Vincerx Pharma Inc. (Nasdaq: VINC), a pioneering biopharmaceutical company striving to improve the lives of cancer patients by providing innovative treatments, announced its financial results for the second quarter of 2023 as well as an update on its operations. The quarter ended on June 30th and the results exceeded expectations, showing a bright future for the company.
We are thrilled to announce that Vincerx’s first antibody-drug conjugate (ADC), VIP943, is now undergoing review by the U.S. Food and Drug Administration (FDA)! Our next-generation ADC technology presents a major advancement in cancer treatment, aiming to surpass the safety and efficacy obstacles of current ADCs.
Our advanced combination of internalizing antibodies, effective linkers, novel payloads, and our exclusive CellTrapper™ technology enhances intracellular uptake of the payload, potentially heightening its efficacy while minimizing side effects. Our first dosing of VIP943 is anticipated to occur in the fourth quarter.
We are excited to be progressing with our Phase 1 dose escalation study for VIP236: our first-in-class small molecule drug-conjugate (SMDC). Preclinical data indicates this innovative therapy has the potential to effectively deliver a camptothecin payload to tumors, including those expressing αvβ3 which are associated with advanced and metastatic tumors.
Results from patient-derived xenograft (PDX) and cell line-derived gastric cancer models show an increase in efficacy independent of HER2 status when compared to existing treatments.We anticipate announcing preliminary results of the dosing approaches tested by late 2023 or early 2024.
We are delighted to welcome Steve Bloom as our new Chief Business Officer! With Steve on board, we can confidently take our business development activities to the next level and seize the growing opportunities created by the burgeoning bioconjugates industry.
As we move into the second half of the year, our resources have been strategically put to use to focus on two of our programs, VIP943 and VIP236, as well as exploring potential research collaborations and other avenues to bolster their advancement. Our cutting-edge, next-generation modular bioconjugation platform has also revealed exciting possibilities for further research and development. Dr. Hamdy concludes: “We’re enthusiastic for the prospect of leveraging the strength of our platform to maximize the potential of our lead programs.”
Second Quarter 2023 Corporate Highlights
VIP943, CD123-KSPi ADC: for Leukemias and Myelodysplastic Syndrome:
- We are excited to announce that VIP943 has filed and anticipates enrolling its first participant in a Phase 1 dose escalation study in Q4 2023! This groundbreaking study will bring us one step closer to understanding the potential of this innovative new therapy.
- At ASH 2022, we presented preclinical data that showed our experimental therapy had superior safety in monkeys and better efficacy in a mouse model of acute leukemia when compared with Mylotarg™. These results are incredibly exciting as they indicate a promising future for our therapy treatment and demonstrate its potential for improving the care of acute leukemia patients.
VIP236, an αvβ3 Integrin Binder Linked to an optCPT Payload SMDC:
- We are currently conducting a Phase 1 first-in-human dose-escalation study with VIP236 monotherapy – a groundbreaking chance to evaluate the safety and efficacy of this potential new therapy – so join us in pioneering the next generation of healthcare solutions with this trial (ClinicalTrials.gov NCT05712889).
- At the AACR 2023 annual meeting, data from multiple mouse models across different tumor types was unveiled, showing that VIP236 can effectively and sustainably inhibit tumor growth in cases of non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), triple negative breast cancer (TNBC), and gastric cancers. These results demonstrate promising potential for further investigation of the therapeutic effects of VIP236.
VIP924, CXCR5-KSPi ADC: for B-cell Malignancies:
- We presented compelling preclinical data at AACR 2023 that showed a remarkable inhibition of tumor growth in a wide range of lymphoma cell lines and cell line-derived and PDX lymphoma models. Our findings were extremely promising and bode well for potential future research.
- We are investing strategically in our lead programs VIP236 and VIP943, ensuring that our resources amplify their potential.
Additional Platform Updates
- At AACR 2023, we presented our preclinical data on the development of a novel SMDC platform, featuring various types of payloads. Our platform successfully demonstrated its broad potential, opening up an exciting range of opportunities for further investigation.
Enitociclib, Positive Transcription Elongation Factor b (P-TEFb)/CDK9 Inhibitor:
- The National Institutes of Health (NIH) are currently conducting a Phase 1 study into the potential of combining enitociclib and venetoclax with prednisone (VVIP) to treat diffuse large B-cell lymphoma (DLBCL) and peripheral T Cell Lymphoma (PTCL). Enrollment is still open and those interested are encouraged to visit ClinicalTrials.gov (NTC05371054) for more information about this exciting new trial.
- Further combination studies are yet to be discovered, but could be unlocked with additional financial or partnering support. Imagine the possibilities!
- Proof-of-concept monotherapy efficacy has been generated in early-stage clinical studies:
- Two incredible cases of hematologic malignancies have been reported – 2 patients with double-hit DLBCL achieved complete metabolic responses after 10 cycles of treatment and remained in remission for over 4 years, while another patient with transformed follicular lymphoma has been successfully on treatment for over 13 months with a maximum 43% reduction in target lesions!
- Thirteen patients with ovarian, pancreatic and salivary gland cancer achieved remarkable results, as they were able to not just stabilize their tumors, but also keep them under control for a long time. This is a huge accomplishment, and these patients and their families should be proud of their perseverance.
- Preclinical evidence is indicating potential for multiple new indications for the treatment of diseases such as multiple myeloma and even pediatric indications. This novel approach has the potential to drastically improve the lives of those affected by these conditions.
Second Quarter 2023 Financial Results
- Boasting a decreased burn rate following the completion of its Chemistry, Manufacturing, and Controls (CMC) activities, Vincerx had a cash, cash equivalents, and marketable securities balance of $27.4 million as of June 30, 2023 – a drop from its December 31, 2022 holdings of $52.5 million. With resources prioritized for its two lead programs, VIP236 and VIP943, the company anticipates its funds will last into late 2024, allowing for smooth progress in its operations.
- During the three- and six-month periods ending June 30th, 2023, research and development expenses decreased substantially from the same time periods in 2022 – dropping from $13.7 million and $29.7 million to $7.9 million and $18.5 million, respectively. The main contributing factors to this dip included reductions of stock-based compensation costs by $2.0 million and $5.0 million for the three- and six-month periods respectively, as well as payroll related costs, clinical services, and third-party research/preclinical work that decreased by $0.9 million, $1.1 million, and $1.1 million respectively. Additionally, a decrease in manufacturing services associated with our ADC program totaled $1.4 million.
- For the three- and six-months ended June 30, 2023, G&A expenses were approximately $3.8 million and $8.3 million respectively—lower than the $4.7 million and $10.4 million recorded in the same periods in 2022. This decrease in costs can primarily be attributed to a decline in stock-based compensation expenses for the same period of $0.7 million and $1.8 million.
- Vincerx reported disastrous second-quarter losses for 2023, with a net loss of $11.2 million, or $0.52 per share. This loss was a marked decrease from the second quarter of 2022, which saw a net loss of $18.4 million, or $0.88 per share. The six-month period from January to June of 2023 didn’t fair much better, with a net loss of $25.5 million, or $1.20 per share, compared to $34.8 million, or $1.66 per share for the same period last year.
About Vincerx Pharma, Inc.
Vincerx Pharma, Inc. is a distinguished biopharmaceutical company focused on discovering and developing innovative and novel therapies to help those suffering from cancer realize relief and improved outcomes. With a distinguished and experienced management team, Vincerx has made great strides forward in oncology-focused drug development leading to value creation.
Their promising pipeline includes VIP943, a next-generation antibody drug-conjugate with a pending IND, VIP924, a preclinical antibody drug conjugate, VIP236, a small molecule drug-conjugate in Phase 1, enitociclib, a CDK9 inhibitor currently in an NIH sponsored Phase 1, and their cutting-edge modular bioconjugation platform.
Vincerx, a Palo Alto-based biopharmaceutical company, has a distinct global focus with a research facility located in Monheim, Germany. With its headquarters in the heart of Silicon Valley and lab in Europe, Vincerx is successfully straddling the two continents and creating breakthroughs that could revolutionize the healthcare industry.
Vincerx is making strides forward in its business strategy. Our expectations around our cash runway, pipeline, strategies, timeline, product candidates and attributes, as well as preclinical and clinical development, have never looked brighter. We are confident that our current plans and projections are firmly on-target and primed to yield strong results, however, the future is inevitably uncertain and full of potential risks that can be difficult to predict. Still, we are equipped and ready to take on the future with gusto.
Vincerx’s future success is uncertain and subject to a range of conditions. These include, but are not limited to, general economic, financial, legal, political, and business conditions; the potential effects of health epidemics and pandemics, including COVID-19; risks associated with preclinical or clinical development and trials; failure to realize the benefits of Vincerx’s license agreement with Bayer; the rollout of Vincerx’s business and its product development milestones; changes in Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; and Vincerx’s capital requirements and availability, uses of capital, and cash runway. Any of these could have an adverse effect on Vincerx and these conditions need to be closely monitored.