On November 8, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported third quarter financial results for the period ended September 30, 2022, and provided a business update (Press release, Olema Oncology, NOV 8, 2022, View Source [SID1234623517]).

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"On the heels of presenting our preliminary monotherapy dose expansion study results at ENA 2022, and with initial combination study data coming later this quarter at SABCS, we believe OP-1250 has shown itself to be a highly differentiated CERAN/SERD that completely shuts down estrogen receptor (ER) transcriptional activity in both wild-type and ESR1 mutant receptors," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We have been granted Fast Track designation from the FDA in second- and third-line ER+/HER2- metastatic breast cancer, and we are rapidly generating more data in support of initiating our first pivotal Phase 3 monotherapy study mid-next year. As we enter the next stage of development and with an evolving competitive landscape, we are driven to continue our mission to improve outcomes for women living with cancer."

Recent Corporate Highlights

●Presented preliminary clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022) in Barcelona, Spain.
●Study results demonstrated that across 68 heavily pre-treated patients at 60 mg and 120 mg once daily oral doses, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
●Following the selection of RP2D based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity, the Phase 2 monotherapy study is rapidly advancing with primary cohorts fully enrolled: patients with measurable disease (N=50) and patients with non-measurable disease (N=15).
●Dose escalation in the Phase 1b combination study with the CDK4/6 inhibitor palbociclib has completed, with Phase 2 dose expansion at 120 mg of OP-1250 in combination with palbociclib now
ongoing. Combinability has been demonstrated across the completed dose escalation cohorts (30 mg, 60 mg, 90 mg, and 120 mg of OP-1250), including no dose limiting toxicities, no change in exposure of palbociclib or OP-1250, and overall tolerability consistent with the expected profile of palbociclib plus an endocrine therapy.
●Initiated Phase 1b combination study with CDK 4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
Anticipated Milestones

●Present preliminary Phase 1b dose escalation study data in combination with CDK4/6 inhibitor, palbociclib, at the 2022 San Antonio Breast Cancer Symposium in December.
●Continue combination studies with CDK4/6 inhibitors, palbociclib and ribociclib, and PI3Ka inhibitor, alpelisib.
●Present additional monotherapy and combination therapy data in 2023.
●Initiate pivotal Phase 3 monotherapy study in the second/third-line ER+/HER2- advanced or metastatic breast cancer in mid-2023.
Financial Results

●Cash, cash equivalents and marketable securities as of September 30, 2022, were $222.6 million. Olema anticipates that this balance will be sufficient to fund operations into the second half of 2024.
●Net loss for the quarter ended September 30, 2022, was $22.7 million, compared to $17.7 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities, and an increase in general and administrative (G&A) costs.
●GAAP research and development (R&D) expenses were $17.6 million for the quarter ended September 30, 2022, compared to $12.5 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250 and an increase in nonclinical research and discovery program activities. Non-GAAP R&D expenses were $14.8 million for the quarter ended September 30, 2022, excluding $2.8 million of non-cash stock-based compensation expense. Non-GAAP R&D expenses were $10.1 million for the quarter ended September 30, 2021, excluding $2.4 million of non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.
●GAAP G&A expenses were $5.6 million for the quarter ended September 30, 2022, as compared to $5.2 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses and other corporate costs. Non-GAAP G&A expenses were $4.1 million for the quarter ended September 30, 2022, excluding $1.5 million of non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.5 million for the quarter ended September 30, 2021, excluding $1.7 million of non-cash stock-based compensation expense.

On November 8, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported third quarter financial results for the period ended September 30, 2022, and provided a business update (Press release, Olema Oncology, NOV 8, 2022, View Source [SID1234623517]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"On the heels of presenting our preliminary monotherapy dose expansion study results at ENA 2022, and with initial combination study data coming later this quarter at SABCS, we believe OP-1250 has shown itself to be a highly differentiated CERAN/SERD that completely shuts down estrogen receptor (ER) transcriptional activity in both wild-type and ESR1 mutant receptors," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We have been granted Fast Track designation from the FDA in second- and third-line ER+/HER2- metastatic breast cancer, and we are rapidly generating more data in support of initiating our first pivotal Phase 3 monotherapy study mid-next year. As we enter the next stage of development and with an evolving competitive landscape, we are driven to continue our mission to improve outcomes for women living with cancer."

Recent Corporate Highlights

●Presented preliminary clinical results from a Phase 1/2 clinical study of OP-1250 at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022) in Barcelona, Spain.
●Study results demonstrated that across 68 heavily pre-treated patients at 60 mg and 120 mg once daily oral doses, OP-1250 was well tolerated with attractive pharmacokinetics (PK) and sustained drug exposure levels approximately 20 times that of fulvestrant at the 120 mg dose. In addition, OP-1250 demonstrated strong anti-tumor activity, with 41% of patients seeing reductions in target tumor lesions, and durable benefit. Six partial responses (four confirmed and two unconfirmed) were observed in 57 efficacy-evaluable patients.
●Following the selection of RP2D based on pharmacokinetics, safety and tolerability, and encouraging early anti-tumor activity, the Phase 2 monotherapy study is rapidly advancing with primary cohorts fully enrolled: patients with measurable disease (N=50) and patients with non-measurable disease (N=15).
●Dose escalation in the Phase 1b combination study with the CDK4/6 inhibitor palbociclib has completed, with Phase 2 dose expansion at 120 mg of OP-1250 in combination with palbociclib now
ongoing. Combinability has been demonstrated across the completed dose escalation cohorts (30 mg, 60 mg, 90 mg, and 120 mg of OP-1250), including no dose limiting toxicities, no change in exposure of palbociclib or OP-1250, and overall tolerability consistent with the expected profile of palbociclib plus an endocrine therapy.
●Initiated Phase 1b combination study with CDK 4/6 inhibitor, ribociclib, and phosphoinositide 3-kinase alpha (PI3Ka) inhibitor, alpelisib.
Anticipated Milestones

●Present preliminary Phase 1b dose escalation study data in combination with CDK4/6 inhibitor, palbociclib, at the 2022 San Antonio Breast Cancer Symposium in December.
●Continue combination studies with CDK4/6 inhibitors, palbociclib and ribociclib, and PI3Ka inhibitor, alpelisib.
●Present additional monotherapy and combination therapy data in 2023.
●Initiate pivotal Phase 3 monotherapy study in the second/third-line ER+/HER2- advanced or metastatic breast cancer in mid-2023.
Financial Results

●Cash, cash equivalents and marketable securities as of September 30, 2022, were $222.6 million. Olema anticipates that this balance will be sufficient to fund operations into the second half of 2024.
●Net loss for the quarter ended September 30, 2022, was $22.7 million, compared to $17.7 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development activities, and an increase in general and administrative (G&A) costs.
●GAAP research and development (R&D) expenses were $17.6 million for the quarter ended September 30, 2022, compared to $12.5 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250 and an increase in nonclinical research and discovery program activities. Non-GAAP R&D expenses were $14.8 million for the quarter ended September 30, 2022, excluding $2.8 million of non-cash stock-based compensation expense. Non-GAAP R&D expenses were $10.1 million for the quarter ended September 30, 2021, excluding $2.4 million of non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.
●GAAP G&A expenses were $5.6 million for the quarter ended September 30, 2022, as compared to $5.2 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses and other corporate costs. Non-GAAP G&A expenses were $4.1 million for the quarter ended September 30, 2022, excluding $1.5 million of non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.5 million for the quarter ended September 30, 2021, excluding $1.7 million of non-cash stock-based compensation expense.

On November 8, 2022 Cardinal Health (NYSE: CAH) reported that its Board of Directors approved a quarterly dividend of $0.4957 per share out of the Company’s capital surplus (Press release, Cardinal Health, NOV 8, 2022, View Source [SID1234623516]). The dividend will be payable on January 15, 2023 to shareholders of record at the close of business on January 3, 2023.

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On November 8, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported third quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, NOV 8, 2022, View Source [SID1234623515]).

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"CytomX’s progress in the third quarter highlights the potential of our pipeline as well as the breadth and versatility of the Probody platform. CX-2051 and CX-801 are wholly owned, next generation therapeutic candidates that build on our deep experience with conditional activation," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics. "We also continued to make progress in our collaborator programs, including CX-904, our first T-cell engager in the clinic, and BMS-986249, for which Bristol Myers Squibb presented updated Phase 1 safety and efficacy data at ESMO (Free ESMO Whitepaper) 2022."

Third Quarter Business Highlights and Recent Developments

CX-2051, EpCAM-directed Antibody Drug Conjugate (ADC), unveiled at World ADC in San Diego – CX-2051 is a wholly-owned, conditionally activated ADC directed toward the epithelial cell adhesion molecule (EpCAM), with potential applicability across multiple EpCAM-expressing cancers. CX-2051 is tailored to optimize the therapeutic index for systemic treatment of EpCAM-expressing cancers, an opportunity that, to date, has not been realized due to dose-limiting toxicities. CytomX’s strategy with CX-2051 is to match target expression and sensitivity to the camptothecin payload with prioritized indications. CX-2051 data presented at World ADC demonstrated strong preclinical activity and a favorable predicted therapeutic index. CytomX anticipates submitting an IND for CX-2051 in the second half of 2023.

CX-801, Interferon (IFN) alpha-2b, preclinical data at SITC (Free SITC Whitepaper) Annual Meeting – CX-801 is a wholly-owned IFN alpha-2b Probody therapeutic that in preclinical studies has demonstrated a wide therapeutic index and potent antitumor effects. At the SITC (Free SITC Whitepaper) 2022 Annual Meeting starting November 9th, pre-clinical data will be presented highlighting CX-801’s tolerability profile, preferential activity in the tumor microenvironment, and the potential for synergistic effects in combination with checkpoint inhibitors. CytomX anticipates submitting an IND for CX-801 in the second half of 2023.

Bristol Myers Squibb presented updated ipilimumab Probody data at ESMO (Free ESMO Whitepaper) 2022 – At the ESMO (Free ESMO Whitepaper) Congress 2022, Bristol Myers Squibb presented updated Phase 1 safety, efficacy, pharmacokinetic, and pharmacodynamic data from the Phase 1/2 study of BMS-986249, a Probody version of ipilimumab, alone and in combination with nivolumab in patients with advanced cancers. The safety profile and disease control rate observed in the updated Phase 1 data for BMS-986249 with and without nivolumab appears promising. BMS-986249 appears to be tolerated at higher doses than traditional ipilimumab clinical dosing, and an encouraging case study was reported of a partial response in microsatellite-stable colorectal cancer. BMS-986249 is being evaluated in a randomized Phase 2 study in combination with nivolumab versus ipilimumab plus nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and triple-negative breast cancer.

Bristol Myers Squibb presentations on next generation anti-CTLA4 programs at SITC (Free SITC Whitepaper) 2022 – During Q3, Bristol Myers Squibb also presented a webinar titled "Building on the Legacy of Ipilimumab" at the SITC (Free SITC Whitepaper) "Targets for Cancer IO: A Deep Dive Webinar Series." This presentation focused on the company’s next generation anti-CTLA-4 molecules, which includes the Probody therapeutics BMS-986249 and BMS-986288. BMS-986288 is a Probody version of non-fucosylated ipilimumab and is being evaluated as monotherapy and in combination with nivolumab in a Phase 1 study in advanced solid tumors. Additionally, at the SITC (Free SITC Whitepaper) annual meeting, a poster presentation will be presented by Bristol Myers Squibb titled "Phase 1/2a study of the novel nonfucosylated anti-CTLA monoclonal antibody BMS-986218 ± nivolumab in advanced solid tumors: Part 1 results," focused on BMS-986218, the non-masked version of BMS-986288. This presentation includes preclinical data on BMS-986288.

CX-2029, CD71-directed antibody-drug conjugate (ADC), program update – CX-2029 is a conditionally activated ADC directed toward CD71, the transferrin receptor, that is being co-developed by CytomX and AbbVie. Patient enrollment in the Phase 2 expansion study has been completed across the squamous non-small cell lung cancer (sqNSCLC), head and neck squamous cell carcinoma, and esophageal/gastro-esophageal junction (E/GEJ) cancer cohorts. A data update for the sqNSCLC cohort is expected in the fourth quarter of 2022. Data from the E/GEJ cancer cohort continues to mature.

CX-904, T-cell-engaging bispecific (TCB) EGFRxCD3, program update – CX-904 is a conditionally activated TCB designed to target the epidermal growth factor receptor (EGFR) on cancer cells and the CD3 receptor on T cells within the tumor microenvironment. CX-904 is partnered with Amgen and is being evaluated by CytomX in an ongoing Phase 1 study in patients with advanced solid tumors. The first patient was dosed in Q2 2022 and the dose escalation portion of the study continues to advance. Additionally, CytomX’s preclinical work highlighting the potential for a conditionally active, EGFR-CD3 Probody TCB to expand the safety window while maintaining efficacy was recently highlighted in Cancer Research, in a publication titled, "A Probody T-cell-engaging bispecific antibody targeting EGFR and CD3 inhibits colon cancer growth with limited toxicity."
Priorities for 2022-2023

Provide a data update for the Phase 2 study of CX-2029 in patients with squamous non-small cell lung cancer in the fourth quarter of 2022
Continue enrolling patients with advanced solid tumors in the Phase 1 study of CX-904
Submit INDs for CX-801 and CX-2051 in the second half of 2023
Provide updated data from the Phase 2 study of praluzatamab ravtansine in advanced breast cancer at the San Antonio Breast Cancer Symposium
Continued progress within the BMS alliance including the anti-CTLA-4 Probody programs
Complete company restructuring announced in July 2022 by the end of 2022
Third Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $194.3 million as of September 30, 2022, compared to $305.2 million as of December 31, 2021.

Total revenue was $16.9 million for the three months ended September 30, 2022, compared to $17.6 million for the corresponding period in 2021.

Research and development expenses increased by $1.2 million during the three months ended September 30, 2022 to $30.4 million compared to $29.1 million for the third quarter of 2021. The increase was primarily due to restructuring expenses, offset by a decrease in personnel related expense and clinical trial expenses due to the workforce reduction and pipeline reprioritization announced in July 2022.

General and administrative expenses decreased by $0.6 million during the third quarter of 2022 to $10.5 million. The decrease was mainly driven by a decrease in personnel related expenses due to the workforce reduction announced in July 2022 and a decrease in outside consulting, legal and intellectual property services, partially offset by restructuring expenses.

Overall expenses related to the company restructuring announced in July 2022 were $7.1 million consisting primarily of employee-related expenses and severance benefits. Total anticipated expenses as a result of the restructuring are expected to be approximately $7.9 million.

Conference Call & Webcast Information
CytomX management will host a conference call and simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at View Source Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the Company’s website.

On November 8, 2022 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a diversified clinical-stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the quarter ended September 30, 2022, and provided an update on its clinical programs (Press release, Processa Pharmaceuticals, NOV 8, 2022, View Source [SID1234623514]).

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Dr. David Young, President and CEO of Processa, commented, "We are delighted to report our push to enroll patients in PCS12852 (Gastroparesis) and PCS6422 (Next Generation Capecitabine) has helped us get critical data and report successful preliminary results in both trials. The data from these trials will help us design Phase 2B trials for both programs.

●Next Generation Capecitabine (NGC) (a combination of PCS6422 and capecitabine): we have identified lower capecitabine dosage regimens when administered in NGC that will help avoid dose-limiting toxicities such as hand-foot syndrome, yet provide approximately 50-times greater potency than capecitabine alone. We will complete this study in the near future and seek FDA confirmation of our plans to implement the principles of the Project Optimus Oncology Initiative, wherein the objective is to optimize dosing to achieve a better balance between efficacy and safety than merely using the maximum tolerated dose.
●PCS12852: we have shown a statistical difference in the gastric emptying rate between the 6 patients on 0.5 mg of PCS12852 and the 8 patients on placebo at p-value < 0.10 with mild to moderate adverse events. We anticipate having the analysis of the gastroparesis symptoms completed by the end of the year.

All our energies have been directed towards the completion of these trials that inform the next steps for these much-needed therapies.

Advancing these drugs in their respective clinical trial allows us to obtain the clinical data to better define each pivotal trial as well as provide us with more insight into how the FDA will review each of these products as we plan the road maps for designing the studies for our New Drug Applications to FDA.

Financial Results for the Nine Months Ended September 30, 2022

Our cash balance on September 30, 2022, was $9.1 million, which should be sufficient to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the nine months ended September 30, 2022, we spent $7.1 million in cash for these three clinical trials and in our operations. This is significantly less than our GAAP net loss of $14.4 million due to the effect of non-cash items like amortization and stock-based compensation, and the application of amounts we had prepaid to our CROs last year.

Our net loss for the nine months ended September 30, 2022, was $14.4 million or $0.90 per share compared to a net loss of $8.2 million, or $0.54 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred in our three ongoing trials. For the nine months ended September 30, 2022, we incurred $8.3 million in research and development costs, an increase of $3.5 million when compared to the same period of 2021. We anticipate clinical trial costs will continue to increase for the rest of the year as our trials continue to progress and we fund development activities for the other drugs in our pipeline.

During the nine months ending September 30, 2022, our general and administrative expenses totaled $6.1 million compared to $3.4 million for the same period in 2021. The increase related primarily to increases in non-cash or stock-based compensation costs, along with other operating and consulting costs. We allocated $6.1 million of non-cash compensation costs between our R&D and G&A costs, with the majority recorded as G&A.

Our net cash used in operating activities during the nine months ended September 30, 2022, increased by $1.1 million to $7.1 million, compared to $6 million for the same period in 2021. While we experienced increased GAAP costs related to our clinical trials and operations, we continued to make use of equity incentives to compensate our executive and development team, thereby reducing our cash outflow, and we were able to apply previously made advanced payments to our CROs against current trial costs.

As of September 30, 2022, we had 15.9 million common shares outstanding.