On August 8, 2022 Daiichi Sankyo (TSE: 4568) reported that the first patient has been dosed in the global HERTHENA-Lung02 phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with disease progression following treatment with one or more EGFR tyrosine kinase inhibitors (TKIs) including a third-generation EGFR TKI (Press release, Daiichi Sankyo, AUG 8, 2022, View Source [SID1234617811]).

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Patritumab deruxtecan is a specifically designed potential first-in-class HER3 directed antibody drug conjugate (ADC) discovered and being developed by Daiichi Sankyo.

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 Approximately 80% to 85% of lung cancer is classified as NSCLC with EGFR mutations occurring in up to 30% of tumors.2,3 While the efficacy and safety of targeted therapy with EGFR TKIs is well-established for the treatment of advanced EGFR-mutated NSCLC, the development of a broad range of resistance mechanisms is likely to lead to disease progression.4,5,6 After failure of one or more EGFR TKIs, platinum-based chemotherapy and subsequent salvage therapies have limited efficacy.7

"We are encouraged by the early results seen with patritumab deruxtecan and have initiated HERTHENA-Lung02 to further evaluate whether this HER3 directed antibody drug conjugate will be more effective than standard chemotherapy in treating patients with previously treated EGFR-mutated metastatic non-small cell lung cancer," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Clinical Development, Oncology R&D, Daiichi Sankyo. "Initiating this phase 3 trial emphasizes our ongoing commitment to accelerate development of patritumab deruxtecan to potentially improve the standard of care for patients with this specific subtype of lung cancer."

About HERTHENA-Lung02

HERTHENA-Lung02 is a global, multicenter, open-label, phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg) versus platinum-based chemotherapy (pemetrexed in combination with cisplatin or carboplatin) in patients with locally advanced or metastatic non-squamous NSCLC with an EGFR-activating mutation (exon 19 deletion or exon 21 L858R mutation) previously treated with an EGFR TKI with disease progression on or after treatment with a third-generation TKI. Patients will be randomized 1:1 to receive patritumab deruxtecan or platinum-based chemotherapy.

The primary endpoint of HERTHENA-Lung02 is progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include overall survival, investigator-assessed PFS as well as BICR and investigator-assessed objective response rate, clinical benefit rate, disease control rate, duration of response, time to response and safety. HERTHENA-Lung02 will enroll approximately 560 patients at multiple sites across Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide.1 Approximately 80% to 85% of lung cancer is classified as NSCLC with EGFR mutations occurring in up to 30% of tumors.2,3 NSCLC is diagnosed at an advanced stage in more than 50% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy.8,9,10

The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic NSCLC, and for patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and PFS compared to chemotherapy.11 However, most patients eventually develop resistance to these therapies and subsequent therapies after EGFR TKI with platinum-based chemotherapy have limited efficacy with PFS of approximately 6.4 months.7,12

HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.13 It is estimated that about 83% of all NSCLC tumors express the HER3 protein. Overexpression is associated with metastatic progression and decreased relapse-free survival.14

New treatment approaches are needed to overcome resistance and improve survival in EGFR-mutated NSCLC. Currently, there is no HER3 directed medicine approved for the treatment of any cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd) is one of three lead DXd ADCs in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other anticancer therapies. In addition to the HERTHENA-Lung02 trial, patritumab deruxtecan is being evaluated in HERTHENA-Lung01, a pivotal phase 2 trial in patients with EGFR-mutated locally advanced or metastatic NSCLC previously treated with a EGFR TKI and platinum-based chemotherapy; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with unresectable or metastatic NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been recently completed.

In December 2021, patritumab deruxtecan was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic or locally advanced EGFR-mutated NSCLC with disease progression on or after treatment with a third-generation TKI and platinum-based therapies.

Patritumab deruxtecan is an investigational medicine that has not been approved for any indication in any country. Safety and efficacy have not been established.

On August 8, 2022 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2022, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook (Press release, Clovis Oncology, AUG 8, 2022, View Source [SID1234617765]).

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"We achieved a key milestone in the second quarter, with the presentations of the first clinical data from the LuMIERE trial of FAP-2286 and from the ongoing imaging-only investigator-initiated study. In addition to seeing the first evidence of safety and clinical activity, these initial results further demonstrate that fibroblast activation protein, or FAP, is a promising theranostic target with expression across many types of solid tumors," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Turning to Rubraca, following the positive results from ATHENA-MONO, we believe Rubraca represents an important new option as a front-line maintenance treatment of ovarian cancer, and we are on track for submissions to the FDA and EMA during the third quarter of 2022. Lastly, we look forward to the anticipated Phase 3 data readout of TRITON3 in the second-line prostate cancer treatment setting for selected patients now expected early in the fourth quarter this year and ATHENA-COMBO in combination with Opdivo in the front-line ovarian cancer maintenance treatment setting in the first quarter of 2023."

Second Quarter 2022 Financial Results
Clovis reported global net product revenues for Rubraca of $32.1 million for Q2 2022, which included US product revenues of $22.7 million and ex-US product revenues of $9.4 million. This represents a sequential 6% decrease over Q1 2022 and a 13% decrease year-over-year, compared to Q2 2021 net product revenues of $36.8 million, which included US net product revenues of $27.7 million and ex-US net product revenues of $9.1 million. The reduction in ovarian cancer diagnoses and fewer patient starts in the US in previous quarters as a result of COVID has continued to impact second-line maintenance treatment. While it does appear that ovarian cancer diagnoses are reverting to pre-COVID levels, the effect of this increase is almost wholly observed on front-line treatments and will not likely impact the second-line indications for several quarters. In addition, we believe that the adoption of PARP inhibitors in the front-line setting is impacting the use of PARP inhibitors in the second-line setting in the US.

Clovis reported net product revenue for Rubraca of $66.4 million for the six months ended June 30, 2022, which included US product revenue of $47.2 million and ex-U.S. product revenue of $19.2 million, compared to net product revenue for same period in 2021 of $74.9 million, which included US net product revenue of $59.4 million and ex-US net product revenue of $15.5 million.

Research and development expenses totaled $36.4 million for Q2 2022, down 20% compared to $45.8 million for the comparable period in 2021, due primarily to lower spending on Rubraca clinical trials. For the six months ended June 30, 2022, research and development expenses totaled $78.7 million, down 20% compared to $98.6 million for the comparable period in 2021.

Selling, general and administrative expenses totaled $32.6 million for Q2 2022, down 1% compared to $32.9 million for the comparable period in 2021. For the six months ended June 30, 2022, SG&A expenses totaled $61.8 million, down 2% compared to $62.9 million for the comparable period in 2021.

Included in Q2 2022 results is a one-time, non-cash adjustment of $9.7 million in other manufacturing costs related to the expected expiration of Rubraca currently in inventory. There were no such costs in Q2 2021.

Clovis reported a net loss for Q2 2022 of $71.3 million, or ($0.50) per share, compared to a net loss for Q2 2021 of $66.4 million, or ($0.61) per share. Net loss for Q2 2022 included share-based compensation expense of $5.4 million, compared to $7.4 million for the comparable period of 2021.

Clovis had $94.6 million in cash and cash equivalents as of June 30, 2022. As of June 30, 2022, the Company had drawn $165.2 million under the Sixth Street Partners, LLC (SSP) ATHENA clinical trial financing and had up to $9.8 million available to draw under the agreement to fund the expenses of the ATHENA trial.

Based on the Company’s current cash, cash equivalents and liquidity available under its ATHENA clinical financing agreement, together with current estimates for revenues generated by sales of Rubraca, the Company will need to raise additional capital in the near term in order to fund its operating plan and to continue as a going concern beyond February of 2023. The proposed reverse stock split of Clovis common stock, which would have had the effect of increasing the number of authorized but unissued and unreserved shares of common stock available for the Company to issue, was not approved at the Clovis 2022 Annual Meeting of Stockholders. Although approximately 58% of shares voted supported the proposal, the affirmative vote of holders of a majority of the issued and outstanding shares of common stock was necessary for this proposal to be approved. Without the approval of an increase in authorized shares of common stock, Clovis is not able to raise meaningful additional capital through public or private equity-based offerings. Therefore, the Company is currently exploring alternatives and strategies to increase the number of shares that would be available for issuance to permit greater flexibility in raising capital through equity financing transactions, including the offer and sale of super-voting mirrored preferred stock that have been utilized by peers in similar situations to support approval of such proposals where the existing votes of stockholders already indicate favorable support.

Clovis is actively exploring sources of funding other than equity financing transactions, including through entering into strategic partnerships or licensing arrangements for one or more of our products or product candidates. Clovis is currently in preliminary discussions related to partnering certain development and commercialization rights to FAP-2286, for which the Company seeks consideration such as an upfront payment and additional payments in the form of milestones, research and development support and royalties. However, Clovis cannot be certain that such efforts will result in a final agreement or that the timing and amounts of such payments, including contingent payments, would be sufficient to meet the Company’s liquidity needs in the absence of other sources of funding. In order to raise sufficient capital to fund the Company’s operating plan and to continue as going concern beyond February of 2023, the Company expects it would need to successfully complete some combination of the strategic initiatives and equity financing.

Net cash used in operating activities was $35.1 million for Q2 2022, down 25% from the $46.8 million reported in Q2 2021.

Cash burn in Q2 2022 was $26.4 million, down 21% from $33.4 million in Q2 2021, and down 46%, or $22.9 million from the $49.3 million of cash burn reported in Q1 2022. Cash burn for the first six months of 2022 was $75.6 million, down 7% from $81.5 million in the first six months of 2021.

Clovis Oncology Pipeline Highlights

Initial Phase 1 FAP-2286 LuMIERE Data Highlighted at SNMMI 2022 Annual Meeting
FAP-2286 is the first peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP) to enter clinical development and is the lead candidate in Clovis Oncology’s targeted radiotherapy (TRT) development program. The Phase 1 portion of the LuMIERE study, for which enrollment in the third of four planned dose cohorts is ongoing, is evaluating the safety of the FAP-targeting investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) is being used as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment in LuMIERE. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types and are expected to initiate in the fourth quarter of 2022.

Initial FAP-2286 Phase 1 data from LuMIERE were presented in an oral session at the SNMMI 2022 Annual Meeting in June. Overall, in nine patients treated in the first two dose cohorts,177Lu-FAP-2286 demonstrated a manageable safety profile and early evidence of activity, with a confirmed RECIST partial response in one patient treated at the lowest dose in the trial.

Treatment-emergent adverse events (TEAEs) were found to be generally mild to moderate among the nine patients in the safety population receiving 3.7 or 5.55 GBq/dose of the investigational therapeutic agent 177Lu-FAP-2286.

Also, updated data from the UCSF investigator-initiated Phase 1 study of FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) as a novel imaging agent to identify metastatic cancer in patients with solid tumors were presented at ASCO (Free ASCO Whitepaper) and SNMMI.

Updated LuMIERE data have been accepted as an oral presentation at the 2022 European Association of Nuclear Medicine (EANM) Annual Congress on October 17, 2022, in Barcelona, Spain.

Finally, in addition to investigating for therapeutic use FAP-2286 labeled with the beta particle-emitting lutetium-177, Clovis is also exploring FAP-2286 labeled with the alpha particle-emitting actinium-225 (Ac-225), and in June, Clovis entered a long-term supply agreement with NorthStar Medical Radioisotopes, LLC, for the therapeutic medical radioisotope, Ac-225. Under terms of the agreement, NorthStar will provide Clovis with its high purity non-carrier-added (n.c.a.) Ac-225.

For more information about FAP-2286, TRT, or Clovis’ TRT development program, click here.

ATHENA-MONO Data Presented at ASCO (Free ASCO Whitepaper) 2022 and published in the Journal of Clinical Oncology (JCO)
ATHENA is a double-blind, placebo-controlled, Phase 3 trial of rucaparib in front-line ovarian cancer maintenance treatment. It has two parts which are statistically independent. The results presented at ASCO (Free ASCO Whitepaper) are from the ATHENA-MONO part (rucaparib versus placebo).

The ATHENA-MONO trial met its primary endpoint, showing Rubraca monotherapy versus placebo improved progression-free survival (PFS) by investigator assessment in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT). Significant improvement in PFS by BICR assessment, a secondary endpoint of the study, was also observed in both the HRD-positive and ITT populations. A benefit in PFS was also seen in the exploratory subgroup of patients with HRD-negative tumors, those within the HRD-positive population with either BRCA mutant or BRCA wild type/loss of heterozygosity (LOH) high tumors and those with BRCA wild type disease whose LOH status could not be determined, with results similar for investigator- and BICR-assessment. The safety of Rubraca observed in ATHENA-MONO was consistent with both the current US and European labels.

For this indication, Clovis intends to submit a supplemental New Drug Application (sNDA) to the US Food and Drug Administration and a Type II variation to the European Medicines Agency (EMA) during the third quarter of 2022. The FDA has recommended that the Company wait for more mature overall survival data from ATHENA-MONO to submit the sNDA or, if it chooses to submit the sNDA prior to receiving more mature overall survival data, then the sNDA may need to be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting. In addition, the FDA will consider overall survival data from other rucaparib clinical trials when it reviews the ATHENA-MONO dataset. The Company believes that the encouraging PFS results, the primary endpoint of the study, are strongly supportive of an approval and of use in the front-line setting, and are grateful for the support of the clinical community familiar with the results. There can be no assurances regarding the timing or outcome of the FDA and EMA reviews of the submissions.

Rubraca is not currently approved in the front-line ovarian cancer maintenance treatment setting.

Two Remaining Rubraca Phase 3 Study Readouts Expected in Next Three Quarters
Top-line data from the ATHENA-COMBO portion of the ATHENA Phase 3 study in front-line maintenance treatment ovarian cancer setting evaluating Rubraca plus Opdivo (nivolumab) versus Rubraca monotherapy are expected in the first quarter of 2023. The timing for the ATHENA-COMBO Phase 3 data readout is contingent upon the occurrence of the protocol-specified PFS events.

Top-line data from the TRITON3 trial, which is the confirmatory study for Rubraca’s approval in metastatic castration-resistant prostate cancer (mCRPC) as well as an opportunity for a potential second-line label expansion, are expected early in the fourth quarter of 2022. TRITON3 is a Phase 3 study evaluating Rubraca versus physician’s choice of chemotherapy or second-line androgen deprivation therapy in patients with mCRPC with BRCA or ATM mutations with a primary endpoint of radiologic PFS.
ATHENA and TRITON3 each provide the potential to reach larger patient populations in earlier lines of therapy for both ovarian and prostate cancers.

Conference Call Details
Clovis will hold a conference call this morning, August 8, at 8:30 am ET, to discuss Q2 2022 results and provide an update on the Company’s clinical development programs and regulatory and commercial outlook. The conference call will be simultaneously webcast on the Clovis Oncology website at clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 888.440.4615, International participants 646.960.0682, conference ID: 2259685.

About FAP-2286
FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non-small cell lung, squamous head and neck cancers, and cancers of unknown primary. High FAP expression has been detected in both primary and metastatic tumor samples, independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy
Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics". Clovis is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed multiple tumor types, including ovarian and prostate cancers, as monotherapy and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Additionally, Rubraca is approved in the US for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed, or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.
Rubraca is an unlicensed medical product outside of the US and Europe.

About the ATHENA Clinical Trial
ATHENA (GOG 3020/ENGOT-ov45) (NCT03522246) is an international, randomized, double-blind, phase III trial consisting of two separate and fully independently powered study comparisons evaluating Rubraca monotherapy (ATHENA-MONO) and Rubraca in combination with nivolumab (ATHENA-COMBO) as maintenance treatment for patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. ATHENA enrolled approximately 1000 patients across 24 countries, all women with newly diagnosed ovarian cancer who responded to their front-line chemotherapy. The trial completed accrual in 2020 and was conducted in association with the Gynecologic Oncology Group (GOG) in the US and the European Network of Gynaecological Oncological Trial groups (ENGOT) in Europe. GOG and ENGOT are the two largest cooperative groups in the US and Europe dedicated to the treatment of gynecological cancers.

ATHENA-MONO is evaluating the benefit of Rubraca monotherapy versus placebo in 538 women in this patient population. The primary efficacy analysis evaluated two prospectively defined molecular sub-groups in a step-down manner: 1) HRD-positive (inclusive of BRCA mutant) tumors, and 2) the intent-to-treat population, or all patients treated in ATHENA-MONO.

The ATHENA-COMBO portion of the trial, anticipated to readout in Q1 2023, is evaluating the magnitude of benefit of adding Opdivo (nivolumab) to Rubraca monotherapy in the ovarian cancer front-line maintenance treatment setting. ATHENA-COMBO is anticipated to be the first Phase 3 dataset to readout evaluating the combination of a PARP inhibitor and an immune checkpoint inhibitor as maintenance treatment following completion and response to front-line chemotherapy.

On August 8, 2022 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the second quarter ending June 30, 2022 (Press release, Akoya Biosciences, AUG 8, 2022, View Source [SID1234617781]).

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"Akoya delivered another quarter of strong financial performance with record revenue and system placements in the second quarter," said Brian McKelligon, Chief Executive Officer, Akoya Biosciences. "This quarter was further highlighted by the announcement of our partnership with Acrivon Therapeutics and the demonstration of our RNA and multi-omics capabilities at AGBT."

Second Quarter 2022 Financial Highlights

Total revenue was $17.9 million in the second quarter of 2022, compared to $13.1 million in the prior year period; an increase of 37%.
Product revenue was $14.2 million in the second quarter of 2022, compared to $10.7 million in the prior year period; an increase of 33%; within product revenue, instrument revenue was $9.5 million and reagent revenue was $4.5 million for the quarter.
Services and other revenue totaled $3.7 million in the second quarter of 2022, compared to $2.4 million in the prior year period; an increase of 54%.
Gross profit was $10.3 million in the second quarter of 2022, compared to $8.1 million in the prior year period; an increase of 27%; gross profit margin was 58% in the second quarter of 2022.
60 instruments were sold in the second quarter of 2022; 16 PhenoCyclers, 44 PhenoImagers (which includes Fusion, HT and Mantra); compared to 31 instruments sold in the prior year period (13 PhenoCyclers, 18 PhenoImagers); an increase of 94%.
Instrument installed base of 808 as of June 30, 2022; 212 PhenoCyclers, 596 PhenoImagers
Combined-unit PhenoCycler-Fusion installed base of 55 as of June 30, 2022.
Second Quarter 2022 Business Highlights

As of June 30, 2022, there have been 618 total publications featuring Akoya’s platform; 91% growth from 324 total publications as of June 30, 2021.
Announced a first-of-its-kind spatial signature CDx deal with Acrivon Therapeutics, a long-standing ABS partner, for the developmental oncology agent ACR-368, a targeted DNA damage response inhibitor therapy, in phase 2 clinical trials for platinum resistant ovarian, endometrial and urothelial cancers.
Previewed Akoya’s proprietary RNA chemistry at 100+ plex, scalable to 1000 plex, as well as simultaneous multi-omic targeting of RNA and protein at 100+ plex on a single tissue section of head and neck cancer at AGBT.
Expanded existing credit facility to increase potential total debt capacity by $20 million, and extended interest only period to mid-2025 providing Akoya with additional capital.
$88 million of cash, cash equivalents, and marketable securities as of June 30, 2022, well capitalized to deliver on our existing strategic plan.
YTD 2022 Financial Highlights

Total revenue was $34.8 million YTD as of June 30, 2022 compared to $25.3 million in the prior year period; an increase of 38%.
Product revenue was $27.5 million YTD as of June 30, 2022, compared to $20.7 million in the prior year period; an increase of 33%.
Services and other revenue totaled $7.3 million YTD as of June 30, 2022, compared to $4.6 million in the prior year period; an increase of 59%.
Gross profit was $20.4 million YTD as of June 30, 2022, compared to $15.5 million in the prior year period; an increase of 32%; gross profit margin was 59% YTD as of June 30, 2022.
111 instruments were sold YTD as of June 30, 2022; 30 PhenoCyclers, 81 PhenoImagers (which includes Fusion, HT and Mantra), compared to 68 instruments sold in the prior year period; an increase of 63%.
2022 Financial Outlook

The company, based on its updated plans and initiatives, is raising its full year 2022 revenue guidance range to $71-74 million.

Webcast and Conference Call Details

Akoya will host a conference call today, August 8, 2022, at 5:00 p.m. Eastern Time to discuss its second quarter 2022 financial results. Investors interested in listening to the conference call are required to register online. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.

On August 8, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported financial results for the three months ended June 30, 2022, and highlighted recent progress (Press release, Verastem, AUG 8, 2022, View Source [SID1234617797]).

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"In the second quarter, we announced findings from the interim analysis of our registration-directed RAMP 201 trial in low-grade serous ovarian cancer and are encouraged by the anti-tumor activity that we have seen to date in patients with both KRAS mutant and KRAS wild-type tumors. We look forward to evaluating a more mature data set to select the go forward regimen." said Brian Stuglik, CEO of Verastem Oncology. "We also advanced our broader development program, including being honored by the Pancreatic Cancer Network as the first recipient of their Therapeutic Accelerator Award. This award will support a Phase 1b/2 clinical trial evaluating VS-6766 and defactinib in addition to standard of care chemotherapy in front-line metastatic pancreatic cancer. The goal of the trial is to increase response rate and survival through a more complete blockade of tumorigenic signaling."

Second Quarter 2022 and Recent Highlights

Low Grade Serous Ovarian Cancer (LGSOC)

Verastem Oncology completed a planned interim analysis of the registration-directed RAMP 201 trial with the goal of selecting a go forward treatment regimen of either VS-6766 monotherapy or VS-6766 in combination with defactinib. The analysis indicated encouraging efficacy results with confirmed responses by independent review in patients treated with VS-6766 monotherapy and patients treated with VS-6766 in combination with defactinib. The findings also include confirmed responses by independent review in both KRAS mutant and KRAS wild-type LGSOC. To date, there have been no additional safety signals with a continued favorable safety profile in both the monotherapy and combination treatment arms with approximately 6% of patients discontinuing due to adverse events.
With approximately 80% of patients in the RAMP 201 study remaining on study treatment with a median duration of follow-up of four months, data from the interim analysis were not mature enough to make a final decision on the go forward treatment regimen and the trial continues with all four cohorts. The Company plans to complete enrollment of all four cohorts of the trial in the second half of this year. Each cohort is expected to have approximately 36 patients for a total of 144 patients.
KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)

The registration-directed RAMP 202 study investigating VS-6766 alone and in combination with defactinib continues to enroll patients with V600E or non-V600E BRAF mutations. Planned enrollment is complete in the selection phase (Part A; n=32) in patients with KRAS G12V-mutant NSCLC. Enrollment has also been completed in the non-G12V mutant cohort in the selection phase (Part A). The Company expects to report topline results from Part A, initiate Part B and discuss the data with regulatory authorities during the second half of 2022.
The Phase 1/2 RAMP 204 clinical trial evaluating VS-6766 in combination with Mirati’s adagrasib in KRAS G12C-mutant NSCLC opened and is enrolling participants.
The Phase 1/2 RAMP 203 clinical trial evaluating VS-6766 in combination with Amgen’s LUMAKRASTM (sotorasib) in KRAS G12C-mutant NSCLC continues to enroll and initial results are expected to be reported during the second half of 2022.
Corporate Updates

The U.S Patent and Trademark Office has granted Patent No. 11,400,090 which covers the novel, intermittent twice-weekly dosing regimen used in the VS-6766 development program. This extends the current patent protection for VS-6766 in RAS-driven cancers (KRAS/NRAS/HRAS mutations) to 2038.
The Company received the first "Therapeutic Accelerator Award" from the Pancreatic Cancer Network (PanCAN). The award will support a Phase 1b/2 clinical trial of the Company’s lead investigational candidates, RAF/MEK Clamp, or VS-6766, with FAK inhibitor, defactinib to evaluate whether a more complete blockade of KRAS signaling in addition to standard of care chemotherapy will improve outcomes for patients with front-line metastatic pancreatic cancer. KRAS mutations occurs in more than 95% of pancreatic cancer tumors.
Results from a Phase 1 investigator-initiated trial evaluating RAF/MEK clamp VS-6766 in combination with everolimus presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) found encouraging responses across various RAS-driven tumor types as well as a tolerable intermittent dosing schedule. The data also included a median progression-free survival interval of 6.3 months in KRAS mutant NSCLC and median progression-free survival of 35.8 and 41.8 months in two enrolled patients with KRAS mutant LGSOC, respectively. The trial is continuing with an ongoing expansion cohort for patients with KRAS mutant NSCLC.
Second Quarter 2022 Financial Results

Verastem Oncology ended the second quarter 2022 with cash, cash equivalents and investments of $94.3 million. With proceeds available upon achievement of certain milestones from the Oxford Finance LLC credit facility and expected milestones and royalties from the sale of COPIKTRA, Verastem Oncology expects that it has a cash runway until at least 2025 to deliver on the current programs for VS-6766 and defactinib, including expenditures and development in LGSOC and KRAS mutant NSCLC.

Total revenue for the three months ending June 30, 2022 (2022 Quarter) was $0.0 million, compared to $0.5 million for the three months ended June 30, 2021 (2021 Quarter).

Total operating expenses for the 2022 Quarter were $21.4 million, compared to $16.4 million for the 2021 Quarter.

Research & development expenses for the 2022 Quarter were $14.9 million, compared to $9.7 million for the 2021 Quarter. The increase of $5.2 million, or 53.6%, primarily resulted from an increase in drug product and drug substance costs, contract research organization costs and investigator fees.

Selling, general & administrative expenses for the 2022 Quarter were $6.5 million, compared to $6.7 million for the 2021 Quarter. The decrease of $0.2 million, or 3.0%, primarily resulted from lower consulting and professional fees.

Net loss for the 2022 Quarter was $22.0 million, or $0.12 per share (basic and diluted), compared to net loss of $16.9 million, or $0.10 per share (basic and diluted), for the 2021 Quarter.

For the 2022 Quarter, non-GAAP adjusted net loss was $20.1 million, or $0.11 per share (diluted), compared to non-GAAP adjusted net loss of $14.0 million, or $0.08 per share (diluted), for the 2021 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

Use of Non-GAAP Financial Measures

To supplement Verastem Oncology’s condensed consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (GAAP), the Company uses the following non-GAAP financial measures in this press release: non-GAAP adjusted net (loss) income and non-GAAP net (loss) income per share. These non-GAAP financial measures exclude certain amounts or expenses from the corresponding financial measures determined in accordance with GAAP. Management believes this non-GAAP information is useful for investors, taken in conjunction with the Company’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to the Company’s operating performance and can enhance investors’ ability to identify operating trends in the Company’s business. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company’s operating results as reported under GAAP, not in isolation or as a substitute for, or superior to, financial information prepared and presented in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures for the three and six months ended June 30, 2022, and 2021 are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.1

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.

On August 8, 2022 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the clinical rationale and protocol for the SURPASS-ET trial evaluating ropeginterferon alfa-2b-njft as a second-line treatment option for adults with high-risk essential thrombocythemia (ET) has been published in the journal, Future Oncology (Press release, PharmaEssentia, AUG 8, 2022, View Source [SID1234617812]).

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ET is a myeloproliferative neoplasm (MPNs), a group of rare blood cancers caused by genetic mutations that trigger the overproduction of blood cells; ET is characterized by the overproduction of platelets. Without proper treatment, these disorders carry a higher risk of thrombosis or other cardiovascular complications, or may progress toward myelofibrosis or secondary acute myeloid leukemia (sAML). Yet many patients who receive conventional approved treatments for ET experience resistance or intolerance, or the efficacy wanes over time, so new therapeutic options are needed to help address these limitations and improve treatment outcomes.

Ropeginterferon alfa-2b-njft is a unique monopegylated, long-acting interferon that was recently approved to treat adults with polycythemia vera (PV), another type of MPN. Given the well-established safety and efficacy profile demonstrated in prior studies, the treatment may represent a useful alternative to approved options for ET.

"Physicians treating people with MPNs have lacked effective, durable therapeutics that are designed specifically for these cancers. To help improve the long-term outlook for these patients, we need to focus not only on normalizing symptoms and improving quality of life, but also targeting driver mutations to more completely control the disease," said Srdan Verstovsek, M.D., Ph.D., Director of the Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms, Department of Leukemia at the University of Texas MD Anderson Cancer Center. "This trial will provide critical data on how use of a monopegylated interferon for the first time in this disease state could reduce the risk of progression for these patients over time."

The global phase 3, randomized, open-label, multicenter SURPASS-ET (NCT04285086) trial is evaluating the safety, efficacy, tolerability, and pharmacokinetics of ropeginterferon alfa-2b-njft compared to anagrelide as second-line therapy in high-risk ET. Approximately 160 patients are being enrolled from 61 study sites across the United States, Canada and multiple regions across Asia, and will be randomized to receive treatment with ropeginterferon alfa-2b-njft (via subcutaneous injection every two weeks starting at 250 mcg, with a target optimal dose of 500 mcg by week four and onwards) or a daily anagrelide capsule (0.5 mg).

The primary efficacy endpoint is durable patient response, as defined by modified ELN response criteria (peripheral blood count remission; improvement or non-progression in disease-related signs; improvement or non-progression based on the MPN-SAF TSS; absence of hemorrhagic or thrombotic events; and durability at months 9 and 12). Other endpoints being evaluated include quality of life and change in allelic burden (the proportion of mutated cells in the blood). Data from the trial are expected by 2024.

"With nearly a decade of ongoing research with interferons in MPNs, we have strong evidence supporting the use of ropeginterferon alfa-2b-njft to treat individuals with ET," said Raymond Urbanski, M.D., Ph.D., U.S. Head of Clinical Development and Medical Affairs, PharmaEssentia. "The series of clinical trials currently underway are providing an increasingly clear picture of the profile of this treatment to potentially improve care standards and patient outcomes across the MPN category."

About Ropeginterferon alfa-2b

Ropeginteferon alfa-2b-njft is an innovative monopegylated, long-acting interferon. With its unique pegylation technology, the product has a long duration of activity in the body.

Ropeginteferon alfa-2b-njft (marketed as BESREMi) has orphan drug designation for treatment of polycythemia vera (PV) in adults in the United States. The product was approved by the European Medicines Agency (EMA) in 2019, in the United States in 2021, and has recently received approval in Taiwan and South Korea. The product was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications.

BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders.

About Essential Thrombocythemia

Essential thrombocythemia (ET) is a myeloproliferative neoplasm (MPN) characterized by an overproduction of platelets in the blood that results from a genetic mutation; data indicates a JAK2 gene mutation is present in approximately half of diagnosed patients. ET is estimated to affect up to 57 per 100,000 people in the U.S. The disease is most commonly diagnosed through routine blood work, and is most common in people over the age of 50, with women 1.5 more times more likely to be diagnosed than men. As a chronic, progressive disease, ET requires regular monitoring and appropriate treatment. Over time, the disease may progress into more deadly conditions such as myelofibrosis or acute leukemia.1,2