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NEXI Neximmune

Filed: 9 Aug 21, 4:26pm

Exhibit 99.1

 

LOGO

NexImmune Reports Second Quarter 2021 Financial Results and Provides Business Updates

 

  

Announcing first solid tumor indication in HPV associated-malignancies – NEXI-003

 

  

Advancing two lead product candidates in Phase 1/2 clinical trials

 

  

Additional clinical and preclinical data anticipated in the second half of 2021

GAITHERSBURG, Md., August 9, 2021 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today reported its financial results for the second quarter of 2021.

“The first half of the year was a very productive period for the company. We are focused on completing enrollment in our Phase I/II clinical trials for NEXI-001 and NEXI-002 and expect to present additional clinical data for each during scientific conferences toward the end of this year,” said Scott Carmer, Chief Executive Officer. “We are also excited to announce our first indication in solid tumors and expect to submit our IND for HPV-associated malignancies in the second quarter of 2022. Additionally, we’ve initiated IND-enabling pre-clinical experiments that will be the basis for multiple IND submissions in support of our injectable nanoparticle (AIM INJ). This progress highlights the promise of our AIM platform across disease areas and delivery modalities, and we look forward to providing further updates on these important programs later this year.”

Select 2Q 2021 Clinical and Business Highlights

Clinical and Preclinical Updates

NEXI-001

 

  

Abstract presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting in June 2021 highlights safety, tolerability, immune responses and early clinical activity in all patients evaluated

 

  

Dose Level 2 (single infusion of 200M cells/month x two cycles) is fully enrolled

 

  

Dose Level 3 (single infusion of 200M cells/week for three weeks x two cycles) is enrolling

 

  

Treatment-related adverse events, including infusion reactions, GVHD, CRS, and neurotoxicity (ICANS), have not been observed in patients who received NEXI-001 at Dose Level 1 and Dose Level 2, either as single or repeat infusions

 

  

Further data expected to be announced during the American Society of Hematology (ASH) Annual Meeting in December 2021


NEXI-002

 

  

Abstract presented at European Hematology Association Annual Meeting in May 2021 highlights safety, tolerability and immune responses in all patients evaluated

 

  

Safety cohort completed and expansion phase is enrolling

 

  

Treatment-related adverse events, including infusion reactions, CRS, and neurotoxicity (ICANS), have not been observed in patients who received NEXI-002

 

  

Further data expected to be announced during the American Society of Hematology (ASH) Annual Meeting in December 2021

NEXI-003

 

  

First solid tumor clinical trial for multi-antigen autologous AIM ACT product will target HPV-associated malignancies

 

  

Preclinical data validating the selection of multiple immunogenic HPV antigen peptides expected to be announced during the Society for Immunotherapy of Cancer’s Annual Meeting (SITC 2021) in November 2021

 

  

Investigational new drug (IND) submission planned for 2Q 2022

Other R&D

 

  

IND enabling preclinical studies for the AIM INJ platform continue; abstract presentations planned for SITC 2021 in November 2021

 

  

First collaboration in autoimmune diseases announced with Yale University to evaluate AIM INJ nanoparticles in Type 1 diabetes

Business Updates

 

  

Announced formation of the company’s Scientific Advisory Board

 

  

Announced the appointments of Dr. Jack Ragheb, SVP, Translational Medicine, and Matthew Schiller, Head of Business Development

Select 2Q 2021 Financial Highlights

Cash, cash equivalents and marketable securities for the company as of June 30, 2021 were $102.8M compared to $118.1M for quarter ending March 31, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the company to fund its operating and capital expenditure requirements through the third quarter of 2022.

Research and development expenses were $8.1M in the second quarter of 2021, compared to $4.2M for the same period in the prior year. The increase in R&D expenses was mainly attributable to costs for the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $4.0M, compared to $2.6M for the same period the prior year. The increase was due primarily to increases in headcount and fees related to professional and consulting services.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $12.2M for the quarter, or a basic and diluted GAAP loss per share of $0.54. This compared to a net loss of $6.9M, or a basic and diluted GAAP loss per share of $6.17, for the same period the prior year.


About NexImmune

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmune’s approach is a proprietary Artificial Immune Modulation (AIM) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities.

NexImmune’s two lead programs, NEXI-001 and NEXI-002, are in Phase 1/2 clinical trials for the treatment of relapsed AML after allogeneic stem cell transplantation and multiple myeloma refractory to 3 or more prior lines of therapy, respectively. NexImmune is also developing new AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology and in disease areas outside of oncology, including autoimmune disorders and infectious disease.

For more information, visit www.neximmune.com.

Forward Looking Statements

This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the “Company”). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our results of operations for the six months ended June 30, 2021; the sufficiency of the Company’s current cash, cash equivalents and marketable securities to fund its planned operations through the third quarter of 2022; our planned and ongoing clinical studies for the Company’s product candidates, including NEXI-001, NEXI-002 and NEXI-003; the initiation, enrollment, timing, progress, release of data from and results of those planned and ongoing clinical studies; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (“SEC”) on March 31, 2021, and subsequent reports that we file with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.


NEXIMMUNE, INC.

BALANCE SHEETS

 

   June 30,
2021
  December 31,
2020
 
   (unaudited)    

ASSETS

   

Current assets:

   

Cash and cash equivalents

  $63,816,106  $5,031,079 

Marketable securities

   38,979,670   —   

Restricted cash

   67,500   67,500 

Prepaid expenses and other current assets

   8,327,117   3,293,858 
  

 

 

  

 

 

 

Total current assets

   111,190,393   8,392,437 

Property and equipment, net

   4,148,875   2,885,260 

Other non-current assets

   53,373   23,373 
  

 

 

  

 

 

 

Total assets

  $115,392,641  $11,301,070 
  

 

 

  

 

 

 

LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

   

Current liabilities:

   

Accounts payable

  $2,169,660  $2,760,129 

Accrued expenses

   2,469,942   2,603,027 

Derivative liability

   —     1,702,359 

Other current liabilities

   843,619   843,619 

Convertible notes issued to related parties

   —     7,324,267 

Convertible notes

   —     11,793,397 
  

 

 

  

 

 

 

Total current liabilities

   5,483,221   27,026,798 
  

 

 

  

 

 

 

Deferred rent, net of current portion

    23,529 

Other non-current liabilities

   —     4,935 
  

 

 

  

 

 

 

Total liabilities

   5,483,221   27,055,262 
  

 

 

  

 

 

 

Commitments and contingencies

   

Redeemable convertible preferred stock

   

Series A Redeemable Convertible Preferred Stock, $0.0001 par value, no shares outstanding as of June 30, 2021 and 121,735,303 shares authorized, issued and outstanding as of December 31, 2020. Liquidation value of $42,314,789 as of December 31, 2020.

   —     35,047,435 

Series A-2 Redeemable Convertible Preferred Stock, $0.0001 par value, no shares outstanding as of June 30, 2021 and 28,384,899 shares authorized, 22,047,361 shares issued and outstanding as of December 31, 2020. Liquidation value of $8,683,746 as of December 31, 2020.

   —     7,685,865 

Series A-3 Redeemable Convertible Preferred Stock, $0.0001 par value, no shares outstanding as of June 30, 2021 and 34,061,879 shares authorized, 31,209,734 shares issued and outstanding as of December 31, 2020. Liquidation value of $11,699,176 as of December 31, 2020.

   —     10,887,449 
  

 

 

  

 

 

 

Total redeemable convertible preferred stock

   —     53,620,749 

Stockholders’ equity (deficit)

   

Common Stock, $0.0001 par value, 250,000,000 shares authorized, 22,628,007 issued and outstanding as of June 30, 2021 and 1,256,609 shares issued and outstanding as of December 31, 2020.

   2,263   126 

Additional paid-in-capital

   207,480,819   8,206,938 

Accumulated other comprehensive loss

   (2,917  —   

Accumulated deficit

   (97,570,745  (77,582,005
  

 

 

  

 

 

 

Total stockholders’ equity (deficit)

   109,909,420   (69,374,941
  

 

 

  

 

 

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

  $115,392,641  $11,301,070 
  

 

 

  

 

 

 


NEXIMMUNE, INC.

STATEMENTS OF OPERATIONS

(unaudited)

 

   Three Months Ended June 30,  Six Months Ended June 30, 
   2021  2020  2021  2020 

Revenue

  $—    $—    $—    $—   

Operating expenses:

     

Research and development

   8,124,973   4,209,261   14,137,581   8,481,428 

General and administrative

   4,038,050   2,565,402   8,095,642   4,653,803 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total operating expenses

   12,163,023   6,774,663   22,233,223   13,135,231 

Loss from operations

   (12,163,023  (6,774,663  (22,233,223  (13,135,231

Other (expense) income:

     

Interest income

   6,851   1,184   10,464   19,868 

Interest expense

   (101  (183,682  (904,220  (184,671

Change in fair value of derivative liability

   —     —     2,424,877   —   

Other (expense) income

   (25,974  26,636   (26,696  54,001 
  

 

 

  

 

 

  

 

 

  

 

 

 

Other (expense) income

   (19,224  (155,862  1,504,425   (110,802
  

 

 

  

 

 

  

 

 

  

 

 

 

Net Loss

  $(12,182,247 $(6,930,525 $(20,728,798 $(13,246,033

Accumulated dividends on Redeemable Convertible Preferred Stock

   —     (815,816  (377,562 $(1,631,632
  

 

 

  

 

 

  

 

 

  

 

 

 

Net loss attributable to common stockholders

  $(12,182,247 $(7,746,341 $(21,106,360 $(14,877,665
  

 

 

  

 

 

  

 

 

  

 

 

 

Basic and diluted net loss attributable to common stockholders per common share

  $(0.54 $(6.17 $(1.20 $(11.86
  

 

 

  

 

 

  

 

 

  

 

 

 

Basic and diluted weighted-average number of common shares outstanding

   22,608,866   1,254,681   17,648,551   1,254,681 

STATEMENTS OF COMPREHENSIVE LOSS

(unaudited)

 

   Three Months Ended June 30,  Six Months Ended June 30, 
   2021  2020  2021  2020 

Net loss

  $(12,182,247 $(6,930,525 $(20,728,798 $(13,246,033
  

 

 

  

 

 

  

 

 

  

 

 

 

Other comprehensive loss:

     

Unrealized (loss) gain on available-for-sale marketable securities, net of tax

   (2,917  —     (2,917  (506
  

 

 

  

 

 

  

 

 

  

 

 

 

Comprehensive loss

  $(12,185,164 $(6,930,525 $(20,731,715 $(13,246,539
  

 

 

  

 

 

  

 

 

  

 

 

 


Contacts

Investors:

Chad Rubin, SVP Corporate Affairs

NexImmune, Inc.

646.319.3261

crubin@neximmune.com

Media:

Mike Beyer

Sam Brown Inc. Healthcare Communications

312.961.2502

mikebeyer@sambrown.com