# EDGAR Filing Document

**Accession Number:** 0001724979
**File Stem:** 0001104659-23-030575
**Filing Date:** 2023-3
**Character Count:** 19603
**Document Hash:** 5a21d0656766d6df1a1287f9dea40d59
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-23-030575.hdr.sgml**: 20230309

**ACCESSION NUMBER**: 0001104659-23-030575

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230309

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230309

**DATE AS OF CHANGE**: 20230309

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Rain Oncology Inc.
- **CENTRAL INDEX KEY:** 0001724979
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 821130967
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-40356
- **FILM NUMBER:** 23719764

**BUSINESS ADDRESS:**
- **STREET 1:** 8000 JARVIS AVENUE
- **STREET 2:** SUITE 204
- **CITY:** NEWARK
- **STATE:** CA
- **ZIP:** 94560
- **BUSINESS PHONE:** (510) 953-5559

**MAIL ADDRESS:**
- **STREET 1:** 8000 JARVIS AVENUE
- **STREET 2:** SUITE 204
- **CITY:** NEWARK
- **STATE:** CA
- **ZIP:** 94560

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Rain Therapeutics Inc.
- **DATE OF NAME CHANGE:** 20171211

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**PURSUANT TO SECTION 13 OR 15(d)**

**OF THE SECURITIES EXCHANGE ACT OF 1934**

**Date of Report (Date of earliest event reported): March 9, 2023**

**Rain Oncology Inc.**

**(Exact **N**ame of **R**egistrant as **S**pecified in its **C**harter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-40356** | **82-1130967** |
| **(State or **O**ther **J**urisdiction**<br> **of **I**ncorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

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**8000 Jarvis Avenue, Suite 204**

**Newark, CA 94560**

**(Address of **P**rincipal **E**xecutive **O**ffices)**

**(510) 953-5559**

**(Registrant's telephone number, including area code)**

**Not Applicable**

**(Former Name or Former Address, if Changed Since Last Report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 210.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading<br> Symbol(s)** | **Name of each exchange<br> on which registered** |
| **Common Stock, par value $0.001 per share** | **RAIN** | **The Nasdaq Global Select Market** |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging growth company ⌧

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻

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| | |
|:---|:---|
| **Item 2.02.** | **Results of Operations and Financial Condition.** |

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On March 9, 2023, Rain Oncology Inc. (the "Company") issued a press release announcing its financial results for the quarter and year ended December 31, 2022. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

This Item 2.02 and the Press Release attached hereto as Exhibit 99.1, insofar as they disclose information regarding the Company's results of operations and financial condition for the quarter and year ended December 31, 2022, are being furnished to the Securities and Exchange Commission.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits** |

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(d) *Exhibits*. The following exhibit is being furnished herewith:

**<u>EXHIBIT INDEX</u>**

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| | |
|:---|:---|
| **Exhibit<br> No.** | **Description** |
| [99.1](tm238959d1_ex99-1.htm) | [Press Release, dated March 9, 2023](tm238959d1_ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

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**SIGNATURES** 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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| | | |
|:---|:---|:---|
| Dated: March 9, 2023 | **Rain Oncology Inc.** | **Rain Oncology Inc.** |
|  | By: | /s/ Avanish Vellanki  |
|  |  | Avanish Vellanki |
|  |  | *Chairman and Chief Executive Officer* |

---

## Exhibit 99.1

**Exhibit 99.1**

**Rain Oncology Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Progress**

*– Year-end cash position of $130.5 million provides runway to complete all ongoing and planned clinical trials of milademetan, including the Phase 3 MANTRA trial in liposarcoma, Phase 2 MANTRA-2 basket trial, and planned Phase 1/2 MANTRA-4 basket trial –*

*– Topline data for Phase 3 pivotal MANTRA trial expected in second quarter of 2023 –*

*– Phase 2 MANTRA-2 trial continues to enroll –*

*– Phase 1/2 MANTRA-4 trial anticipated to commence in mid-2023 –*

*– Management to host conference call and webcast today at 5:00 PM Eastern Time –*

NEWARK, Calif., March 9, 2023 (GLOBE NEWSWIRE) -- Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a late-stage biotechnology company developing precision oncology therapeutics with a lead product candidate, milademetan, an oral, small molecule inhibitor of the MDM2-p53 complex that reactivates p53, today reports financial results for the fourth quarter and full year ended December 31, 2022, along with an update on the Company's key corporate highlights and upcoming milestones.

"We are excited for the release of the topline MANTRA data in the second quarter of this year, which has the potential to assert the importance of p53's role across cancers," said Avanish Vellanki, co-founder and chief executive officer of Rain. "We anticipate a read-through to opportunity for p53 restoration in other tumor types, and believe milademetan's safety profile may evidence its potential to be used in combination with a plethora of other agents. We remain hopeful that a well-tolerated reactivator of p53 in wildtype p53 cancers has the potential to become a meaningful option for patients, either as a monotherapy or as an essential combo agent used broadly in clinical practice."

Dr. Robert Doebele, MD, PhD, president and chief scientific officer of Rain continued, "We have already observed early monotherapy activity of milademetan from the MANTRA-2 trial, across a diverse set of solid tumor types, which may suggest a sound therapeutic strategy with single-agent milademetan, and possibly through combination regimens as well. We look forward to initiating our Phase 1/2 MANTRA-4 trial in advanced solid tumors exhibiting loss of the CDKN2A gene, with combination of milademetan and Roche's atezolizumab."

**2022 Key Research and Development (R&D), Corporate Highlights and Upcoming Milestones**

· **Phase 3 Dedifferentiated Liposarcoma (DD LPS) Trial (MANTRA)** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Topline data expected in the second quarter of 2023

o Subject to supportive clinical data, Rain anticipates filing regulatory
 applications in the United States and Europe thereafter

· **Phase 2 Basket Trial (MANTRA-2) of Milademetan for MDM2-Amplified Advanced Solid Tumors** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o As of the latest data cutoff on October 26, 2022, 10 patients were
 efficacy-evaluable with copy number greater than or equal to 8 by central testing.

o Observed rapid anti-tumor effect of milademetan in heavily pretreated,
 refractory patients, with a median of four prior therapies

o Safety profile as of the latest data cutoff is preliminarily consistent
 with a prior Phase 1 milademetan trial

o Clinical trial continues to enroll

· **Phase 1/2 Basket Trial (MANTRA-4) in Advanced Solid Tumors Exhibiting Loss of the CDKN2A Gene** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Commencement of MANTRA-4 to evaluate the combination of milademetan
 with Roche's FDA-approved immune-oncology therapy, atezolizumab, anticipated in mid-2023

· **Recent publication titled, "A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas" in the *Journal of Clinical Oncology*** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Phase 1 trial evaluated the safety, pharmacokinetics, pharmacodynamics,
 and preliminary efficacy of milademetan in patients with advanced cancers

o Intermittent dosing schedule of 260 mg qd, 3/14 days of milademetan
 resulted in favorable safety profile and clinical activity in DD LPS patients, and may provide
 for a more favorable tolerability profile across a multitude of future therapeutic indications

o Phase 1 data in advanced DD LPS provides foundation for the registrational
 Phase 3 MANTRA trial

· **RAD52 Research Program** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Program terminated to focus use of financial
 and personnel resources on milademetan clinical program

· **$50.0 Million Registered Offering of Common Stock** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Completed a $50.0 million registered offering of common stock and
 non-voting common stock on November 8, 2022, which resulted in net proceeds of $53.2 million,
 including the exercise of overallotment

Our updated corporate presentation is available at the "<u>Corporate Presentation</u>" section of the Rain website.

**Fourth Quarter and Full Year 2022 Financial Results**

For the three months and year ended December 31, 2022, Rain reported a net loss of $22.7 million and $75.7 million, respectively, as compared to a net loss of $18.0 million and $51.4 million for the same periods in 2021, respectively. Net loss per share for the three months and year ended December 31, 2022, was $0.70 and $2.71, respectively, as compared to a net loss per share of $0.68 and $2.65 for the same periods in 2021, respectively.

R&D expenses were $19.1 million and $61.4 million for the three months and year ended December 31, 2022, respectively, as compared to $14.7 million and $40.8 million for the same periods in 2021, respectively. The increases were primarily related to clinical trial costs for milademetan, higher payroll-related costs for our R&D personnel, and various other R&D costs for milademetan. Non-cash stock-based compensation expenses included in R&D expenses were approximately $1.0 million and $3.8 million in the three months and year ended December 31, 2022, respectively, as compared to $1.1 million and $2.5 million in the same periods in 2021, respectively.

General and administrative (G&A) expenses were $4.5 million and $15.7 million for the three months and year ended December 31, 2022, respectively, as compared to $3.4 million and $10.7 million for the same periods in 2021, respectively. The increases were primarily due to higher payroll-related costs for Rain's G&A personnel, outside consulting, legal costs and various third-party G&A costs. Non-cash stock-based compensation expense included in G&A expenses were approximately $0.3 million and $1.1 million for the three months and year ended December 31, 2022, respectively, as compared to $0.2 million and $0.6 million for the same periods in 2021, respectively.

Total non-cash stock-based compensation expenses were approximately $1.3 million and $4.9 million for the three months and year ended December 31, 2022, respectively, as compared to $1.3 million and $3.1 million for the same periods in 2021, respectively.

As of December 31, 2022, Rain had $130.5 million in cash, cash equivalents and short-term investments. Rain will not provide guidance on cash runway at this time. Rain will continue to assess its cash runway and provide further guidance, if appropriate, after the release of MANTRA topline results in the second quarter of this year.

As of December 31, 2022, Rain had approximately 36.3 million shares of common stock outstanding.

**Fourth Quarter 2022 Results Conference Call and Webcast Details**

The management of Rain Oncology will host a conference call and webcast for the investment community today, March 9, 2023 at 2:00 pm PT (5:00 pm ET). A live webcast may be accessed here: https://edge.media-server.com/mmc/p/pdg97w5e. The conference call can be accessed by dialing (877) 704-4453 (domestic) or (201) 389-0920 (international). The passcode for the conference call is 13735982.

Replay of the call will be available by visiting the "Events" section of the Rain website after the conclusion of the presentation and will be archived on the Rain website for 30 days.

**About Milademetan**

Milademetan (also known as RAIN-32) is an oral small molecule inhibitor of the p53-MDM2 complex that reactivates p53. Milademetan has demonstrated antitumor activity in an MDM2-amplified subtype of liposarcoma (LPS) and other solid tumors in a Phase 1 clinical trial, supported by a rationally designed dosing schedule to mitigate safety concerns and widen the potential therapeutic window of inhibition of the p53-MDM2 complex. Rain has completed enrollment in a Phase 3 trial of milademetan (MANTRA) in patients with LPS, and is evaluating milademetan in a Phase 2 tumor-agnostic basket trial in certain solid tumors with MDM2 amplification (MANTRA-2). Rain anticipates commencing a Phase 1/2 clinical trial to evaluate the safety, tolerability and efficacy of milademetan in combination with Roche's atezolizumab in patients with loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and wildtype p53 advanced solid tumors (MANTRA-4), in mid-2023. Milademetan has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LPS.

**About Rain Oncology Inc.**

Rain Oncology Inc. is a late-stage precision oncology company developing therapies that target oncogenic drivers to genetically select patients it believes will most likely benefit. This approach includes using a tumor-agnostic strategy to select patients based on their tumors' underlying genetics rather than histology. Rain's lead product candidate, milademetan, is a small molecule, oral inhibitor of the p53-MDM2 complex that reactivates p53.

**Forward Looking Statements**

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the efficacy and safety profile of milademetan, Rain's ongoing and planned trials for milademetan, patient enrollment, timing for topline and interim data, including anticipated timing for topline data in the Phase 3 MANTRA trial, timing for the commencement of planned trials, including anticipated commencement of Phase 1/2 MANTRA-4 trial, expected trial designs, and the timing for the filing of potential regulatory applications in the United States and Europe. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "plans," "will", "anticipates," "goal," "potential," "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rain's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Rain's business in general and limited operating history, Rain's ability to execute on its strategy; Rain's reliance on third parties to conduct and support its preclinical studies and clinical trials, positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical studies; the effect of public health crises on Rain's clinical trials and business operations, the impact of general economic, health, industrial or political conditions in the United States or internationally, the sufficiency of Rain's capital resources and its ability to raise additional capital, and the other risks described in Rain's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Rain undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

**Media Contact**

Jordyn Temperato

LifeSci Communications

<u>jtemperato@lifescicomms.com</u>

**Investor Contact**

Daniel Ferry

LifeSci Advisors

+1.646.597.6989

<u>daniel@lifesciadvisors.com</u>

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| |
|:---|
| **RAIN ONCOLOGY INC.** |
| **CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** |
| **(in thousands, except share and per share amounts)** |

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended** <br> **December 31,** | **Three Months Ended** <br> **December 31,** | **Twelve Months Ended** <br> **December 31,** | **Twelve Months Ended** <br> **December 31,** |
|  | **2022** | **2021** | **2022** | **2021** |
|  | **(unaudited)** | **(unaudited)** | | |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $19078 | $14672 | $61400 | $40773 |
| &nbsp;&nbsp;&nbsp;General and administrative | 4479 | 3405 | 15736 | 10739 |
| Total operating expenses | 23557 | 18077 | 77136 | 51512 |
| Loss from operations | (23557) | (18077) | (77136) | (51512) |
| Other income: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Interest and other income | 882 | 94 | 1415 | 120 |
| Total other income | 882 | 94 | 1415 | 120 |
| Net loss before income tax expense | (22675) | (17983) | (75721) | (51392) |
| Income tax expense | (3) | (2) | (3) | (2) |
| Net loss | $(22678) | $(17985) | $(75724) | $(51394) |
| Net loss per share, basic and diluted | $(0.70) | $(0.68) | $(2.71) | $(2.65) |
| Weighted-average shares used to compute net loss per share, basic and diluted | 32288083 | 26470600 | 27985446 | 19405833 |

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**SUMMARY CONSOLIDATED BALANCE SHEET DATA**

**(in thousands)**

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| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2022** | **December 31,**<br>**2021** |
| Cash, cash equivalents and short-term investments | $130454 | $140218 |
| Total assets | 135180 | 147140 |
| Stockholders' equity | 113036 | 130504 |

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