On May 4, 2022 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, reported first quarter 2022 financial results and provided business updates (Press release, Seres Therapeutics, MAY 4, 2022, View Source [SID1234613474]).

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"Seres continued to make important progress toward bringing SER-109 to patients suffering with recurrent C. difficile infection (rCDI). Given the robust profile of SER-109 observed in our Phase 3 study, we expect the product to have a significant impact on rCDI, a serious disease with approximately 170,000 cases annually in the US. We look forward to meaningful additional clinical data, including in first recurrence CDI patients, from our SER-109 open label study later this quarter, supporting a mid-2022 completion of our BLA submission with the U.S. Food and Drug Administration (FDA)," said Eric Shaff, President and Chief Executive Officer at Seres. "We are also advancing our commercialization efforts alongside our collaborator, Aimmune Therapeutics, Inc., a Nestlé Health Science company, in anticipation of a potential SER-109 product launch in the first half of 2023."

"In tandem, we are excited about our earlier stage pipeline and continue to enroll our Phase 1b clinical study of SER-155 designed to evaluate safety, microbiome alterations, and the impact on infections and/or graft versus host disease (GvHD) in adult subjects who are undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). Preclinical activities are also underway for additional Infection Protection development candidates, leveraging our prior compelling clinical data in this therapeutic category, for indications such as cancer neutropenia, solid organ transplant, and antimicrobial resistant infections more broadly," continued Mr. Shaff.

Program and Corporate Updates

SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved its primary endpoint of superiority to placebo in reducing CDI recurrence in patients with rCDI.

Seres has achieved target enrollment in an open-label study of SER-109 in patients with rCDI (ClinicalTrials.gov identifier: NCT03183141), which also enrolled over 25% of patients with a single recurrence of rCDI, to expand the SER-109 database in support of the planned BLA filing. Study results are anticipated in Q2 2022. The FDA recently endorsed Seres’ plans regarding a rolling BLA submission for SER-109. Seres intends to begin the BLA rolling submission in the coming weeks, and to complete the BLA submission, including data from the open-label study, in mid-2022.

Seres has an active SER-109 expanded access program at various sites across the U.S. The program is designed to enable eligible adults with rCDI to obtain access to SER-109 prior to a potential FDA product approval.

The Company continues to prepare for a successful product launch with Aimmune Therapeutics, Inc., a Nestlé Health Science company, who will be leading commercialization efforts. The Company believes that a substantial commercial opportunity exists for SER-109. The cost of a patient with recurrence of CDI has been estimated to result in approximately $34,000 in annual direct healthcare expenses; this does not include the substantial indirect costs associated with this disease. There are approximately 170,000 cases of rCDI annually in the U.S. and CDI results in over 20,000 deaths.

Seres continues to execute pre-commercialization activities in collaboration with Aimmune Therapeutics, including market education and data dissemination to the medical community. Medical Affairs led engagement of key opinion leaders has increased following the publication of the SER-109 Phase 3 data in the New England Journal of Medicine. In addition, activities have been initiated to engage payers in accordance with FDA guidance on pre-approval information exchange.

In January 2022, the New England Journal of Medicine (NEJM) published data from the SER-109 Phase 3 ECOSPOR III study evaluating SER-109 for the treatment of rCDI. The publication highlights key results including that SER-109 was superior to placebo in reducing CDI recurrence, with 88% of SER-109 patients achieving a sustained clinical response compared to 60% on placebo. SER-109 was well tolerated, with a side effect profile comparable to placebo and no serious drug-related adverse events observed.

SER-155 Phase 1b clinical study activities: In December 2021, Seres announced the enrollment of the first patient in the Company’s Phase 1b clinical study of SER-155 designed to evaluate safety, microbiome alterations, and the impact on infections and/or GvHD associated with SER-155 in adult subjects who are undergoing allo-HSCT. In April 2022, the SER-155 Data and Safety Monitoring Committee met as part of a planned data review, and approved a recommendation to continue with enrollment in Cohort 1 based on an evaluation of available safety data. The study is being conducted with Memorial Sloan Kettering Cancer Center and the University of Chicago with additional sites expected to be added soon.

SER-155 is an investigational oral, rationally designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal infections, bloodstream infections, and GvHD in patients receiving allo-HSCT. SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development platforms. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays and in vivo disease models. The SER-155 composition aims to decrease the colonization and translocation of antibiotic-resistant bacteria in the gastrointestinal tract to decrease the incidence of bloodstream infections and additionally to modulate host immune responses to decrease GvHD. In addition to SER-109, SER-155 represents Seres’ second active development program in its Infection Protection franchise.

Infection Protection investor event: In January 2022, Seres held a webcast event that highlighted development of microbiome therapeutics as a novel approach for Infection Protection in medically compromised individuals. Building upon SER-109, and in addition to SER-155, Seres is also evaluating additional preclinical stage programs in indications such as cancer neutropenia, solid organ transplant, and antimicrobial resistant infections more broadly.

Ulcerative colitis (UC) research: The Company previously reported clinical, microbiome and metabolomic data from the SER-287 Phase 2b study and the first cohort of its SER-301 Phase 1b study. Available data suggest that there may be an opportunity to utilize biomarker-based patient selection and stratification for future studies. Research activities remain ongoing to inform potential further development activities.

Financial Results

Seres reported a net loss of $56.6 million for the first quarter of 2022, as compared with a net loss of $35.5 million for the same period in 2021.

Research and development expenses for the first quarter of 2022 were $39.6 million, compared with $29.3 million for the same period in 2021. The research and development expenses were primarily related to Seres’ late-stage SER-109 clinical development program and manufacturing costs, as well as personnel expenses.

General and administrative expenses for the first quarter of 2022 were $18.6 million, compared with $11.7 million for the same period in 2021. General and administrative expenses were primarily related to personnel expenses, professional fees, including SER-109 commercial readiness and pre-launch expenses, and facility costs.

Seres ended the first quarter of 2022 with approximately $248.0 million in cash, cash equivalents and investments as compared with $291.2 million at the end of 2021.

Conference Call Information

Seres’ management will host a conference call today, May 4, 2022, at 8:30 a.m. ET. To access the conference call, please dial 877-270-2148 (domestic) or 412-902-6510 (international) and reference the Seres Therapeutics conference call. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On May 4, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported first quarter 2022 financial results and highlighted recent achievements and developments (Press release, Oncorus, MAY 4, 2022, View Source [SID1234613473]).

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"Early 2022 has been focused on clinical and operational execution as we work toward operational completion of our manufacturing facility, as well as extending our cash runway to support our dual platform approach to next-generation viral immunotherapies. We plan to share additional ONCR-177 Phase 1 data from the surface lesion monotherapy expansion and the initial combination expansion data with KEYTRUDA in the second half of 2022, while we continue to advance our vRNA drug candidates and LNP capabilities in parallel," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We recently presented exciting preclinical data from our selectively self-amplifying vRNA/LNP immunotherapy platform at AACR (Free AACR Whitepaper) demonstrating the full potential of our IV-administered viral immunotherapy candidates, ONCR-021 and ONCR-788, in overcoming well-established limitations of RNA-based therapeutics. We look forward to further positioning Oncorus for growth driven by our dual-platform pipeline of product candidates targeting cancers with significant unmet need, which is enabled by our wholly owned GMP-compliant manufacturing infrastructure."

First Quarter 2022 and Recent Business Highlights

On track to report additional ONCR-177 monotherapy and combination data in the second half of 2022. Oncorus has completed enrollment in the dose expansion portion of its Phase 1 open-label, multi-center trial in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. The Company continues to enroll patients in the combination cohort with future data readouts expected in the second half of 2022. Data readouts are expected to include both additional surface lesion monotherapy expansion data for ONCR-177 and initial surface lesion combination expansion data for ONCR-177 administered with KEYTRUDA.
Presented preclinical data for ONCR-021 and ONCR-788 supporting the company’s selectively self-amplifying viral RNA (vRNA)/lipid nanoparticle (LNP) immunotherapy platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. In April 2022, Oncorus presented preclinical data for both ONCR-021 and ONCR-788 in two e-posters at the AACR (Free AACR Whitepaper) Annual Meeting demonstrating robust preclinical anti-tumor efficacy in multiple tumor models while avoiding the challenges seen in previous studies that incorporate IV administration of RNA-based oncology therapeutics. Oncorus plans to submit an investigational new drug (IND) application for ONCR-021 with the U.S. Food and Drug Administration (FDA) in mid-2023 and a subsequent IND submission for ONCR-788.
Announced debt capital facility with K2 HealthVentures (K2HV); $20 million funded at closing: In April 2022, Oncorus entered into a loan and security agreement with K2HV, a healthcare-focused specialty finance company. The term loan facility provides Oncorus with up to $45 million available in multiple tranches upon the achievement of certain time-based, clinical and regulatory milestones, with the initial tranche of $20 million funded at closing. Oncorus intends to use the proceeds of the initial tranche of the loan facility to complete the buildout of its Andover facility and to continue the advancement of its pipeline of next generation viral immunotherapies for cancer and LNP technologies.
Announced relocation of all operations to Andover, Massachusetts facility in fourth quarter of 2022 to increase operational efficiency: In April 2022, Oncorus announced plans to relocate all operations to its facility in Andover, Massachusetts in the fourth quarter of 2022, allowing research, process development and Good Manufacturing Practice (GMP)-compliant manufacturing to occur all in one facility.
First Quarter 2022 Financial Results

Cash and cash equivalents and investments totaled $98.7 million as of March 31, 2022 compared to $123.9 million as of December 31, 2021.

Research and development expenses for the quarter ended March 31, 2022 were $12.5 million compared to $8.4 million for the corresponding quarter in 2021. The increase was primarily attributable to employee compensation costs, which was driven by increased headcount and increased stock-based compensation, increased development costs related to the Company’s nominated candidates, as well as increased rent expense related to the Company’s manufacturing facility.

General and administrative expenses for the quarter ended March 31, 2022 were $5.3 million compared to $4.2 million for the corresponding quarter in 2021. The increase was primarily attributable to employee compensation costs, including higher stock-based compensation, increased headcount and increased salary and related expenses.

Net loss for the quarter ended March 31, 2022 was $17.8 million, or $0.69 per share, as compared to a net loss of $12.7 million, or $0.53 per share for the corresponding quarter in 2021. The increase in net loss was due to increased expenses associated with the Company’s preclinical development costs of its nominated candidates.
Financial Guidance

As a result of the debt capital facility and operations relocation, as well as other initiatives to increase operational efficiency, Oncorus now expects its cash, cash equivalents and investments to fund its capital expenditures and operating expenses into early 2024.

On May 4, 2022 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported management will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on Thursday, May 12, 2022, at 11:20 a.m. PT (Press release, Alector, MAY 4, 2022, View Source [SID1234613472]).

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A live webcast of the fireside chat will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source A replay will be available on the Alector website for 90 days following the event.

On May 4, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported financial results for the first quarter ended March 31, 2022, and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 4, 2022, View Source [SID1234613471]).

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"We have made significant progress on our 2022 goals so far this year, demonstrating our commercial success with QINLOCK, strengthening our balance sheet, and rapidly advancing our potential best-in-class and first-in-class clinical-stage pipeline," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "The strong commercial launch of QINLOCK in Germany underscores the long-term potential for this medicine to benefit patients with GIST around the world. The pivotal Phase 3 MOTION study of vimseltinib, which we are developing for the treatment of tenosynovial giant cell tumor, or TGCT, is now enrolling patients and we expect to present updated results from the Phase 1/2 study in patients with TGCT in the second half of this year."

Mr. Hoerter continued, "We are very excited about our potential first-in-class autophagy pathway inhibitor, DCC-3116. At this year’s AACR (Free AACR Whitepaper) Annual Meeting, we presented encouraging preclinical data for DCC-3116 in combination with KRASG12C inhibitors highlighting the broad potential of this product candidate to benefit patients. We expect to present initial data from the single agent dose escalation portion of the Phase 1 study later this year."

First Quarter 2022 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $28.8 million in QINLOCK net product revenue in the first quarter of 2022, including $23.4 million in U.S. net product revenue and $5.4 million in international net product revenue.
Launched in Germany and received authorization for the post-approval paid access program in France.
Received a favorable ASMR III rating for QINLOCK from the Transparency Commission of the French National Authority for Health.
Vimseltinib

Continued enrollment and site activation in the pivotal Phase 3 MOTION study of vimseltinib for the treatment of TGCT. MOTION is a two-part, randomized, double-blind, placebo-controlled study of vimseltinib to assess the efficacy and safety in patients with TGCT who are not amenable to surgery. The primary endpoint of the study is objective response rate at week 25 as measured by RECIST v1.1 by blinded independent central review.
Expects to present updated results from the ongoing Phase 1/2 study in TGCT patients in the second half of 2022.
DCC-3116

Presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022.
The results showed that treatment of mutant KRASG12C NSCLC cell lines with KRASG12C inhibitors sotorasib and adagrasib induced autophagy via activation of ULK1/2 kinases as measured by an increase in ULK-mediated phosphorylation of the key ULK autophagy substrate ATG13 and resulting increase in autophagic flux.
DCC-3116 in combination with KRASG12C inhibitors translated to deeper and longer tumor regressions in mutant KRASG12C NSCLC models in vivo than with KRASG12C inhibitors alone.
Expects to present data in the second half of 2022 from the single agent dose escalation portion of the Phase 1 study of DCC-3116 in patients with advanced or metastatic tumors with a mutant RAS or RAF gene.
Expects to initiate three Phase 1b study combination dose escalation cohorts in the second half of 2022:
In combination with trametinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations.
In combination with binimetinib, an FDA-approved MEK inhibitor, in patients with advanced or metastatic solid tumors with RAS, NF1 or RAF mutations, subject to feedback from regulatory authorities.
In combination with sotorasib, an FDA- approved KRASG12C inhibitor, in patients with advanced or metastatic solid tumors with KRASG12C mutations, subject to feedback from regulatory authorities.
Expects to present additional preclinical data for DCC-3116 in the second half of 2022 and continue to explore preclinical combinations with multiple additional anti-cancer agents with diverse mechanisms of action.
Proprietary Drug Discovery Platform

Expects to nominate a development candidate in 2022 from the pan-RAF inhibitor research program discovered using the Company’s novel switch-control inhibitor platform.
Corporate Updates

Announced the closing in April 2022 of an underwritten public offering of 7,501,239 shares of the Company’s common stock at a public offering price of $10.00 per share and, in lieu of common stock to certain investors, the Company issued pre-funded warrants to purchase 9,748,761 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The shares of common stock sold include 2,250,000 shares pursuant to the option granted by the Company to the underwriters, which option was exercised in full. This offering resulted in net proceeds of $163.4 million after deducting underwriting discounts and commissions and other offering expenses.
First Quarter 2022 Financial Results

Revenue: Total revenue for the first quarter was $29.2 million, which includes $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue compared to $25.2 million of total revenue, including $20.0 million of net product revenue of QINLOCK and $5.2 million of collaboration revenue, for the same period in 2021.
Cost of Sales: Cost of sales were $0.4 million in the first quarter ended March 31, 2022 compared to $0.2 million in the same period in 2021. Cost of sales for newly launched products will not include the full cost of manufacturing until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. Deciphera does not expect the cost of sales as a percentage of net sales of QINLOCK to increase significantly after the Company has sold all zero cost inventories and commenced the sales of inventories that will reflect the full cost of manufacturing. The Company expects to continue to sell zero cost inventories of QINLOCK in the U.S. during 2022.
R&D Expenses: Research and development expenses for the first quarter of 2022 were $47.4 million, compared to $55.7 million for the same period in 2021. The decrease was primarily due to lower clinical trial costs related to QINLOCK, including INTRIGUE, our Phase 3 study for the treatment of second-line GIST for which top-line results were announced in November 2021, and the discontinuation of our rebastinib program following the corporate restructuring implemented in the fourth quarter of 2021, partially offset by an increase in clinical trial costs related to our Phase 1 study of DCC-3116, preclinical costs, and personnel costs. Non-cash, stock-based compensation was $6.3 million and $5.0 million for the first quarters of 2022 and 2021, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2022 were $28.3 million, compared to $30.7 million for the same period in 2021. The decrease was primarily due to a decrease in professional and consultant fees. Non-cash, stock-based compensation was $8.0 million and $6.2 million for the first quarters of 2022 and 2021, respectively.
Net Loss: For the first quarter of 2022, Deciphera reported a net loss of $46.9 million, or $0.80 per share, compared with a net loss of $61.3 million, or $1.06 per share, for the same period in 2021.
Cash Position: As of March 31, 2022, cash, cash equivalents, and marketable securities were $275.4 million, compared to $327.6 million as of December 31, 2021. In April 2022, the Company completed an underwritten public offering that resulted in aggregate net proceeds of $163.4 million. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2025.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 4, 2022 at 8:00 AM ET. The conference call may be accessed by dialing (877) 270-2148 (domestic) or (412) 902-6510 (international). A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On May 4, 2022 Bristol Myers Squibb (NYSE: BMY) reported that the company will take part in a fireside chat at the Bank of America Securities 2022 Healthcare Conference in Las Vegas, Nevada on Wednesday, May 11, 2022 (Press release, Bristol-Myers Squibb, MAY 4, 2022, View Source [SID1234613470]). Adam Lenkowsky, Senior Vice President and General Manager, U.S. Commercialization, will answer questions about the company at 12:00 p.m. PT/3:00 p.m. ET.

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Investors and the general public are invited to listen to a live webcast of the session at View Source Material related to the company’s presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.