On May. 6, 2022 Forma Therapeutics Holdings, Inc.(Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported financial results for the first quarter ended March 31, 2022 (Press release, Forma Therapeutics, MAY 6, 2022, View Source [SID1234613762]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"The first quarter of 2022 was one of continued progress in enrolling ongoing trials of etavopivat and FT-7051, and also expansion into other areas where red blood cell health may play an important role," said Frank Lee, president and chief executive officer of Forma. "We also continue to strengthen our capabilities and focus on the patients we serve with the addition of talented leaders."

Key Business Updates

•Ifeyinwa (Ify) Osunkwo, M.D., MPH, joined Forma as the company’s inaugural chief patient officer and senior vice president. Dr. Osunkwo leads Forma’s efforts to be a trusted partner, collaborating with patients, advocates and healthcare providers who share a dedication to changing the care and treatment paradigm.
•Arturo Molina, M.D., elected to Board of Directors and R&D Committee. Dr. Molina is an internationally acclaimed clinician, hematology and oncology researcher, practicing physician and pioneer addressing healthcare inequities. He has over 25 years of experience in biopharma, hematology and oncology and currently serves as chief medical officer at Sutro Biopharma, where he is responsible for the clinical development of oncology and hematology therapeutics.
•Virtual Research and Development (R&D) Day to be held May 26, 2022. The company will provide an overview of its clinical development programs and research pipeline strategy, including the introduction of a new molecule currently undergoing IND-enabling studies. The live webcast will be available in the "News & Investors" section of Forma’s website.

Upcoming Milestones

•Patient enrollment in global pivotal Phase II/III trial of etavopivat for the treatment of SCD, the Hibiscus Study. The first interim analysis (IA1) in the Hibiscus Study is expected to be reached by the end of 2022. IA1 is designed to select the dose for the Phase III portion of the trial.

•Additional etavopivat development programs. Forma has initiated a Phase II trial in patients with either transfusion dependent SCD, transfusion dependent thalassemia, or non-transfusion dependent thalassemia, with initial results expected in late 2022. During 2022, Forma plans to begin clinical trials in pediatric SCD and lower-risk myelodysplastic syndrome (MDS).
•Update on FT-7051 clinical trial in mCRPC. Men with metastatic castration-resistant prostate cancer (mCRPC) continue to be enrolled in the Phase I trial. Forma plans to provide an update at its May R&D Day and further results later in 2022.
•Possibility of COVID-19 impact remains. The COVID-19 pandemic remains a factor in the successful completion of these milestones and ongoing clinical trials. Many clinical trials across the biopharma industry, including Forma’s, have been impacted by the COVID-19 pandemic. Clinical trial sites implementing new policies in response to COVID-19 have impacted enrollment of clinical trials and/or the ability to access sites participating in clinical trials.

Financial Results

•Cash Position: Cash, cash equivalents and marketable securities were $441.3 million as of March 31, 2022, as compared to $490.3 million as of December 31, 2021. Current cash runway is projected through the third quarter of 2024.

R&D Expenses: R&D expenses were $31.3 million for the quarter ended March 31, 2022, compared to $26.3 million for the quarter ended March 31, 2021. The increase was primarily attributable to an increase in research and development staff to support advancement of etavopivat and other programs, an increase in equity-based compensation, the conduct of our Phase II/III trial in SCD patients, and study start-up costs related to our trial in thalassemia.

General and Administrative (G&A) Expenses: G&A expenses were $13.1 million for the quarter ended March 31, 2022, compared to $9.9 million for the quarter ended March 31, 2021. The increase was primarily attributable to equity-based compensation, costs due to executive and staff hiring, and other related general and administrative costs.

Net Loss: Net loss was $44.1 million for the quarter ended March 31, 2022, compared to net loss of $36.0 million for the quarter ended March 31, 2021.

Forma will conduct a conference call and webcast May 6, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss first quarter 2022 results and business updates. The call can be accessed by dialing (833) 301-1146 in the U.S., and (914) 987-7386 internationally, with conference ID 1879297.

The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.

On May 6, 2022 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company with a mission to deliver targeted therapies that treat rare forms of cancer, reported its financial and operating results for the first quarter ended March 31, 2022 (Press release, Sierra Oncology, MAY 6, 2022, View Source [SID1234613761]).

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"By entering into a merger agreement with GSK, we are one step closer to realizing our mission of delivering transformative therapies for patients with rare cancers, while also delivering compelling and certain value for our stockholders. We are working to continue to progress our timeline and our NDA submission remains on track for later this quarter," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology.

Key Business Highlights

On April 13, 2022, Sierra announced it had entered into an agreement to be acquired by GSK for $55 per share of common stock, representing an approximate total equity value of $1.9 billion. The per share price represents a premium of approximately 39 percent to Sierra’s closing stock price on April 12, 2022, and approximately 63 percent to Sierra’s volume-weighted average price (VWAP) over the prior thirty trading days. The transaction is expected to close in the third quarter of 2022 or before.

On January 25, 2022, Sierra announced momelotinib achieved a statistically significant benefit on symptoms, anemia and splenic size in the pivotal MOMENTUM Phase 3 study. The trial met all of its primary and key secondary endpoints. Data from this study, as well as previous data from the SIMPLIFY-1 and SIMPLIFY-2 Phase 3 studies, will serve as the foundation for the submission of a New Drug Application to the US Food & Drug Administration in the second quarter of 2022. If approved, the company anticipates momelotinib being commercially available early in the first half of 2023.

The Journal of Hematology and Oncology published a review article on momelotinib, titled "Momelotinib: an emerging treatment for myelofibrosis patients with anemia." The article highlights the use of momelotinib for the potential treatment of myelofibrosis patients who are anemic based on published data from the SIMPLIFY studies as well as earlier Phase 2 studies. The full article is available for review here.

Sierra ended the quarter with a cash balance of $274.0 million. Included in this total is $145.3 million in net proceeds from a public equity offering early in the first quarter of 2022. The company also secured a debt facility with Oxford Finance, LLC for up to $125.0 million, announced in January of this year. Under the terms of the loan agreement, Sierra drew an initial $5.0 million term loan at closing. Additionally, during the first quarter of 2022, the company received proceeds of $9.6 million from the exercise of a warrant by Gilead, $4.6 million from the exercise of stock options, and $30.5 million from the exercise of Series B warrants. In April 2022, the company received an additional $2.8 million in proceeds from the exercise of the remaining Series B warrants prior to their expiration on April 10, 2022.

First Quarter 2022 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $17.6 million for the three months ended March 31, 2022 compared with $14.0 million for the three months ended March 31, 2021. The increase primarily related to a $2.6 million increase in personnel-related and allocated overhead costs, a $1.6 million increase in third-party manufacturing costs of which $0.9 million pertained to momelotinib, and a $0.2 million increase in other research and support costs. These increases were partially offset by a $0.8 million decrease in clinical trial and development costs primarily for momelotinib. Research and development expenses included non-cash stock-based compensation of $1.6 million and $1.7 million for the three months ended March 31, 2022 and 2021, respectively.

General and administrative expenses were $10.3 million for the three months ended March 31, 2022, compared to $5.9 million for the three months ended March 31, 2021. The increase was due to a $3.2 million increase in personnel-related and allocated overhead costs, of which $0.9 million related to severance and a stock-based compensation charge pursuant to a transition agreement with a former executive, and a $1.2 million increase in professional fees primarily relating to pre-commercial costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $1.7 million and $1.3 million for the three months ended March 31, 2022 and 2021, respectively.

For the three months ended March 31, 2022, Sierra incurred a net loss of $27.9 million compared to a net loss of $19.9 million for the three months ended March 31, 2021.

Cash and cash equivalents totaled $274.0 million as of March 31, 2022, compared to $104.7 million as of December 31, 2021.

As of March 31, 2022, there were 23,800,409 total shares of common stock outstanding and warrants to purchase 7,984,428 shares of common stock outstanding and pre-funded warrants to purchase 925,925 shares of common stock. There were Series B warrants with an exercise price of $13.20 to purchase 212,477 shares of common stock that were fully exercised after March 31, 2022, and prior to expiration on April 10, 2022 and provided $2.8 million of proceeds to the company. In addition, there were Series A warrants that contain a cash and/or cashless exercise provision to purchase 7,771,951 shares of common stock, with an exercise price equal to $13.20 per share. There were 5,466,822 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

On May 6, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or "the Company"), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that it will hold a conference call and webcast on Friday, May 13, 2022, at 8:00 a.m. ET to discuss the company’s 2022 first quarter financial and operational results (Press release, IMV, MAY 6, 2022, View Source [SID1234613760]).

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Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5396906

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On May 6, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the first quarter 2022 financial results and provide a corporate update on Thursday, May 12, 2022 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, MAY 6, 2022, View Source [SID1234613759]).

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Conference Call and Webcast:

The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

On May 6, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended March 31, 2022 (Press release, ImmunoGen, MAY 6, 2022, View Source [SID1234613758]).

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"Following the presentation of the results from our positive pivotal SORAYA trial at SGO, we were pleased to submit the BLA to support the accelerated approval of mirvetuximab monotherapy in FRα-high platinum-resistant ovarian cancer. We requested Priority Review for the BLA and look forward to acceptance towards the end of May and a PDUFA date on the application later this year," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "In preparation for potential commercialization, we have significantly ramped our launch readiness activities, with a focus on increasing mirvetuximab and FRα awareness among prescribers."

Enyedy continued, "The broader mirvetuximab program is also advancing nicely, with accrual accelerating in MIRASOL following the release of the SORAYA results in late November, enrollment continuing in PICCOLO, and initiation of our GLORIOSA and Trial 0420 combination studies anticipated by mid-year. Based upon a reforecast generated in conjunction with the recent pre-specified interim futility analysis for MIRASOL, we now expect to reach the requisite number of PFS events in the fourth quarter and will report top-line data from MIRASOL in early 2023. Turning to our second pivotal program, pivekimab, with the recommended phase 2 dose for the triplet in combination with azacitidine and venetoclax determined, we have moved forward with expansion cohorts in both frontline and relapsed AML patients and are on track to report preliminary efficacy data from our pivotal CADENZA study in BPDCN before year-end. Regarding our earlier-stage programs, dose-escalation continues in the Phase 1 trial of IMGC936 in multiple solid tumors and the activities to generate the CMC information needed for our IND for IMGN151 are on track. With a strong start and intense focus on execution, we are well positioned to deliver on our near-term objectives and transform ImmunoGen into a fully-integrated oncology company this year."

RECENT PROGRESS

Submitted the biologics license application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) for mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments.
Presented results from the pivotal SORAYA trial of mirvetuximab, demonstrating impressive anti-tumor activity and durability of response, together with a differentiated safety profile, at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting.
Continued enrollment in the confirmatory MIRASOL study and recently completed a pre-specified interim futility analysis with a recommendation from the Independent Data Monitoring Committee for MIRASOL to proceed without modification.
Advanced accrual in PICCOLO, a single-arm study of mirvetuximab monotherapy in FRα-high recurrent platinum-sensitive ovarian cancer.
Supported investigator-sponsored trials of mirvetuximab plus carboplatin in a single-arm study in the neoadjuvant setting and a randomized study in patients with recurrent platinum-sensitive ovarian cancer.
Progressed the pivotal Phase 2 CADENZA study of pivekimab sunirine (pivekimab, formerly IMGN632) in frontline and relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Initiated expansion cohorts in the Phase 1b/2 study evaluating pivekimab, Vidaza (azacitidine), and Venclexta (venetoclax) in both relapsed and frontline unfit acute myeloid leukemia (AML) patients.
Advanced dose escalation and opened additional sites in the Phase 1 study of IMGC936 in multiple solid tumor types.
Progressed the generation of supplemental chemistry, manufacturing, and controls (CMC) information to the FDA to support the investigational new drug (IND) application for IMGN151.
Announced a global licensing agreement granting Eli Lilly and Company (Lilly) exclusive rights to research, develop, and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen’s novel camptothecin technology in exchange for up to $1.7 billion in potential exercise fees and milestone payments.
ANTICIPATED UPCOMING EVENTS

Potential for BLA acceptance by FDA under the accelerated approval pathway for mirvetuximab as a monotherapy in patients with FRα-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments.
Present additional efficacy and safety analyses from the mirvetuximab program at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Generate top-line data for MIRASOL in early 2023.
Initiate two combination studies for mirvetuximab in platinum-sensitive ovarian cancer by mid-2022: Trial 0420, a single-arm Phase 2 trial of mirvetuximab in combination with carboplatin followed by mirvetuximab continuation in FRα-low, medium, and high patients; and GLORIOSA, a randomized Phase 3 trial of mirvetuximab in combination with Avastin (bevacizumab) maintenance in FRα-high patients.
Report preliminary efficacy data from the pivotal CADENZA study of pivekimab in BPDCN before year-end.
Present initial data from frontline and relapsed AML expansion cohorts combining pivekimab, azacitidine, and venetoclax at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.
Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated before year-end.
Begin enrollment in the Phase 1 study of IMGN151 following the submission of supplemental CMC information to the FDA.
FINANCIAL RESULTS

Total revenues were $38.1 million for the quarter ended March 31, 2022 compared to $15.7 million for the quarter ended March 31, 2021. The increase was driven by the recognition of $21.6 million of fees previously received and deferred pursuant to the Company’s collaboration agreement with Huadong Medicine and the recognition of $9.2 million of a $13.0 million upfront payment received pursuant to the Company’s license agreement with Lilly in the first quarter of 2022. Partially offsetting these increases, non-cash royalty revenue decreased $9.1 million due to the completion of the first tranche of payments under the 2015 KADCYLA royalty agreement in the second quarter of 2021.

Operating expenses for the quarter ended March 31, 2022 were $60.9 million, compared with $44.6 million for the same quarter in 2021. Research and development expenses rose to $44.3 million for the quarter ended March 31, 2022 compared to $34.4 million for the quarter ended March 31, 2021, driven by increases in personnel and temporary staffing costs, regulatory filing fees, third-party service fees, and external manufacturing costs in support of commercial readiness. Selling, general and administrative expenses increased to $16.6 million for the quarter ended March 31, 2022 compared to $10.2 million for the quarter ended March 31, 2021, due primarily to building commercial capabilities, including the hiring of personnel, in anticipation of a potential US launch of mirvetuximab in the second half of 2022.

Net loss for the first quarter of 2022 was $24.1 million, or $0.10 per basic and diluted share, compared to a net loss of $34.1 million, or $0.17 per basic and diluted share, for the first quarter of 2021. Weighted average shares outstanding increased to 253.3 million for the 2022 period from 198.8 million in the prior year.

ImmunoGen had $437.7 million in cash and cash equivalents as of March 31, 2022, compared with $478.8 million as of December 31, 2021. Cash used in operations was $41.4 million for the first three months of 2022, compared with cash used in operations of $44.6 million for the same period in 2021, with the current period benefitting from a $13.0 million upfront license payment received from Lilly. Capital expenditures were $0.3 million and $0.9 million for the first three months of 2022 and 2021, respectively.

FINANCIAL GUIDANCE

ImmunoGen’s financial guidance for 2022 remains unchanged; the Company continues to expect:

revenues between $75 million and $85 million;
operating expenses between $285 million and $295 million; and
cash and cash equivalents at December 31, 2022 to be between $245 million and $255 million.
Given the range in timing for potential approval, revenue guidance does not yet include potential product sales from mirvetuximab.

ImmunoGen expects that its current cash, combined with anticipated product and collaboration revenues, will fund operations into 2024.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 5444669. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.