On November 14, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the third quarter ended September 30, 2022 and highlighted recent developments (Press release, Inhibikase Therapeutics, NOV 14, 2022, View Source [SID1234623997]).

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Inhibikase Therapeutics, Inc. Logo (PRNewsfoto/Inhibikase Therapeutics, Inc.)

"While the FDA clinical hold on our IkT-148009 programs for Parkinson’s disease and Multiple System Atrophy was unexpected, we are actively working with the agency to understand their concerns and resolve them as soon as possible. To date we have not seen any serious adverse events in our Phase 2a ‘201’ trial and believe the recently presented results from our Phase 1/1b ‘101’ trial continues to support the safety, tolerability and pharmacokinetics of IkT-148009," commented Milton Werner, Ph.D., President and Chief Executive Officer of Inhibikase. "As we work to resolve the clinical hold, we remain on track to initiate the ‘501’ bioequivalence study to evaluate IkT-001Pro for the treatment of stable phase Chronic Myelogenous Leukemia in the fourth quarter. In addition, we will continue to gather preclinical data for IkT-148009 in MSA and expect to advance a second animal model study in the fourth quarter. We remain committed to our mission to improve the lives of patients suffering from devastating neurodegenerative diseases and look forward to providing updates as appropriate."

Recent Developments and Upcoming Milestones:

Phase 2a ‘201’ Clinical Trial of IkT-148009 for the Treatment of Parkinson’s Disease: In August 2022, Inhibikase announced dosing of the first patient in its ‘201 trial’ evaluating IkT-148009 for the treatment of Parkinson’s disease. The 201 trial is a 1:1:1:1 randomized, double-blind, twelve-week dosing trial evaluating three-dose levels of IkT-148009. The primary endpoints will assess the safety, tolerability and steady-state pharmacokinetics of IkT-148009. The trial will also measure a hierarchy of fifteen Parkinson’s-related disease assessments in the brain and gut as secondary or exploratory endpoints. On November 7, 2022, Inhibikase announced that the U.S. Food and Drug Administration ("FDA") had issued a clinical hold on the IkT-148009 development programs. The FDA indicated it will provide an official clinical hold letter to Inhibikase within 30 days to explain the reason for this action. To date, the Company has dosed eleven patients in the trial and will conduct a blinded safety assessment, but there have been no serious adverse events seen in the trial to date and only two mild adverse events have been recorded. Since none of the initial eleven patients completed the study, once the clinical hold is lifted, the study will need to be restarted.
Presented data supporting c-Abl inhibitor therapy and the patient experience with IKT-148009 at two expert industry and academic conferences. In September 2022, Inhibikase presented data at two scientific conferences highlighting five animal model studies of acute, inherited and sporadic disease demonstrating the functional benefit of IkT-148009 in Parkinson’s disease. At the annual Movement Disorder Society Congress in Madrid Spain, Inhibikase presented data detailing the dosing experience of healthy subjects and Parkinson’s patients from multiple doses of IkT-148009 therapy between 12.5 mg and 325 mg for up to 7 days. In addition, an assessment of Parkinson’s-related disease measures demonstrated that IkT-148009 did not worsen disease.

At the Van Andel Institute’s Grand Challenges in Parkinson’s Disease conference, the Company elaborated on the fundamental studies of five distinct animal models of either acute, inherited or idiopathic disease that forms the basis of the Company’s understanding of Parkinson’s disease initiation and the critical role of c-Abl in the disease process. Data presented also demonstrated that treatment with IkT-148009 in animals led to functional recovery correlating with clearance of pathological alpha-synuclein protein. Clinical data presented at both conferences from the Phase 1/1b ‘101’ trial demonstrated a favorable safety and tolerability profile up to a dose of 325 mg with no clinically significant adverse events observed.
Received FDA Clearance for Investigational New Drug (IND) Application for IkT-001Pro for Chronic Myelogenous Leukemia (CML): In August 2022, Inhibikase received clearance by the FDA for its IND application for IkT-001Pro, the Company’s prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib (marketed as Gleevac). The Company is advancing IkT-001Pro into a single, ascending dose bioequivalence study for safety and efficacy evaluation of IkT-001Pro. The study will enroll approximately 56 male and female healthy volunteers between the ages of 25 and 55 who will be administered IkT-001Pro at one of three doses. In addition to safety and efficacy evaluations, the study will be designed to identify a dose that mimics the systemic exposure and pharmacokinetics of 400 mg imatinib mesylate, the standard-of-care dose for Stable-Phase CML. The Company expects to dose the first patient in its ‘501’ bioequivalence study in the fourth quarter of 2022.
Appointed Gisele Dion to Board of Directors: In September 2022, Inhibikase appointed Gisele Dion to the Board of Directors. Ms. Dion serves as chair of the Audit Committee, as well as a member of the Compensation Committee. Ms. Dion brings extensive experience in the public company space and has previously spearheaded financial, accounting and M&A strategies across large pharma.
Third Quarter 2022 Financial Results

Net Loss: Net loss for the three months ended September 30, 2022 was $4.49 million, or $0.18 per share, compared to a net loss of $4.47 million, or $0.18 per share for the comparable quarter in 2021.

Net loss for the nine months ended September 30, 2022, was $13.78 million or $0.55 per share, compared to a net loss of $9.74 million, or $0.61 per share in the comparable period in 2021.

R&D Expenses: Research and development expenses were $2.98 million for the three months ended September 30, 2022, compared to $3.15 million in the comparable quarter in 2021. The $0.17 million decrease in research and development expenses for the third quarter 2022 was due to a $0.77 million decrease in stock compensation partially offset by a net increase of $0.60 million of all other normal R&D expenses expenditures as the Company continued to focus on and progress its PD clinical trial activities.

Research and development expenses were $8.98 million for the nine months ended September 30, 2022 compared to $7.97 million in comparable period in 2021. The $1.01 million increase was driven by a $0.49 million decrease in non-cash stock compensation expenses offset by a $0.48 million increase in compensation and related costs, a $0.90 million increase in external R&D services and consultants, a $0.08 million increase in legal and a net increase of $0.04 million in all other normal R&D expensed.

SG&A Expenses: Selling, general and administrative expenses for the three months ended September 30, 2022 were $1.54 million compared to $1.64 million for the comparable quarter in 2021. The decrease was primarily driven by a $0.36 million decrease in stock compensation expense partially offset by increases of $0.13 million and $0.08 million of legal fees and compensation and related costs, respectively, and a $0.04 million net increase in all other normal selling, general and administrative expenses.

Selling, general and administrative expenses for the nine months ended September 30, 2022 were $4.87 million compared to $4.85 million for comparable period in 2021. The major drivers were a $1.07 million decrease in non-cash stock compensation expense for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021. The stock compensation decrease was offset by increased compensation and related costs of $0.38 million, increased legal fees of $0.35 million, increased compliance, regulatory and consultants of $0.30 million and a net increase all other normal selling, general and administrative expenses of $0.02 million.

Cash Position: Cash, cash equivalents and marketable securities were $26.5 million as of September 30, 2022.

Conference Call Information

The conference call is scheduled to begin at 8:00am ET on November 15, 2022. Participants should dial 1-844-825-9789 (United States) or 1-412-317-5180 (International) with the conference code 10172407. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On November 14, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported its third quarter 2022 financial results, provided a business update, and in a separate press release provided more mature data from the Phase 2 MARIO-3 1L TNBC clinical trial (Press release, Infinity Pharmaceuticals, NOV 14, 2022, View Source [SID1234623996]).

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"Our top priority is entering into a strategic partnership to advance eganelisib development and pave the way to eventual approval. Current business development discussions are directed towards an initial, focused development plan in a randomized controlled setting. It is our goal to announce a partnership, and the focus of the next clinical study for eganelisib, in the first quarter of 2023," said Adelene Perkins, Chief Executive Officer and Chair of Infinity. "We are encouraged by the long-term benefit seen in front-line TNBC patients reported earlier today from MARIO-3. These data are consistent with the long-term benefit seen in other indications in which eganelisib has been studied, giving us multiple potential paths forward to be prioritized with a prospective partner."

MARIO-3 Clinical Update:

The Company reported today an update from its MARIO-3 study of eganelisib in combination with atezolizumab and nab-paclitaxel in front-line metastatic triple negative breast cancer (TNBC) patients: (Press release here)

Encouraging one-year progression free survival rates in MARIO-3 1L TNBC study regardless of PD-L1 status
52% increase in one-year progression free survival rate in ITT patient population compared to IMpassion130 benchmark
No new safety signals were observed during the extended period on treatment, and the MARIO-3 safety profile continued to be consistent with expectations for the three component drugs.
Third Quarter 2022 Financial Results:

At September 30, 2022, Infinity had total cash and cash equivalents of $47.2 million, compared to $80.7 million at December 31, 2021.
Research and development expenses for the third quarter of 2022 were $7.7 million, compared to $7.1 million in the same period in 2021. The increase is primarily related to higher compensation expense due to additional staff to support the future development of eganelisib.
General and administrative expenses were $3.5 million for the third quarter of 2022, compared to $3.8 million in the same period in 2021. The decrease is primarily related to a decrease in professional services.
Net loss for the third quarter of 2022 was $10.7 million, or a basic and diluted loss per common share of $0.12, compared to a net loss of $10.7 million, or a basic and diluted loss per common share of $0.12 in the same period in 2021.
2022 Financial Outlook:

Infinity’s 2022 financial guidance remains as follows:

Net Loss: Infinity continues to expect net loss for 2022 to range from $40 million to $50 million.
Cash and Investments: Infinity continues to expect to end 2022 with a cash and cash equivalents balance ranging from $35 million to $45 million, which provides a cash runway into 2024. Infinity’s financial guidance does not include additional funding or business development activities even as we move toward a strategic partnership on eganelisib which is our goal to announce in the first quarter of 2023.
Conference Call Information

Infinity will host a conference call today, November 14, 2022, at 8:30 AM ET to discuss these financial results and business updates. To access the conference call, please register at https://register.vevent.com/register/BId44f86e6a2af42faadbb2844131346a8. Upon registering, each participant will be provided with call details and access codes. All participants are encouraged to join 10 minutes prior to the start time. A live webcast of the conference call can be accessed from the Events & Presentations page in the Investors/Media section of Infinity’s website at www.infi.com. An archived version of the webcast will be available on Infinity’s website for 30 days following the event.

On November 14, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity" or the "Company"), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported an update from its MARIO-3 study of eganelisib in combination with atezolizumab and nab-paclitaxel in front-line metastatic triple negative breast cancer (TNBC) patients (Press release, Infinity Pharmaceuticals, NOV 14, 2022, View Source [SID1234623995]).

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"Given our goal of improving long-term patient outcomes, we are particularly pleased to see that the addition of eganelisib to standard of care therapy showed benefit in the one-year progression free survival rate in MARIO-3 regardless of PD-L1 status," said Robert Ilaria, Jr., MD, Chief Medical Officer of Infinity. "These data reinforce the positive two-year landmark overall survival data from MARIO-275 in 2L urothelial cancer, also regardless of PD-L1 status, and the encouraging PFS observed in checkpoint inhibitor refractory squamous cell cancer of the head and neck in our MARIO-1 study, which all support the potential of eganelisib to improve long term outcomes for patients."

MARIO-3 mTNBC Updated Data:

62 patients were enrolled and evaluable for safety, and 57 patients were evaluable for efficacy, with a median duration of follow-up of 10.0 (8.1,14.2) months. Of the 57 evaluable patients:
35 patients (61.4%) had PD-L1(-) tumors
18 patients (31.6%) had PD-L1(+) tumors
4 patients (7.0%) had tumors of undetermined PD-L1 status
With an additional year of data maturity since the San Antonio Breast Cancer Symposium 2021, there is now encouraging evidence of a long-term patient progression-free survival (PFS) benefit with improved one-year PFS rates in MARIO-3, including in patients with both PD-L1(+) and PD-L1(-) tumors, compared to the benchmark IMpassion130 study.

ITT

PD-L1 (+)

PD-L1 (-)

MARIO-3

n=57^

IMpassion130

n=451^^

MARIO-3

n=18

IMpassion130

n=185

MARIO-3

n=35

IMpassion130

n=266

One-Year PFS Rate, % (95% CI)

36.0%

(23.7, 49.3)

23.7%

(19.6, 27.9)

37.5%

(16.8, 60.9)

29.1%

(22.2, 36.1)

34.7%

(19.6, 51.6)

NR*

One-Year PFS Rate improvement compared to IMpassion130

52%

relative improvement

29%

relative improvement

NE**

[46% relative improvement compared to IMpassion130 ITT]

Median duration of follow up, months (95% CI)

10.0

(8.1, 14.2)

13.0

(NR*)

9.9

(5.5, NA)

NR*

9.3

(5.9, 14.2)

NR*

Data Snapshot: 8 October 2022

^4 patients of unknown PD-L1 status

^^ Schmid et al NEJM 2018

* NR = Not Reported

**NE = Not Evaluable

Additional data from the MARIO-3 study, by patient population and relative to IMpassion130 benchmarks:

PD-L1 (+)

PD-L1 (-)

MARIO-3

n=18

IMpassion130^

n=185

MARIO-3

n=35

IMpassion130^

n=265

CR, % (n)^^

16.7 (3)

10.3 (19)

5.7 (2)

4.9 (13)

ORR, % (n)^^

66.7 (12)

58.9 (109)

54.3 (19)

54.0 (143)

mDOR (mos) n (95% CI)^

11.7

n=12

(1.8, NA)

8.5

n=109

(7.3, 9.7)

7.4

n=19

(3.7, NA)

NR*

mDOR increase compared to IMpassion130

3.2 mos

(37.6% increase)

NE**

mPFS, mos

(95% CI)

6.4
(3.6, NA)

7.5
(6.7, 9.2)

7.3
(5.2, 13.3)

5.6
(5.5, 7.3)

Data Snapshot: 8 October 2022

^Schmid et al NEJM 2018 with PD-L1(-) data calculated based on ITT and PD-L1(+) data

^^ Includes unconfirmed and confirmed responses for MARIO-3

*NR = Not Reported

** NE = Not Evaluable

No new safety signals were observed during the extended period on treatment, and the MARIO-3 safety profile continued to be consistent with expectations for the three component drugs.
Most Common Treatment-Related TEAEs in ≥ 10% of All Treated Patients^* (n=62)
Preferred
Term/Grouped Term

Treatment
related TEAE
(All), n (%)

Treatment-related
TEAE (≥ Gr. 3),
n (%)

Fatigue

30 (48.4)

4 (6.5)

Skin AEs

29 (46.8)

7 (11.3)

Nausea

28 (45.2)

0 (0.0)

Hepatic AEs**

24 (38.7)

15 (24.2)

Diarrhea

18 (29.0)

3 (4.8)

Alopecia

16 (25.8)

0 (0.0)

Neutropenia AEs

16 (25.8)

9 (14.5)

Vomiting

13(21.0)

1 (1.6)

Pyrexia

10 (16.1)

0 (0.0)

Peripheral neuropathy

19 (30.6)

7 (11.3)

Stomatitis

9 (14.5)

0 (0.0)

Decreased appetite

8 (12.9)

0 (0.0)

Headache

8 (12.9)

0 (0.0)

Weight decreased

7 (11.3)

1 (1.6)

Dysgeusia

7 (11.3)

0 (0.0)

Constipation

7 (11.3)

0 (0.0)

Data Snapshot: 23 July 2022

Presented in descending order of All Treatment-Related TEAE

^ Treatment-related is related to any of the study drugs (eganelisib, atezolizumab, nab-paclitaxel)

* No treatment-related Grade 5 AEs

** One Grade 4 event and no event met Hy’s Law criteria

Hepatic, skin, neutropenia, and peripheral neuropathy represent grouped preferred terms.

Treatment Discontinuation:
74% of patients were able to remain on treatment with the MARIO-3 TNBC triplet regimen compared to 81% of patients with the IMpassion130 doublet.

On November 14, 2022 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing DNA-mediated immunotherapy and next-generation vaccines, reported financial results for the three-month and nine-month periods ended September 30, 2022 (Press release, IMUNON, NOV 14, 2022, View Source [SID1234623994]). Highlights of the quarter and recent weeks include:

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Compelling results from ongoing NHP study confirms PLACCINE as a viable modality for the development of the next generation of prophylactic vaccines
Agreement with Acuitas Therapeutics to evaluate IMUNON’s plasmid DNA with Acuitas lipid nanoparticle delivery system
Enrollment of Phase I/II OVATION 2 study with GEN-1 in advanced ovarian cancer fully completed
Cash runway expected into 2025
The Company also provided an update on its preclinical studies of PLACCINE, a proprietary DNA-based plasmid technology powered by synthetic, non-viral delivery systems, being evaluated in proof-of-concept studies in COVID-19; its clinical development of GEN-1, a DNA-based interleukin-12 (IL-12) immunotherapy in Phase II clinical development for the treatment of advanced-stage ovarian cancer; and, recent partnership agreements aiming at strengthening the development of our DNA plasmid platform.

"I am pleased to report that IMUNON is making excellent progress with our innovative development modalities in infectious diseases and immuno-oncology, while maintaining a strong financial position," said Dr. Corinne Le Goff, IMUNON’s President and Chief Executive Officer. "Our PLACCINE modality continues to advance with very promising data from a non-human primate proof-of-concept study comparing our vaccine with commercial mRNA vaccines. Furthermore, I am looking forward to productive collaborations to continue developing our next generation DNA plasmid platform. Enrollment in our 110-patient OVATION 2 Study of GEN-1 in advanced ovarian cancer was completed during the third quarter." She added: "With the continuing volatility of the public markets, our decision to raise additional capital earlier this year to strengthen our balance sheet and extend our operating roadway into 2025 was well timed. We expect to report several value-creating developments during this period."

Recent Developments

PLACCINE: Development of the prophylactic vaccines of the future

Partial Results from Ongoing Non-Human Primate Study Support PLACCINE as Viable Prophylactic Vaccine Development Modality. In October 2022, the Company reported partial results from an ongoing non-human primate study designed to examine the immunogenicity of its proprietary DNA-based vaccine in support of PLACCINE as a viable alternative to commercial mRNA vaccines. The study examined a single plasmid DNA vector containing the SARS-CoV-2 Alpha variant spike antigen formulated with a synthetic DNA delivery system and administered by intramuscular injection.

In the study, Cynomolgus monkeys were vaccinated with the PLACCINE vaccine or a commercial mRNA vaccine on Day 1, 28 and 84. Analysis of blood samples for IgG and neutralizing antibodies showed evidence of immunogenicity both in PLACCINE and mRNA vaccinated subjects. Analysis of bronchoalveolar lavage for viral load by quantitative PCR showed viral clearance by more than 90% of the non-vaccinated controls. Viral clearance from nasal swab followed a similar pattern in a majority of vaccinated animals and a similar clearance profile was observed when viral load was analyzed by the tissue culture infectious dose method.

In a head-to-head comparison, the protection efficiency as measured by viral clearance following challenge with the SARS-CoV-2 virus was similar between PLACCINE and a commercial mRNA vaccine. In an ongoing stability study, the physio-chemical properties and immunogenicity of the Company’s PLACCINE vaccine did not change during storage at 4° C for up to three months.

PLACCINE DNA-based Vaccine Demonstrated Robust Response in Murine Model. In September 2022, the Company provided an update on the development of a DNA-based vaccine using its PLACCINE platform technology.

Final data from its completed proof-of-concept mouse challenge study confirmed that a PLACCINE DNA-based vaccine can produce robust levels of IgG, neutralizing antibodies and T-cell responses. The data demonstrated the ability of the PLACCINE vaccine to protect a SARS-CoV-2 mouse model in a live viral challenge. In the study, mice were vaccinated with a PLACCINE vaccine expressing the SARS-CoV-2 spike antigen from the D614G variant, the Delta variant or a combination vaccine expressing both the D614G and Delta spike variants. The vaccinations were administered by intramuscular injection on Day 0 and Day 14, followed by challenge with live SARS-CoV-2 virus on Day 42. All three vaccines, including the single and dual antigen vaccines, were found to be safe and elicited IgG responses and inhibited the viral load by 90-95%. The dual-antigen vaccine was equally effective against both variants of the SARS CoV-2 virus. The murine model data suggest that the Company’s approach provides not only flexibility, but also the potential for efficacy comparable to benchmark COVID-19 commercial vaccines with durability to protect expected to exceed six months.

GEN-1 Immunotherapy

Full Enrollment Reached in Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer. In September 2022, the Company announced its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer completed enrollment with 110 patients. GEN-1 is the Company’s IL-12 gene-mediated immunotherapy. Topline results are expected in the first half of 2024.

The OVATION 2 Study combines GEN-1 with standard-of-care neoadjuvant chemotherapy (NACT) in patients newly diagnosed with Stage III/IV ovarian cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. IL-12 is a pluripotent cytokine associated with the stimulation of innate and adaptive immune response against cancer. The GEN-1 nanoparticle comprises a DNA plasmid encoding IL-12 and a synthetic polymer facilitating plasmid delivery vector. Cell transfection is followed by persistent, local secretion of the IL-12 protein at therapeutic levels.

In October 2022, following a pre-planned interim safety review, the Data Safety Monitoring Board (DSMB) unanimously recommended that the OVATION 2 Study continue treating patients with the dose of 100 mg/m2. The DSMB also determined that safety is satisfactory with an acceptable risk/benefit. No dose-limiting toxicities were reported. The Company also announced that interim clinical data from 87 patients who underwent interval debulking surgery showed that those in the GEN-1 treatment arm had improvement in R0 surgical resection rates and CRS 3 chemotherapy response scores versus the control arm. A complete tumor resection (R0) is a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed. The chemotherapy response score is a three-tier standardized scoring system for histological tumor regression into complete/near complete (CRS 3), partial (CRS 2) and no/minimal (CRS 1) response based on examination of the omentum. However, with only 50% of the PFS events so far, the data are still very immature.

In 2021 the Company announced GEN-1 received FDA Fast Track Designation in advanced ovarian cancer. The Company plans to request FDA Breakthrough Therapy Designation for GEN-1 based on the encouraging clinical data.

Partnerships and Collaborations

IMUNON entered into an agreement with Acuitas Therapeutics to evaluate PLACCINE Plasmid DNA with Acuitas’ lipid nanoparticle delivery system. Under this agreement, Acuitas will evaluate the administration of IMUNON’s vector constructs formulated in various LNP formulations for gene expression and immunogenicity in murine models.

Corporate Developments

During the third quarter of 2022, Company management presented at two healthcare conferences. They are:

Chardan’s 6th Annual Genetic Medicines Conference held October 3-4, 2022.
H.C. Wainwright 24th Annual Global Investment Conference held September 12-14, 2022.
Dr. Le Goff presented a corporate overview and members of senior management participated in the conferences.

James E. Dentzer, CEO of Curis, appointed to IMUNON’s Board of Directors. In October 2022, the Company announced the appointment of James E. Dentzer to its Board of Directors. Mr. Dentzer is the chief executive officer of Curis, Inc., a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer and brings to IMUNON more than 20 years of leadership in the global pharmaceutical industry.

Mr. Dentzer has been President and Chief Executive Officer and a member of the Board of Directors of Curis, Inc. since September 2018. From March 2018 to September 2018, Mr. Dentzer served as Curis’ Chief Operating Officer and Chief Financial Officer. From March 2016 to March 2018, Mr. Dentzer served as Curis’ Chief Administrative Officer and Chief Financial Officer. Prior to joining Curis, Mr. Dentzer served as Chief Financial Officer of Dicerna Pharmaceuticals, Inc. from December 2013 to December 2015, and of Valeritas and Amicus Therapeutics, Inc. from October 2006 to October 2009. In prior positions, he spent six years as Corporate Controller of Biogen Inc. and six years in various senior financial roles at E.I. du Pont de Nemours and Company in the U.S. and Asia.

Dr. Corinne Le Goff Appointed as President and Chief Executive Officer; Michael H. Tardugno Appointed Executive Chairman of the Board. In July 2022, the Company announced its Board of Directors appointed biopharmaceutical executive Corinne Le Goff, Pharm. D., MBA as President, Chief Executive Officer and Director, effective July 18, 2022. Michael H. Tardugno continues to serve as Executive Chairman of IMUNON’s Board of Directors. Dr. Le Goff brings decades of global healthcare leadership experience to the Company across a range of therapeutic areas including oncology, vaccines, immunology, CNS and cardio-metabolism. She brings a wealth of experience in developing and launching successful drugs from her tenure at large pharmaceutical companies and small, innovative biotech companies.

Prior to IMUNON, Dr. Le Goff most recently served as Chief Commercial Officer of Moderna, responsible for developing the global presence and capabilities necessary to ensure the global distribution of Moderna’s COVID-19 vaccine. She also led the development of Moderna’s mRNA platform long-term commercial strategy. Dr. Le Goff joined Moderna from Amgen, where she served as President of the U.S. business, driving the growth strategy with increased contributions from Repatha and Aimovig.

Dr. Le Goff was recently recognized by Forbes magazine as one of the women over the age of 50 who are changing the world.

Third Quarter Financial Results

IMUNON reported a net loss for the third quarter of 2022 of $6.1 million ($0.87 per share), compared with a net loss of $5.4 million ($0.94 per share) for the third quarter of 2021. Operating expenses were $6.3 million for the third quarter in 2022, an increase of $1.1 million (21%) from $5.2 million for the comparable prior-year period.

Research and development expenses were $2.4 million for the third quarter of 2022, a decrease of $0.1 million (2%) from $2.5 million for the comparable period in 2021. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA vaccine technology platform increased to $1.5 million for the third quarter of 2022, compared with $1.3 million for the same period of 2021. Costs associated with the OPTIMA Phase III study were $0.1 million for the third quarter of 2022, which represented expenses associated with closing out this previously discontinued study. Other clinical, CMC and regulatory costs were $0.8 million for the third quarter of 2022, compared with $1.0 million for the comparable period of 2021.

General and administrative expenses were $3.9 million for the third quarter of 2022, compared with $2.7 million for the same period of 2021. This $1.2 million increase was primarily attributable to higher professional fees (largely legal fees to defend various suits filed after the announcement in July 2020 of the OPTIMA Phase III study results), higher premiums for directors’ and officers’ insurance and higher compensation expenses related to the CEO succession plan announced in July 2022, offset by lower non-cash stock compensation expense.

Other non-operating income was $26,276 for the third quarter of 2022, compared with other non-operating expenses of $0.3 million for the comparable prior-year period. This increase was attributable to higher investment income in the current quarter.

Nine Month Financial Results

For the nine months ended September 30, 2022, the Company reported a net loss of $22.7 million ($3.42 per share), compared with a net loss of $16.5 million ($3.12 per share) for the same period of 2021. Operating expenses were $18.4 million for the first nine months of 2022, a $2.5 million (16%) increase from $15.9 million for the comparable prior-year period.

Research and development expenses increased $1.1 million for the first nine months of 2022 to $8.7 million, compared with $7.6 million for the comparable prior-year period. R&D costs associated with the development of GEN-1 to support the OVATION 2 Study as well as development of the PLACCINE DNA technology platform increased to $5.3 million for the first nine months of 2022, compared with $4.1 million for the comparable 2021 period. Costs for the OPTIMA Phase III study increased $0.4 million to $1.0 million for the first nine months of 2022, compared with $0.6 million for the first nine months of 2021, due to closing out this discontinued study in the first quarter of 2021. Other costs related to clinical supplies and regulatory support for the Company’s clinical development programs decreased $0.5 million for the first nine months of 2022, compared with the same prior-year period.

General and administrative expenses were $9.6 million for the first nine months of 2022, compared with $8.3 million for the same period of 2021. The $1.4 million increase was primarily attributable to higher legal and professional fees coupled with higher compensation expenses related to the CEO succession plan announced in July 2022, offset by lower non-cash stock compensation expense.

Other non-operating expenses were $4.7 million for the first nine months of 2022, compared with $1.0 million for the comparable prior-year period. The increase was primarily attributable to the one-time payment of $4.5 million in interest and offering expenses resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022 offset by higher investment income.

Net cash used for operating activities was $18.1 million for the first nine months of 2022, compared with $11.4 million for the same period in 2021. This increase was primarily due to the one-time payment of $4.5 million in interest expense resulting from the sale and subsequent redemption of $30 million of Series A & B convertible redeemable preferred stock in the first quarter of 2022, as well as higher operating costs attributable to the development of GEN-1 and the PLACCINE DNA technology platform and higher legal and professional fees. Cash provided by financing activities of $6.3 million during the first nine months of 2022 resulted from an at-the-market equity offering (with no warrants) in April 2022. The Company also received net proceeds of $1.4 million from the sale of its unused 2020 New Jersey NOLs in February 2022. The Company’s projected cash utilization for the balance of 2022 is approximately $5 million.

The Company ended the third quarter of 2022 with $43.4 million in cash, investments, restricted cash and accrued interest receivable. Along with future planned sales of the Company’s State of New Jersey NOLs, the Company believes it has sufficient capital resources to fund its operations into 2025.

Conference Call and Webcast

The Company is hosting a conference call to provide a business update, discuss third quarter 2022 financial results and answer questions at 11:00 a.m. ET today. To participate in the call, please dial 866-777-2509 (Toll-Free/North America) or 412-317-5413 (International/Toll). The call will also be broadcast live at www.imunon.com.

The call will be archived for replay until November 28, 2022 at 877-344-7529 (U.S. Toll Free), 855-669-9658 (Canada Toll Free) or 412-317-0088 (International Toll), using replay access code 8042590. An audio replay will also be available at www.imunon.com for 90 days.

On November 14, 2022 Immunome, Inc. (Nasdaq: IMNM), a clinical stage biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported financial results for the third quarter ended September 30, 2022 and provided a corporate update (Press release, Immunome, NOV 14, 2022, View Source [SID1234623993]).

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"We look forward to completing our clinical trial for IMM-BCP-01, our COVID-19 antibody program, while continuing to expand our oncology portfolio including our planned submission of the IND for IMM-ONC-01 by mid-2023. Our Discovery Engine provides unique insights into how the human immune system sees disease and continues to highlight interesting areas of cancer biology and identify novel targets and corresponding antibodies."

Dr. Sarma continued, "In parallel with our oncology pre-clinical initiatives, we continue to monitor the evolution of multiple new variants of SARS-CoV-2, including BA.4.6, BQ.1, BQ.1.1 and BF.7, and expect to complete enrolment of our Phase 1b trial of IMM-BCP-01 by the end of the year. We also anticipate obtaining topline safety and PK data by the end of the year and look forward to announcing those results in the beginning of 2023."

Highlights

Preclinical Data on Novel Anti-EPN1 Antibody IMM20059 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting. In November 2022, Immunome announced that it presented a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting. Immunome’s preclinical research of IMM20059 demonstrated that IMM20059, in the combination with the anti-PD-L1 atezolizumab, significant tumor regression was induced compared to IMM20059 or atezolizumab treatment alone, suggesting a potential combinatorial effect between the two anti-tumoral pathways.
Publication in Clinical & Translational Immunology Highlighting B Cell Repertoires in Patients with Breast Cancer. In August 2022, Immunome announced the publication of a peer-reviewed article in Clinical & Translational Immunology characterizing B cell repertories in tissue samples from patients with breast cancer. The results published by Immunome and its collaborators, provide a framework for understanding how features of tumours relate to the potential for B cells to target cancer cells and these cancer specific B cells are disseminated across tumours, sentinel lymph nodes and blood in the same patient.
IMM-BCP-01 Retains Neutralizing Activity Against Prevalent Omicron Subvariants, BA.4/.5 and BA.2.12.1. In July 2022, Immunome announced that its antibody cocktail retained activity against the BA.4/.5 and BA.2.12.1 subvariants in pseudovirus testing. Data recently published in the peer-reviewed journal Science Immunology provides a mechanistic basis for how IMM20253 binding, which is conserved across all variants to date including Omicron and its sub-lineages, neutralized SARS-CoV-2.
Financial Highlights

Research and development (R&D) expenses: R&D expenses for the three months ended September 30, 2022, were $5.2 million.
General and administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2022, were $3.3 million.
Net loss: Net loss for the three months ended 2022 was $8.5 million.
Cash and cash equivalents: As of September 30, 2022, cash and cash equivalents totaled $27.1 million.
The investigational work for IMM-BCP-01 was funded by the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) in collaboration with the Defense Health Agency (DHA) (Contract number: W911QY-20-9-0019).