On November 10, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported financial results for the third quarter ended September 30, 2021 (Press release, Alpine Immune Sciences, NOV 10, 2021, View Source [SID1234595087]).

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"We continue to make considerable progress across our portfolio and anticipate opportunities to share clinical updates for both ALPN-202 and ALPN-303 in the first half of 2022," said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. "Importantly, the recently completed private placement will enable us to accelerate and expand development plans for both of these molecules, as well as our discovery pipeline, as we work to advance innovative therapies to treat cancer, autoimmune and inflammatory diseases."

Third Quarter 2021 and Recent Corporate and Clinical Updates

ALPN-303: Dual APRIL/BAFF inhibitor (autoimmune/inflammation)
Data demonstrating the superior efficacy of ALPN-303 in preclinical models was shared in an oral presentation in the Plenary III session of the American College of Rheumatology (ACR) Convergence 2021 Annual Meeting.
A first-in-human, phase 1 study of ALPN-303 is expected to begin enrolling in the fourth quarter of 2021 with topline results expected in the first half of 2022. The randomized, placebo-controlled study in healthy adult participants will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously and subcutaneously administered ALPN-303.
ALPN-202: Conditional CD28 co-stimulator and dual checkpoint inhibitor (oncology)
A trial-in-progress presentation on NEON-2, a phase 1 study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, will be shared at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on Friday, November 12, 2021. The poster (#497) will be available both on site and as an ePoster.
NEON-1, a phase 1 study of ALPN-202 monotherapy in patients with advanced malignancies, continues to proceed, with completion of dose escalation anticipated in the fourth quarter of 2021. Further updates are anticipated for the first half of 2022.
Corporate: $91M securities offering completed September 2021
Completed a private placement of common stock and prefunded warrants, for gross proceeds of approximately $91.0 million, which was led by Frazier Life Sciences Public Fund with participation from Decheng Capital, BVF Partners, TCG X, Avidity Partners, OrbiMed, Omega Fund, and Logos Capital, among others.
Third Quarter 2021 Financial Results

As of September 30, 2021, we had cash, cash equivalents, restricted cash, and investments totaling $219.9 million. We recorded net losses of $13.5 million and $6.1 million for the quarters ended September 30, 2021 and 2020, respectively.

Collaboration revenue for the quarter ended September 30, 2021 was $8.5 million compared to $1.9 million for the quarter ended September 30, 2020. The increase was primarily attributable to the revenue recognized under our AbbVie Agreement.

Research and development expenses for the quarter ended September 30, 2021 were $18.3 million compared to $6.2 million for the quarter ended September 30, 2020. The increase was primarily attributable to clinical trial activities for the acazicolcept and ALPN-202 studies, direct research activities, contract manufacturing and process development of our product candidates, and personnel-related expenses.

General and administrative expenses for the quarter ended September 30, 2021 were $3.5 million compared to $2.7 million for the quarter ended September 30, 2020. The increase was primarily attributable to personnel-related expenses to support the growth and expansion of our business.

Alpine expects that its current cash resources are sufficient to fund Alpine’s planned operations through 2023.

On November 10, 2021 Rain Therapeutics Inc. (NasdaqGS: RAIN), (Rain), a late-stage company developing precision oncology therapeutics, reported financial results for the third quarter and nine months ended September 30, 2021, along with an update on the company’s key developments, business operations and upcoming milestones (Press release, Rain Therapeutics, NOV 10, 2021, View Source [SID1234595086]).

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"Rain has had a number of important recent accomplishments including data presentations at various medical conferences and announcement of plans to progress our lead candidate, milademetan, into a Phase 2 trial for patients with Merkel cell carcinoma," said Avanish Vellanki, co-founder and chief executive officer of Rain. "We continue to view milademetan as having a differentiated therapeutic index and will remain focused on strategies to further enhance its value for patients with MDM2-dependent cancers."

Key Developments and Operational Updates

Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors
Rain anticipates enrolling the first patient in its multicenter, open-label Phase 2 basket trial (MANTRA-2) this quarter, evaluating milademetan, an oral mouse double minute 2 (MDM2) inhibitor for the treatment of MDM2-amplified advanced solid tumors.
Non-Clinical Data on Milademetan Presented at IASLC 2021 (Sept. 8-14, 2021) and AACR (Free AACR Whitepaper)-NCI-EORTC ("Triple Cancer Conference") 2021 (Oct. 7-10, 2021)
Rain, in collaboration with certain research partners, presented non-clinical data on milademetan in MDM2-amplified tumors, Merkel cell carcinoma, GATA3-mutant ER+ breast cancer, and mesothelioma models.
Rain Highlights Plans for Phase 2 Trial for Milademetan in Merkel Cell Carcinoma (MANTRA-3)
On the strength of recent non-clinical data from the Dana-Farber Cancer Institute presented at the Triple Cancer Conference, Rain is now prioritizing a Phase 2 clinical trial of milademetan as monotherapy in MCC patients failing first-line checkpoint inhibitors, with a trial start anticipated in mid-2022. The Phase 2 MCC clinical trial will replace the previously planned Phase 2 clinical trial of milademetan in intimal sarcoma.
Research and Development (R&D) Day
Rain hosted a R&D Day webinar on November 9, 2021 which featured several key opinion leaders in oncology, along with members of Rain’s management team, who discussed the Company’s R&D program, as well as select clinical and preclinical data. A replay of the event is archived on the Company’s corporate website here.
Anticipated Near-term Milestones

Milademetan MDM2-Amplified Phase 2 Basket Trial (MANTRA-2)
Phase 2 trial anticipated to commence enrollment this quarter
Interim data anticipated in the second half of 2022
Milademetan MCC Phase 2 Trial (MANTRA-3)
Phase 2 trial anticipated to commence in mid-2022
Milademetan Dedifferentiated Liposarcoma Phase 3 Trial (MANTRA)
Data anticipated in 2023
RAD52 Research Program
Lead candidate selection anticipated in 2022
Third Quarter Financial Results
For the three and nine months ended September 30, 2021, Rain reported a net loss of $18.4 million and $33.4 million, respectively, as compared to a net loss of $10.4 million and $15.6 million for the same periods in 2020, respectively. Net loss per share for the three and nine months ended September 30, 2021, was $0.70 and $1.96, respectively, as compared to a net loss per share of $3.05 and $4.73 for the same periods in 2020, respectively.

R&D expenses were $15.3 million and $26.1 million for the three and nine months ended September 30, 2021, respectively, as compared to $7.9 million and $11.2 million for the same periods in 2020, respectively. The increases were primarily driven by development milestone fees to Daiichi Sankyo Co., Ltd, R&D costs for Rain’s lead candidate, milademetan, mainly for its on-going Phase 3 pivotal trial in dedifferentiated liposarcoma, as well as personnel costs. Non-cash stock-based compensation expenses included in R&D expenses were approximately $0.7 million and $1.4 million in the three and nine months ended September 30, 2021, respectively, as compared to $0.2 million and $0.4 million in the same periods in 2020, respectively.

General and administrative (G&A) expenses were $3.2 million and $7.3 million for the three and nine months ended September 30, 2021, respectively, as compared to $0.6 million and $2.3 million for the same periods in 2020, respectively. The increases were primarily due to increases in various third-party G&A costs, including legal costs, outside consulting fees and accounting and audit fees associated with maintaining compliance with exchange listing and SEC requirements as a public company, as well as personnel costs. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.1 million and $0.4 million for the three and nine months ended September 30, 2021, respectively as compared to $0.1 million and $0.2 million for the same periods in 2020, respectively.

Total non-cash stock-based compensation expenses were approximately $0.8 million and $1.8 million in the three and nine months ended September 30, 2021, respectively, as compared to $0.3 million and $0.6 million for the same periods in 2020, respectively.

As of September 30, 2021, Rain had $150.1 million in cash, cash equivalents and short-term investments. Rain expects that its quarter-end cash position will provide runway to continue advancing its R&D pipeline and complete all three planned clinical trials of milademetan.

As of September 30, 2021, Rain had approximately 26.5 million shares of common stock outstanding.

The Company continues to expect its full year 2021 net cash used in operating activities to be approximately $50 million to $60 million and a projected year end cash balance of approximately $137 million to $147 million in cash, cash equivalents and short-term investments.

Third Quarter 2021 Results Conference Call and Webcast Details
The management of Rain Therapeutics will host a conference call and webcast for the investment community today, November 10, 2021, at 1:30 p.m. PT (4:30 p.m. ET). The conference call can be accessed by dialing 1 (833) 562-0127 (U.S. Toll Free) / 1 (661) 567-1105 (U.S. Toll). The passcode for the conference call is 1985710. A live webcast may be accessed by visiting the "Investors" section of the Rain Therapeutics’ website at www.rainthera.com. The call will be recorded and available for replay on the Company’s website for approximately 30 days after the call.

About Milademetan

Milademetan is a small molecule, oral inhibitor of MDM2, which is oncogenic in numerous cancers. Milademetan has already demonstrated meaningful antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, validating a rationally-designed dosing schedule to mitigate safety concerns and widen the therapeutic window of MDM2 inhibition. Milademetan is being evaluated in an ongoing Phase 3 clinical trial in patients with LPS (MANTRA) with a planned Phase 2 tumor-agnostic basket trial in certain solid tumors (MANTRA-2) anticipated to start in the fourth quarter of 2021. Rain Therapeutics also anticipates commencing a Phase 2 clinical trial of milademetan (MANTRA-3), for the treatment of patients with Merkel cell carcinoma refractory to immune checkpoint inhibition (ICI), in mid-2022. Milademetan has received U.S. Food and Drug Administration Orphan Drug Designation for patients with LPS.

On November 10, 2021 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, reported financial results for the third quarter ended September 30, 2021 (Press release, Nkarta, NOV 10, 2021, View Source [SID1234595085]).

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"We are on track to achieve key data milestones for our two co-lead programs in 2022 with the recently announced dosing of patients in our clinical trial of NKX019 and further progress in our first-in-human clinical trial of NKX101," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "We continue to be excited about the early advancements we are making in our collaboration with CRISPR Therapeutics on CD70 engineered CAR NK cell and NK plus T cell candidates, and we look forward to sharing updates on potential clinical applications of multiple platform enhancements during the SITC (Free SITC Whitepaper) annual meeting."

RECENT UPDATES

NKX101

In October 2021, Nkarta updated guidance to the first half of 2022 for when it expects to announce initial clinical data from its ongoing Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (MDS).
NKX019

In October 2021, Nkarta announced the dosing of the first patients in the Phase 1 clinical trial evaluating NKX019 in CD19+ advanced B cell malignancies. Initial data are expected in 2022.
Manufacturing

Nkarta is producing the clinical supply of NKX019 at its recently commissioned in-house cGMP clinical manufacturing facility in South San Francisco, California.
Nkarta entered a lease agreement to establish a new 88,000 square foot combined manufacturing facility and company headquarters. Once operational, the manufacturing facility will increase Nkarta’s manufacturing footprint with capacity to produce materials for potential pivotal trials and commercial launch of Nkarta’s engineered NK cell therapy products.
Pipeline and Platform

Nkarta is announcing updates on multiple platform and pipeline enhancements at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36TH Annual Meeting and Pre-Conference Program (SITC 2021) November 10 – 13, 2021. Preclinical data on CRISPR/Cas9 genome engineering and CD70 chimeric antigen receptor (CAR) targeting are being jointly presented with CRISPR Therapeutics. In addition, Nkarta will be presenting data on donor selection in next generation NK cell development programs and novel methods for scaling the expansion of engineered NK cells.
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents: As of September 30, 2021, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $259.8 million.

R&D Expenses: Research and development expenses were $16.6 million for the third quarter of 2021. Non-cash share-based compensation expense included in R&D expense was $1.7 million for the third quarter of 2021.

G&A Expenses: General and administrative expenses were $5.8 million for the third quarter of 2021. Non-cash share-based compensation expense included in G&A expense was $2.0 million for the third quarter of 2021.

Net Loss. Net loss was $22.4 million, or $0.68 per basic and diluted share, for the third quarter of 2021.
FINANCIAL GUIDANCE

Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into at least the second half of 2023.
About NKX101
NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL-15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound interleukin-15 (IL-15), a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

About NKX019
NKX019 is an investigational, allogeneic, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of IL-15 for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov.

On November 10, 2021 Ascendis Pharma A/S (Nasdaq: ASND), reported financial results for the third quarter ended September 30, 2021 (Press release, Ascendis Pharma, NOV 10, 2021, View Source [SID1234595084]).

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"We are at a defining moment on our way to fulfilling Vision 3×3, our strategy to build a leading global biopharma company. In late August, we received U.S. FDA approval for TransCon hGH, and in mid-October we launched in the U.S.," said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. "We believe this first FDA-approval for a TransCon product validates our technology platform, product innovation algorithm, and product development capabilities. Our robust, diverse pipeline, which today includes five unique clinical stage product candidates across endocrinology rare diseases and oncology, demonstrates our passion for following the science to address important unmet patient needs."

Company Highlights & Progress

TransCon hGH
Now commercially available in the U.S. for the treatment of pediatric GHD. Sales in the U.S. will be reported under the brand name.
In Europe, final decision anticipated from the European Commission on our Marketing Authorisation Application, for TransCon hGH in pediatric GHD by the end of 2021 or early 2022.
Enrollment continues in our foresiGHt Trial, a global Phase 3 trial in adult GHD and in the riGHt Trial, a Phase 3 trial in Japan in pediatric GHD.
TransCon PTH
Completed enrollment in the Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism, with topline results expected in Q1 2022.
58 subjects continue in the PaTH Forward Trial open-label extension as of November 7, 2021, with 84-week topline results expected in Q4 2021.
Enrollment continues in the PaTHway Japan Trial, a single-arm Phase 3 trial of TransCon PTH designed to enroll a minimum of 12 adult Japanese subjects.
TransCon CNP
Continued execution in the ongoing Phase 2 ACcomplisH Trial and ACcomplisH China Trial (through VISEN Pharmaceuticals) to evaluate the safety and efficacy of TransCon CNP in children ages 2-10 years with achondroplasia.
TransCon TLR7/8 Agonist
Patient enrollment continues in transcendIT-101, a Phase 1/2 study of TransCon TLR7/8 Agonist with or without pembrolizumab in patients with advanced or metastatic solid tumors.
Presenting new non-clinical data at this week’s SITC (Free SITC Whitepaper) 2021 (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th annual meeting) in Washington D.C.
TransCon IL-2 β/γ
Initiated IL βelieγe ("I’ll Believe") Trial, a Phase 1/2 clinical trial to evaluate TransCon IL-2 β/γ in patients with advanced cancer.
Ended the third quarter of 2021 with cash, cash equivalents and marketable securities totaling €929.9 million.
Completed a successful public offering of American Depositary Shares raising net proceeds of approximately $436 million.
Completed $25 million share repurchase program of Ascendis’ American Depositary Shares in connection with the Company’s planned share-based incentive program. In total, 154,837 shares were repurchased with a weighted average purchase price of $161.43.
Virtual R&D update on Ascendis’ pipeline planned for mid-December.
Third Quarter 2021 Financial Results
For the third quarter, Ascendis Pharma reported a net loss of €80.3 million, or €1.47 per share (basic and diluted) compared to a net loss of €121.7 million, or €2.31 per share (basic and diluted) for the same period in 2020.

Revenue for the third quarter was €1.1 million compared to €2.8 million in the same quarter of 2020. The decrease was due to lower sale of clinical supplies to VISEN Pharmaceuticals compared to the same period last year.

Research and development (R&D) costs for the third quarter were €58.8 million compared to €64.1 million during the same period in 2020. The decline in R&D costs in 2021 reflect a one-time reversal of pre-launch inventories, which had been recognized as research and development costs in current and previous periods. The reversal of pre-launch inventories followed the U.S. FDA approval of SKYTROFA (lonapegsomatropin-tcgd) on August 25, 2021.

Selling, general and administrative expenses for the third quarter were €39.3 million compared to €17.5 million during the same period in 2020. The increase is primarily due to higher personnel-related and IT costs.

Net loss of associate for the third quarter was €3.9 million compared to a net loss of €3.1 million in the same quarter of 2020. The net loss of associate represents our share of the net result from VISEN Pharmaceuticals.

As of September 30, 2021, Ascendis Pharma had cash, cash equivalents and marketable securities of €929.9 million compared to €641.3 million as of June 30, 2021. As of September 30, 2021, Ascendis Pharma had 56,877,723 ordinary shares outstanding.

Conference Call Details

A live webcast of the conference call will be available on the Investors & News section of the Ascendis Pharma website at View Source A webcast replay will be available on the site shortly after conclusion of the event and will stay available for 30 days.

On November 10, 2021 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period ended September 30, 2021 and provided a corporate update (Press release, Spectrum Pharmaceuticals, NOV 10, 2021, View Source [SID1234595083]).

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"The submission of the poziotinib NDA this quarter remains our top corporate priority. The front line data presented at ESMO (Free ESMO Whitepaper) and the preclinical combination data with KRAS inhibitors at the Triple meeting has the potential to significantly expand the poziotinib opportunity," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "Following a productive Type A meeting with the FDA on ROLONTIS, we anticipate the remediation efforts at Hanmi to be completed by the end of the year and would expect to resubmit our BLA for ROLONTIS shortly thereafter."

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

Submission of the NDA, based on the positive results of Cohort 2 in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations is on track for this year under a Fast Track designation. There is currently no treatment specifically approved for this indication.
Encouraging results from Cohort 4 of the ZENITH20 clinical trial were presented at the European Society of Medical (ESMO) (Free ESMO Whitepaper) Congress 2021. The primary endpoint of objective rate of response (ORR) was 44% (95% CI:29.5-58.8%) in the first 48 treated patients including one complete response. 88% of patients showed tumor reduction with a disease control rate of 75%. Median duration of response was 5.4 months (range 2.8-19.1+). Median progression free survival was 5.6 months (range 0-20.2+). The most common treatment related Grade ≥ 3 adverse effects (AEs) were rash, stomatitis, diarrhea, and paronychia. In addition, only one patient experienced Grade ≥ 3 pneumonitis. Poziotinib demonstrated clinically meaningful anti-tumor activity in newly diagnosed NSCLC patients with HER2 exon 20 mutations with 16mg QD dosing. The safety profile was manageable and similar to those observed in previous studies and other second-generation tyrosine kinase inhibitors.
Preclinical data showed the synergistic impact of poziotinib when combined with KRAS inhibitors in KRASG12C mutant specific cell lines. Jacqulyne Robichaux, Ph.D., Assistant Professor, University of Texas, MD Anderson Cancer Center presented a poster titled "Pan-ErbB inhibition enhances activity of KRASG12C inhibitors in preclinical models of KRASG12C mutant cancers" at the 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) hosted by the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the National Cancer Institute (NCI), and the European Organization for Research and Treatment of Cancer (EORTC). The preclinical data showed that inhibition of EGFR, HER2, HER3, and HER4 signaling was synergistic when combined with KRASG12C inhibitors. These results highlight the importance of a pan inhibitor of the Erb family of proteins.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF

The company held a Type A meeting with the U.S. Food and Drug Administration (FDA) to better understand the issues identified in the Complete Response Letter (CRL). At that meeting, the company learned that the deficiencies at the fill finish site have been adequately addressed. Remediation of deficiencies at the drug substance facility are well under way and expected to be completed by the end of the year. The FDA confirmed that the reinspection of the drug substance facility would be in-person.
Three-Month Period Ended September 30, 2021 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a net loss of $33.1 million, or $0.21 loss per basic and diluted share, in the three-month period ended September 30, 2021, compared to a net loss of $48.5 million, or $0.37 loss per basic and diluted share, in the comparable period in 2020. Total research and development expenses were $20.9 million in the quarter, as compared to $24.5 million in the same period in 2020. Selling, general and administrative expenses were $12.2 million in the quarter, compared to $15.1 million in the same period in 2020.

The company ended the quarter with cash, cash equivalents, and marketable securities of $133.6 million.

Non-GAAP Results

Spectrum recorded a non-GAAP net loss of $25.8 million, or $0.16 loss per basic and diluted share, in the three-month period ended September 30, 2021, compared to a non-GAAP net loss of $35.2 million, or $0.27 loss per basic and diluted share, in the comparable period in 2020. Non-GAAP research and development expenses were $16.7 million, as compared to $23.3 million in the same period of 2020. Non-GAAP selling, general and administrative expenses were $9.2 million, as compared to $12.3 million in the same period in 2020.

Conference Call

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website View Source on November 10, 2021 at 4:30 p.m. Eastern/1:30 p.m. Pacific.