Forma Therapeutics Holdings, Inc. (FMTX)
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Forma Therapeutics Holdings, Inc., a clinical-stage biopharmaceutical company, focuses on development and commercialization of novel therapeutics for treatment of rare hematologic diseases and cancers. Its core product candidates for development include FT-4202, which is Phase 1 trial for the treatment of sickle cell disease and other hemoglobinopathies; and FT-7051 for the treatment of metastatic castration-resistant prostate cancer. The company is also developing Olutasidenib, a selective inhibitor for cancers with isocitrate dehydrogenase 1 gene mutations, which is in Phase II trial for the treatment of relapsed/refractory acute myeloid leukemia and Phase I trial to treat glioma; and FT-8225, a liver-targeted fatty-acid synthase inhibitor designed to block de novo lipogenesis in the liver. Forma Therapeutics Holdings, Inc. was founded in 2007 and is headquartered in Watertown, Massachusetts. As of October 14, 2022, Forma Therapeutics Holdings, Inc. operates as a subsidiary of Novo Nordisk A/S.
NEWS

Novo Nordisk announces the completion of the Forma Therapeutics acquisition
globenewswire.com
2022-10-14 08:35:00Bagsværd, Denmark, 14 October 2022 – Novo Nordisk today announced that the acquisition of Forma Therapeutics Holdings, Inc. (Forma), announced on 1 September 2022, has been completed.

FORMA THERAPEUTICS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Forma Therapeutics, Holdings Inc. - FMTX
businesswire.com
2022-09-27 11:42:00NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Forma Therapeutics, Holdings Inc. (NasdaqGM: FMTX) to Novo Nordisk A/S (NYSE: NVO). Under the terms of the proposed transaction, shareholders of Forma will receive $20 in cash for each share of Forma that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequa

SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates GMTX, FMTX, TRQ, SGFY
prnewswire.com
2022-09-26 00:00:00NEW YORK , Sept. 26, 2022 /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: Gemini Therapeutics, Inc. (NASDAQ: GMTX) 's merger with Disc Medicine, Inc. Pre-merger Gemini shareholders are expected to own approximately 28% of the combined company.

SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates IEA, CYBE, FMTX, TRQ
prnewswire.com
2022-09-19 01:43:00NEW YORK , Sept. 19, 2022 /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: Infrastructure & Energy Alternatives, Inc. (NASDAQ: IEA) 's sale to MasTec for $10.50 per share in cash and 0.0483 of a MasTec share for each IEA share.

Forma Therapeutics shares jump 50%; here is why
invezz.com
2022-09-02 22:38:36Forma Therapeutics Holdings Inc (NASDAQ: FMTX) shares are up 50% after announcing a definitive agreement with Novo Nordisk.

FORMA THERAPEUTICS INVESTOR ALERT by The Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Forma Therapeutics, Holdings Inc. - FMTX
businesswire.com
2022-09-02 15:46:00NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Forma Therapeutics, Holdings Inc. (NasdaqGM: FMTX) to Novo Nordisk A/S (NYSE: NVO). Under the terms of the proposed transaction, shareholders of Forma will receive $20 in cash for each share of Forma that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequa

SHAREHOLDER ALERT: Weiss Law Investigates Forma Therapeutics Holdings, Inc.
prnewswire.com
2022-09-01 16:57:00NEW YORK , Sept. 1, 2022 /PRNewswire/ -- Weiss Law is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Forma Therapeutics Holdings, Inc. ("Forma Therapeutics" or the "Company") (NASDAQ: FMTX), in connection with the proposed acquisition of the Company by Novo Nordisk A/S (NYSE: NVO) via tender offer.

Why Forma Therapeutics Holdings Stock Is On Fire Today
fool.com
2022-09-01 14:36:07The rare blood disorder specialist is the latest biotech buyout target.

Novo Nordisk Jumps Into Sickle Cell Fray With $1.1 Billion Forma Therapeutics Buyout
investors.com
2022-09-01 12:14:05Novo Nordisk said Thursday it will spend $1.1 billion to acquire Forma in a deal that sent biotech stock Forma flying. The post Novo Nordisk Jumps Into Sickle Cell Fray With $1.1 Billion Forma Therapeutics Buyout appeared first on Investor's Business Daily.

Why Novo Nordisk (NVO) Is Buying Forma Therapeutics (FMTX) For $1.1 Billion
pulse2.com
2022-09-01 09:20:18Novo Nordisk (NYSE: NVO) is buying Forma Therapeutics, Holdings Inc (Nasdaq: FMTX) for $1.1 billion. This is why.

Novo Nordisk to acquire Forma Therapeutics in $1.1. billion deal
reuters.com
2022-09-01 08:19:00Danish drugmaker Novo Nordisk will acquire Forma Therapeutics in a deal valued at $1.1 billion to expand its rare blood disorders portfolio, the companies said on Thursday.

Forma Therapeutics to be acquired by Novo Nordisk in a cash deal valued at $1.1 billion
marketwatch.com
2022-09-01 08:18:27Forma Therapeutics Holdings Inc. FMTX, +1.67% announced Thursday and agreement to be acquired by Denmark-based Novo Nordisk NVO, +0.06% NOVO.B, -0.59% in a deal with an equity value of $1.1 billion. Forma shares are halted for news until 8:30 a.m.

Forma Therapeutics: Rare Disease Play
seekingalpha.com
2022-08-31 10:32:4972% technical buy signal. 15 new highs and up 59.18% in the last month.

Forma Therapeutics Holdings Inc. (FMTX) CEO Frank Lee on Q2 2022 Results - Earnings Call Transcript
seekingalpha.com
2022-08-05 10:21:10Forma Therapeutics Holdings Inc. (NASDAQ:FMTX ) Q2 2022 Earnings Conference Call August 5, 2022 8:00 AM ET Company Participants Adam Bero - Investor Relations Frank Lee - President and Chief Executive Officer Agustin Melian - Executive Vice President, Research and Development Cameron Trenor - Executive Director, Clinical Development Dave Cook - Chief Scientific Officer Todd Shegog - Chief Financial Officer Conference Call Participants Mark Breidenbach - Oppenheimer Maury Raycroft - Jefferies Andrew Berens - SVB Prakhar Agrawal - Cantor Operator Good morning, my name is Josh and I will be your conference operator today. At this time, I would like to welcome everyone to the Forma Therapeutics Second Quarter 2022 Financial Results and Business Update Conference Call.

Forma Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update
businesswire.com
2022-08-05 07:00:00WATERTOWN, Mass.--(BUSINESS WIRE)--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, today reported financial results for the second quarter ended June 30, 2022. The company also highlighted recent progress and upcoming milestones for its pipeline programs. “In the second quarter, we announced encouraging new analyses from the etavopivat program in sickle cell disease at our inaugural R&D Day. We also recently appointed two new members of our executive team to help drive our next phase of global development and commercialization and entered into a license agreement for olutasidenib,” said Frank Lee, President and Chief Executive Officer of Forma. “We are well-positioned to continue to advance our pipeline and are actively managing expenses as we progress in our mission to deliver transformative medicines to patients with rare hematologic diseases and cancers.” Key Business Updates On July 27, 2022 Forma entered into an exclusive worldwide license agreement with Rigel Pharmaceuticals, Inc. to develop, manufacture, and commercialize olutasidenib. Olutasidenib is a mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor for the treatment of relapsed or refractory acute myeloid leukemia. Under the terms of the agreement, Forma will receive an upfront payment of $2.0 million, and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones. In addition, Forma is eligible to receive a total of up to an additional $215.5 million in connection with the achievement of certain development and commercial milestones. Forma is also eligible to receive tiered royalties in the low-teens to mid-thirties. The U.S. Food and Drug Administration (FDA) has accepted Forma’s new drug application (NDA) for olutasidenib. The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023. Agustín Melián, M.D., named Executive Vice President, Head of Research and Development. Dr. Melián is a physician-scientist with over 20 years of experience developing patient-centric, rare, and orphan disease therapeutics across multiple therapeutic areas, modalities, and phases of development. Linea Aspesi named Senior Vice President, Chief Human Resources Officer. Ms. Aspesi brings over 25 years of human resources leadership experience in life sciences and health care services and has a track record of aligning talent plans to company vision and strategy while fostering an equitable and inclusive environment. Forma presented new data on the etavopivat clinical development program at multiple hematology conferences. Presentations included analyses from the Phase I open-label extension study of etavopivat in sickle cell disease indicating that etavopivat decreased the frequency and severity of pain-related adverse events, and the design of the Phase II Gladiolus study of etavopivat in patients with sickle cell disease (SCD) receiving chronic transfusions or transfusion-dependent or non-transfusion-dependent thalassemia. These data were presented at the European Hematology Association (EHA) 2022 Hybrid Congress, the Foundation for Sickle Cell Disease Research (FSCDR) Sickle Cell Disease Research and Educational Symposium and Sickle Cell Disease Scientific Meeting, and the Global Congress on Sickle Cell Disease (GCSCD). Forma hosted its first Research and Development (R&D) Day. The company provided an overview of its clinical development programs and research pipeline strategy. Upcoming Milestones Patient enrollment ongoing 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 TD-SCD, TD-thalassemia, or non-TD-thalassemia, with initial results expected in late 2022. By year-end 2022, Forma plans to begin clinical trials in pediatric SCD and lower-risk myelodysplastic syndrome (MDS). Update on FT-7051 clinical trial in mCRPC. Forma is planning to evaluate an alternative dosing schedule in a less heavily pretreated population and is currently processing the protocol amendment. Forma plans to provide updated results in the first half of 2023. 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 trials, 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 $395.9 million as of June 30, 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 $39.1 million for the quarter ended June 30, 2022, as compared to $31.6 million for the quarter ended June 30, 2021. The increase was primarily attributable to the increase in research and development staff to support the advancement of etavopivat and other programs, including the conduct of our Phase II/III Hibiscus trial in SCD patients and Phase II trial of etavopivat in thalassemia. General and Administrative (G&A) Expenses: G&A expenses were $13.9 million for the quarter ended June 30, 2022, as compared to $12.5 million for the quarter ended June 30, 2021. The increase was primarily attributable to professional services, costs due to executive and staff hiring, and other related general and administrative costs. Net Loss: Net loss was $52.6 million for the quarter ended June 30, 2022, as compared to net loss of $43.6 million for the quarter ended June 30, 2021. Forma will conduct a conference call and webcast August 5, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss second quarter 2022 results and business updates. Investors may participate in the call by using the registration link here. Once registered, participants will receive a dial-in number as well as a PIN to enter the event. A live webcast of the conference call will be available in the “News & Investors” section of Forma’s website at www.formatherapeutics.com. About Forma Therapeutics Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our pipeline is led by etavopivat, an investigational, once-daily, selective pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy with the potential to improve red blood cell (RBC) health and transform the lives of people living with sickle cell disease, thalassemia, and lower risk MDS. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company’s beliefs and expectations regarding its: business plans and objectives; future plans for etavopivat and FT-7051, including expectations regarding potential development and expansion plans relating to, as well as the enrollment, timing, success and data announcements of, planned and ongoing clinical trials; therapeutic and market potential, clinical benefits, mechanisms of action and safety of our product candidates; upcoming milestones and potential payments related thereto; growth as a company; the anticipated contributions of new members of our executive team to our operations and progress; uses and need of capital, expenses and other financial results currently or in the future as well as the expected cash runway through the third quarter of 2024; and the potential impact of COVID-19 on patient retention and enrollment, future operations or clinical trials. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with the following: the impact of the COVID-19 pandemic on the company’s business, operations, supply chain, patient enrollment and retention, clinical trials, strategy, goals and anticipated milestones, as well as global economies and financial markets; the therapeutic potential of our product candidates and the timing and completion of our clinical trials and related data analyses; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; any one or more of our product candidates may not be successfully developed and commercialized; regulatory developments in the United States and foreign countries; our ability to protect and maintain our intellectual property position; and our ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and subsequent filings with the SEC. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. Statement of Operations Items: For the Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Collaboration revenue $ — $ — $ — $ — Operating expenses: Research and development 39,059 31,587 70,332 57,930 General and administrative 13,939 12,471 27,075 22,338 Total operating expenses 52,998 44,058 97,407 80,268 Loss from operations (52,998 ) (44,058 ) (97,407 ) (80,268 ) Other income: Interest income 599 309 888 571 Other (expense) income, net (192 ) 272 (227 ) 268 Total other income, net 407 581 661 839 Loss before taxes (52,591 ) (43,477 ) (96,746 ) (79,429 ) Income tax (benefit) expense (13 ) 108 (10 ) 116 Net loss and comprehensive loss $ (52,578 ) $ (43,585 ) $ (96,736 ) $ (79,545 ) Net loss allocable to shares of common stock, basic and diluted $ (52,578 ) $ (43,585 ) $ (96,736 ) $ (79,545 ) Net loss per share of common stock, basic and diluted $ (1.10 ) $ (0.92 ) $ (2.03 ) $ (1.68 ) Weighted-average shares of common stock outstanding, basic and diluted 47,805,493 47,339,464 47,684,236 47,317,361 Selected Balance Sheet Items: June 30, 2022 December 31, 2021 Cash, cash equivalents, and marketable securities $ 395,903 $ 490,273 Total assets $ 475,169 $ 561,061 Accounts payable, accrued expenses, and other current liabilities $ 33,421 $ 35,018 Total stockholders’ equity $ 414,492 $ 498,356

Forma Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 5, 2022
businesswire.com
2022-07-29 07:05:00WATERTOWN, Mass.--(BUSINESS WIRE)--Forma Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 5, 2022
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Novo Nordisk announces the completion of the Forma Therapeutics acquisition
globenewswire.com
2022-10-14 08:35:00Bagsværd, Denmark, 14 October 2022 – Novo Nordisk today announced that the acquisition of Forma Therapeutics Holdings, Inc. (Forma), announced on 1 September 2022, has been completed.

FORMA THERAPEUTICS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Forma Therapeutics, Holdings Inc. - FMTX
businesswire.com
2022-09-27 11:42:00NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Forma Therapeutics, Holdings Inc. (NasdaqGM: FMTX) to Novo Nordisk A/S (NYSE: NVO). Under the terms of the proposed transaction, shareholders of Forma will receive $20 in cash for each share of Forma that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequa

SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates GMTX, FMTX, TRQ, SGFY
prnewswire.com
2022-09-26 00:00:00NEW YORK , Sept. 26, 2022 /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: Gemini Therapeutics, Inc. (NASDAQ: GMTX) 's merger with Disc Medicine, Inc. Pre-merger Gemini shareholders are expected to own approximately 28% of the combined company.

SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates IEA, CYBE, FMTX, TRQ
prnewswire.com
2022-09-19 01:43:00NEW YORK , Sept. 19, 2022 /PRNewswire/ -- Halper Sadeh LLC, an investor rights law firm, is investigating the following companies for potential violations of the federal securities laws and/or breaches of fiduciary duties to shareholders relating to: Infrastructure & Energy Alternatives, Inc. (NASDAQ: IEA) 's sale to MasTec for $10.50 per share in cash and 0.0483 of a MasTec share for each IEA share.

Forma Therapeutics shares jump 50%; here is why
invezz.com
2022-09-02 22:38:36Forma Therapeutics Holdings Inc (NASDAQ: FMTX) shares are up 50% after announcing a definitive agreement with Novo Nordisk.

FORMA THERAPEUTICS INVESTOR ALERT by The Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Forma Therapeutics, Holdings Inc. - FMTX
businesswire.com
2022-09-02 15:46:00NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Forma Therapeutics, Holdings Inc. (NasdaqGM: FMTX) to Novo Nordisk A/S (NYSE: NVO). Under the terms of the proposed transaction, shareholders of Forma will receive $20 in cash for each share of Forma that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequa

SHAREHOLDER ALERT: Weiss Law Investigates Forma Therapeutics Holdings, Inc.
prnewswire.com
2022-09-01 16:57:00NEW YORK , Sept. 1, 2022 /PRNewswire/ -- Weiss Law is investigating possible breaches of fiduciary duty and other violations of law by the board of directors of Forma Therapeutics Holdings, Inc. ("Forma Therapeutics" or the "Company") (NASDAQ: FMTX), in connection with the proposed acquisition of the Company by Novo Nordisk A/S (NYSE: NVO) via tender offer.

Why Forma Therapeutics Holdings Stock Is On Fire Today
fool.com
2022-09-01 14:36:07The rare blood disorder specialist is the latest biotech buyout target.

Novo Nordisk Jumps Into Sickle Cell Fray With $1.1 Billion Forma Therapeutics Buyout
investors.com
2022-09-01 12:14:05Novo Nordisk said Thursday it will spend $1.1 billion to acquire Forma in a deal that sent biotech stock Forma flying. The post Novo Nordisk Jumps Into Sickle Cell Fray With $1.1 Billion Forma Therapeutics Buyout appeared first on Investor's Business Daily.

Why Novo Nordisk (NVO) Is Buying Forma Therapeutics (FMTX) For $1.1 Billion
pulse2.com
2022-09-01 09:20:18Novo Nordisk (NYSE: NVO) is buying Forma Therapeutics, Holdings Inc (Nasdaq: FMTX) for $1.1 billion. This is why.

Novo Nordisk to acquire Forma Therapeutics in $1.1. billion deal
reuters.com
2022-09-01 08:19:00Danish drugmaker Novo Nordisk will acquire Forma Therapeutics in a deal valued at $1.1 billion to expand its rare blood disorders portfolio, the companies said on Thursday.

Forma Therapeutics to be acquired by Novo Nordisk in a cash deal valued at $1.1 billion
marketwatch.com
2022-09-01 08:18:27Forma Therapeutics Holdings Inc. FMTX, +1.67% announced Thursday and agreement to be acquired by Denmark-based Novo Nordisk NVO, +0.06% NOVO.B, -0.59% in a deal with an equity value of $1.1 billion. Forma shares are halted for news until 8:30 a.m.

Forma Therapeutics: Rare Disease Play
seekingalpha.com
2022-08-31 10:32:4972% technical buy signal. 15 new highs and up 59.18% in the last month.

Forma Therapeutics Holdings Inc. (FMTX) CEO Frank Lee on Q2 2022 Results - Earnings Call Transcript
seekingalpha.com
2022-08-05 10:21:10Forma Therapeutics Holdings Inc. (NASDAQ:FMTX ) Q2 2022 Earnings Conference Call August 5, 2022 8:00 AM ET Company Participants Adam Bero - Investor Relations Frank Lee - President and Chief Executive Officer Agustin Melian - Executive Vice President, Research and Development Cameron Trenor - Executive Director, Clinical Development Dave Cook - Chief Scientific Officer Todd Shegog - Chief Financial Officer Conference Call Participants Mark Breidenbach - Oppenheimer Maury Raycroft - Jefferies Andrew Berens - SVB Prakhar Agrawal - Cantor Operator Good morning, my name is Josh and I will be your conference operator today. At this time, I would like to welcome everyone to the Forma Therapeutics Second Quarter 2022 Financial Results and Business Update Conference Call.

Forma Therapeutics Reports Second Quarter 2022 Financial Results and Provides Business Update
businesswire.com
2022-08-05 07:00:00WATERTOWN, Mass.--(BUSINESS WIRE)--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, today reported financial results for the second quarter ended June 30, 2022. The company also highlighted recent progress and upcoming milestones for its pipeline programs. “In the second quarter, we announced encouraging new analyses from the etavopivat program in sickle cell disease at our inaugural R&D Day. We also recently appointed two new members of our executive team to help drive our next phase of global development and commercialization and entered into a license agreement for olutasidenib,” said Frank Lee, President and Chief Executive Officer of Forma. “We are well-positioned to continue to advance our pipeline and are actively managing expenses as we progress in our mission to deliver transformative medicines to patients with rare hematologic diseases and cancers.” Key Business Updates On July 27, 2022 Forma entered into an exclusive worldwide license agreement with Rigel Pharmaceuticals, Inc. to develop, manufacture, and commercialize olutasidenib. Olutasidenib is a mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor for the treatment of relapsed or refractory acute myeloid leukemia. Under the terms of the agreement, Forma will receive an upfront payment of $2.0 million, and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones. In addition, Forma is eligible to receive a total of up to an additional $215.5 million in connection with the achievement of certain development and commercial milestones. Forma is also eligible to receive tiered royalties in the low-teens to mid-thirties. The U.S. Food and Drug Administration (FDA) has accepted Forma’s new drug application (NDA) for olutasidenib. The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023. Agustín Melián, M.D., named Executive Vice President, Head of Research and Development. Dr. Melián is a physician-scientist with over 20 years of experience developing patient-centric, rare, and orphan disease therapeutics across multiple therapeutic areas, modalities, and phases of development. Linea Aspesi named Senior Vice President, Chief Human Resources Officer. Ms. Aspesi brings over 25 years of human resources leadership experience in life sciences and health care services and has a track record of aligning talent plans to company vision and strategy while fostering an equitable and inclusive environment. Forma presented new data on the etavopivat clinical development program at multiple hematology conferences. Presentations included analyses from the Phase I open-label extension study of etavopivat in sickle cell disease indicating that etavopivat decreased the frequency and severity of pain-related adverse events, and the design of the Phase II Gladiolus study of etavopivat in patients with sickle cell disease (SCD) receiving chronic transfusions or transfusion-dependent or non-transfusion-dependent thalassemia. These data were presented at the European Hematology Association (EHA) 2022 Hybrid Congress, the Foundation for Sickle Cell Disease Research (FSCDR) Sickle Cell Disease Research and Educational Symposium and Sickle Cell Disease Scientific Meeting, and the Global Congress on Sickle Cell Disease (GCSCD). Forma hosted its first Research and Development (R&D) Day. The company provided an overview of its clinical development programs and research pipeline strategy. Upcoming Milestones Patient enrollment ongoing 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 TD-SCD, TD-thalassemia, or non-TD-thalassemia, with initial results expected in late 2022. By year-end 2022, Forma plans to begin clinical trials in pediatric SCD and lower-risk myelodysplastic syndrome (MDS). Update on FT-7051 clinical trial in mCRPC. Forma is planning to evaluate an alternative dosing schedule in a less heavily pretreated population and is currently processing the protocol amendment. Forma plans to provide updated results in the first half of 2023. 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 trials, 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 $395.9 million as of June 30, 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 $39.1 million for the quarter ended June 30, 2022, as compared to $31.6 million for the quarter ended June 30, 2021. The increase was primarily attributable to the increase in research and development staff to support the advancement of etavopivat and other programs, including the conduct of our Phase II/III Hibiscus trial in SCD patients and Phase II trial of etavopivat in thalassemia. General and Administrative (G&A) Expenses: G&A expenses were $13.9 million for the quarter ended June 30, 2022, as compared to $12.5 million for the quarter ended June 30, 2021. The increase was primarily attributable to professional services, costs due to executive and staff hiring, and other related general and administrative costs. Net Loss: Net loss was $52.6 million for the quarter ended June 30, 2022, as compared to net loss of $43.6 million for the quarter ended June 30, 2021. Forma will conduct a conference call and webcast August 5, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss second quarter 2022 results and business updates. Investors may participate in the call by using the registration link here. Once registered, participants will receive a dial-in number as well as a PIN to enter the event. A live webcast of the conference call will be available in the “News & Investors” section of Forma’s website at www.formatherapeutics.com. About Forma Therapeutics Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the research, development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our pipeline is led by etavopivat, an investigational, once-daily, selective pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy with the potential to improve red blood cell (RBC) health and transform the lives of people living with sickle cell disease, thalassemia, and lower risk MDS. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the company’s beliefs and expectations regarding its: business plans and objectives; future plans for etavopivat and FT-7051, including expectations regarding potential development and expansion plans relating to, as well as the enrollment, timing, success and data announcements of, planned and ongoing clinical trials; therapeutic and market potential, clinical benefits, mechanisms of action and safety of our product candidates; upcoming milestones and potential payments related thereto; growth as a company; the anticipated contributions of new members of our executive team to our operations and progress; uses and need of capital, expenses and other financial results currently or in the future as well as the expected cash runway through the third quarter of 2024; and the potential impact of COVID-19 on patient retention and enrollment, future operations or clinical trials. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties associated with the following: the impact of the COVID-19 pandemic on the company’s business, operations, supply chain, patient enrollment and retention, clinical trials, strategy, goals and anticipated milestones, as well as global economies and financial markets; the therapeutic potential of our product candidates and the timing and completion of our clinical trials and related data analyses; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; any one or more of our product candidates may not be successfully developed and commercialized; regulatory developments in the United States and foreign countries; our ability to protect and maintain our intellectual property position; and our ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and subsequent filings with the SEC. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent our views only as of the date hereof and should not be relied upon as representing our views as of any subsequent date. Statement of Operations Items: For the Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Collaboration revenue $ — $ — $ — $ — Operating expenses: Research and development 39,059 31,587 70,332 57,930 General and administrative 13,939 12,471 27,075 22,338 Total operating expenses 52,998 44,058 97,407 80,268 Loss from operations (52,998 ) (44,058 ) (97,407 ) (80,268 ) Other income: Interest income 599 309 888 571 Other (expense) income, net (192 ) 272 (227 ) 268 Total other income, net 407 581 661 839 Loss before taxes (52,591 ) (43,477 ) (96,746 ) (79,429 ) Income tax (benefit) expense (13 ) 108 (10 ) 116 Net loss and comprehensive loss $ (52,578 ) $ (43,585 ) $ (96,736 ) $ (79,545 ) Net loss allocable to shares of common stock, basic and diluted $ (52,578 ) $ (43,585 ) $ (96,736 ) $ (79,545 ) Net loss per share of common stock, basic and diluted $ (1.10 ) $ (0.92 ) $ (2.03 ) $ (1.68 ) Weighted-average shares of common stock outstanding, basic and diluted 47,805,493 47,339,464 47,684,236 47,317,361 Selected Balance Sheet Items: June 30, 2022 December 31, 2021 Cash, cash equivalents, and marketable securities $ 395,903 $ 490,273 Total assets $ 475,169 $ 561,061 Accounts payable, accrued expenses, and other current liabilities $ 33,421 $ 35,018 Total stockholders’ equity $ 414,492 $ 498,356

Forma Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 5, 2022
businesswire.com
2022-07-29 07:05:00WATERTOWN, Mass.--(BUSINESS WIRE)--Forma Therapeutics to Report Second Quarter 2022 Financial Results and Provide Business Update on August 5, 2022









