverse events.
Received positive U.S. Food and Drug Administration (FDA) feedback for AB-SA01 in September 2018, following a Type B pre-IND meeting. AmpliPhi announced that the FDA is in general agreement with the design of two proposed randomized clinical trials of AB-SA01, for S. aureus bacteremia and prosthetic joint infections, and that no additional preclinical or clinical data are required to proceed with both trials. In addition, AmpliPhi continues to investigate if AB-SA01 may be eligible for approval under the limited population pathway for antibacterial and antifungal drugs (LPAD) which is intended to facilitate development of therapeutics to treat serious or life-threatening infections in a limited population of patients with unmet need.
Received positive feedback from the FDA for AB-PA01 in September 2018. The company announced that the FDA is in general agreement with the design of two proposed randomized clinical trials of AB-PA01, hospital-acquired and ventilator-associated pneumonia (HAP/VAP) due to P. aeruginosa and for P. aeruginosa bacteremia, and no additional preclinical or clinical data are required to proceed. AmpliPhi intends to seek non-dilutive financing and explore other opportunities to conduct these clinical trials.
Presented clinical case data from the expanded access program at the ID Week 2018 Conference in October 2018. Thirteen patients with serious and life-threatening S. aureus infections were treated with AB-SA01 at the Westmead Hospital in Sydney. 83% (10 out of 12) patients in the modified intent-to-treat (mITT) population achieved treatment success at the end of therapy as reported by treating physicians. Bacteriophage treatment was well tolerated, with no adverse events attributable to the therapy.
Completed an underwritten public offering in October 2018 that raised gross proceeds of $6.8 million, before deducting underwriting discounts and commissions and other offering expenses. AmpliPhi anticipates using the net proceeds from the offering for general corporate purposes, including manufacturing, research and development and general and administrative expenses.
Third Quarter and Nine Months Ended September 30, 2018 Financial Results

Research and development (R&D) expenses for the third quarter of 2018 were $0.4 million compared to an $0.8 million benefit for the third quarter of 2017. The change was primarily attributable to a $1.2 million tax incentive payment received in July 2018 from the Australian tax authority, compared to a $2.0 million tax incentive payment from the Australian tax authority received in the same quarter of 2017. Excluding any benefit from tax incentive payments, R&D expense was $1.6 million in the third quarter versus $1.2 million in the prior year period. The increase of $0.4 million was primarily attributable to a $0.3 million increase in clinical costs and a $0.1 million increase in payroll-related costs.
R&D expenses for the nine months ended September 30, 2018, net of incentive tax payments, were $3.5 million, up from $1.8 million for the nine months ended September 30, 2017. Excluding any benefit from tax incentive payments, R&D expense for the nine months ended September 30, 2018 and 2017 were $4.7 million and $3.8 million, respectively. The increase of $0.9 million was primarily related to a $0.7 million increase in clinical costs, a $0.1 million increase in professional and consulting fees, and a $0.1 million increase in payroll-related costs.
General and administrative (G&A) expenses were $1.3 million for the third quarter of 2018 compared to $1.6 million for the third quarter of 2017. The decrease was primarily due to lower legal and professional fees, as well as a $0.1 million decrease in certain non-cash charges.
G&A expenses for the nine months ended September 30, 2018 decreased by $2.1 million to $4.2 million from $6.3 million for the nine months ended September 30, 2017. The decrease was primarily attributable to a decrease in payroll-related costs and professional fees and the non-recurrence of a non-cash fair value adjustment charge of $0.5 million.
Net cash used in operating activities for the nine months ended September 30, 2018 was $7.0 million compared to $6.8 million for the nine months ended September 30, 2017.
Cash and cash equivalents as of September 30, 2018 totaled $4.5 million, which excludes the proceeds from the company’s October 2018 public offering.
As of November 5, 2018, there were approximately 32.3 million shares of common stock outstanding.

On November 8, 2018 Cue Biopharma, Inc. (NASDAQ: CUE), an innovative immunotherapy company developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system to treat cancer, autoimmune and chronic infectious diseases, reported that it has entered into a multi-target strategic collaboration with LG Chem Life Sciences, the life sciences division of LG Chem Ltd., to develop multiple Immuno-STAT biologics focused in the field of oncology (Press release, Cue Biopharma, NOV 8, 2018, View Source [SID1234531185]).

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The collaboration provides LG Chem with the rights to develop and commercialize, in Asia, Cue Biopharma’s lead product, CUE-101, as well as Immuno-STAT biologics that target T cells against two additional cancer antigens. Under the terms of the collaboration, Cue Biopharma will engineer the selected Immuno-STATs for up to three alleles, while LG Chem will leverage its experience in biologics manufacturing to establish a quality chemistry, manufacturing and controls (CMC) process for development and commercialization of the selected candidates. LG Chem will also retain the right to elect one additional Immuno-STAT biologic within two years of the agreement for a worldwide development and commercialization license, and Cue Biopharma will retain an option to co-develop and co-commercialize the additional program worldwide. Cue Biopharma retains rights to develop and commercialize all assets included in the agreement in the United States and in global markets outside of Asia.

Under the terms of the agreement, LG Chem will make an undisclosed upfront payment as well as a $5M equity investment at a 20% premium. Cue Biopharma will be eligible to receive up to an additional $400M in research, development, regulatory and sales milestone payments with tiered royalties on sales of collaboration products in the LG Chem territory. In addition, LG Chem will further contribute to the collaboration by providing Cue Biopharma with research funding, CMC process development and potentially additional downstream manufacturing capabilities, including clinical and commercial supply for the collaboration products. LG Chem in return will receive royalties on sales of collaboration products in Cue Biopharma’s territories outside of Asia. If LG Chem elects the option for an additional program worldwide, Cue Biopharma will receive an undisclosed payment and be eligible to receive greater than $500M in fees and milestone payments. Cue Biopharma will also receive tiered royalties on future global sales. In addition, prior to the first pivotal trial for the optional Immuno-STATs, Cue Biopharma will have the option to elect worldwide co-development rights for the additional program.

"Cue Biopharma is proud to be launching this strategic collaboration with LG Chem as our partner," stated Dan Passeri M.Sc., J.D., President and CEO of Cue Biopharma. "We believe they offer world-class biologics capabilities as well as clinical development capabilities that will enhance our ability to achieve our global corporate objectives. Our partnership with LG Chem is an important strategic development, as it allows us to expand our reach into more diverse patient populations with our Immuno-STAT Biologics platform and leverage the leading biologics manufacturing and clinical development capabilities that LG Chem has successfully established."

"We are very pleased to enter this strategic collaboration with Cue Biopharma; it is more than a licensing deal, it is a partnership with a shared vision and great strategic fit," said Dr. Jeewoong Son, President of LG Chem Life Sciences. "By combining Cue Biopharma’s pioneering approach to selectively modulating disease-associated T cells with LG Chem’s biologics capabilities in development and manufacturing, we aim to accelerate bringing this novel therapy to a greater number of cancer patients."

About Immuno-STATs

Immuno-STAT Biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology, autoimmune and chronic infectious disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-MHC complex (pMHC) to provide selectivity through the pMHC T-cell receptor (TCR) interaction, and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-stimulatory molecules and pMHC binding mimics the signals delivered by APCs to T cells during a natural immune response. This design enables Immuno-STAT Biologics to engage with the T cell population of interest exclusively, resulting in highly targeted T cell modulation. Because our drugs are delivered in vivo, they are fundamentally different from other T cell therapeutic approaches such as Adoptive Cell Therapy (ACT), which require the patients’ T cells to be extracted, then stimulated and expanded outside the body (ex vivo) and reinfused in an activated state. At Cue Biopharma we are working to develop drugs that will represent a potent pharmaceutical analog to the ex vivo approach deployed by current cellular therapies. Furthermore, we believe the pharmacological effect in the patients can be more precisely controlled via an administered therapeutic.