On November 13, 2023 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported financial results for the third quarter ended September 30, 2023, and provided a business update (Press release, Point Biopharma, NOV 13, 2023, View Source [SID1234637573]).

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"The founding mission of our company is to accelerate the discovery, development and global access to radiopharmaceuticals," said Joe McCann, Ph.D., CEO of POINT Biopharma. "I view Lilly’s agreement to acquire POINT as validation of the uniqueness of our team, infrastructure and pipeline. Together, we can become a global radiopharmaceutical leader, executing on our mission and transforming lives touched by cancer."

POINT to be Acquired by Lilly

On October 3, 2023, Eli Lilly and Company (NYSE: LLY) and POINT Biopharma Global Inc. (NASDAQ: PNT) announced a definitive agreement for Lilly to acquire POINT for a purchase price of $12.50 per share in cash (an aggregate of approximately $1.4 billion) payable at closing. The purchase price payable at closing represents a premium of approximately 87% to POINT’s closing stock price on Oct. 2, 2023, the last trading day before the announcement of the transaction, and 68% to the 30-day volume-weighted average price. The tender offer, which was previously scheduled to expire at one minute past 11:59 p.m., Eastern time, on Nov. 9, 2023, has been extended until 5:00 p.m., Eastern time, on Nov. 16, 2023, unless the tender offer is further extended or earlier terminated, in order for the parties to satisfy outstanding closing conditions. The proposed acquisition is expected to close near the end of 2023, subject to customary closing conditions, including the tender of at least a majority of the outstanding Shares as of the expiration of the tender offer.

Business Highlights and Upcoming Milestones

Pipeline Updates

PNT2002: 177Lu-labelled PSMA-targeted radioligand therapy

Enrollment in PNT2002’s phase 3 SPLASH trial (NCT04647526) is complete and topline data is expected in the fourth quarter of 2023.

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PNT2004: fibroblast activation protein-α (FAP-α) targeted radioligand therapy

The PNT2004 program leverages the D-ala-boroPro FAP targeting warhead, which is a potent and selective FAP inhibitor. PNT6555 is the current clinical lead in the PNT2004 program.

The phase 1 FRONTIER trial (NCT05432193) utilizing 68Ga/177Lu-labelled PNT6555 closed enrollment after the dosing of cohort 3 (12 GBq) in October. There are no plans for expansion of the third cohort, and there were no dose limiting toxicities. Analysis of the dosimetry and clinical data from the FRONTIER trial is underway and includes pancreatic ductal adenocarcinoma, colorectal cancer, cholangiocarcinoma, and esophageal cancer subjects.

Presentation of data from the FRONTIER study is anticipated in the first half of 2024, and based on initial promising data we expect to advance at least one 2nd-generation D-ala-boroPro-based lead into the clinic next year.

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PNT2001: 225Ac-labelled next-generation PSMA-targeted radioligand therapy

For the phase 1 portion of ACCEL, the first-in-human phase 1/2 clinical trial for PNT2001’s actinium-225 program, we expect the first patient dosed in this trial to be in the first quarter of 2024. The trial was designed to enable the parallel exploration of PNT2001 in two populations: patients with later-stage mCRPC and patients with earlier-stage BCR or PSMA-positive oligorecurrent disease.

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Manufacturing & Supply Chain Updates

In July 2023, we announced an expanded agreement with ITM Isotope Technologies Munich SE (ITM), which broadens the supply of ITM’s no-carrier-added lutetium-177 (n.c.a. 177Lu) to POINT to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in POINT’s development pipeline.

In September 2023, we signed a supply agreement with Eckert & Ziegler AG for no-carrier-added lutetium-177 (n.c.a. 177Lu).

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Discovery Updates

In September 2023, we announced a collaboration and license agreement to develop and commercialize DARPin-targeted radioligands ("Radio-DARPins"). The collaboration gives POINT exclusive access to Athebio’s intellectual property and capabilities in DARPin development in the radioligand therapy field. Together, the parties will collaborate in discovery, candidate selection and preclinical development of Athebody DARPins for use as Radio-DARPin drug entities. POINT will be solely responsible for the clinical development and commercialization of Radio-DARPins translated from the discovery collaboration.

Third Quarter 2023 Financial Results

Cash, Cash Equivalents, and Investments: As of September 30, 2023, POINT had approximately $399.0 million in cash, cash equivalents, and investments, which is anticipated to fund operations into 2026.

Net Loss: Net loss was $24.8 million and $66.7 million, or $0.23 and $0.63 net loss per share, for the three and nine months ended September 30, 2023, respectively, as compared to a net loss of $24.0 million and $65.0 million, or $0.26 and $0.71 net loss per share, respectively, for the same periods in 2022.

Research and Development Expenses: Research and development expenses were $26.9 million and $85.1 million for the three and nine months ended September 30, 2023, respectively, as compared to $20.8 million and $54.1 million, respectively, for the same periods in 2022.

General and Administrative Expenses: General and administrative expenses were $5.5 million and $15.6 million for the three and nine months ended September 30, 2023, respectively, as compared to $3.8 million and $11.7 million for the same periods in 2022.

On November 13, 2023 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the third quarter of 2023 (Press release, Y-mAbs Therapeutics, NOV 13, 2023, View Source [SID1234637567]).

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"We delivered $20 million in DANYELZA (naxitamab-gqgk) net product sales in the third quarter of 2023, reflecting 59% growth compared to the same period in 2022, as sales continued trending upward since our initial launch," said Mike Rossi, President and Chief Executive Officer. "Our U.S. commercial team has made excellent progress by penetrating more high-volume Children’s Oncology Group ("COG") sites while our ex-U.S. partners continue to gain further traction with physicians prescribing DANYELZA across Europe and China for relapsed or refractory high-risk neuroblastoma patients."

Mr. Rossi continued, "Supported by a solid financial foundation, we have advanced our novel SADA radioimmunotherapy platform with the continued execution of our Phase 1 GD2-SADA trial and the recent Investigational New Drug ("IND") clearance of our CD38-SADA program. With existing cash and cash equivalents anticipated to support our business operations as currently planned into 2027, a growing commercial product in DANYELZA, and a differentiated radioimmunotherapy platform in SADA, we believe Y-mAbs is on a path to potentially transform the treatment paradigm for a variety of cancers and improve patients’ lives."

Third Quarter 2023 and Recent Corporate Developments

· On October 18, 2023, Y-mAbs announced that its Board of Directors appointed Mr. Rossi as President and Chief Executive Officer, effective November 6, 2023. Thomas Gad, who founded Y-mAbs in 2015 and has served as Interim Chief Executive Officer since 2022, has transitioned to the role of Vice Chairman of the Board of Directors and Chief Business Officer.
· On October 17, 2023, the U.S. Food & Drug Administration ("FDA") cleared Y-mAbs’ IND for CD38-SADA, marking the second clinical development program utilizing the Company’s novel SADA technology platform.
· On October 16, 2023, Y-mAbs announced the publication of the study of naxitamab-based chemoimmunotherapy in patients with chemoresistant high-risk neuroblastoma ("HR-NB") in the journal Cancers. The study investigated the HITS combination in patients with high-risk neuroblastoma who did not respond well to induction therapy. Patients who received HITS immediately after induction had higher response rates (47% vs. 18%) and superior estimated three-year overall survival (85% vs. 29%) compared with those who received the same combination regimen later in the course of treatment. The publication is entitled, "Early Salvage Chemo-Immunotherapy with Irinotecan, Temozolomide and Naxitamab Plus GM-CSF (HITS) for Patients with Primary Refractory High-Risk Neuroblastoma Provide the Best Chance for Long-Term Outcomes."

· On October 11, 2023, Y-mAbs showcased three poster presentations, in addition to an online publication, of DANYELZA at the 55th Congress of the International Society of Pediatric Oncology in Ottawa, Canada.
· On September 28, 2023, Y-mAbs received approval of its Mexican Marketing Authorization Application ("MAA") by COFEPRIS for DANYELZA, marking the Company’s second approval in Latin American with its distribution partner Adium Pharma S.A.

Financial Results

Revenues

DANYELZA net product revenues were $20.0 million and $61.0 million for the third quarter and nine months ended September 30, 2023, which represented increases of 59% and 86%, respectively, over $12.5 million and $32.8 million in the comparable periods of 2022.

The DANYELZA net product revenues of $20.0 million in the third quarter of 2023, represented a marginal decline compared to the second quarter of 2023, primarily driven by modest unevenness in international revenues after a series of inventory stocking orders from the Company’s international partners as reported in recent quarters.

As of September 30, 2023, Y-mAbs has delivered DANYELZA to 57 centers across the U.S. since initial launch, with nine new accounts added so far in 2023. During the third quarter ended September 30, 2023, approximately 63% of the vials sold in the U.S. were sold outside of Memorial Sloan Kettering Cancer Center ("MSK"), compared to 61% in the second quarter ended June 30, 2023.

Y-mAbs reported total revenues of $20.5 million and $61.5 million for the third quarter and nine months ended September 30, 2023, which represented increases of 63% and 82%, respectively, over $12.5 million and $33.8 million in the comparable periods of 2022. Total revenues in the third quarter and nine months ended September 30, 2023 included $0.5 million of license revenue recognized upon the September 2023 achievement of marketing authorization for DANYELZA in Mexico under the Company’s sublicense agreement with Adium. There was no license revenue in the third quarter ended September 30, 2022, and license revenue for the nine months ended September 30, 2022 was $1.0 million.

Operating Costs and Expenses

Cost of Goods Sold

Cost of goods sold was $2.6 million and $2.5 million for the third quarter ended September 30, 2023 and 2022, respectively. Cost of goods sold was $9.3 million and $5.4 million for the nine months ended September 30, 2023 and 2022, respectively. The increase in cost of goods sold in both periods was primarily driven by increased product revenue in the three and nine months ended September 30, 2023, and inventory write-downs of $0.4 million and $0.8 million in the three and nine months ended September 30, 2023, respectively, partially offset by a $1.2 million charge related to an inventory batch that did not meet the Company’s quality specifications during the three and nine months ended September 30, 2022.

Excluding the above inventory charges, the Company’s gross margin decreased slightly in the three and nine months ended September 30, 2023, compared to the same periods in 2022, due to an increase in ex-U.S. revenues, which were at lower gross margins.

Research and Development

Research and development expenses were $15.4 million for the third quarter ended September 30, 2023, a reduction of 32% compared to $22.5 million for the third quarter ended September 30, 2022. The $7.1 million decrease was primarily due to decreased spending on deprioritized programs, which resulted in a $5.7 million decrease in outsourced manufacturing, decreased personnel-related costs, inclusive of stock-based compensation, of $2.0 million, a $2.0 million decrease in outsourced research and supplies, and a $0.3 million decrease in clinical trials, partially offset by a $4.1 million increase in milestones and license acquisition costs related to the Company’s SADA License Agreement, as the Company determined that certain time-based clinical milestones within the agreement are probable of achievement based on the availability of necessary data and the assessment of clinical progress in the third quarter of 2023.

For the nine months ended September 30, 2023, research and development expenses were $40.8 million, a reduction of 43% compared to $71.8 million for the nine months ended September 30, 2022. The $31.0 million decrease was primarily due to decreased spending on deprioritized programs as described above, resulting in a $17.9 million decrease related to outsourced manufacturing, a $6.8 million decrease in outsourced research and supplies, a $3.1 million decrease in clinical trials and a $4.1 million decrease in personnel-related costs, partially offset by a $4.1 million increase in milestones and license acquisition costs related to the Company’s SADA License Agreement, as the Company determined that certain time-based clinical milestones within the agreement are probable of achievement based on the availability of necessary data and the assessment of clinical progress in the third quarter of 2023.

The $2.0 million and $4.1 million decreases in personnel-related costs during the three and nine months ended September 30, 2023, respectively, were driven by the headcount reduction as part of Company’s restructuring plan announced in January 2023, partially offset by severance charges recognized in conjunction with the restructuring plan.

Selling, General, and Administration

Selling, general, and administrative expenses were $10.2 million for the third quarter ended September 30, 2023, a reduction of 25% compared to $13.6 million for the third quarter ended September 30, 2022. The $3.4 million decrease in selling, general and administrative expenses was primarily attributable to a $1.9 million decrease in commercialization expenses, incurred in 2022 in anticipation of the potential omburtamab launch.

For the nine months ended September 30, 2023, selling, general, and administrative expenses were $33.7 million, a reduction of 33% compared to $50.1 million for the nine months ended September 30, 2022. The $16.4 million decrease in selling, general and administrative expenses was primarily attributable to a $10.9 million charge in the nine months ended September 30, 2022 related to contractual severance-related benefits for the Company’s former Chief Executive Officer, and, to a lesser extent, a $2.9 million decrease in commercialization expenses, incurred in 2022 in anticipation of a potential omburtamab launch.

Net Loss

Y-mAbs reported a net loss for the third quarter ended September 30, 2023, of $7.7 million, or ($0.18) per basic and diluted share, compared to a net loss of $27.5 million, or ($0.63) per basic and diluted share, for the quarter ended September 30, 2022. For the nine months ended September 30, 2023, the Company reported a net loss of $20.4 million, or ($0.47) per basic and diluted share, compared to a net loss of $96.7 million, or ($2.21) per basic and diluted share, for the nine months ended September 30, 2022. The favorable decrease in net loss was primarily driven by an increase in DANYELZA U.S. and international product revenues in the third quarter and nine months ended September 30, 2023, decreased research and development cost, and decreased selling, general and administration cost.

Cash and Cash Equivalents

As of September 30, 2023, Y-mAbs had approximately $86.6 million in cash and cash equivalents which, together with anticipated DANYELZA product revenues, is expected to support operations as currently planned into 2027. This estimate reflects the Company’s current business plan that is supported by assumptions that may prove to be inaccurate, such that Y-mAbs could use its available capital resources sooner than it currently expects.

Financial Guidance

The Company is updating and reiterating its full-year 2023 financial guidance, as follows:

· Reiterating anticipated DANYELZA net product revenues of between $80 million and $85 million;
· Lowering anticipated operating expenses to between $110 million and $115 million from previous guidance of between $115 million and $120 million;
· Lowering anticipated total annual cash burn to between $27 million and $32 million from previous guidance of between $40 million and $50 million; and
· Cash and cash equivalents now anticipated to support operations as currently planned into 2027 compared to previous cash runway guidance into 2026.

Webcast and Conference Call

Y-mAbs will host a conference call on Tuesday, November 14, 2023, at 9:00 a.m. ET. To participate in the call, please use the following dial-in information.

Investors (domestic): 877-407-0792
Investors (international): 201-689-8263
Conference ID: 13741478

To access a live webcast of the update, please use this link. Prior to the call and webcast, a slide presentation pertaining to Y-mAbs’ quarterly earnings will be made available in the investor relations section of the Company’s website, www.ymabs.com, shortly before the call begins.

On November 13, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, reported financial results for the third quarter ended September 30, 2023 and provided a corporate update on progress in key programs (Press release, Vaccinex, NOV 13, 2023, View Source [SID1234637566]).

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Vaccinex achieved several important clinical milestones for pepinemab in both Alzheimer’s disease and Head and Neck Cancer.

Alzheimer’s Disease (AD):

Completed enrollment in the randomized, double-blind, Phase 1b/2a SIGNAL-AD trial of pepinemab in patients with mild Alzheimer’s disease (NCT04381468), funded in part by the Alzheimer’s Drug Discovery Foundation and by a grant from the Alzheimer’s Association.
Anticipate completing 12-months treatment in June 2024 at which time we will evaluate the impact of treatment on brain metabolic activity, a key biomarker of clinical progression in AD, as well as treatment effects on cognition employing several validated, clinically meaningful Alzheimer’s cognitive scales.
An improving AD-drug development environment, based on FDA’s recent full approval of LEQEMBI, enables the pathway to reimbursement and supports further investment in Alzheimer’s Disease drug development.
As previously reported, pepinemab has a differentiated mechanism of action, blocking SEMA4D, which is upregulated in neurons during stress of Alzheimer’s and Huntington’s disease and triggers the transformation of astrocytes and microglia from normal homeostatic functions to neuroinflammatory activity. Blockade of SEMA4D restores healthy astrocyte and neuronal functions while reducing neuroinflammation (Nature Medicine 2022).
We believe that the prevalence of AD (6 million people diagnosed with AD in the US alone) and current concerns about the limitations of anti-Aβ amyloid antibodies would make pepinemab attractive as a potential alternative to anti-Aβ antibodies or possibly for use in combination with an anti-Aβ for greater efficacy.
The potential impact of the AD program on Vaccinex valuation and financial resources make this Vaccinex’s most important near-term catalyst.
Head and Neck Cancer:

As previously reported, analysis of interim data from the first 36 patients in the single-arm, Phase 2 KEYNOTE B-84 study (NCT04815720) evaluating pepinemab in combination with KEYTRUDA in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) suggests that the combination of pepinemab and KEYTRUDA resulted in an approximately 2X increase in objective responses (ORR) and progression free survival (PFS) in the subset of patients with hard-to-treat PD-L1-low tumors compared to historical response rates for checkpoint monotherapy in this population.
Biomarker data indicate that treatment induced the formation of highly organized lymphoid aggregates in tumor that correlate with disease control and have previously been shown to be important for positive response to checkpoint inhibitors.
Vaccinex and Merck are currently in the design stages for an expansion of the KEYNOTE-B84 study that may extend benefits to more patients.
Recent Milestones and News

Clinical Trials in Alzheimer’s Disease (CTAD) Conference Presentation:

In a highlighted podium presentation at the CTAD Conference on September 28, 2023. Vaccinex’s Senior Vice President for Clinical Development, Terrence Fisher, PhD, described the many physiological parallels between neurodegenerative processes in Alzheimer’s and Huntington’s disease (HD). A key common feature is the contribution of astrocyte activation (astrogliosis) to brain inflammation and damage. Vaccinex scientists have demonstrated that the stress of disease in both AD and HD leads to upregulation of SEMA4D in neurons and that this can trigger astrocytes to switch from their normal supportive physiological functions to inflammatory activity. This transition is marked by release of glial fibrillary acidic protein (GFAP), a characteristic astrocyte protein, into blood. Importantly, treatment with pepinemab was shown to result in a significant reduction in plasma GFAP levels in HD patients. Elevated plasma GFAP levels have also been reported to correlate with Aβ amyloid deposits in brain and to be associated with higher risk of dementia and faster rates of cognitive decline in AD.

ActivMAb Platform Technology:

The first clinical candidate selected through use of this technology (SRF114, a fully human monoclonal antibody targeting CCR8 for the potential treatment of solid tumors), is in a Phase 1/2 study sponsored by our licensee, Surface Oncology, recently acquired by Coherus Biosciences, Inc. (transaction closed September 8, 2023). The technology and its potential applications for drug discovery against complex membrane protein targets including the "hard to drug" class of membrane-associated G protein-coupled receptors (GPCRs) and ion channels is also being utilized in multiple Vaccinex antibody discovery collaborations with leading biopharmaceutical companies.

Financial Results for the Three Months Ended September 30, 2023:

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on September 30, 2023 were $0.1 million, as compared to $6.4 million as of December 31, 2022.

During Q3 2023, the Company raised finances of $1.3 million. On August 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.20 million shares1 of common stock for aggregate proceeds of $0.7 million. Similarly, on September 22, 2023, Vaccinex completed a Private Placement and issued approximately 0.25 million shares of common stock for aggregate proceeds of $0.6 million. Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, the Company’s President, Chief Executive Officer, and a member of its board of directors purchased approximately 0.14 million shares of common stock for gross proceeds of $0.3 million.

In addition, on October 3, 2023, the Company issued and sold to certain investors (i) 7,600,000 shares of the Company’s common stock together with common warrants to purchase up to 7,600,000 shares of common stock and (ii) 2,000,000 pre-funded warrants to purchase up to 2,000,000 shares of common stock together with common warrants to purchase up to 2,000,000 shares of common stock, at a purchase price of $1.00 and $0.999, respectively, for aggregate gross proceeds of $9.60 million. FCMI, which is controlled by Albert D. Frieberg, the chairman of the Company’s board of directors, and Vaccinex (Rochester) L.L.C. purchased 3,000,000 and 500,000 shares of our common stock and accompanying common warrants, respectively, for an aggregate purchase price of $3.50 million.

Finally, in Q3 2023, the Company recorded a receivable of $0.9 million for the Employee Retention Credit. The Company expects to receive the cash proceeds by the end of 2023 or early Q1 2024.

Research and Development Expenses. Research and development expenses for the quarter ended September 30, 2023 were $4.4 million as compared to $3.4 million for the comparable period in 2022.

The increase in research and development expenses is primarily attributable to increased patient enrollment in the SIGNAL-AD study and the Phase 1b/2 KEYNOTE B84 study in HNSCC.

General and Administrative Expenses. General and administrative expenses for the quarter ended September 30, 2023 were $1.5 million as compared to $1.4 million for the comparable period in 2022.

The increase was attributable to increased legal and patent related services.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended September 30, 2023 was $4.9 million and $(1.09) compared to $4.8 million and $(1.67) for the comparable period in 2022.

Full financial tables are included below. For further details on Vaccinex’s financials, refer to its Form 10-Q filed November 13, 2023 with the S.E.C.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can trigger collapse of the actin cytoskeleton and loss of homeostatic functions of astrocytes and glial cells in the brain and dendritic cells in immune tissue. Pepinemab has been administered to more than 400 patients and appears to be well-tolerated and to have a favorable safety profile.

On November 13, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported that it will highlight data from two key Phase 3 trials evaluating UGN-102, an investigational treatment in development for LG-IR-NMIBC at the 2023 Society of Urologic Oncology (SUO) annual meeting, November 28-December 1 in Washington D.C (Press release, UroGen Pharma, NOV 13, 2023, View Source [SID1234637565]). These data presentations further UroGen’s mission of developing and commercializing innovative treatments for urothelial and specialty cancers that provide patients with novel non-surgical options to fulfill the unmet needs that exist with current standards of care.

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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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"The ATLAS and ENVISION Phase 3 clinical trials broaden our understanding of potentially using a new approach to treat LG-IR-NMIBC," says Mark Schoenberg, M.D., Chief Medical Officer of UroGen. "We’re particularly excited that the SUO selected the ENVISION study as one of only two late-breaking trials designated for oral presentations, which we believe further reinforces its potential in advancing bladder cancer treatment. We are optimistic for what the future may hold for LG-IR-NMIBC patients who suffer from this highly prevalent and recurrent disease."

Key highlights of UGN-102 data accepted by SUO:

Abstract Title

Presentation Details

Primary chemoablation for recurrent low-grade intermediate risk (LG IR) NMIBC: The ENVISION trial

Podium Oral Presentation: Urothelial Cancer Session I

Thursday, Nov 30th,

12:04 p.m. – 12:09 p.m. EST

*Abstract available day of presentation

Presenter:

Sandip Prasad, M.D.

Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, NJ

Treatment of low-grade intermediate risk non-muscle invasive bladder cancer with UGN-102 + transurethral resection of bladder tumor (TURBT) compared to TURBT monotherapy: the Phase 3 ATLAS trial

Poster #132

Poster Available:
Thursday, Nov 30th,

2:15 p.m. – 3:15 p.m. EST

Presenter:

Sandip Prasad, M.D.

Morristown Medical Center/Atlantic Health System and Garden State Urology, Morristown, NJ

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting an NDA for UGN-102 in 2024.

On November 13, 2023 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported its financial results for the third quarter of 2023, its recent business highlights, and a preview of select anticipated milestones (Press release, Sutro Biopharma, NOV 13, 2023, View Source [SID1234637564]).

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"The last few months have been productive for Sutro, with the recent presentation of encouraging early data for luvelta in endometrial cancer, as well as the appointment of Dr. Hans-Peter Gerber as our CSO. Dr. Gerber’s extensive experience in discovering and developing novel ADCs further strengthens our position as a scientific leader in this important therapeutic modality," said Bill Newell, Sutro’s Chief Executive Officer. "The recent encouraging update with luvelta in endometrial cancer gave us further confidence in the potential for luvelta to be a targeted treatment for a range of indications with significant unmet need. Additionally, we are pleased with the pace of enrollment of our Phase 2/3 trial for luvelta in patients with platinum resistant ovarian cancer, REFRaME-O1."

"Sutro’s remarkable platform has the potential to yield best in class product candidates from all of our ADC design concepts – including ADCs, iADCs, and ADC2. The diversity of product candidate attributes enabled by Sutro technology is what originally attracted me to the company," said Hans-Peter Gerber, Sutro’s CSO. "After an in-depth review of the platform and programs developed at Sutro, I am excited to combine our industry leading technology with our established development capabilities to deliver fit-for-purpose molecules that could transform the lives of cancer patients with limited options."

Recent Business Highlights and Select Anticipated Milestones

STRO-002, International Nonproprietary Name, "luveltamab tazevibulin," abbreviated as "luvelta," FolRα-Targeting ADC: Luvelta is being studied in the clinic globally for patients with ovarian and endometrial cancers.

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Initial results from the Phase 1 dose-expansion study for luvelta in patients with endometrial cancer were presented in a mini oral presentation at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress held in Madrid, Spain in October 2023. Luvelta demonstrated encouraging preliminary anti-tumor activity in FolRα-selected patients, defined by a Tumor Proportion Score (TPS) of >25% FolRα expression, and the safety profile was consistent with prior data in patients with platinum-resistant ovarian cancer.

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Previous data from the Phase 1 dose-expansion study for luvelta in ovarian cancer demonstrated meaningful clinical benefit in FolRα-selected patients, defined by a TPS of >25%, irrespective of staining intensity, in which the data collected has shown to represent approximately 80% of the advanced ovarian cancer patient population.
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In June 2023, Sutro announced the initiation of Part I of REFRaME-O1, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer. The trial is well underway, and sites have been activated globally. Sutro is also in discussions with both the FDA and EMA to refine the trial design for REFRaME-O1 to potentially support global registration of luvelta.
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Patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, a highly refractory and uniformly fatal subtype of acute myeloid leukemia found exclusively in infants and young children, were treated with luvelta under compassionate use. Preliminary results from compassionate use of luvelta in this ultra rare indication suggested that luvelta was well tolerated as a monotherapy agent and in combination with standard cancer therapies. Soheil Meshinchi, M.D., Ph.D., expects to present updated data from this program in a poster at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2023) to be held December 9-12, 2023 in San Diego, CA.
Title: Anti-Leukemic Activity of Luveltamab Tazevibulin (LT, STRO-002), a Novel Folate Receptor-α (FR-α)-Targeting Antibody Drug Conjugate (ADC) in Relapsed/Refractory CBFA2T3::GLIS2 AML

Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III

Date & Time: Monday, December 11, 2023, 6:00 PM – 8:00 PM PT

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Luvelta is also being studied in combination with bevacizumab for patients with advanced ovarian cancer.
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Translational work is ongoing to support an Investigational New Drug (IND) application for the initiation of a study of luvelta for patients with non-small cell lung cancer (NSCLC), for which the protocol is under development.
Additional Pipeline Development: STRO-003, a ROR1-targeting ADC, and STRO-004, a tissue factor-targeting ADC, have INDs planned for 2024 and 2025, respectively.

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STRO-003, a novel, next-generation ADC that has been designed to target ROR1, features eight precisely placed β-Glucuronidase-cleavable linkers attached to next-generation exatecan warheads, which, when released, inhibit topoisomerase-1 (TOPO-1) and cause DNA disruption.
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STRO-003 has demonstrated, in NSCLC and breast cancer patient-derived xenograft models, strong cell-killing activity in low and heterogeneous ROR1-expressing tumors. STRO-003 has also exhibited promising tolerability in preclinical studies involving rodents and non-human primates, with potentially reduced lung toxicity relative to other TOPO-1 inhibiting ADCs.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $785 million in payments through September 30, 2023, including equity investments.

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In June 2023, Sutro announced a royalty monetization agreement with Blackstone Life Sciences, an affiliate of Blackstone, under which Sutro received $140 million upfront and is eligible to receive up to an additional $250 million in future milestone payments in exchange for the 4% royalty, or revenue interest, in potential future sales of Vaxcyte’s products. This transaction with Blackstone provides non-dilutive capital to Sutro for continued pipeline advancement. Sutro retains the right to discover and develop vaccines for the treatment or prophylaxis of any disease that is not caused by an infectious pathogen, including cancer.
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In December 2022, Sutro and Vaxcyte expanded upon a nearly decade-long relationship through a new agreement, under which Vaxcyte acquired an option to access expanded rights to develop and manufacture cell-free extract, among other rights, and includes a $22.5 million upfront payment and, upon exercise of the option, up to an additional $135 million in option exercise and contingent payments.
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Sutro’s collaboration with Astellas on the discovery of immunostimulatory antibody-drug conjugates (iADCs) for three targets is ongoing, for which Sutro receives financial support for its research efforts, potential milestone payments and royalties, and has an option to co-develop and co-commercialize product candidates in the U.S.
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Sutro is manufacturing initial drug supply for its partners including for Merck’s MK-1484, currently in Phase 1 as monotherapy and in combination with pembrolizumab in advanced or metastatic solid tumors. Sutro is providing clinical drug supply to BioNova for clinical studies for BN301 (STRO-001) in Greater China. Sutro is currently supporting Tasly Biopharmaceuticals (Tasly), which recently received its first IND clearance by the National Medical Products Administration, or NMPA, for their initiation of clinical development activities in Greater China for STRO-002 and will provide initial drug supply for their Phase 1 study.
Corporate Updates: Sutro strengthened and continues to build a world-class leadership team through the appointment of a new Chief Scientific Officer.

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Hans-Peter Gerber, Ph.D., joined Sutro as Chief Scientific Officer in September 2023, overseeing the research and early discovery functions, with a focus on the design and discovery of new molecules to rapidly progress into the clinic, in addition to being a member of Sutro’s Senior Management Team.
Upcoming Events: Sutro plans to participate in two upcoming investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the events.

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Jefferies London Healthcare Conference in London, Wednesday, November 14-16, 2023
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Piper Sandler 35th Annual Healthcare Conference in New York, November 28-30, 2023
Third Quarter 2023 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of September 30, 2023, Sutro had cash, cash equivalents and marketable securities of $321.1 million, as compared to $358.3 million as of June 30, 2023, and approximately 0.7 million shares of Vaxcyte common stock with a fair value of $34.0 million, which together provide a projected cash runway into the first half of 2025, based on current business plans and assumptions. Current market conditions provide a challenging financing environment. In this context, Sutro is evaluating its programs and spending as it fully develops its 2024 goals and financial plan.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

The non-operating, unrealized gain of $0.7 million in the quarter ended September 30, 2023 was due to the increase since June 30, 2023 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’s statements of operations.

Revenue

Revenue was $16.9 million for the quarter ended September 30, 2023, as compared to $25.1 million for the same period in 2022, with the 2023 amount related principally to the Astellas collaboration and the recognition of a contingent payment from Tasly. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments.

Operating Expenses

Total operating expenses for the quarter ended September 30, 2023 were $60.9 million, as compared to $46.4 million for the same period in 2022. The third quarter of 2023 includes non-cash expenses for stock-based compensation of $6.0 million and depreciation and amortization of $1.7 million, as compared to $6.8 million and $1.4 million, respectively, in the comparable 2022 period. Total operating expenses for the quarter ended September 30, 2023 were comprised of research and development expenses of $45.7 million and general and administrative expenses of $15.3 million.

Royalty Monetization Agreement

As related to the royalty monetization agreement between Sutro and an affiliate of Blackstone Life Sciences, Sutro received in June 2023 a $140.0 million upfront payment and is eligible to receive up to an additional $250.0 million in future milestone payments. Sutro recorded the $140.0 million upfront payment from Blackstone as a deferred royalty obligation related to the sale of future royalties on the Company’s condensed Balance Sheets as of June 30, 2023. Due to the Company’s ongoing manufacturing obligations, the Company accounted for the proceeds as imputed debt and will recognize future non-cash royalty revenues. Non-cash interest expense will be recognized over the estimated life of the royalty term arrangement using the effective interest method based on the imputed interest rate derived from estimated amounts and timing of future royalty payments to be received from Vaxcyte. As part of the sale, Sutro incurred approximately $3.8 million in transaction costs, which are being amortized over the estimated life of the royalty term arrangement using the effective interest method. As future royalties are earned from Vaxcyte by Blackstone, the balance of the deferred royalty obligation will be amortized over the estimated life of the royalty term arrangement.