On August 8, 2018 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter ended June 30, 2018 (Press release, Coherus Biosciences, AUG 8, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2362846 [SID1234528753]).

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Second Quarter 2018 Corporate Highlights Include:

UDENYCA (pegfilgrastim-cbqv), biosimilar candidate to Neulasta
On May 3, 2018, Coherus announced the re-submission of its biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) under the 351(k) pathway.
On May 14, 2018, Coherus announced the FDA accepted and acknowledged for review the resubmission of this BLA.
On May 28, 2018, Coherus submitted its day-181 responses to the European Medicines Agency’s day-180 questions regarding its marketing authorization application in Europe.
On July 26, 2018, Coherus received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use of the European Medicines Agency.

On May 10, 2018, Coherus announced the appointment of Samuel Nussbaum, M.D. to its Board of Directors. From 2000 until 2016, Dr. Nussbaum served as Executive Vice President, Clinical Health Policy, and Chief Medical Officer for Anthem. In that role, he was the key spokesperson and policy advocate and oversaw clinical strategy and corporate medical and pharmacy policy. He currently serves as a Strategic Consultant to EBG Advisors, consulting arm for Epstein Becker and Green, where he advises life science companies, health care systems and provider organizations. In May 2018, Coherus completed an underwritten public offering of 5,948,274 shares of its common stock at a price to the public of $14.50 per share, which includes the closing of the full exercise of the underwriters’ option to purchase an additional 775,861 shares of common stock. Coherus received net proceeds of $80.8 million from the offering.
Second Quarter 2018 Financial Results:

Research and development (R&D) expenses for the second quarter of 2018 were $26.5 million compared to $34.5 million for the same period in 2017. R&D expenses for the six months ended June 30, 2018 were $52.0 million, as compared to $88.3 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of our clinical trials for the immunology biosimilar drug candidates, CHS-1420 (adalimumab (Humira) biosimilar) and CHS-0214 (etanercept (Enbrel) biosimilar), and the reprioritization of resources to advance UDENYCA. General and administrative (G&A) expenses for the second quarter of 2018 were $18.4 million, compared to $23.5 million for the same period in 2017. G&A expenses for the six months ended June 30, 2018 were $35.0 million, as compared to $42.3 million for the same period in 2017. The decreases in G&A expenses in 2018 were mainly attributable to a decrease in personnel and in certain legal and consulting services as a result of cost control steps taken since June 2017. Net loss attributable to Coherus for the second quarter of 2018 was ($43.6) million, or ($0.68) per share, compared to a net loss of ($55.3) million, or ($1.08) per share, for the same period in 2017. Cash and cash equivalents and investments in marketable securities – totaled $159.8 million as of June 30, 2018, compared to $95.2 million as of March 31, 2018.
Guidance for 2018:
UDENYCA (pegfilgrastim-cbqv), biosimilar candidate to Neulasta

FDA action date is set for November 3, 2018. Anticipate regulatory approval for UDENYCA from the European Commission on or before October 1, 2018. Commercial partnering discussions are projected to continue for certain ex-U.S. territories. Anticipate U.S. commercial launch directly following the FDA action date, dependent on regulatory review and approval timing.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of a BLA. Continue to develop partnering options for ex-U.S. territories.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Initiate clinical development of CHS-3351. Continue preclinical development of CHS-2020.
Cash flow

Anticipate cash use in operations of approximately $48 to $53 million for the third quarter of 2018.
Conference Call Information
When: Wednesday, August 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 4562488
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On August 8 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported financial results for the second quarter ended June 30, 2018 (Press release, Akebia, AUG 8, 2018, View Source [SID1234528547]).

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"In the second quarter, we continued to drive our Phase 3 vadadustat program while executing on our long-term growth strategy with the announcement of the pending merger with Keryx Biopharmaceuticals," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "The combination is expected to create a fully-integrated company focused on the development and commercialization of therapeutics for patients with kidney disease. We are actively engaged in integration planning and continue to target the closing of the transaction by the end of 2018."

Second Quarter 2018 and Recent Corporate Highlights

Merger Announcement:

The definitive merger agreement with Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) was announced, offering potential operating and product portfolio synergies and the opportunity to create significant value and accelerate the growth potential beyond what either company would achieve separately;
The combined company will have an expanded and highly complementary nephrology portfolio, with Auryxia (ferric citrate), a U.S. Food and Drug Administration (FDA)-approved product in two indications with significant growth opportunity, and vadadustat, an investigational late-stage hypoxia-inducible factor prolyl hydroxylase inhibitor, which has the potential to provide a new oral standard of care to patients with anemia due to chronic kidney disease (CKD);
The combined company will have an established renal development, manufacturing and commercial organization, positioning it as a partner of choice for the renal community and for companies developing renal products; and
The combined company plans to leverage its leadership’s extensive expertise in the commercial renal market with the goal of maximizing sales of Auryxia while driving launch momentum for vadadustat in the United States, subject to FDA approval.
Clinical Development:

Completed U.S. enrollment of the Phase 3 INNO2VATE Conversion study, targeting full enrollment of the INNO2VATE program globally by the end of 2018. The company expects top-line results for the program in the fourth quarter of 2019 or the first quarter of 2020, subject to the accrual of major adverse cardiac events (MACE);
Continued to enroll subjects in the Phase 3 PRO2TECT program, with top-line results anticipated in mid-2020, subject to the accrual of MACE;
Initiated the Phase 2 FO2RWARD-2 study in dialysis dependent patients with anemia due to CKD, with top-line results expected in the first half of 2019. Results from this study are expected to provide additional characterization and differentiation of vadadustat and may further strengthen the company’s commercial position, subject to vadadustat’s regulatory approval; and
Completed a type-C meeting with the FDA, in which Akebia and the agency aligned on the statistical analysis plan in advance of a planned NDA filing for vadadustat.
Financial Results

Akebia reported a net loss of $34.1 million, or ($0.60) per share, for the second quarter of 2018 as compared to a net loss for the second quarter of 2017 of $21.5 million or ($0.53) per share.

Collaboration revenue was $48.8 million for the second quarter of 2018 compared to $28.5 million for the second quarter of 2017. Collaboration revenue recognized in the second quarter of 2018 related to revenue recognized under both the collaboration agreement with Otsuka Pharmaceutical Co. Ltd., or Otsuka, related to the United States, or the Otsuka U.S. Agreement, and the collaboration agreement with Otsuka related to Europe, China and certain other regions, or the Otsuka International Agreement, as well as revenue recognized in connection with the collaboration agreement with Mitsubishi Tanabe Pharma Corporation. Collaboration revenue recognized in the second quarter of 2017 only related to the Otsuka U.S. Agreement and the Otsuka International Agreement, which were consummated in December 2016 and April 2017, respectively.

Research and development expenses were $71.9 million for the second quarter of 2018 compared to $43.8 million for the second quarter of 2017. The increase was primarily attributable to external costs related to the continued advancement of the global PRO2TECT and INNO2VATE Phase 3 programs, including enrollment; and the manufacture of drug substance and drug product in support of the global Phase 3 program. Research and development expenses were further increased by headcount and compensation-related costs.

General and administrative expenses were $12.5 million for the second quarter of 2018 compared to $6.9 million for the second quarter of 2017. The increase was primarily attributable to an increase in costs to support the company’s research and development programs, including headcount and compensation-related costs, and costs incurred related to the proposed merger with Keryx Biopharmaceuticals.

Akebia ended the second quarter of 2018 with cash, cash equivalents and available for sale securities of $402.1 million. The company also generally receives cost-share funding from its collaboration agreements with Otsuka on a prepaid quarterly basis. Akebia expects its existing cash resources, including the prepaid quarterly committed cost-share funding from its collaborators, to fund its current operating plan into the first quarter of 2020.

Conference Call and Webcast

Akebia management will host its second quarter 2018 investor update conference call and webcast beginning at 4:30 p.m. Eastern Time today, Wednesday, August 8, 2018.

Individuals interested in participating in the call should dial (877) 458-0977 (U.S. and Canada) or (484) 653-6724 (international) using conference ID number 1398303. To access the webcast, visit the Investors section of Akebia’s website at www.akebia.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.

Beginning the morning of August 9, 2018, the call will be available for replay via telephone and the archived webcast will be available on Akebia’s website. To listen to the telephone replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 1398303. The telephone replay will be available for six days following the call.

On August 8, 2018 Synthetic Biologics, Inc. (NYSE American: SYN), a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, reported financial results for the three months ended June 30, 2018 (Press release, Synthetic Biologics, AUG 8, 2018, View Source [SID1234528532]).

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"Following several productive meetings earlier this year, we are pleased to have reached preliminary agreement on key elements of our planned Phase 3 clinical trial for ribaxamase, our first-in-class therapeutic intervention designed to prevent the onset of primary C. difficile infection (CDI) by protecting the gut microbiome from antibiotic-mediated dysbiosis. We are in the process of optimizing a protocol synopsis for the Phase 3 clinical trial which we will discuss with the FDA at our end of Phase 2 meeting which is currently planned to take place towards the end of the third quarter," stated Steven A. Shallcross, Interim Chief Executive Officer and Chief Financial Officer.

"We will continue to work closely and collaboratively with the FDA to define a clear and achievable pathway toward gaining marketing approvals. In our ongoing interactions with FDA, what has become clear is their recognition of the unmet need for novel interventions to combat and prevent the proliferation of CDI. With more than 450,000 cases of CDI each year in the U.S., if approved, ribaxamase will be the first intervention specifically designed to prevent CDI associated with the most commonly used IV antibiotics," concluded Shallcross.

Clinical Development and Operational Update

Announced the Company reached preliminary agreement with the FDA on key elements of a proposed Phase 3 clinical program for SYN-004 (ribaxamase), which is expected to:
Comprise a global, event driven clinical trial with a fixed maximum number of patients for total enrollment,
Evaluate the potential efficacy and safety of ribaxamase in a broader patient population by the inclusion of additional IV β-lactam antibiotics in addition to ceftriaxone and by enrolling patients with a variety of underlying infections,
Evaluate the ability of ribaxamase to reduce the incidence of Clostridium difficile infection (CDI) in the ribaxamase treatment group compared to placebo as the primary efficacy endpoint,
Evaluate mortality risk as the co-primary safety endpoint which will be separate from the primary efficacy endpoint of reduction in the incidence of CDI,
Anticipate End-of-Phase 2 meeting with the FDA in 3Q 2018 to solidify the remaining elements of the planned SYN-004 (ribaxamase) Phase 3 clinical trial;
Plan to initiate SYN-004 (ribaxamase) Phase 3 clinical trial in 2H 2019;
Continue efforts to solidify clinical infrastructure, including exploring international regulatory and market access structures to support advancement of SYN-010, designed to treat an underlying cause of the symptoms associated with irritable bowel syndrome with constipation (IBS-C);
Reported supportive data from a second canine animal model demonstrating that when co-administered with oral amoxicillin and oral Augmentin, oral SYN-007 did not interfere with systemic absorption of the antibiotics but did diminish microbiome damage associated with these antibiotics in 2Q 2018.
Quarter Ended June 30, 2018 Financial Results

General and administrative expenses decreased by 13% to $1.4 million for the three months ended June 30, 2018, compared to $1.6 million for the same period in 2017. This decrease is primarily the result of lower salary expense, stock compensation, and related benefits costs incurred during the three months ended June 30, 2018 as compared to the three months ended June 30, 2017 due to the resignation of the Chief Executive Officer, along with the reduction of travel and consulting expense, offset by higher registration, investor relations and legal costs. The charge related to stock-based compensation expense was $264,000 for the three months ended June 30, 2018, compared to $539,000 for three months ended June 30, 2017.

Research and development expenses decreased by 25% to $3.6 million for the three months ended June 30, 2018, from $4.8 million for the three months ended June 30, 2017. This decrease is primarily the result of lower SYN-004 (ribaxamase) and SYN-010 program costs for 2018 since no clinical trials were ongoing during the quarter. The research and development costs incurred during the quarter were primarily related to planning for future Phase 3 (SYN-004) and Phase 2b/3 (SYN-010) clinical programs as we seek to secure the financial resources necessary for the completion of these clinical trials. The charge related to stock-based compensation expense was $293,000 for the three months ended June 30, 2018, compared to $331,000 for the same period in 2017.

Other income was $789,000 million for the three months ended June 30, 2018, compared to other income of $2.2 million for the same period in 2017. Other income for the three months ended June 30, 2018 is primarily comprised of non-cash income of $783,000 million from the change in fair value of warrants. The decrease in the fair value of the warrants was due to the decrease in our stock price from the prior quarter.

Cash and cash equivalents as of June 30, 2018 was $7.1 million, a decrease of $10.0 million from December 31, 2017.

Conference Call

Synthetic Biologics will hold a conference call today, Wednesday, August 8, 2018, at 4:30 p.m. (EDT). The dial-in information for the call is as follows, U.S. toll free: +1 888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On August 8, 2018 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the second quarter ended June 30, 2018 (Press release, Celldex Therapeutics, AUG 8, 2018, View Source [SID1234528548]). The Company will host a conference call at 4:30 p.m. ET today to provide an in-depth update on its pipeline and upcoming milestones for 2018.

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"During the second quarter, we continued to focus on advancing CDX-1140, our promising antibody targeted to CD40, a key activator of immune response, and CDX-3379, which blocks the ErbB3 receptor, an important regulator of cancer cell growth and survival," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We have completed the third monotherapy dose level in the ongoing Phase 1 study of CDX-1140 and are encouraged with the tolerability, immune system activation and early signs of biological activity we have seen to date. We will also be exploring the potential of combining CDX-1140 with our dendritic cell mobilizer, CDX-301, and plan to begin enrolling those cohorts in September. In the next few months, we expect to complete enrollment in the first stage of our Phase 2 combination study of CDX-3379 and Erbitux in advanced head and neck squamous cell carcinoma. Additionally, we have IND enabling studies underway with CDX-0159, our anti-KIT antibody, with the aim of adding it as a new clinical program in 2019."

Recent Highlights:

Enrollment continues in the Phase 1 dose-escalation study of CDX-1140 in multiple types of solid tumors. CD40 has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses; however, balancing systemic dosing and safety has proven elusive to date for CD40 targeted activating therapeutics. CDX-1140 is a unique, potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile. Three dosing cohorts have been completed, 0.01, 0.03 and 0.09 mg/kg, and data to date from these cohorts suggest that CDX-1140 has a desirable safety profile and, based on biomarker data, is demonstrating early signs of biological activity. The fourth cohort at 0.18 mg/kg is currently being enrolled. As planned, the study protocol was recently amended to explore CDX-1140 in combination with CDX-301, and enrollment to this cohort is expected to begin in September. CDX-301 is a dendritic cell growth factor that will be used as a priming agent to potentially increase the number of cells available to respond to CDX-1140. In addition, combination with varlilumab could have significant potential, especially in lymphomas which co-express CD40 and CD27 receptors.

Enrollment continues in the Phase 2 study of CDX-3379 in advanced head and neck squamous cell carcinoma (HNSCC) in combination with Erbitux in Erbitux-resistant patients who have been previously treated with checkpoint therapy or are not candidates for checkpoint therapy. Celldex intends to complete enrollment to the first stage of the Phase 2 study and will use these data to inform next decisions. In line with this, the Company continues to explore potential other opportunities in additional indications where ErbB3 is believed to play a role.

Data from the Phase 1/2 study of varlilumab in combination with Opdivo across multiple solid tumors were presented in an oral presentation at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting in June. In the ovarian cancer cohort, for patients with paired tumor samples from before and during treatment, increases in tumor expression of PD-L1 and CD8+ tumor infiltrating lymphocyte (TIL) levels were observed. These increases were associated with improved clinical outcomes, including improved progression-free survival (PFS) and response rate. Celldex recently reviewed preliminary data from the HNSCC and renal cell carcinoma (RCC) cohorts. Twenty-seven patients with HNSCC were treated in the study (3 in Phase 1; 24 in Phase 2). Patients had a median of two prior lines of therapy. 96% had Stage IV disease. 63% had PD-L1 negative tumors. 52% had HPV positive tumors. The overall response rate was 15% (n=4 confirmed) across 27 response-evaluable patients. In this small sample size, no correlation between PD-L1 status and clinical outcome was observed. Given the changing treatment paradigm in renal cell carcinoma, only 14 patients with RCC were treated in the study, all in Phase 2. All patients had prior anti-angiogenic therapy, with a range of 1 to 4 prior treatments. 100% had Stage IV disease, and 50% had PD-L1 negative tumors. 39% of patients experienced stable disease. Celldex plans to present data from the glioblastoma cohort at a medical meeting later this year.
Second Quarter and First Six Months 2018 Financial Highlights and 2018 Guidance

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2018 were $114.0 million compared to $123.2 million as of March 31, 2018. The decrease was primarily driven by second quarter cash used in operating activities of approximately $17.4 million, of which $5.5 million were glembatumumab vedotin-related payments, partially offset by the receipt of $8.3 million from sales of common stock under the Cantor agreement. Celldex expects that it will make an additional $5.0 to $6.0 million in glembatumumab vedotin-related payments related to the discontinuation of that program. At June 30, 2018, Celldex had 156.6 million shares outstanding.

Revenues: Total revenue was $2.8 million in the second quarter of 2018 and $6.8 million for the six months ended June 30, 2018, compared to $3.8 million and $5.4 million for the comparable periods in 2017. The decrease in revenue for the second quarter of 2018 compared to the second quarter of 2017 was primarily due to lower contract revenue from the International AIDS Vaccine Initiative. The increase in revenue for the six months ended June 30, 2018 compared to the six months ended June 30, 2017 was primarily due to an increase in revenue related to the collaboration agreement with Bristol-Myers Squibb Company.

R&D Expenses: Research and development (R&D) expenses were $21.4 million in the second quarter of 2018 and $43.3 million for the six months ended June 30, 2018, compared to $25.0 million and $50.8 million for the comparable periods in 2017. The decrease in R&D expenses was primarily due to lower personnel, clinical trial, contract manufacturing and contract research expense, partially offset by severance expense of $1.0 million.

G&A Expenses: General and administrative (G&A) expenses were $5.6 million in the second quarter of 2018 and $11.2 million for the six months ended June 30, 2018, compared to $6.5 million and $13.8 million for the comparable periods in 2017. The decrease in G&A expenses was primarily due to lower personnel and marketing expense.

Changes in Fair Value Remeasurement of Contingent Consideration: Gain on the fair value remeasurement of contingent consideration related to the Kolltan acquisition was $7.4 million in the second quarter of 2018 and $21.0 million for the six months ended June 30, 2018, primarily due to discontinuation of the glembatumumab vedotin and CDX-014 programs and updated assumptions for the varlilumab program.

Net Loss: Net loss was $16.4 million, or ($0.11) per share, for the second quarter of 2018, and $134.5 million, or ($0.93) per share, for the six months ended June 30, 2018, compared to a net loss of $28.6 million, or ($0.23) per share, for the second quarter of 2017 and $62.8 million, or ($0.51) per share, for the six months ended June 30, 2017.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at June 30, 2018, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Webcast and Conference Call

Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2018 objectives. The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 4768019.

A replay of the call will be available approximately two hours after the live call concludes through August 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 4768019. The webcast will also be archived on the Company’s website.

On August 8, 2018 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported on its corporate activities, product pipeline and financials for the second quarter ended June 30, 2018 (Press release, G1 Therapeutics, AUG 8, 2018, View Source [SID1234528755]).

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"We have made impressive clinical progress on trilaciclib in the first half of 2018 and are approaching several important clinical milestones later this year. Additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line small cell lung cancer have been accepted for presentation at the European Society for Medical Oncology Congress in October. We will also be reporting preliminary data from our randomized Phase 2 trials of trilaciclib in second-/third-line SCLC and triple-negative breast cancer in the fourth quarter," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "We have been engaged in productive discussions with U.S. and European regulatory authorities regarding the trilaciclib development program and expect that dialogue to continue."

Dr. Velleca added: "We presented the first clinical data on lerociclib in patients with ER+, HER2- breast cancer in June at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which showed promising safety, tolerability and anti-tumor activity. We are currently enrolling the Phase 2a dose-expansion portion of that trial, with patients receiving 500 mg once daily without a dosing holiday. In addition, we have initiated the first clinical trial for G1T48, our oral SERD, in ER+, HER2- breast cancer and expect preliminary data next year."

Corporate Highlights

Completed enrollment of Phase 2 trials of trilaciclib in second-/third-line small cell lung cancer (SCLC) and triple negative breast cancer (TNBC): G1 expects to report preliminary data from both randomized trials in the fourth quarter of 2018.

USAN name lerociclib adopted for G1T38: G1 has received approval from the United States Adopted Names Council that lerociclib has been adopted to refer to G1T38. All future communications from G1 will refer to G1T38 as lerociclib.

Reported positive lerociclib data in breast cancer patients at ASCO (Free ASCO Whitepaper) 2018: in June, G1 announced preliminary Phase 1b data on lerociclib in combination with Faslodex (fulvestrant) that showed promising safety, tolerability and anti-tumor activity when lerociclib was dosed continuously as a treatment for people with estrogen receptor-positive, HER2-negative (ER+, HER2-) breast cancer.

Initiated enrollment of Phase 2a expansion of lerociclib in combination with Faslodex in ER+, HER2- breast cancer: based on Phase 1b data, the Phase 2a dose expansion portion of the trial is enrolling. Approximately 30 patients will receive lerociclib 500 mg once daily without a dosing holiday.

Initiated Phase 1/2a clinical trial of G1T48, an oral SERD, as monotherapy for treatment of ER+, HER2- breast cancer: in June, G1 initiated the first clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD). This open-label study is expected to enroll up to 96 patients in two parts: a safety, pharmacokinetic and dose escalation portion (Phase 1); and an expansion portion at the recommended Phase 2 dose (Phase 2a). G1 plans to study a G1T48/lerociclib combination regimen for breast cancer in 2019, contingent on the Phase 1 findings.

Expanded leadership team, appointing Chief Commercial Officer and General Counsel: in July, the company named John Demaree as Chief Commercial Officer and Stillman Hanson as General Counsel. Mr. Demaree has more than 20 years of oncology experience, building commercial capabilities and leading multiple successful product launches. Mr. Hanson most recently served as Associate General Counsel and Vice President at IQVIA, and has extensive life sciences corporate legal experience.

Appointed Cynthia Schwalm and Willie Deese to G1 Board of Directors: in June, the company announced the election of two new Board members. Ms. Schwalm most recently served as President and Chief Executive Officer of Ipsen North America. Mr. Deese previously served as President of the Merck Manufacturing Division and as a member of the Merck Executive Committee before retiring in 2016.

Anticipated Upcoming Milestones

Present additional data from the randomized Phase 2 trilaciclib/chemotherapy trial in first-line SCLC at ESMO (Free ESMO Whitepaper) 2018, being held October 19-23 in Munich, Germany.

Report preliminary data from the randomized Phase 2 trilaciclib/chemotherapy trials in second-/third-line SCLC and first-/second-/third-line TNBC in the fourth quarter of 2018.

Complete enrollment of the Phase 2a trial of lerociclib/Faslodex in ER+, HER2- breast cancer by the end of 2018.

Second Quarter 2018 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $188.2 million as of June 30, 2018, compared to $103.8 million as of December 31, 2017. This increase results from the receipt of $107.9 million in net proceeds from the secondary offering in March of this year and $12.1 million in net-proceeds from "at the market offerings" in June, partially offset by cash used in operating activities.

Operating Expenses: Operating expenses were $21.7 million for the second quarter of 2018, compared to $15.4 million for the second quarter of 2017. GAAP operating expenses include stock-based compensation expense of $2.1 million for the second quarter of 2018, compared to $0.8 million for the second quarter of 2017.

Research and Development Expenses: Research and development (R&D) expenses for the second quarter of 2018 were $18.4 million, compared to $13.7 million for the second quarter of 2017. The increase in expense was due to an increase in clinical program costs, drug

manufacturing costs to support clinical programs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the second quarter of 2018 were $3.3 million, compared to $1.7 million for the second quarter of 2017. The increase in expense was largely due to an increase in personnel-related costs.

Net Loss: G1 reported a net loss of $20.9 million for the second quarter of 2018, compared to $15.2 million for the second quarter of 2017.

Webcast and Conference Call

The G1 management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the second quarter of 2018. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3088562. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com.