On March 2, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that the phase 3 CONTACT-03 study did not meet its primary endpoint of progression-free survival (PFS) (Press release, Exelixis, MAR 2, 2023, View Source [SID1234628091]). CONTACT-03 evaluated cabozantinib (CABOMETYX) in combination with atezolizumab versus cabozantinib alone in patients with locally advanced or metastatic clear cell or non-clear cell (papillary or unclassified only) renal cell carcinoma (RCC) who progressed during or after immune checkpoint inhibitor therapy (either combination or monotherapy).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The safety profile of the combination of cabozantinib and atezolizumab observed in the trial was consistent with the known safety profiles for each single agent, and no new safety signals were identified with the combination.

Detailed findings will be presented at an upcoming medical meeting.

About CONTACT-03
CONTACT-03 is a global, multicenter, randomized, phase 3, open-label study that enrolled 522 patients who were randomized 1:1 to the experimental arm of cabozantinib in combination with atezolizumab and the control arm of cabozantinib alone. There is limited data available to suggest the optimal treatment for these patients and CONTACT-03 was initiated in the hope of defining the clinical benefit of the combination of a multi-tyrosine kinase inhibitor and an immune checkpoint inhibitor following progression. The primary endpoints of the trial are PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 as assessed by independent radiology review and overall survival. Key secondary endpoints include PFS, objective response rate and duration of response as assessed by the investigators. CONTACT-03 is sponsored by Roche and co-funded by Exelixis. More information about CONTACT-03 is available at ClinicalTrials.gov.

About RCC
Kidney cancer is among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 An estimated 81,800 Americans will be diagnosed with kidney cancer in 2023.1 Clear cell RCC is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 14%.3 In 2022, approximately 32,200 patients with advanced kidney cancer required systemic therapy in the U.S., with over 20,000 patients receiving first-line treatment.4

About CABOMETYX (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib; for patients with advanced RCC as a first-line treatment in combination with nivolumab; and for adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen Pharma SAS exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan. In 2017, Exelixis granted exclusive rights to Takeda for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

CABOMETYX in combination with atezolizumab is not indicated as a treatment for RCC.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage and prior to surgery as recommended. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 37% (16% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Permanently discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 62% of CABOMETYX patients. Grade 3 diarrhea occurred in 10% of CABOMETYX patients. Monitor and manage patients using antidiarrheals as indicated. Withhold CABOMETYX until improvement to ≤ Grade 1, resume at a reduced dose.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 45% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.

With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade ≥2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade ≥2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade ≥2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab. Withhold and resume at a reduced dose based on severity.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab and resume CABOMETYX at a reduced dose depending on severity.

Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.

Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.

Proteinuria: Proteinuria was observed in 8% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. For Grade 2 or 3 proteinuria, withhold CABOMETYX until improvement to ≤ Grade 1 proteinuria, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution, resume at a reduced dose.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Thyroid Dysfunction: Thyroid dysfunction, primarily hypothyroidism, has been observed with CABOMETYX. Based on the safety population, thyroid dysfunction occurred in 19% of patients treated with CABOMETYX, including Grade 3 in 0.4% of patients.

Patients should be assessed for signs of thyroid dysfunction prior to the initiation of CABOMETYX and monitored for signs and symptoms of thyroid dysfunction during CABOMETYX treatment. Thyroid function testing and management of dysfunction should be performed as clinically indicated.

Hypocalcemia: CABOMETYX can cause hypocalcemia. Based on the safety population, hypocalcemia occurred in 13% of patients treated with CABOMETYX, including Grade 3 in 2% and Grade 4 in 1% of patients. Laboratory abnormality data were not collected in CABOSUN.

In COSMIC-311, hypocalcemia occurred in 36% of patients treated with CABOMETYX, including Grade 3 in 6% and Grade 4 in 3% of patients.

Monitor blood calcium levels and replace calcium as necessary during treatment. Withhold and resume at reduced dose upon recovery or permanently discontinue CABOMETYX depending on severity.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information View Source

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

On March 2, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present in a panel titled, "Novel Oncology Targets" at the 43rd Annual Cowen Healthcare Conference on Tuesday, March 7, 2023 at 9:10 a.m. ET (Press release, Fusion Pharmaceuticals, MAR 2, 2023, View Source [SID1234628090]). Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days following their respective presentation dates.

On March 2, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update (Press release, , MAR 2, 2023, View Source [SID1234628089]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2022 was an important year for demonstrating the benefits onvansertib could bring to patients with KRAS-mutated mCRC, an area where no targeted therapies are currently approved. The results of our Phase 1b/2 trial in KRAS-mutated mCRC continue to show onvansertib plus standard-of-care was well-tolerated and outperformed historical control trials on key endpoints including the durability of response. Furthermore, we observed an unexpectedly high objective response rate and progression-free survival in the bevacizumab-naïve subgroup of patients which will be evaluated in the ongoing ONSEMBLE trial," said Mark Erlander, PhD, chief executive officer of Cardiff Oncology. "Looking forward, this will be an important year for advancing our ONSEMBLE randomized Phase 2 trial and generating additional safety and efficacy signals from our other company-sponsored and investigator-initiated clinical programs."

"As we build on these findings and accelerate onvansertib’s clinical development, we will benefit greatly from the deep clinical expertise of our new CMO, Dr. Fairooz Kabbinavar, who served as the lead investigator for two practice-changing trials of bevacizumab combinations leading to the approval of bevacizumab in mCRC," continued Dr. Erlander. "We are confident we can fund our onvansertib clinical programs into 2025, and we believe our clinical data supports our approach to leveraging PLK1 inhibition to address current gaps in cancer therapies and make an important contribution to oncology patient care."

Upcoming potential milestones

mPDAC data readout from Phase 2 trial expected Q2/Q3 ’23
SCLC data readout from investigator-initiated (with UPMC) Phase 2 trial expected Q2/Q3 ’23
TNBC data readout from investigator-initiated (with Dana-Farber Cancer Institute) Phase 1b/2 trial expected Q4 ’23/Q1 ’24
mCRC randomized data readout from Phase 2 ONSEMBLE trial expected Q3/Q4 ’24
Company highlights for the year ended December 31, 2022, and subsequent weeks include:

Strengthened management team with appointments of Fairooz Kabbinavar, MD, FACP, as CMO, Tod Smeal, Ph.D., as CSO and Charles Monahan, R.Ph., SVP, regulatory affairs. Overseeing the clinical development program for onvansertib, Dr. Kabbinavar brings world class capabilities and deep expertise in colorectal cancer and other solid tumor indications to Cardiff Oncology from his 30-plus years of experience across the academic and biotech/pharmaceutical sectors. During his time as an academic oncologist, he was the lead investigator on two practice-changing clinical trials of bevacizumab (Avastin) combinations leading to approval of bevacizumab in mCRC1,2. As principal medical director of Genentech’s immuno-oncology program, he led the clinical development of atezolizumab (TECENTRIQ) in extensive stage small cell lung cancer and oversaw the filing of the supplemental biologics license application that led to the drug’s FDA approval. Dr. Smeal has over 20 years of industry experience developing targeted therapies and previously served as CSO of Cancer Biology at Eli Lilly and Company, and director of the Oncology Research Unit of Pfizer. Mr. Monahan is a registered pharmacist with over 20 years of regulatory experience developing drugs and biologics for oncology, infectious diseases, and ocular indications. Prior to joining Cardiff Oncology, he most recently served as the global head of regulatory affairs for Erytech PharmaSA.

Announced ONSEMBLE, a Phase 2, open-label, randomized trial for second line treatment of KRAS/NRAS-mutated mCRC, as the next step in our mCRC clinical development program. We designed the ONSEMBLE trial to corroborate the robust efficacy signal observed in the Phase 1b/2 trial of onvansertib plus standard-of-care (SoC) FOLFIRI/bevacizumab in second-line KRAS-mutated mCRC, demonstrate onvansertib’s contribution above SoC alone and confirm the optimal dose.

Presented robust data from the Phase 1b/2 trial of onvansertib plus FOLFIRI/bevacizumab in second line KRAS-mutated mCRC on a company webcast in September 2022. Objective response rate (ORR) across all evaluable patients was 35% (n=48) as compared to an ORR of 5-13% observed historically, and the median duration of response (mDoR) across all evaluable patients was 11.7 months. Median progression-free survival (mPFS) was 9.3 months across all evaluable patients, as compared to mPFS of ~4.5 – 5.7 months observed historically in combination trials that included the standard-of-care FOLFIRI with bevacizumab.3-6

Completed subgroup analysis from Phase 1b/2 mCRC trial shows improved ORR and mPFS in bevacizumab-naïve patients. A subgroup analysis from the ongoing Phase 1b/2 clinical trial of onvansertib plus FOLFIRI/bevacizumab in second line KRAS-mutated mCRC showed an ORR of 69% and mPFS of 13.5 months in bevacizumab naïve patients (n=13). These data compare favorably to historical control trials in mCRC, which show an ORR of approximately 25% and a mPFS of approximately 6.9 months in bevacizumab naïve patients6-11.

Data presented at the ESMO (Free ESMO Whitepaper) Congress 2022 suggest combining onvansertib with irinotecan (a component of FOLFIRI) overcomes irinotecan-resistance in RAS-mutated mCRC. Findings from our Expanded Access Program (EAP) of onvansertib in KRAS-mutated mCRC as well as preclinical data from patient-derived xenograft (PDX) models of irinotecan-resistant, RAS-mutated mCRC were featured in a poster at the ESMO (Free ESMO Whitepaper) Congress 2022 showing EAP patients with prior irinotecan treatment (43 of 51) showed clinical benefit following treatment and the combination of onvansertib and irinotecan showed significantly greater anti-tumor activity compared to onvansertib monotherapy in 5 of 6 tested PDX models of irinotecan-resistant, RAS-mutated mCRC.

Presented preliminary data from our clinical trial in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC). Preliminary data from five evaluable patients in an ongoing open-label Phase 2 trial of onvansertib in combination with nanoliposomal irinotecan and 5-FU in second-line metastatic PDAC provide early signal of efficacy and compare favorably to historical control trials.

Enrolled first patients in two investigator-initiated trials in triple negative breast cancer (TNBC) and small cell lung cancer (SCLC).
Full Year 2022 Financial Results:

Liquidity, cash burn, and cash runway

As of December 31, 2022, Cardiff Oncology had approximately $105.3 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the full year 2022 was approximately $33.8 million, an increase of approximately $10.8 million from $23.0 million for the same period in 2021.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into 2025.

Operating results

Total operating expenses were approximately $40.3 million for the full year ended December 31, 2022, an increase of $11.1 million from $29.2 million for the same period in 2021. The increase in operating expenses was primarily due to advancing the development of onvansertib through chemistry, manufacturing, and controls (CMC) activities, pharmacology and other development programs, salaries and staff costs primarily due to increased headcount, stock-based compensation for additional grants to employees and higher facility costs for insurance and the amending of our operation lease.

References

H. Hurwitz, L. Fehrenbacher, W. Novotny, T. Cartwright, J. Hainsworth, W. Heim, J. Berlin, A. Baron, S. Griffing, E. Holmgren, N. Ferrara, G. Fyfe, B. Rogers, R. Ross, and F. Kabbinavar; Bevacizumab Plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer; The New England Journal of Medicine, Vol. 350, Jun 3, 2004, pp. 2335-2342.
Fairooz F. Kabbinavar, Joseph Schulz, Michael McCleod, Taral Patel, John T. Hamm, J. Randolph Hecht, Robert Mass, Brent Perrou, Betty Nelson, and William F. Novotny; Addition of Bevacizumab to Bolus Fluorouracil and Leucovorin in First-Line Metastatic Colorectal Cancer: Results of a Randomized Phase II Trial; Journal of Clinical Oncology, Vol. 23, Jun 1, 2005, pp. 3697-3705.
Giessen et al., Acta Oncologica 2015, 54: 187-193
Cremolini et al., Lancet Oncol 2020, 21: 497–507
Antoniotti et al., Correspondence Lancet Oncol June 2020
Bennouna et al., Lancet Oncol 2013; 14: 29–37
Hansen et al., Cancers 2021, 13, 1031
Tabernaro et al. Eur J Cancer, 2014, 50, 320-332
Van Cutsem et al., J. Clin. Oncol. 2012, 30,3499–3506
Tabenaro et al, Lancet Oncol 2015, 16, 499–508
Beretta et al., Med Oncol 2013, 30:486
About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company’s lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard-of-care (SoC) therapeutics in clinical programs targeting indications such as KRAS/NRAS-mutated metastatic colorectal cancer (mCRC) and metastatic pancreatic ductal adenocarcinoma (mPDAC), as well as in investigator-initiated trials in triple negative breast cancer (TNBC) and small cell lung cancer (SCLC). These programs and the Company’s broader development strategy is designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit View Source

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; risks related to business interruptions, including the outbreak of COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

On March 2, 2023 Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary nanosecond pulsed field ablation (nsPFA) technology for electrophysiology and the treatment of atrial fibrillation, reported it will report financial results for the fourth quarter and full year of 2022 after market close on Thursday, March 30, 2023 (Press release, Pulse Biosciences, MAR 2, 2023, View Source [SID1234628088]). Company management will host a corresponding conference call beginning at 1:30pm PT / 4:30pm ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

On March 2, 2023 Sesen Bio, Inc. (Nasdaq: SESN) ("Sesen Bio" or the "Company"), reported that its stockholders have voted to approve all proposals, including the pending merger with Carisma Therapeutics Inc. ("Carisma"), at the Company’s Special Meeting of Stockholders (the "Special Meeting") held earlier today (Press release, Sesen Bio, MAR 2, 2023, View Sourcenews-releases/news-release-details/sesen-bio-stockholders-approve-merger-carisma-therapeutics" target="_blank" title="View Sourcenews-releases/news-release-details/sesen-bio-stockholders-approve-merger-carisma-therapeutics" rel="nofollow">View Source [SID1234628087]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio, said, "We are pleased with the outcome of today’s Special Meeting and thank our stockholders for their support of the merger with Carisma. The fact that over 88% of stockholders voted in favor of the merger provides further confidence that our thorough strategic process maximizes value for stockholders. Throughout the process, we have been actively conserving capital and we are closing the merger with approximately $150 million in cash and cash equivalents, of which roughly half will go directly to Sesen Bio stockholders in the form of a $75 million special dividend we announced today, with the remainder going toward funding the combined company."

"Looking ahead, our stockholders are positioned to benefit from the upside potential of ownership in the combined company, as well as the CVR, which provides additional potential cash upside from any sale of Sesen Bio’s legacy assets, including Vicineum, and from the potential $30 million milestone payment under the Roche Asset Purchase Agreement. We look forward to completing the merger and realizing our bright future with Carisma."

Based on a preliminary count of the voting results from today’s meeting of stockholders, more than 88% of the votes cast were voted in favor of Proposal No. 1 to approve the issuance of Sesen Bio common stock to Carisma stockholders in the merger and approximately 86% of votes were cast in favor of Proposal No. 2, representing more than 57% of outstanding shares of Sesen Bio common stock, to approve the amendment to Sesen Bio’s certificate of incorporation to effect a reverse stock split of outstanding shares of Sesen Bio common stock at a ratio of 1-for-20. The approval of Proposal Nos. 1 and 2 was needed to complete the merger. Sesen Bio currently anticipates that the reverse stock split will become effective after trading hours on March 7, 2023, such that trading of post-split Carisma ("CARM") common stock will commence on March 8, 2023.

The merger is expected to close on March 7, 2023, subject to customary closing conditions. The final voting results for the company’s special meeting will be disclosed in a Form 8-K filed with the Securities and Exchange Commission (the "SEC") and will also be available at View Source, after certification by the company’s inspector of elections.

In connection with the transaction, the Sesen Bio Board of Directors has declared a one-time, special cash dividend of $75 million. Based on the current number of shares outstanding, the special cash dividend is expected to result in $0.361 per share to all common stockholders of record as of the close of business on March 7, 2023, payable no later than March 10, 2023.

Sesen Bio stockholders of record will also be issued one Contingent Value Right (CVR) for each outstanding share of Sesen Bio common stock, representing the right to receive any potential proceeds from the sale of Vicineum and Sesen Bio’s preclinical assets prior to March 31, 2027 and any proceeds from the potential milestone payment under the Roche Asset Purchase Agreement. The issuance of the special cash dividend and CVR remain contingent on the closing of the approved transaction.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the SEC on January 19, 2023, which is available at the SEC’s website, www.sec.gov, and at the company’s website, www.sesenbio.com.

SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel.