On May 4, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 4, 2022, View Source [SID1234613471]).

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"We have made significant progress on our 2022 goals so far this year, demonstrating our commercial success with QINLOCK, strengthening our balance sheet, and rapidly advancing our potential best-in-class and first-in-class clinical-stage pipeline," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "The strong commercial launch of QINLOCK in Germany underscores the long-term potential for this medicine to benefit patients with GIST around the world. The pivotal Phase 3 MOTION study of vimseltinib, which we are developing for the treatment of tenosynovial giant cell tumor, or TGCT, is now enrolling patients and we expect to present updated results from the Phase 1/2 study in patients with TGCT in the second half of this year."

Mr. Hoerter continued, "We are very excited about our potential first-in-class autophagy pathway inhibitor, DCC-3116. At this year’s AACR (Free AACR Whitepaper) Annual Meeting, we presented encouraging preclinical data for DCC-3116 in combination with KRASG12C inhibitors highlighting the broad potential of this product candidate to benefit patients. We expect to present initial data from the single agent dose escalation portion of the Phase 1 study later this year."

First Quarter 2022 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $28.8 million in QINLOCK net product revenue in the first quarter of 2022, including $23.4 million in U.S. net product revenue and $5.4 million in international net product revenue.
Launched in Germany and received authorization for the post-approval paid access program in France.
Received a favorable ASMR III rating for QINLOCK from the Transparency Commission of the French National Authority for Health.
Vimseltinib

Continued enrollment and site activation in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT who are not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST v1.1 by blinded independent central review.
Expects to present updated results from the ongoing Phase 1/2 study in TGCT patients in the second half of 2022.
DCC-3116

Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022.
The results showed that treatment of mutant KRASG12C NSCLC cell lines with KRASG12C inhibitors sotorasib and adagrasib induced autophagy via activation of ULK1/2 kinases as measured by an increase in ULK-mediated phosphorylation of the key ULK autophagy substrate ATG13 and resulting increase in autophagic flux.
DCC-3116 in combination with KRASG12C inhibitors translated to deeper and longer tumor regressions in mutant KRASG12C NSCLC models in vivo than with KRASG12C inhibitors alone.
Expects to present data in the second half of 2022 from the single agent dose escalation portion of the Phase 1 study of DCC-3116 in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.
Expects to initiate three Phase 1b study combination dose escalation cohorts in the second half of 2022:
In combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations.
In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations, subject to feedback from regulatory authorities.
In combination with sotorasib, an FDA- approved KRASG12C inhibitor, in patients with advanced or metastatic solid tumors with KRASG12C mutations, subject to feedback from regulatory authorities.
Expects to present additional preclinical data for DCC-3116 in the second half of 2022 and continue to explore preclinical combinations with multiple additional anti-cancer agents with diverse mechanisms of action.
Proprietary Drug Discovery Platform

Expects to nominate a development candidate in 2022 from the pan-RAF inhibitor research program discovered using the Company’s novel switch-control inhibitor platform.
Corporate Updates

Announced the closing in April 2022 of an underwritten public offering of 7,501,239 shares of the Company’s common stock at a public offering price of $10.00 per share and, in lieu of common stock to certain investors, the Company issued pre-funded warrants to purchase 9,748,761 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The shares of common stock sold include 2,250,000 shares pursuant to the option granted by the Company to the underwriters, which option was exercised in full. This offering resulted in net proceeds of $163.4 million after deducting underwriting discounts and commissions and other offering expenses.
First Quarter 2022 Financial Results

Revenue: Total revenue for the first quarter was $29.2 million, which includes $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue compared to $25.2 million of total revenue, including $20.0 million of net product revenue of QINLOCK and $5.2 million of collaboration revenue, for the same period in 2021.
Cost of Sales: Cost of sales were $0.4 million in the first quarter ended March 31, 2022 compared to $0.2 million in the same period in 2021. Cost of sales for newly launched products will not include the full cost of manufacturing until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. Deciphera does not expect the cost of sales as a percentage of net sales of QINLOCK to increase significantly after the Company has sold all zero cost inventories and commenced the sales of inventories that will reflect the full cost of manufacturing. The Company expects to continue to sell zero cost inventories of QINLOCK in the U.S. during 2022.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $47.4 million, compared to $55.7 million for the same period in 2021. The decrease was primarily due to lower clinical trial costs related to QINLOCK, including INTRIGUE, our Phase 3 study for the treatment of second-line GIST for which top-line results were announced in November 2021, and the discontinuation of our rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, partially offset by an increase in clinical trial costs related to our Phase 1 study of DCC-3116, preclinical costs, and personnel costs. Non-cash, stock-based compensation was $6.3 million and $5.0 million for the first quarters of 2022 and 2021, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2022 were $28.3 million, compared to $30.7 million for the same period in 2021. The decrease was primarily due to a decrease in professional and consultant fees. Non-cash, stock-based compensation was $8.0 million and $6.2 million for the first quarters of 2022 and 2021, respectively.
Net Loss: For the first quarter of 2022, Deciphera reported a net loss of $46.9 million, or $0.80 per share, compared with a net loss of $61.3 million, or $1.06 per share, for the same period in 2021.
Cash Position: As of March 31, 2022, cash, cash equivalents, and marketable securities were $275.4 million, compared to $327.6 million as of December 31, 2021. In April 2022, the Company completed an underwritten public offering that resulted in aggregate net proceeds of $163.4 million. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 4, 2022 at 8:00 AM ET. The conference call may be accessed by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international). A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On May 4, 2022 Bristol Myers Squibb (NYSE: BMY) reported that the company will take part in a fireside chat at the Bank of America Securities 2022 Healthcare Conference in Las Vegas, Nevada on Wednesday, May 11, 2022 (Press release, Bristol-Myers Squibb, MAY 4, 2022, View Source [SID1234613470]). Adam Lenkowsky, Senior Vice President and General Manager, U.S. Commercialization, will answer questions about the company at 12:00 p.m. PT/3:00 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source Material related to the company’s presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.

On May 4, 2022 PharmaMar (MSE:PHM) reported that it has submitted a conditional marketing authorization application to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, PharmaMar, MAY 4, 2022, View Source [SID1234613469]). The application is to seek approval for treatment with Zepzelca (lurbinectedin) in adult patients with metastatic Small Cell Lung Cancer (SCLC) who have progressed following prior platinum-based chemotherapy.

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This registration application is based on data from the Phase II basket trial with lurbinectedin, in monotherapy, for the treatment of SCLC. This is the same trial that was used for the conditional approval of lurbinectedin in the US for the same indication and whose results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), ASCO (Free ASCO Whitepaper), meeting in June 2019.

Lurbinectedin received "Accelerated Approval" from the FDA in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression and is already the standard of care in the US. In 2021, lurbinectedin also received marketing authorization in the United Arab Emirates, Canada, Australia and Singapore.

According to regulations, an accelerated authorization requires a confirmatory trial, so PharmaMar announced in December 2021 the start of a confirmatory Phase III clinical trial, LAGOON, evaluating lurbinectedin for the treatment of patients with recurrent SCLC, which will also be used to apply for registration in Europe.

On May 4, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that financial results for the first quarter of 2022 and provided a business update (Press release, Regeneron, MAY 4, 2022, View Source [SID1234613468]).

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"Our strong first quarter performance was marked by top- and bottom-line growth, accompanied by R&D progress and continued investment in our pipeline," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We continued to see substantial U.S. sales growth for EYLEA and Dupixent worldwide. We are well-positioned to reach even more patients with type 2 inflammatory disease through FDA priority review designations for Dupixent in children with atopic dermatitis and in adults and adolescents with eosinophilic esophagitis."

"Our business achieved strong revenue growth in the first quarter of 2022 as we continue to realize the benefits of our sustained R&D investment and our focus on commercial execution," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "We remain confident that our differentiated products and significant pipeline opportunities position us well to deliver strong results and provide sustainable value to patients and shareholders."

Business Highlights

Key Pipeline Progress

Regeneron has approximately 35 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

EYLEA (aflibercept) Injection

A supplemental Biologics License Application (sBLA) for EYLEA for an every-16-weeks dosing regimen in patients with non-proliferative diabetic retinopathy (NPDR) was submitted.
Aflibercept 8 mg

In February 2022, the Company announced detailed results from its Phase 2 trial evaluating an investigational 8 mg high dose of aflibercept compared to the currently-approved 2 mg dose of EYLEA in patients with neovascular age-related macular degeneration (wet AMD). The trial met its primary endpoints for safety, and no new safety signals were observed through week 44. Consistent with initial data announced last year, aflibercept 8 mg continued to show numeric improvements in anatomical and vision outcomes compared to EYLEA through 44 weeks.
Dupixent (dupilumab)

In April 2022, the European Commission (EC) approved Dupixent for the treatment of severe asthma in children aged 6 to 11 years.
The U.S. Food and Drug Administration (FDA) accepted for priority review the sBLA for Dupixent for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis, with a target action date of June 9, 2022. A regulatory application was also submitted in the European Union (EU).
The FDA accepted for priority review the sBLA for Dupixent for adults and adolescents aged 12 years and older with eosinophilic esophagitis (EoE), with a target action date of August 3, 2022. A regulatory application was also submitted in the EU.
In January 2022, the Company and Sanofi announced positive results from a second Phase 3 trial in adults with uncontrolled prurigo nodularis. An sBLA and a regulatory submission in the EU for Dupixent for adults with uncontrolled prurigo nodularis were subsequently submitted.
In February 2022, the Company and Sanofi provided an update on Dupixent in patients with chronic spontaneous urticaria (CSU), in which they had previously reported positive results from the first trial in biologic-naïve patients (i.e., not previously treated with omalizumab) that showed Dupixent significantly reduced itch and hives compared to standard-of-care antihistamines alone. The Company and Sanofi announced that they stopped a second trial in patients refractory to omalizumab due to futility.
Antibodies to SARS-CoV-2 virus

In April 2022, the Company announced that the FDA extended by three months its review of the BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. The FDA determined these additional data constitute a Major Amendment to the BLA and provided a new target action date of July 13, 2022.
A regulatory application was submitted in the EU for RonapreveTM(b) for the treatment of COVID-19 in hospitalized patients.
In January 2022, the FDA revised the Emergency Use Authorization (EUA) for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as an Omicron-lineage variant that is not susceptible to the treatment. If, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised.
The Company is progressing investigational "next generation" antibodies that are active against multiple variants including those of Omicron-lineage, and has initiated a first-in-human clinical trial.
Fianlimab, an antibody to LAG-3

A Phase 3 study in first-line metastatic melanoma was initiated.
Odronextamab, a CD20xCD3 bispecific antibody

The FDA granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma.
NTLA-2001, a CRISPR/Cas9 therapeutic for TTR gene knockout

In February 2022, Intellia Therapeutics, Inc. and the Company reported updated positive interim data from the Phase 1 trial in transthyretin (ATTR) amyloidosis.
Business Development Update

In April 2022, the Company entered into a definitive merger agreement to acquire Checkmate Pharmaceuticals, Inc. at a total equity value of approximately $250 million. On May 2, 2022, the Company initiated a tender offer to acquire any and all outstanding shares of Checkmate common stock at a price of $10.50 per share, to be paid to each shareholder tendering Checkmate shares in cash, without interest, subject to reduction for any applicable withholding taxes. The transaction is expected to close, subject to the satisfaction of customary closing conditions including regulatory approvals, in mid-2022.
First Quarter 2022 Financial Results

Revenues

Total revenues increased by 17% to $2.965 billion in the first quarter of 2022, compared to $2.529 billion in the first quarter of 2021. Total revenues excluding REGEN-COV and Ronapreve(b) revenues for both periods increased by 25% to $2.749 billion in the first quarter of 2022, compared to the first quarter of 2021(a).

Net product sales recorded by the Company consist of the following:

Total revenues also include collaboration revenues(c) of $1.233 billion in the first quarter of 2022, compared to $754 million in the first quarter of 2021. Sanofi collaboration revenue increased primarily due to the Company’s share of profits from commercialization of antibodies, which were $415 million in the first quarter of 2022, compared to $261 million in the first quarter of 2021. The change in the Company’s share of profits from commercialization of antibodies was driven by higher Dupixent profits. In the first quarter of 2022, the Company earned a $50 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States exceeding $2.0 billion on a rolling twelve-month basis.

Bayer collaboration revenue increased to $385 million in the first quarter of 2022, compared to $323 million in the first quarter of 2021.

The Company also recorded Roche collaboration revenue of $216 million for the first quarter of 2022, compared to $67 million in the first quarter of 2021, in connection with payments from Roche attributable to global gross profits from sales of Ronapreve.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue in the first quarter of 2022 included a $30 million up-front payment received from Ultragenyx in connection with the Company’s Evkeeza license and collaboration agreement.

GAAP and non-GAAP R&D expenses increased in the first quarter of 2022, compared to the first quarter of 2021, primarily due to higher headcount and headcount-related costs, an increase in clinical manufacturing activities, and lower reimbursements from Roche related to REGEN-COV. The increase was partly offset by lower costs incurred in connection with REGEN-COV development activities.
Acquired IPR&D in the first quarter of 2022 included a $20 million opt-in payment in connection with a product candidate under the Company’s collaboration agreement with Adicet Bio, Inc.
The increase in GAAP and non-GAAP SG&A expenses in the first quarter of 2022, compared to the first quarter of 2021, was primarily due to higher headcount and headcount-related costs and an increase in commercialization-related expenses for EYLEA.
GAAP COGS in the first quarter of 2022 included $58 million of costs related to REGEN-COV, including inventory write-offs and reserves, as a result of the FDA revision of the EUA for REGEN-COV (as described above). GAAP and non-GAAP COGS in the first quarter of 2022 included lower REGEN-COV manufacturing costs since there were no net product sales in the United States.
COCM increased in the first quarter of 2022, compared to the first quarter of 2021, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent and an increase in shipments of commercial supplies of Praluent for Sanofi outside the United States.
Other Financial Information

GAAP other income (expense) included the recognition of net unrealized losses on equity securities of $211 million in the first quarter of 2022, compared to $144 million of net unrealized gains in the first quarter of 2021.

In the first quarter of 2022, the Company’s GAAP effective tax rate was 8.3%, compared to 11.0% in the first quarter of 2021. The decrease in the GAAP effective tax rate was due in part to the impact of stock-based compensation. In the first quarter of 2022, the non-GAAP effective tax rate was 11.6%, compared to 10.5% in the first quarter of 2021.

GAAP net income per diluted share was $8.61 in the first quarter of 2022, compared to $10.09 in the first quarter of 2021. Non-GAAP net income per diluted share was $11.49 in the first quarter of 2022, compared to $9.89 in the first quarter of 2021. A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

During the first quarter of 2022, the Company repurchased shares of common stock under its share repurchase program, and recorded the cost of the shares received, or $352 million, as Treasury Stock. As of March 31, 2022, $2.493 billion remained available for share repurchases under the program.

Net cash provided by operating activities in the first quarter of 2022 was $2.102 billion, compared to $669 million in the first quarter of 2021, resulting in $1.960 billion in free cash flow for the first quarter of 2022, compared to $553 million for the first quarter of 2021. The increase in free cash flow in the first quarter of 2022 was primarily due to the Company’s collection of amounts due from the U.S. government in connection with REGEN-COV sales in the fourth quarter of 2021.

2022 Financial Guidance(d)

The Company’s full year 2022 financial guidance consists of the following components:

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded.

** ETR guidance excludes the impact of the provision requiring capitalization and amortization of R&D expenses enacted as part of the Tax Cuts and Job Act (TCJA), as management’s current expectation is it will be deferred or repealed by Congress in 2022. If this provision of the TCJA is not deferred or repealed, the Company would expect its ETR to be lower than the guidance disclosed herein.

A reconciliation of full year 2022 GAAP to non-GAAP financial guidance is included below:

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its first quarter 2022 financial and operating results on Wednesday, May 4, 2022, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast on the "Investors and Media" page of Regeneron’s website at www.regeneron.com. To participate via telephone, please register in advance at View Source Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On May 4, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that financial update for the first quarter ended March 31, 2022 (Press release, G1 Therapeutics, MAY 4, 2022, View Source [SID1234613467]).

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"The first quarter of 2022 was a period of transition and execution across the G1 business," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "In March of this year, we entered a new phase for COSELA promotion as we transitioned fully away from our commercial launch partner Boehringer Ingelheim and put the promotion of COSELA into the hands of our newly deployed G1 sales team; the strong month over month sales performance in March adds to the evidence of good early access to key accounts by our team. Our sales and commercial teams are now fully engaged in driving depth in key top organizations. Regarding our clinical programs, we are approaching a data-rich period, as we currently expect initial results from each of our ongoing Phase 2 and Phase 3 trials over the coming 18 months, starting with data from our three Phase 2 trials in the fourth quarter of this year."

First Quarter 2022 and Recent Highlights

Financial

Achieved Total Revenue of $6.9 Million: G1 recognized total revenues of $6.9 million in the first quarter of 2022, including $5.5 million in net product revenue from sales of COSELA.
Ended the First Quarter 2022 with Cash and Cash Equivalents of $183.0 Million: The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures into 2024.
Commercial

Fully Deployed COSELA Sales Team: On March 2, 2022, the co-promotion agreement for COSELA between G1 and Boehringer Ingelheim was terminated. As of February 15, 2022, G1 had fully deployed its sales team into regions across the U.S. to accelerate sales activities and help maximize the adoption of COSELA.
Clinical

Reiterated Expectation of Initial Data in the Fourth Quarter of 2022 from Three Phase 2 Trials of Trilaciclib: G1 has reiterated that it expects to release initial data from multiple ongoing Phase 2 clinical trials of trilaciclib in the fourth quarter of 2022. These trials include a Phase 2 trial of trilaciclib in combination with avelumab in bladder cancer; a Phase 2 trial in combination with the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC); and a Phase 2 trial designed to confirm the mechanism of action of trilaciclib in modulating the anti-tumor immune response with and without a checkpoint inhibitor in early stage TNBC.
Reiterated Expectation of Initial Data in 2023 from Two Phase 3 Trials of Trilaciclib: G1 expects to release data from two ongoing pivotal Phase 3 clinical trials of trilaciclib in 2023. Initial results including myeloprotection and Objective Response Rate (ORR) endpoints from PRESERVE 1, our ongoing line extension trial of trilaciclib in patients with colorectal cancer (CRC) receiving first line trilaciclib or placebo administered prior to FOLFOXIRI and bevacizumab, are expected in the first quarter of 2023. Initial results including interim results for Overall Survival (OS) from PRESERVE 2, our ongoing line extension trial of trilaciclib in PD-L1 positive and negative patients with TNBC receiving first line gemcitabine and carboplatin, are expected in the second half of 2023.
Medical

Presented New Real-World Data at the Annual Conference of the National Comprehensive Cancer Network (NCCN) Showing the Impact of Trilaciclib on Hospitalizations and the Burden of Myelosuppression in Patients with ES-SCLC Treated with Chemotherapy: Results showed that the use of trilaciclib prior to chemotherapy was associated with a 50% reduction in the percent of patients with grade ≥ 3 myelosuppressive hematologic adverse events in at least one blood cell lineage and a 74% reduction in the percent of all-cause hospitalizations (days 1 to 21 after treatment), compared to patients who received chemotherapy alone. The analyses were derived using structured, real-world, de-identified clinical patient level data from the Integra Connect oncology warehouse. (Press release here)
Published Data in Cancer Treatment and Research Communications Showing Treatment Patterns and the Burden of Myelosuppression for Patients with Small Cell Lung Cancer (SCLC): Results of this retrospective study showed that 42 percent of small-cell lung cancer patients failed to complete the recommended number of chemotherapy cycles, and 74 percent of patients were admitted to the hospital due to a myelosuppressive event, thus underscoring the burden of myelosuppression. Additionally, health care resource utilization associated with myelosuppression was prominent, suggesting a substantial burden on older patients with SCLC. These data were derived from a descriptive, retrospective study of patients with SCLC aged ≥65 years, identified from linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data. (Publication available here)
Corporate

Strategic Decision Made to Discontinue the Rintodestrant Program: After completing our evaluation of the rintodestrant partnering options and recent data in the highly competitive oral SERD space, G1 has made the strategic decision to discontinue the program, including all clinical and partnering efforts. G1 will responsibly wind down all remaining clinical efforts for rintodestrant by the end of this year and revert the rights back to the originator (University of Illinois Chicago); there are no additional financial obligations due to the originator resulting from the reversion.
First Quarter 2022 Financial Results

As of March 31, 2022, cash and cash equivalents totaled $183.0 million, compared to $221.2 million as of December 31, 2021.

Total revenues for the first quarter of 2022 were $6.9 million, including $5.5 million in net product sales of COSELA and license revenue of $1.4 million. This license revenue is primarily related to clinical trial reimbursements from EQRx and Simcere.

Operating expenses for the first quarter of 2022 were $53.7 million, compared to $39.8 million for the first quarter of 2021. GAAP operating expenses include stock-based compensation expense of $5.8 million for the first quarter of 2022, compared to $5.9 million for the first quarter of 2021.

Cost of goods sold expense for the first quarter of 2022 were $0.7 million compared to $0.2 for the first quarter of 2021. The increase is related to the Company’s period costs for the sales of COSELA, including third-party logistics costs for the sales of COSELA, inventory overhead costs, and personnel costs.

Research and development (R&D) expenses for the first quarter of 2022 were $26.3 million, compared to $16.5 million for the first quarter of 2021. The increase in R&D expenses was driven by an increase in clinical trial spend related to increased activity in all of our clinical trials including an acceleration of enrollment in our Phase 3 CRC trial, which is partially offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug product to support clinical trials.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2022 were $26.7 million, compared to $23.0 million for the first quarter of 2021. The increase in SG&A expenses was largely due to an increase in personnel costs due to increased headcount, and an increase in professional services, insurance and other administrative costs.

The net loss for the first quarter of 2022 was $49.2 million, compared to $26.4 million for the first quarter of 2021. The basic and diluted net loss per share for the first quarter of 2022 was $(1.15) compared to $(0.65) for the first quarter of 2021.

Financial Guidance

G1 expects its current cash position of $183.0 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 first quarter 2022 ended March 31, 2022. The live call may be accessed by dialing (866) 763-6020 (domestic) or (409) 216-0626 (international) and entering the conference code: 2229795. 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.

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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.