On March 1, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the fourth quarter ended December 31, 2021. In addition, the Company provided a clinical and business update (Press release, Syndax, MAR 1, 2022, View Source [SID1234609275]).

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"2021 was marked by substantial progress advancing our pipeline of novel cancer therapies, including the initiation of our two pivotal programs for which we expect to report topline data starting in the first half of 2023," said Michael A. Metzger, Chief Executive Officer. "We believe SNDX-5613 is poised to serve as a first-to-market and best-in-class menin inhibitor for patients with genetically defined acute leukemias. With our first regulatory filing for SNDX-5613 expected in 2023, we are keenly focused on laying the groundwork for the potential commercial launch, while concurrently expanding into the frontline and maintenance settings, with three new trials expected to begin in the first half of this year."

Mr. Metzger continued, "Enrollment remains on track in our global pivotal Phase 2 AGAVE-201 trial of axatilimab in chronic graft-versus-host disease (cGVHD), with topline data expected in the first half of 2023 and a potential Biologic License Application (BLA) filing in 2023. Beyond cGVHD, we are also working to unlock axatilimab’s full potential in additional fibrotic diseases where the monocyte-macrophage lineage plays a vital role, with commencement of a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) expected in the fourth quarter of this year."

Recent Pipeline Progress and Anticipated Milestones

SNDX-5613

During an oral presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021, the Company reported positive data demonstrating continued robust clinical activity with durable responses in the Phase 1 portion of the AUGMENT-101 trial of SNDX-5613, the Company’s highly selective oral menin inhibitor, in relapsed/refractory (R/R) patients with mutant nucleophosmin (NPM1) or mixed lineage leukemia rearranged (MLLr) acute leukemias.
The pivotal Phase 2 portion of AUGMENT-101 is ongoing and the Company expects to complete enrollment in at least one of the three pivotal cohorts later this year. The trials are expected to enroll a total of 64 adult and up to 10 pediatric patients across each of three distinct trial populations: patients with NPM1 mutant acute myeloid leukemia (AML), patients with MLLr AML, and patients with MLLr acute lymphocytic leukemia (ALL). Based on discussions with the U.S. Food and Drug Administration (FDA), AUGMENT-101 may serve as the basis for regulatory filings in each of the three distinct populations. The Company expects to receive initial topline data from the trials starting in the first half of 2023, with the potential for the first NDA filing in 2023.
In December 2021, the Company announced that the European Commission granted Orphan Drug Designation (ODD) to SNDX-5613 for the treatment of AML. SNDX-5613 was previously granted ODD for the treatment of adult and pediatric AML by the U.S. FDA.
The Company expects to initiate three additional trials in the first half of 2022 to assess the safety, tolerability, and preliminary anti-leukemic efficacy of SNDX-5613 in combination with venetoclax and azacitidine as part of the Leukemia & Lymphoma Society’s Beat AML Master Clinical Trial, in combination with chemotherapy in patients with R/R NPM1 or MLLr acute leukemias in the AUGMENT-102 trial, and in NPM1 or MLLr patients with measurable residual disease progression following initial treatment as part of the Australian Leukemia and Lymphoma Group (ALLG) INTERCEPT Master Clinical Trial.
Axatilimab

In December 2021, the Company reported updated positive data demonstrating broad activity and tolerability of axatilimab, its anti-CSF-1R monoclonal antibody, in a Phase 1/2 trial in patients with cGVHD. The data were presented during an oral session at the 63rd ASH (Free ASH Whitepaper) Annual Meeting.
Enrollment is ongoing in the Company’s global pivotal Phase 2 AGAVE-201 trial of axatilimab in patients with cGVHD, with topline data expected in the first half of 2023. The trial is evaluating the safety and efficacy of three doses and schedules of axatilimab. The primary endpoint will assess objective response rate based on the 2014 NIH consensus criteria for cGVHD, with key secondary endpoints including duration of response and improvement in modified Lee Symptom Scale score. Topline data from the trial are expected in the first half of 2023, with the potential for a BLA filing in 2023.
In December 2021, Syndax and Incyte closed its previously announced exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab. Closing of the agreement triggered a $117 million upfront payment by Incyte to Syndax, as well as Incyte’s $35 million equity investment in Syndax.
Corporate Updates

Earlier today, the Company announced the appointment of Kate Madigan, M.D., as Chief Medical Officer. Dr. Madigan brings to Syndax over 20 years of clinical hematology expertise and broad experience in the design and execution of early to late-stage clinical programs across oncology and rare diseases.
In February 2022, the Company announced the transition of Michael A. Metzger to the role of Chief Executive Officer and Briggs W. Morrison, M.D., to President, Head of Research and Development. Mr. Metzger and Dr. Morrison, who both serve on the Company’s Board of Directors, joined Syndax together in 2015.
Fourth Quarter 2021 Financial Results

As of December 31, 2021, Syndax had cash, cash equivalents and short-term investments of $439.9 million and 59.0 million shares and share equivalents issued and outstanding. This includes 4.0 million pre-funded warrants.

Fourth quarter 2021 research and development expenses increased to $23.9 million from $15.5 million, and for the full year increased to $88.2 million compared to $50.4 million for 2020. The fourth quarter and full year increases were primarily due to increased clinical trial and CMC activities.

General and administrative expenses for the fourth quarter 2021 increased to $6.9 million from $4.7 million, and, for the year ended December 31, 2021, increased to $25.2 million compared to $22.5 million for the prior year. The fourth quarter and full year increases were primarily due to increased professional fees and employee related expenses.

License revenue for the fourth quarter 2021 increased to $126.6 million from $0.4 million, and, for the year ended December 31, 2021, increased to $139.7 million compared to $1.5 million for the prior year due to revenue related to the license and collaboration agreement with Incyte and the termination of the Company’s license agreement with KKC.

For the three months ended December 31, 2021, Syndax reported a net profit attributable to common stockholders of $96.2 million or $1.81 per share compared to a net loss attributable to common stockholder of $20.4 million or $0.44 per share for the prior year period. For the year ended December 31, 2021, Syndax reported a net profit attributable to common stockholders of $24.9 million or $0.48 per share, compared to a net loss attributable to common stockholders of $77.8 million or $1.87 per share for the prior year.

Financial Update and Guidance

In December 2021, Syndax issued 4,945,000 shares of its common stock and pre-funded warrants to purchase shares of its common stock at approximately $17.50 per share. As a result, Syndax received gross proceeds of approximately $86.5 million. Syndax also issued 1,421,523 shares of its common stock in connection with the Share Purchase Agreement with Incyte Pharmaceuticals at a 30% premium to market for proceeds of $35.0 million.

For the first quarter of 2022, research and development expenses are expected to be $30 to $35 million, and total operating expenses are expected to be $38 to $42 million. For the full year of 2022, research and development expenses are expected to be $130 to $140 million, and total operating expenses are expected to be $160 to $170 million. This does not include any potential cost offsets due to the Incyte collaboration.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, March 1, 2022.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 4019975
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On March 1, 2022 CatalYm reported treatment of the first patients in a series of phase 2a cohorts targeting solid tumors, initiating phase 2 development of CTL-002 (Press release, Catalym, MAR 1, 2022, View Source [SID1234609291]). The trial will evaluate the safety and efficacy of the company’s lead product candidate, the GDF-15 neutralizing antibody CTL-002 (visugromab), at the confirmed target dose in five cohorts in combination with nivolumab in patients that are relapsed/refractory to anti-PD1/-L1 treatment and in one cohort that is anti-PD-1/-L1 naïve. All six target tumor types were identified by translational research data to exhibit GDF-15-mediated tumoral immunosuppression.

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CTL-002, which the company will going forward refer to as visugromab, the recently approved International Nonproprietary Name (INN) by the World Health Organization, is a monoclonal antibody against the novel cancer target Growth and Differentiation Factor 15 (GDF-15). GDF-15 has been shown to play a central role in immune system evasion mechanisms in the tumor microenvironment and its overexpression correlates with reduced immune cell influx into the tumor, suppression of the adaptive immune response and poor outcome including anti-PD1/-L1 treatment resistance.

Visugromab has successfully completed phase 1 development demonstrating excellent tolerability as a monotherapy as well as in combination with a PD-1 checkpoint inhibitor. Initial results from the trial have been presented at the AACR (Free AACR Whitepaper)-EORTC-NCI meeting in October 2021 and at the SITC (Free SITC Whitepaper) Annual Meeting in Nov 2021. In this dose escalation trial named GDFATHER-1 (GDF-15 Antibody-mediaTed Human Effector cell Relocation phase 1, NCT04725474), several patients with solid tumor indications known to be difficult to treat with immune-oncology (I/O) therapy have shown deep and lasting responses post treatment with visugromab + nivolumab after prior failure of anti-PD1/-L1 therapy. Two of the three responders have already passed the six-month follow-up mark showing lasting and continued responses. The full results from the phase 1 part of the study including biomarker profile correlations are planned to be shared at an upcoming conference in the first half of 2022.

Prof. Ignacio Melero (Center for Advanced Medical Research, CIMA/Pamplona, Spain), Principal Investigator of the GDFATHER-1 trial, commented: "There is mounting evidence from several research groups demonstrating that GDF-15 plays an important role in tumor-mediated immunosuppression across various major solid tumor indications. Visugromab has the potential to neutralize GDF-15 in the tumor microenvironment and to reverse this immunosuppression. The initial signs of efficacy combined with a very safe combination treatment profile even in heavily pretreated patients are very encouraging to me and I look forward to seeing the impact visugromab will have on larger patient populations treated at earlier stages of the disease."

The initial phase 2a exploration, the GDFATHER-2 trial series, is planned to enroll up to 164 patients across six major solid tumor indications in trial sites in Spain, Germany and Switzerland in a Simon-2-stage design. The study will evaluate the efficacy of visugromab at target dose in combination with the PD-1 checkpoint inhibitor, nivolumab, in six solid tumor indications that were selected based on significant translational research data obtained by CatalYm and the phase 1 results. The first five cohorts will include patients with relapsed/refractory tumors that received PD-1 checkpoint inhibitor treatment prior to this study. The sixth cohort is recruiting PD-1 checkpoint naïve patients. The first results from the phase 2a study are expected in the second half of 2022.

Prof. Eugen Leo, Chief Medical Officer at CatalYm stated: "In 2021, we were able to demonstrate in the GDFATHER-1 trial that treatment with visugromab is not only safe and very well tolerated in a very advanced and heavily pretreated patient population, but we also saw encouraging signs of potent antitumoral activity in previously anti-PD1/-L1 relapsed/refractory patients. Now, in 2022, our goal is to maximize the clinical impact of our lead candidate in a variety of cancer indications both PD-1 refractory and naïve with the phase 2a GDFATHER-2 trial series. Advancing into phase 2a development marks an important scientific and clinical milestone for CatalYm and we are looking forward to sharing further data from our phase 1 trial and early phase 2 data with the scientific and medical community in the near future."

CatalYm’s CEO, Phil L’Huillier concluded: "Advancing this program into phase 2 at such a fast pace demonstrates the dedication and experience of our clinical operations and translational research team as well as our collaborators and I applaud them for their enormous contributions in making this possible. In light of the exciting emerging preclinical and clinical data for the program we will add further trial segments to our phase 2 program over the course of 2022 to further accelerate visugromab development towards a registration trial."

About the GDFATHER-2 Trials

The GDFATHER-2 trials (GDF-15 Antibody-mediaTed Human Effector cell Relocation phase 2) (NCT04725474) are ongoing first-in-human phase 2a cohorts investigating the effect of visugromab (CTL-002) as monotherapy and/ or in combination with a PD-1 checkpoint inhibitor in patients with advanced-stage, relapse/refractory solid tumors. The study consists of two segments with a total of six cohorts, enrolling up to 164 patients in Simon-2-stage designs to confirm a certain response rate within each tumor type. Five cohorts are within tumor types with anti-PD1/-L1 label, recruiting patients that either were refractory to or relapsed post prior anti-PD1/-L1 treatment. One cohort entails treatment of an anti-PD1/-L1 naïve tumor type in an indication without anti-PD1/-L1 approval.

About Visugromab (CTL-002)

Visugromab, formerly known as CTL-002, is a humanized, monoclonal antibody designed to neutralize the tumor-produced Growth Differentiation Factor-15 (GDF-15). GDF-15 secretion by the tumor has been shown to prevent T cell migration into the tumor and suppresses T cell function and the adaptive immune response in the tumor microenvironment. This enables the tumor to evade the immune system and become resistant to standard of care and current immunotherapy approaches such as checkpoint inhibitors. Visugromab counteracts these immuno-suppressive mechanisms by neutralizing GDF-15, enhancing the infiltration of immune cells into the tumor, improving both priming of T cells by dendritic cells and tumor killing by T cells and NK cells.

On March 1, 2022 Bold Therapeutics, a clinical-stage biopharmaceutical company, reported that they have successfully completed the Phase 1b (dose-escalation) portion of its seamless adaptive oncology trial of BOLD-100 in combination with FOLFOX in the treatment of advanced gastrointestinal cancers (colorectal, pancreatic, gastric and bile duct) (Press release, Bold Therapeutics, MAR 1, 2022, View Source [SID1234609309]).

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Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers
Bold Therapeutics Successfully Completes Phase 1b Trial and Advances into Global Phase 2 Trial of BOLD-100 in the Treatment of Advanced GI Cancers
BOLD-100 is a first-in-class ruthenium-based small molecule therapeutic that (1) alters the unfolded protein response (UPR) through selective GRP78 inhibition; and (2) induces reactive oxygen species (ROS) which causes DNA damage and cell cycle arrest. Collectively, these effects result in cell death in both sensitive and resistant solid and liquid cancers and in combination with a wide range of existing anti-cancer therapies. The FDA previously granted BOLD-100 Orphan Drug Designations (ODDs) in both Gastric and Pancreatic cancers, and Bold Therapeutics anticipates leveraging clinical data from the Phase 1b portion of its trial for one or more Breakthrough Therapy Designations (BTDs) in 2022.

The Phase 1b data – which Bold Therapeutics anticipates presenting at an upcoming cancer conference – indicate that (1) BOLD-100 can be safely combined with FOLFOX chemotherapy at a dose of 625 mg / m2 (the highest dose level tested), with no new Grade 3 or 4 treatment-emergent adverse events; and (2) patients can safely remain on treatment for an extended number of treatment cycles. Based on this strong safety and tolerability profile, the Study Steering Committee unanimously endorsed proceeding immediately into the Phase 2 (dose-expansion) portion of the study.

"Completing our Phase 1b trial with a strong safety profile for BOLD-100 is a significant achievement for Bold Therapeutics – and while it is too early to say anything definitive, preliminary efficacy data is undoubtedly encouraging," said Jim Pankovich, EVP, Clinical Development. "Despite substantial headwinds from the ongoing COVID-19 pandemic, we were nevertheless able to successfully enroll and treat patients at our six clinical sites in Canada, and I wish to recognize the patients for their contribution to this study as well as the persistent and resilient efforts of our investigators."

The Phase 2 (dose-expansion) portion of the seamless adaptive trial of BOLD-100 will enroll 80 additional patients at 13 investigational sites worldwide: 6 sites in Canada; 2 sites in the U.S.; and 5 sites in South Korea. Interim and complete Phase 2 data is expected by year-end 2022 and late 2023, respectively.

"As BOLD-100 advances into Phase 2, Bold Therapeutics crosses another significant value inflection point," stated Glenn Walthall, Chairman of the Board of Bold Therapeutics. "As Bold Therapeutics’ largest institutional investor, we are encouraged with the results that we’ve seen thus far and optimistic that BOLD-100 may significantly improve outcomes in these difficult-to-treat cancers that are often refractory to conventional treatment options. Consistent with preclinical observations, a number of patients in the study who had previously failed on FOLFOX alone suddenly responded when BOLD-100 was added to the treatment regimen – a result that can only be described as remarkable."

Bold Therapeutics executed a regional option agreement with an undisclosed biopharmaceutical company in South Korea in 2020 and is actively seeking development partners in other territories. Bold Therapeutics is also seeking investors for a data-driven institutional Series B round to be closed later in 2022, likely concurrent with interim Phase 2 results.

"I am exceptionally proud of the agile and industrious Bold Therapeutics team without whom this success would not be possible," added E. Russell McAllister, CEO of Bold Therapeutics. "Through innovative programs like NRC-IRAP, the Canadian government has provided Bold Therapeutics with substantial support in advancing our scientific understanding of BOLD-100 that not only allowed us to advance in the treatment of gastrointestinal cancer indications, but also opened up promising areas for future development. As a result, they share this win with us. The strong results from this Phase 1b trial and the overall accumulation of data on BOLD-100 continue to excite support for the development of this innovative therapeutic for patients with a wide range of advanced cancers."

On March 1, 2022 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at Cowen’s 42nd Annual Health Care Conference on Tuesday, March 8, 2022 at 2:50 p.m. ET (Press release, Vertex Pharmaceuticals, MAR 1, 2022, https://investors.vrtx.com/news-releases/news-release-details/vertex-present-cowens-42nd-annual-health-care-conference-march-8 [SID1234609395]).

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A live webcast of management’s remarks will be available through Vertex’s website, www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

On March 1, 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 year ended December 31, 2021 (Press release, Forma Therapeutics, MAR 1, 2022, View Source [SID1234609220]). The company also highlighted recent progress and upcoming milestones for its pipeline programs.

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"2021 was a year of continued growth for Forma as we completed our comprehensive Phase I etavopivat trial, and further advanced the importance of assessing red blood cell health," said Frank Lee, president and chief executive officer of Forma. "2022 represents a year of expansion for Forma, expanding the breadth of the etavopivat development plan into new indications, proof of concept readout for FT-7051 in metastatic prostate cancer, and a new development candidate emerging from our research pipeline."

Key Business and Clinical Highlights

Pyruvate Kinase-R (PKR) Program in Sickle Cell Disease (SCD):

•Comprehensive etavopivat Phase I trial completed. Open label extension (OLE) results for 15 patients administered etavopivat 400 mg once daily for up to 12 weeks with a data cutoff as of November 23, 2021 were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2021. Improvements were observed in measures of hematologic and hemolytic response, and biomarkers of red blood cell (RBC) health, including oxygenation and deformability, as well as systemic biomarkers of SCD. Etavopivat administered for up to 12 weeks reduced anemia by significantly raising and sustaining hemoglobin levels and also significantly increased the lifespan of RBCs with decreased hemolysis. In addition, an analysis of all patients in the 12-week open label cohort showed a decreasing trend in vaso-occlusive crises (VOCs) requiring hospitalization when compared to the rate 12 months prior to trial entry. Etavopivat was well tolerated in the trial and safety was consistent with underlying SCD.
CBP/p300 Program in Metastatic Castrate Resistant Prostate Cancer (mCRPC):

•FT-7051 well tolerated with signs of clinical activity in initial Phase I clinical trial results. Initial results from eight men in the trial were presented at the NCI/AACR/EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October 2021. Pharmacokinetic (PK) analysis of FT-7051 documented rapid absorption, with drug concentrations that approached the predicted efficacious dose based on estimates from preclinical models. In addition, skin biopsies demonstrated a reduction in a marker of activity in the CBP/p300 pathway. The majority of treatment-emergent adverse events (TEAEs) observed were mild or moderate with no events leading to treatment discontinuation. The first evaluable patient completing 12 weeks of treatment demonstrated a >80% decline in prostate-specific antigen (PSA80) from baseline at 16 weeks with stable disease.
IDH1 Program in Acute Myeloid Leukemia (AML)

•First Phase II results of olutasidenib used in combination with a chemotherapy were presented at the ASH (Free ASH Whitepaper) annual meeting in December 2021. The trial included patients who had not yet received therapy and were candidates for azacitidine as a first-line treatment, and also patients with relapsed/refractory (R/R) AML that had prior therapy with a hypomethylating agent (HMA) or an IDH1 inhibitor. The results support the potential of olutasidenib as the basis of combination therapy in patients with AML who have not achieved a durable response from prior therapy. Olutasidenib was well tolerated in the trial in combination with azacitidine and the combination had a safety profile largely consistent with that of olutasidenib alone. Forma is progressing a new drug application (NDA) for the treatment of R/R AML.
Corporate

•Appointed Ifeyinwa (Ify) Osunkwo, MD, MPH, as the company’s inaugural chief patient officer and senior vice president. Dr. Osunkwo will be responsible for realizing Forma’s vision to transform the lives of patients, including improving access and care through partnerships with global patient and community stakeholders.
•Launched formabridge and grants program. Through formabridge grants, Forma has committed $1 million in funding for promising and innovative initiatives that address unmet needs in transition from pediatric to adult care in SCD.
•Upcoming investor conference participation. Forma will participate in the Oppenheimer Healthcare Conference taking place March 15-16, 2022. The presentation webcast will be available in the "News & Investors" section of Forma’s website at www.FormaTherapeutics.com.
•Virtual research and development (R&D) review to be held in May, 2022. The company will provide an overview of its internal research pipeline strategy and review compounds in clinical and pre-clinical development. The live webcast will be available in the "News & Investors" section of Forma’s website www.FormaTherapeutics.com.
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, with dose selection for the Phase III portion of the trial.
•Etavopivat development plans expanding. Forma began a Phase II trial in transfusion dependent SCD and both transfusion dependent and non-transfusion dependent thalassemia in late 2021, with initial results expected in late 2022. During 2022, Forma plans to begin clinical trials in pediatric SCD and low risk myelodysplastic syndrome (MDS).

•Additional FT-7051 clinical trial results in mCRPC. Men with mCRPC continue to be enrolled in the dose escalation portion of the Phase I trial. Forma plans to present updated results from the trial in mid-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 or and the ability to access sites participating in clinical trials.
Financial Results

•Cash Position: Cash, cash equivalents and marketable securities were $490.3 million as of December 31, 2021, as compared to $645.6 million as of December 31, 2020. Current cash runway is projected through the third quarter of 2024.
•R&D Expenses: R&D expenses were $37.0 million and $125.7 million for the quarter and year ended December 31, 2021, compared to $24.9 million and $93.4 million for the quarter and year ended December 31, 2020. The increase was primarily attributable to the conduct of etavopivat Phase II/III and Phase I trials in SCD patients, as well as start-up costs related to the thalassemia trial, manufacturing activities, and increases in research and development staff, equity-based compensation, and investment in preclinical programs.
•General and Administrative (G&A) Expenses: G&A expenses were $13.2 million and $48.3 million for the quarter and year ended December 31, 2021, compared to $7.9 million and $30.8 million for the quarter and year ended December 31, 2020. The increase was primarily attributable to increases in equity-based compensation, personnel-related costs related to executive and staff hiring, professional fees, and insurance related expenses.
•Net Loss: Net loss was $50.1 million and $173.0 million for the quarter and year ended December 31, 2021, compared to net loss of $28.6 million and $70.4 million for the quarter and year ended December 31, 2020.

Forma will conduct a conference call and webcast March 1, 2022 at 8:00 a.m. Eastern Daylight Time (EDT) to discuss year end 2021 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 3322907.

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