On August 3, 2022 Kintara Therapeutics, Inc. (Nasdaq: KTRA) (Kintara or the Company), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported it has entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital Fund, LLC (LPC), a Chicago-based institutional investor (Press release, Kintara Therapeutics, AUG 3, 2022, View Source [SID1234617379]).

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Under the terms of and subject to satisfaction of the conditions contained in the agreement, Kintara will have the right in its sole discretion, but not the obligation, to sell to LPC up to $20 million worth of shares of its common stock from time to time over the 36-month term of the agreement. Kintara controls the timing and amount of any future sales of its shares of common stock and LPC is obligated to make purchases in accordance with the terms of the purchase agreement, subject to various limitations contained in the agreement, including those under the Nasdaq listing rules. Any common stock that is sold by Kintara to LPC under the agreement will occur at a purchase price that is based on the market prices prevailing at the time of each sale to LPC. There is no upper limit to the price per share that LPC may pay for future stock issuances under the purchase agreement, and LPC has agreed not to cause or engage in any direct or indirect short selling or hedging of Kintara’s common stock. No warrants are being issued in this transaction and the purchase agreement does not contain any rights of first refusal, participation rights, penalties or liquidated damages provisions in favor of any party. Kintara may terminate the purchase agreement at any time, at its sole discretion, without any cost or penalty.

The Company expects this commitment from LPC will provide financial flexibility and is aligned with Kintara’s long-term strategy for value creation. Kintara intends to use any net proceeds from the sale of its common stock to LPC for working capital and general corporate purposes, including development expenses for VAL-083 and REM-001.

"We are excited to enter into this transaction with Lincoln Park Capital and believe that this agreement provides us an opportunity to access capital in a very efficient manner," said Robert E. Hoffman, President and Chief Executive Officer of Kintara. "We believe that the financial flexibility provided by this agreement will further support our clinical development efforts with VAL-083 in glioblastoma and REM-001 in cutaneous metastatic breast cancer."

Additional information regarding the purchase agreement is set forth in a Current Report on Form 8-K, which Kintara will file with the Securities and Exchange Commission (SEC).

The securities described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-254662) filed with the SEC on March 24, 2021 and declared effective on April 1, 2021. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by request from Kintara Therapeutics at 9920 Pacific Heights Blvd., Suite 150, San Diego, CA 92121 or at (858) 350-4364.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On August 3, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and business highlights for the second quarter of 2022 as well as upcoming anticipated corporate milestones (Press release, Surface Oncology, AUG 3, 2022, View Source [SID1234617395]).

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"In the second quarter, we presented encouraging new SRF388 clinical data in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting," said Rob Ross, M.D., chief executive officer. "SRF388, our first-in-class anti-IL27 antibody, demonstrated activity as both a monotherapy and in combination with other IO agents, bolstering our belief that this agent holds the potential to treat a broad range of tumor types. With cash runway into 2024, we believe we are well positioned to deliver a series of meaningful clinical data updates across our pipeline beginning later this year and through the first half of 2023."

Second Quarter and Subsequent Corporate Highlights

In June, Surface announced the publication of a new study highlighting the role of the IL-27 pathway in hepatocellular carcinoma (HCC). Surface collaborated with Cedars-Sinai Medical Center and Fox Chase Cancer Center to conduct the study which evaluated the role of the IL-27 pathway in the development of HCC. The study was published in the online edition of Cancer Discovery, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

In June, Surface presented new SRF388 Phase 1/1b clinical data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. SRF388 demonstrated clinical activity in multiple solid tumor types with three partial responses across non-small-cell lung cancer (NSCLC), renal cell carcinoma (RCC) and HCC. Surface also announced plans to conduct a new expansion study of SRF388 in combination with pembrolizumab in up to 40 patients with relapsed/refractory NSCLC.

In June, Surface announced the appointment of Carsten Brunn, Ph.D., to the board of directors. Dr. Brunn brings more than 25 years of senior leadership experience within multiple biotech and pharmaceutical companies worldwide.

In April, Surface announced the initiation of two Phase 2 clinical studies evaluating SRF388 in multiple tumor types, including a randomized Phase 2 clinical study evaluating SRF388 in combination with atezolizumab and bevacizumab in patients with treatment-naïve HCC and a Phase 2 monotherapy study in patients with previously-treated NSCLC. In addition, the company announced an expansion of the open-label lead-in of the SRF388 randomized Phase 2 study in first-line HCC. The 30-patient lead-in is expected to inform the start of the randomized stage and could elucidate important biomarkers to support enriched patient selection.

At the AACR (Free AACR Whitepaper) Annual Meeting 2022 in April, Surface presented preclinical and translational data supporting the SRF388 recommended Phase 2 monotherapy dose of 10 mg/kg administered intravenously every four weeks.

In April, the company announced that it was recognized by the Boston Business Journal as one of the Best Places to Work for the second year in a row

In Q2, Surface received the anticipated $30 million milestone payment from GlaxoSmithKline for the initiation of the first Phase 1 study for GSK4381562. As part of the licensing agreement, Surface is eligible to receive up to $700 million in potential milestone payments, as well as tiered royalties on global net sales.

The company granted non-qualified stock options to one new employee to purchase 80,000 shares of the company’s common stock with a per share exercise price of $1.64, the closing price on August 1, 2022. The option grant was made under Surface’s 2021 Inducement Plan (the Plan) as an inducement material to the employee entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4) and was granted pursuant to the terms of the Plan.
Selected Anticipated Near-term Corporate Milestones

The company expects to provide a clinical data update on SRF617, a fully human antibody designed to inhibit CD39, in the fourth quarter of 2022.

Surface remains on track to file an Investigational New Drug (IND) application for SRF114, a fully human IgG1 anti-CCR8 antibody, before the end of the year.

Surface anticipates providing multiple SRF388 clinical updates in the first half of 2023, including initial safety and efficacy data from the expanded 30 patient lead-in to the Phase 2 study in first-line HCC.
Financial Results
As of June 30, 2022, cash, cash equivalents and marketable securities were $156.6 million, compared to $154.1 million on December 31, 2021.

General and administrative (G&A) expenses were $6.4 million for both the second quarter ended June 30, 2022, and for the same period in 2021. Decreases in legal and professional fees were partially offset by increased personnel related costs and increased insurance premiums. G&A expenses included $1.3 million in stock-based compensation expense for the second quarter ended June 30, 2022.

Research and development (R&D) expenses were $18.2 million for the second quarter ended June 30, 2022, compared to $12.7 million for the same period in 2021. This increase was primarily driven by progress on our SRF617 and SRF388 Phase 1 and Phase 2 clinical trials. R&D expenses included $0.8 million in stock-based compensation expense for the second quarter ended June 30, 2022.

For the second quarter ended June 30, 2022, net loss was $25.2 million, or basic and diluted net loss per share of $0.46. Net loss was $19.0 million for the same period in 2021, or basic and diluted net loss per share of $0.44.

Surface Oncology continues to project that current cash and cash equivalents are sufficient to fund the company into 2024.

On August 3, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the European Commission granted marketing authorisation for the expanded use of IMBRUVICA (ibrutinib) in an all-oral, fixed-duration (FD) treatment combination with venetoclax (I+V) for adults with previously untreated chronic lymphocytic leukaemia (CLL) (Press release, Johnson & Johnson, AUG 3, 2022, View Source [SID1234617416]). The approval is based on the pivotal Phase 3 GLOW study that demonstrated superior progression-free survival (PFS) in patients treated with I+V versus chlorambucil-obinutuzumab (Clb+O), and the FD cohort of the Phase 2 CAPTIVATE study, which showed deep and durable responses in patients treated with I+V, including those with high-risk features.1,2

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"Developing innovative therapies remains vitally important in CLL, to ensure we have the option and ability to best tailor treatment to meet individual patient needs and preferences," said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "Over the past 11 years, the efficacy and safety profile of ibrutinib has been established in clinical trials and real-world settings. With this approval, healthcare professionals will now have the flexibility to use ibrutinib either in a fixed-duration combination with venetoclax or as a continuous monotherapy in first-line CLL."

In Europe, ibrutinib is already approved as a continuous therapy in several indications across three blood cancers (CLL, mantle cell lymphoma and Waldenström’s macroglobulinaemia).3 In CLL, patient outcomes have improved over the last decade.4 A wave of innovation, including the advent of novel oral therapies that target the underlying disease biology, has shifted the standard of care from chemoimmunotherapy to targeted agents and combination therapies.4 Unmet needs remain, including time-limited combinations of targeted therapies that provide durable remissions and the flexibility to better tailor first-line therapy.1

"The distinct and complementary mechanisms of action of ibrutinib and venetoclax, and the potential of this combination regimen to provide treatment-free remissions, mark important progress for how we approach first-line CLL therapy," said Arnon Kater†, M.D., Ph.D., Deputy Head of Haematology, Amsterdam University Medical Centres, University of Amsterdam and Chairman of the HOVON CLL Working Group, the Netherlands and GLOW principal study investigator. "These highly active blood cancer treatments not only combine to deliver superior progression-free survival versus chlorambucil plus obinutuzumab, but also demonstrate robust disease clearance in lymphoid tissue, blood and bone marrow, and early sustainability of those responses after stopping treatment."

The EC approval is supported by data from the pivotal Phase 3 GLOW study (NCT03462719), which demonstrated that I+V was superior to Clb+O with respect to the primary endpoint, PFS assessed by an independent review committee, in elderly or unfit patients with CLL (PFS hazard ratio [HR]: 0.216; 95 percent confidence interval [CI], 0.131 to 0.357; P<0.001).1 The improvement in PFS with I+V was consistent across predefined subgroups, including older patients and those with comorbidities and high-risk features.1 It is also supported by the FD cohort of the Phase 2 CAPTIVATE study (NCT02910583) which evaluated I+V in patients with previously untreated CLL who were 70 years or younger, including patients with high-risk CLL disease.2

Data from these studies were recently published in NEJM Evidence1 and Blood,2 respectively, and primary analyses were originally featured as oral presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Congress. Secondary analyses from GLOW were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 Annual Meeting, and additional data from the CAPTIVATE study including clinical outcomes at three years and evidence of immune restoration post-treatment were presented at the EHA (Free EHA Whitepaper) 2022 Congress.

Updated data for both studies showed the safety profile of the I+V regimen was consistent with known safety profiles of ibrutinib and venetoclax.1,2 In GLOW, the most common adverse events (AEs) were diarrhoea (50.9 percent) and neutropenia (41.5 percent) in the I+V arm and neutropenia (58.1 percent) and infusion-related reactions (29.5 percent) in the Clb+O arm.1 AEs of Grade 3 or greater occurred in 75.5 percent and 69.5 percent of patients in the I+V and Clb+O arms, respectively.1 Any-grade atrial fibrillation occurred in 15 patients (14.2 percent) receiving I+V and two patients (1.9 percent) receiving Clb+O, however, only two patients (1.9 percent) discontinued ibrutinib due to atrial fibrillation while continuing venetoclax.1 Although overall survival data is not mature, with a median follow-up of 34 months, there were 11 deaths in the I+V arm and 16 deaths in the Clb+O arm (HR: 0.760; 95 percent CI, 0.352 to 1.642).1 In the CAPTIVATE FD cohort, the most common AEs were diarrhoea (62 percent), nausea (43 percent), neutropenia (42 percent), and arthralgia (33 percent) and were primarily Grade 1 or 2 in severity.2 The most common Grade 3/4 AEs were neutropenia (33 percent), hypertension (6 percent), and neutrophil count decreased (5 percent). Serious AEs occurred in 36 patients (23 percent) and one fatal AE occured.2

"Ibrutinib is the first approved BTK inhibitor globally, which has helped transform outcomes and quality of life for patients living with blood cancers, such as CLL," said Craig Tendler, M.D., Global Head of Late Development, Diagnostics & Medical Affairs, Hematology & Oncology, Janssen Research & Development, LLC. "This approval reinforces our relentless ambition to advance and optimise treatment regimens, including this all-oral, once-daily, fixed-duration combination of ibrutinib-venetoclax, delivering deep and durable remissions for patients with previously untreated CLL."

#ENDS#

About Ibrutinib
Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.3 Ibrutinib blocks the Bruton’s tyrosine kinase (BTK) protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread.5 By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation.6

Ibrutinib is approved in more than 100 countries and has been used to treat more than 250,000 patients worldwide.7 There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib.3,8 In October 2021, ibrutinib was added to the World Health Organization’s Model Lists of Essential Medicines (EML), which refers to medicines that address global health priorities and which should be available and affordable for all.9

Ibrutinib was first approved by the European Commission (EC) in 2014, and approved indications to date include:3

As a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated CLL
As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy
As a single agent for the treatment of adult patients with relapsed or refractory (RR) mantle cell lymphoma (MCL)
As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. In combination with rituximab for the treatment of adult patients with WM
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

About the GLOW study
The Phase 3 GLOW study (N=211; median age, 71 years) is a randomised, open-label trial which evaluated the efficacy and safety of first-line, fixed-duration I+V vs. Clb+O in elderly patients (≥65 years of age) with CLL/SLL, or patients aged 18-64 with a cumulative illness rating scale (CIRS) score of greater than six or creatinine clearance less than 70 mL/min, without del(17p) or known TP53 mutations.1 Patients in the study were randomized to receive either 3 cycles of ibrutinib lead-in, followed by 12 cycles of I+V (n=106), or 6 cycles of Clb+O (n=105).1 The primary end point was PFS assessed by an independent review committee.1

About the CAPTIVATE study
The Phase 2 CAPTIVATE study evaluated previously untreated adult patients with CLL who were 70 years or younger, including patients with high-risk disease, in two cohorts: an MRD-guided cohort (N=164; median age, 58 years) and a fixed-duration cohort (N=159; median age, 60 years).10 Patients in the fixed-duration cohort received 3 cycles of ibrutinib lead-in followed by 12 cycles of I+V (oral ibrutinib [420 mg/d]; oral venetoclax [5-week ramp-up to 400 mg/d]) and the primary endpoint was complete response (CR) rate.2

About Chronic Lymphocytic Leukaemia
Chronic lymphocytic leukaemia (CLL) is typically a slow-growing blood cancer of the white blood cells.11 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.12 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.13

While patient outcomes have dramatically improved in the last few decades, the disease is still characterised by consecutive episodes of disease progression and the need for therapy.4 Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.14

On August 3, 2022 CivicaScriptTM, a public benefit company dedicated to bringing lower-cost generic medicines to U.S. consumers, reported the availability of its first product: abiraterone acetate 250 mg tablets (Press release, CivicaScript, AUG 3, 2022, View Source [SID1234617432]). Abiraterone is used together with steroid medication (prednisone) to treat prostate cancer that has spread to other parts of the body.

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Starting today, CivicaScript will offer abiraterone 250 mg for sale to pharmacies for $160 per bottle of 120 tablets – typically a month’s supply. CivicaScript recommends that pharmacies charge patients no more than $171 per bottle (CivicaScript’s maximum retail price, or MaxRP).

This is about $3,000 per month less than the average cost2 for someone with Medicare Part D, the type of insurance people with prostate cancer are most likely to have. Part D patients who use CivicaScript’s abiraterone product will significantly reduce their out-of-pocket cost both during the deductible phase, in which they pay full price for drugs, and during the "doughnut hole" phase, when they again face substantial out-of-pocket costs.

Abiraterone was chosen by CivicaScript members as a priority generic medicine based on its high list price from other manufacturers and significant patient need for the product.

"This is a proud day for CivicaScript as we advance our mission to make generic medicines affordable and available to everyone," said CivicaScript President Gina Guinasso. "I want to thank our members for their active participation in our drug-selection process, which ensures we are focusing on the right medications at the right time, and where we believe we can have immediate impact on people’s lives."

CivicaScript was co-founded in 2020 by Civica Inc., the Blue Cross Blue Shield Association (BCBSA) and 18 independent and locally operated Blue Cross and Blue Shield (BCBS) companies to bring affordable versions of common but high-priced generic medicines to market. Its model is to identify select high-priced generic medicines and work with manufacturing partners to bring them to market at a fraction of their current cost. CivicaScript then works with like-minded payors, PBMs and pharmacies across the country who pass along the cost savings to their customers.

While many generic medicines cost less than brand-name drugs, some high-cost generics are more expensive than they need to be due to lack of competition in the market. Numerous studies confirm that medication costs can dictate whether patients ration their prescriptions or even fill them in the first place. CivicaScript, its members and its manufacturing partners are intent on addressing that problem.

"We’re proud the first lower-cost generic drug of our partnership with CivicaScript is entering the market," said Kim Keck, president and CEO of BCBSA. "This is an important milestone in our shared commitment to help make prescription drugs more affordable for millions of Americans. No one should have to face breaking the bank from buying a life-saving medication."

Initially, CivicaScript’s abiraterone will be available through Lumicera Health Services, a specialty pharmacy that focuses on medicines for chronic and serious conditions, and through Intermountain Healthcare. Additional pharmacies will be listed on the CivicaScript website as they come on board. "We welcome the partnership of other health plans, employers and pharmacies who share our belief that patients come before profits," Guinasso said.

The guiding principle for CivicaScript’s portfolio development is to target both specialty and traditional generics where there is greatest opportunity to substantially reduce prices for patients. The organization is initially focused on six to 10 medications for which there currently is not enough market competition to ensure low, sustainable prices.

Starting in 2024, CivicaScript also intends to distribute low-priced insulin, which will be manufactured by Civica, subject to FDA approval. Civica is building a state-of-the-art manufacturing facility in Petersburg, Virginia, and has entered into a co-development and commercial agreement with GeneSys Biologics for three insulin biosimilars: glargine, lispro and aspart (biologics corresponding to Lantus, Humalog and Novolog, respectively).

Civica plans to set a recommended price to the consumer of no more than $30 per insulin vial and no more than $55 for a box of five insulin pen cartridges, a significant discount to prices charged to uninsured individuals today.3

On August 3, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the second quarter ended June 30, 2022 (Press release, G1 Therapeutics, AUG 3, 2022, View Source [SID1234617334]).

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"The second quarter of 2022 was a period of continued momentum across the G1 organization toward our mission of improving the lives of those impacted with cancer," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "For the first time, our sales team was in full control of COSELA, interacting with prescribers and driving usage and uptake. Thanks to the quality of these engagements, we experienced nearly 60 percent vial volume growth quarter over quarter – our highest quarterly growth rate since the initial launch period. In addition, our clinical team continued to execute on each of our ongoing clinical trials, including achieving important enrollment milestones in our Phase 3 trial of trilaciclib in patients with colorectal cancer and in our Phase 2 bladder cancer and mechanism of action trials."

Second Quarter 2022 and Recent Highlights

Financial

Achieved $8.7 Million in Net COSELA Revenue: G1 recognized total revenues of $10.6 million in the second quarter of 2022, including $8.7 million in net product revenue from sales of COSELA.
Ended the Second Quarter 2022 with Cash and Cash Equivalents of $144.0 Million: The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures into 2024.
Clinical

Completed Enrollment in Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mCRC: Enrollment in PRESERVE 1 is complete at 326 randomized patients; the trial was over-enrolled by approximately 10 percent to compensate for potential loss to follow up at trial sites in Ukraine. The primary endpoint is myeloprotection as measured by duration of severe neutropenia and the occurrence of severe neutropenia during induction. Key secondary endpoints include the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo and the effect of trilaciclib on progression free survival and overall survival compared with placebo. Initial data including the primary endpoint of myeloprotection are expected in the first quarter of 2023. (Press release here)
Completed Enrollment in Phase 2 Clinical Trial Assessing the Mechanism of Action (MOA) of Trilaciclib in Neoadjuvant Breast Cancer: Enrollment is complete at 24 patients in the Phase 2 trial in early stage TNBC to confirm the mechanism of action of trilaciclib in modulating the anti-tumor immune response. The primary endpoints will assess the immune-based MOA, including the impact of trilaciclib on CD8+ T cells and regulatory T cells, or Tregs, in the tumor microenvironment. Secondary endpoints include pathological complete response (pCR), immune response, and profiling measures. Initial data from the primary endpoint are expected in the fourth quarter of 2022.
Achieved Target Patient Enrollment in Phase 2 Clinical Trial of Trilaciclib in Combination with Chemotherapy and Avelumab in Patients with Bladder Cancer (mUC): Target enrollment of 90 patients was achieved in PRESERVE 3; the last few consented patients are expected to enroll shortly. The trial builds on the strong rationale for trilaciclib in combination with chemotherapy and a checkpoint inhibitor (anti-PD-L1); preclinical and published data to date suggest potential for a synergistic effect in known immunogenic tumors. The primary endpoint is progression-free survival. Key secondary endpoints include overall survival, overall response rate, duration of response, and myeloprotection. Initial data including top line response rate and myeloprotection data are expected in the fourth quarter of 2022 followed by data on the primary endpoint of progression free survival in 2023.
Confirmed Expectation for Initial Data from Pivotal Phase 3 Trial of Trilaciclib in Triple Negative Breast Cancer (mTNBC) in the Second Half of 2023: Initial results including interim results for Overall Survival from PRESERVE 2, the Company’s ongoing line extension trial of trilaciclib in approximately 170 patients with PD-L1 positive and negative metastatic TNBC receiving first line gemcitabine and carboplatin, are expected in the second half of 2023. If the trial meets the interim analysis stopping rule, it will terminate, and we will report the topline results. If it does not, the trial will continue to the final analysis.
Confirmed Expectation for Initial Data in the Fourth Quarter of 2022 from Phase 2 Trial of Trilaciclib in Combination with an Antibody-Drug Conjugate (ADC): G1 has reiterated that it expects to release preliminary safety data in the fourth quarter of 2022 from a Phase 2 trial in combination with the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic TNBC.
Medical

Presented Data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Showing that Trilaciclib Helps Protect Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Against Single- and Multilineage Myelosuppressive Events When Used Prior to Chemotherapy: Results of the analysis showed that throughout cycles one through four of first-line therapy, fewer patients with ES-SCLC treated with trilaciclib experienced single-lineage (neutrophil, red blood cell or platelet lineages) and multilineage myelosuppressive events (severe neutropenia, severe anemia, and severe thrombocytopenia)—and fewer events occurred per person—than patients who received placebo. (Press release here)
Presented Data at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Describing the Economic Impact of Trilaciclib for Chemotherapy-Induced Myelosuppression in ES-SCLC): Data showed that from both the US provider and patient-caregiver perspectives, the use of trilaciclib prior to chemotherapy in patients with ES-SCLC is associated with fewer myelosuppressive AEs and less healthcare resource use, translating into lower total cost of care. (Poster available here)
Corporate

Announced Approval of COSELA with Simcere in China: The China National Medical Products Administration (NMPA) has conditionally approved COSELA (trilaciclib hydrochloride for injection), which was jointly developed for use in Greater China by Simcere and G1. As a result of receiving approval in China, G1 will receive a $13 million milestone payment. In total, G1 may receive up to $156M in total milestones, and double-digit royalties on annual net sales of COSELA in China (Press release here)
Announced Appointments of Norman E. "Ned" Sharpless, M.D. and Jacks Lee to Board of Directors: Dr. Sharpless, the former Director of the National Cancer Institute (NCI) of the National Institutes of Health, is an accomplished oncologist and seasoned public servant who has treated cancer patients, investigated the biologic basis of cancer, and has led academic institutions and government agencies including the NCI. (Press release here). Mr. Lee, the Senior Vice President – Manufacturing & Supply of Merck & Co., brings more than 30 years of experience in manufacturing and supply chain management in the life sciences industry, spanning across technical, operational, and strategic leadership roles in science-technology, engineering, quality, supply chain, and manufacturing. (Press release here)
Second Quarter 2022 Financial Results

As of June 30, 2022, cash and cash equivalents totaled $144.0 million, compared to $221.2 million as of December 31, 2021.

Total revenues for the second quarter of 2022 were $10.6 million, including $8.7 million in net product sales of COSELA and license revenue of $1.9 million. This license revenue is primarily related to revenue recognized from amounts to be reimbursed by EQRx and Simcere for costs associated with clinical trials.

Operating expenses for the second quarter of 2022 were $47.5 million, compared to $44.8 million for the second quarter of 2021. GAAP operating expenses include stock-based compensation expense of $5.6 million for the second quarter of 2022, compared to $5.7 million for the second quarter of 2021.

Cost of goods sold expense for the second quarter of 2022 was $1.0 million compared to $0.8 million for the second quarter of 2021, primarily due to an increase in product sales.

Research and development (R&D) expenses for the second quarter of 2022 were $20.8 million, compared to $18.8 million for the second quarter of 2021. The increase in R&D expenses was primarily due to an increase in clinical trial costs offset by a decrease in costs for manufacturing of active pharmaceutical ingredients and drug product to support clinical trials.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2022 were $25.7 million, compared to $25.2 million for the second quarter of 2021. The increase in SG&A expenses was due to increased personnel costs related to headcount and an increase in insurance and other administrative costs. The increase is offset by a decrease in medical affairs costs, commercialization activities, professional and legal fees, and IT-related costs.

The net loss for the second quarter of 2022 was $39.4 million, compared to $39.4 million for the second quarter of 2021. The basic and diluted net loss per share for the second quarter of 2022 was $(0.92) compared to $(0.94) for the second quarter of 2021.

Financial Guidance

G1 expects its current cash and cash equivalents of $144.0 million to be sufficient to fund its operations and capital expenditures into 2024.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the second quarter 2022 ended June 30, 2022.

Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.